Doug Brunk

SAN DIEGO — Patients with mild hidradenitis suppurativa (HS) treated with ruxolitinib cream experienced a greater reduction in the abscess and inflammatory nodule (AN) count from baseline to week 16 than those who applied a vehicle cream, in a phase 2 trial.

“HS is a chronic, recurring inflammatory skin disease that is associated with painful inflammatory modules and abscesses,” said presenting author Martina J. Porter, MD, a dermatologist at Beth Israel Deaconess Medical Center and Harvard Medical School, both in Boston, Massachusetts. Dr. Porter presented the data during a late-breaking session at the annual meeting of the American Academy of Dermatology.

“Over time, these patients may progress to having tunnels, ulcerations, malodorous discharge, and permanent scarring,” she said. “Currently, there are no approved therapies for milder HS, and the standard treatments that we apply in clinical practice are often inadequate.”

Ruxolitinib is a selective Janus kinase (JAK) 1/JAK2 inhibitor that has demonstrated efficacy in other inflammatory and autoimmune skin diseases. Ruxolitinib cream, 1.5%, is approved for treating mild to moderate atopic dermatitis and nonsegmental vitiligo in patients ages 12 years and older.

The phase 2 double-blind, vehicle-controlled trial evaluated the efficacy and safety of ruxolitinib cream for mild HS. Researchers assigned 69 adults with Hurley stage I or II HS to receive 1.5% ruxolitinib cream or vehicle cream twice daily for 16 weeks. The primary endpoint was the change from baseline in AN count at week 16. To be eligible, patients had to have an AN count between 3 and 10.

“This is much more mild than what we have seen in any systemic therapy trials,” Dr. Porter said. “And, if patients had 3 lesions, they all needed to be in one anatomic area, but if they had 4-10 lesions, they had to have two anatomic areas involved. Also, no patients with active draining tunnels were allowed in the study.”

Of the 69 patients, 34 received ruxolitinib cream and 35 received vehicle. About 51% of patients in the vehicle arm were Black and 34% were White, while about 32% of patients in the ruxolitinib arm were Black and 56% were White.

[embed:render:related:node:268385]

The mean age of patients overall was 29 years, and about half the patients in both study arms had Hurley stage I disease, while the other half had Hurley stage II disease. Their average AN count ranged between 5.3 and 5.6 — mostly inflammatory nodules and few abscesses. Patients were not allowed to receive any type of intervention or rescue therapy during the study.

Dr. Porter reported that the least square mean change in AN count from baseline to week 16 was -2.42 in the vehicle arm vs -3.61 in the ruxolitinib cream arm (P <.05). The proportion of patients who achieved a 50% decrease in AN count was 79.2% in the ruxolitinib cream arm, compared with 56.5% of patients in the vehicle arm, respectively. More patients in the ruxolitinib cream arm achieved a 75% decrease in AN count (54.2% vs 25%), a 90% decrease in AN count (20.8 vs 12.5%), and a 100% decrease in AN count (20.8% vs 12.5%).

In other findings, 79.2% of patients in the ruxolitinib cream arm achieved a Hidradenitis Suppurativa Clinical Response score from baseline through week 16, compared with 50% of those in the vehicle group. The International Hidradenitis Suppurativa Severity Score System results favored the ruxolitinib cream arm (-4.46 vs -2.66 in the vehicle arm). Skin Pain and Itch numeric rating scale scores were moderate at baseline and improved similarly in both groups during the study.

Ruxolitinib cream was generally well tolerated over 16 weeks. No serious treatment-emergent adverse events were reported. The most common adverse event reported in the ruxolitinib cream group was COVID-19 and nasopharyngitis (two cases each) and one case of an application site reaction.

“Twice-daily 1.5% ruxolitinib cream was effective in patients with milder HS,” Dr. Porter concluded. “Modifications to our traditionally accepted clinical endpoints may be needed in studies of patients with milder HS.”

Jennifer L. Hsiao, MD, a dermatologist who directs the HS clinic at the University of Southern California, Los Angeles, who was asked to comment on the results, characterized the study as exciting for several reasons.

Hsiao_Jennifer_CALIFweb1.jpg

“First, with the global push in recent years to increase HS awareness, I am already seeing more patients earlier in their disease course with milder disease, and there is currently a gap in approved therapies for this patient population,” she told this news organization.

“Second, patients are very interested in topical therapies for HS and are thrilled whenever they learn that topical options are under investigation. This study had small patient numbers, but it was encouraging to see the positive results for ruxolitinib cream and that the treatment appeared well-tolerated.”

The trial was sponsored by the Incyte Corporation. Dr. Porter disclosed that she has received consulting fees from AbbVie, Alumis, Eli Lilly, Incyte, Janssen, Novartis, Pfizer, Prometheus Laboratories, Sanofi, Sonoma Biotherapeutics, Trifecta Clinical, and UCB. Dr. Hsiao disclosed that she is a member of the board of directors for the HS Foundation. She has also served as a consultant for AbbVie, Aclaris, Boehringer Ingelheim, Incyte, Novartis, and UCB; as a speaker for AbbVie, Novartis, and UCB; and as an investigator for Amgen, Boehringer Ingelheim, and Incyte.

A version of this article appeared on Medscape.com .

SAN DIEGO — Patients with mild hidradenitis suppurativa (HS) treated with ruxolitinib cream experienced a greater reduction in the abscess and inflammatory nodule (AN) count from baseline to week 16 than those who applied a vehicle cream, in a phase 2 trial.

“HS is a chronic, recurring inflammatory skin disease that is associated with painful inflammatory modules and abscesses,” said presenting author Martina J. Porter, MD, a dermatologist at Beth Israel Deaconess Medical Center and Harvard Medical School, both in Boston, Massachusetts. Dr. Porter presented the data during a late-breaking session at the annual meeting of the American Academy of Dermatology.

“Over time, these patients may progress to having tunnels, ulcerations, malodorous discharge, and permanent scarring,” she said. “Currently, there are no approved therapies for milder HS, and the standard treatments that we apply in clinical practice are often inadequate.”

Ruxolitinib is a selective Janus kinase (JAK) 1/JAK2 inhibitor that has demonstrated efficacy in other inflammatory and autoimmune skin diseases. Ruxolitinib cream, 1.5%, is approved for treating mild to moderate atopic dermatitis and nonsegmental vitiligo in patients ages 12 years and older.

The phase 2 double-blind, vehicle-controlled trial evaluated the efficacy and safety of ruxolitinib cream for mild HS. Researchers assigned 69 adults with Hurley stage I or II HS to receive 1.5% ruxolitinib cream or vehicle cream twice daily for 16 weeks. The primary endpoint was the change from baseline in AN count at week 16. To be eligible, patients had to have an AN count between 3 and 10.

“This is much more mild than what we have seen in any systemic therapy trials,” Dr. Porter said. “And, if patients had 3 lesions, they all needed to be in one anatomic area, but if they had 4-10 lesions, they had to have two anatomic areas involved. Also, no patients with active draining tunnels were allowed in the study.”

Of the 69 patients, 34 received ruxolitinib cream and 35 received vehicle. About 51% of patients in the vehicle arm were Black and 34% were White, while about 32% of patients in the ruxolitinib arm were Black and 56% were White.

[embed:render:related:node:268385]

The mean age of patients overall was 29 years, and about half the patients in both study arms had Hurley stage I disease, while the other half had Hurley stage II disease. Their average AN count ranged between 5.3 and 5.6 — mostly inflammatory nodules and few abscesses. Patients were not allowed to receive any type of intervention or rescue therapy during the study.

Dr. Porter reported that the least square mean change in AN count from baseline to week 16 was -2.42 in the vehicle arm vs -3.61 in the ruxolitinib cream arm (P <.05). The proportion of patients who achieved a 50% decrease in AN count was 79.2% in the ruxolitinib cream arm, compared with 56.5% of patients in the vehicle arm, respectively. More patients in the ruxolitinib cream arm achieved a 75% decrease in AN count (54.2% vs 25%), a 90% decrease in AN count (20.8 vs 12.5%), and a 100% decrease in AN count (20.8% vs 12.5%).

In other findings, 79.2% of patients in the ruxolitinib cream arm achieved a Hidradenitis Suppurativa Clinical Response score from baseline through week 16, compared with 50% of those in the vehicle group. The International Hidradenitis Suppurativa Severity Score System results favored the ruxolitinib cream arm (-4.46 vs -2.66 in the vehicle arm). Skin Pain and Itch numeric rating scale scores were moderate at baseline and improved similarly in both groups during the study.

Ruxolitinib cream was generally well tolerated over 16 weeks. No serious treatment-emergent adverse events were reported. The most common adverse event reported in the ruxolitinib cream group was COVID-19 and nasopharyngitis (two cases each) and one case of an application site reaction.

“Twice-daily 1.5% ruxolitinib cream was effective in patients with milder HS,” Dr. Porter concluded. “Modifications to our traditionally accepted clinical endpoints may be needed in studies of patients with milder HS.”

Jennifer L. Hsiao, MD, a dermatologist who directs the HS clinic at the University of Southern California, Los Angeles, who was asked to comment on the results, characterized the study as exciting for several reasons.

Hsiao_Jennifer_CALIFweb1.jpg

“First, with the global push in recent years to increase HS awareness, I am already seeing more patients earlier in their disease course with milder disease, and there is currently a gap in approved therapies for this patient population,” she told this news organization.

“Second, patients are very interested in topical therapies for HS and are thrilled whenever they learn that topical options are under investigation. This study had small patient numbers, but it was encouraging to see the positive results for ruxolitinib cream and that the treatment appeared well-tolerated.”

The trial was sponsored by the Incyte Corporation. Dr. Porter disclosed that she has received consulting fees from AbbVie, Alumis, Eli Lilly, Incyte, Janssen, Novartis, Pfizer, Prometheus Laboratories, Sanofi, Sonoma Biotherapeutics, Trifecta Clinical, and UCB. Dr. Hsiao disclosed that she is a member of the board of directors for the HS Foundation. She has also served as a consultant for AbbVie, Aclaris, Boehringer Ingelheim, Incyte, Novartis, and UCB; as a speaker for AbbVie, Novartis, and UCB; and as an investigator for Amgen, Boehringer Ingelheim, and Incyte.

A version of this article appeared on Medscape.com .

SAN DIEGO — Patients with mild hidradenitis suppurativa (HS) treated with ruxolitinib cream experienced a greater reduction in the abscess and inflammatory nodule (AN) count from baseline to week 16 than those who applied a vehicle cream, in a phase 2 trial.

“HS is a chronic, recurring inflammatory skin disease that is associated with painful inflammatory modules and abscesses,” said presenting author Martina J. Porter, MD, a dermatologist at Beth Israel Deaconess Medical Center and Harvard Medical School, both in Boston, Massachusetts. Dr. Porter presented the data during a late-breaking session at the annual meeting of the American Academy of Dermatology.

“Over time, these patients may progress to having tunnels, ulcerations, malodorous discharge, and permanent scarring,” she said. “Currently, there are no approved therapies for milder HS, and the standard treatments that we apply in clinical practice are often inadequate.”

Ruxolitinib is a selective Janus kinase (JAK) 1/JAK2 inhibitor that has demonstrated efficacy in other inflammatory and autoimmune skin diseases. Ruxolitinib cream, 1.5%, is approved for treating mild to moderate atopic dermatitis and nonsegmental vitiligo in patients ages 12 years and older.

The phase 2 double-blind, vehicle-controlled trial evaluated the efficacy and safety of ruxolitinib cream for mild HS. Researchers assigned 69 adults with Hurley stage I or II HS to receive 1.5% ruxolitinib cream or vehicle cream twice daily for 16 weeks. The primary endpoint was the change from baseline in AN count at week 16. To be eligible, patients had to have an AN count between 3 and 10.

“This is much more mild than what we have seen in any systemic therapy trials,” Dr. Porter said. “And, if patients had 3 lesions, they all needed to be in one anatomic area, but if they had 4-10 lesions, they had to have two anatomic areas involved. Also, no patients with active draining tunnels were allowed in the study.”

Of the 69 patients, 34 received ruxolitinib cream and 35 received vehicle. About 51% of patients in the vehicle arm were Black and 34% were White, while about 32% of patients in the ruxolitinib arm were Black and 56% were White.

[embed:render:related:node:268385]

The mean age of patients overall was 29 years, and about half the patients in both study arms had Hurley stage I disease, while the other half had Hurley stage II disease. Their average AN count ranged between 5.3 and 5.6 — mostly inflammatory nodules and few abscesses. Patients were not allowed to receive any type of intervention or rescue therapy during the study.

Dr. Porter reported that the least square mean change in AN count from baseline to week 16 was -2.42 in the vehicle arm vs -3.61 in the ruxolitinib cream arm (P <.05). The proportion of patients who achieved a 50% decrease in AN count was 79.2% in the ruxolitinib cream arm, compared with 56.5% of patients in the vehicle arm, respectively. More patients in the ruxolitinib cream arm achieved a 75% decrease in AN count (54.2% vs 25%), a 90% decrease in AN count (20.8 vs 12.5%), and a 100% decrease in AN count (20.8% vs 12.5%).

In other findings, 79.2% of patients in the ruxolitinib cream arm achieved a Hidradenitis Suppurativa Clinical Response score from baseline through week 16, compared with 50% of those in the vehicle group. The International Hidradenitis Suppurativa Severity Score System results favored the ruxolitinib cream arm (-4.46 vs -2.66 in the vehicle arm). Skin Pain and Itch numeric rating scale scores were moderate at baseline and improved similarly in both groups during the study.

Ruxolitinib cream was generally well tolerated over 16 weeks. No serious treatment-emergent adverse events were reported. The most common adverse event reported in the ruxolitinib cream group was COVID-19 and nasopharyngitis (two cases each) and one case of an application site reaction.

“Twice-daily 1.5% ruxolitinib cream was effective in patients with milder HS,” Dr. Porter concluded. “Modifications to our traditionally accepted clinical endpoints may be needed in studies of patients with milder HS.”

Jennifer L. Hsiao, MD, a dermatologist who directs the HS clinic at the University of Southern California, Los Angeles, who was asked to comment on the results, characterized the study as exciting for several reasons.

Hsiao_Jennifer_CALIFweb1.jpg

“First, with the global push in recent years to increase HS awareness, I am already seeing more patients earlier in their disease course with milder disease, and there is currently a gap in approved therapies for this patient population,” she told this news organization.

“Second, patients are very interested in topical therapies for HS and are thrilled whenever they learn that topical options are under investigation. This study had small patient numbers, but it was encouraging to see the positive results for ruxolitinib cream and that the treatment appeared well-tolerated.”

The trial was sponsored by the Incyte Corporation. Dr. Porter disclosed that she has received consulting fees from AbbVie, Alumis, Eli Lilly, Incyte, Janssen, Novartis, Pfizer, Prometheus Laboratories, Sanofi, Sonoma Biotherapeutics, Trifecta Clinical, and UCB. Dr. Hsiao disclosed that she is a member of the board of directors for the HS Foundation. She has also served as a consultant for AbbVie, Aclaris, Boehringer Ingelheim, Incyte, Novartis, and UCB; as a speaker for AbbVie, Novartis, and UCB; and as an investigator for Amgen, Boehringer Ingelheim, and Incyte.

A version of this article appeared on Medscape.com .

On April 4, 2024, the US Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) to review bimekizumab-bkzx, an interleukin (IL)-17A and IL-17F inhibitor, for the treatment of adults with moderate to severe hidradenitis suppurativa (HS).

The agency also accepted a second sBLA for a bimekizumab-bkzx 2-mL device.

The developments were announced in a press release from UCB, the manufacturer of bimekizumab-bkzx (Bimzelx), which was first approved in the United States in October 2023 for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

[embed:render:related:node:268365]

According to the press release, acceptance of the sBLA was based on results from two phase 3 studies known as BE HEARD I and BE HEARD II, which found that bimekizumab-bkzx showed clinically meaningful improvements compared with placebo at week 16 and were sustained to week 48. If approved, this would be the first HS approval for bimekizumab-bkzx worldwide. In the European Union, it is approved for treating adults with psoriatic arthritis and axial spondyloarthritis, in addition to moderate to severe psoriasis.

According to the company, approval of the 2-mL injection device would mean that patients would have an alternative one-injection regimen option; currently, one dose for psoriasis is administered as two 1-mL injections. Full US prescribing information for bimekizumab-bkzx can be found here.

A version of this article first appeared on Medscape.com.

On April 4, 2024, the US Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) to review bimekizumab-bkzx, an interleukin (IL)-17A and IL-17F inhibitor, for the treatment of adults with moderate to severe hidradenitis suppurativa (HS).

The agency also accepted a second sBLA for a bimekizumab-bkzx 2-mL device.

The developments were announced in a press release from UCB, the manufacturer of bimekizumab-bkzx (Bimzelx), which was first approved in the United States in October 2023 for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

[embed:render:related:node:268365]

According to the press release, acceptance of the sBLA was based on results from two phase 3 studies known as BE HEARD I and BE HEARD II, which found that bimekizumab-bkzx showed clinically meaningful improvements compared with placebo at week 16 and were sustained to week 48. If approved, this would be the first HS approval for bimekizumab-bkzx worldwide. In the European Union, it is approved for treating adults with psoriatic arthritis and axial spondyloarthritis, in addition to moderate to severe psoriasis.

According to the company, approval of the 2-mL injection device would mean that patients would have an alternative one-injection regimen option; currently, one dose for psoriasis is administered as two 1-mL injections. Full US prescribing information for bimekizumab-bkzx can be found here.

A version of this article first appeared on Medscape.com.

On April 4, 2024, the US Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) to review bimekizumab-bkzx, an interleukin (IL)-17A and IL-17F inhibitor, for the treatment of adults with moderate to severe hidradenitis suppurativa (HS).

The agency also accepted a second sBLA for a bimekizumab-bkzx 2-mL device.

The developments were announced in a press release from UCB, the manufacturer of bimekizumab-bkzx (Bimzelx), which was first approved in the United States in October 2023 for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

[embed:render:related:node:268365]

According to the press release, acceptance of the sBLA was based on results from two phase 3 studies known as BE HEARD I and BE HEARD II, which found that bimekizumab-bkzx showed clinically meaningful improvements compared with placebo at week 16 and were sustained to week 48. If approved, this would be the first HS approval for bimekizumab-bkzx worldwide. In the European Union, it is approved for treating adults with psoriatic arthritis and axial spondyloarthritis, in addition to moderate to severe psoriasis.

According to the company, approval of the 2-mL injection device would mean that patients would have an alternative one-injection regimen option; currently, one dose for psoriasis is administered as two 1-mL injections. Full US prescribing information for bimekizumab-bkzx can be found here.

A version of this article first appeared on Medscape.com.

SAN DIEGO — While the concept of zoom dysmorphia is well accepted in today’s clinical practice, diagnostic criteria are lacking, especially in virtual settings, according to George Kroumpouzos, MD, PhD, who, with colleagues, recently proposed a screening tool to help identify patients with zoom dysmorphia.

The term, coined in 2020 by dermatologist Shadi Kourosh, MD, MPH, and colleagues at Harvard Medical School, Boston, refers to an altered or skewed negative perception of one’s body image that results from spending extended amounts of time on video calls. Speaking at the annual meeting of the American Academy of Dermatology, Dr. Kroumpouzos, clinical associate professor of dermatology at Brown University, Providence Rhode Island, explained that most people believe that zoom dysmorphia falls within the spectrum of body dysmorphic disorder (BDD). He described zoom dysmorphia as “a facial dysmorphia triggered or aggravated by frequent virtual meetings. Frequent use of videoconferencing platforms is linked to a distorted perception of facial images, which leads to dysmorphic concerns.”

Kroumpouzos_George_RI_web.jpg

Individuals with zoom dysmorphia tend to scrutinize their facial features and fixate on what they think needs to improve, he continued. They experience anxiety about attending video conferences with the camera on and feel pressured to appear perfect before virtual meetings. “They find facial flaws during virtual meetings, and they believe others notice their perceived flaws,” he said. “This all has drastic effects on body dissatisfaction and self-esteem, which leads to a desire to seek cosmetic procedures. It interferes with an individual’s life and can trigger or aggravate body dysmorphic disorder.”

While several tools have been validated in cosmetic settings to screen for BDD, such as the 9-item Body Dysmorphic Disorder Questionnaire–Dermatology questionnaire, the 7-item Body Dysmorphic Disorder Questionnaire–Aesthetic Surgery questionnaire, the Cosmetic Procedure Screening Questionnaire, and the Body Dysmorphic Disorder Symptom Scale, no formal screening tools exist to identify zoom dysmorphia. To complicate matters, “identifying dysmorphic concerns in virtual settings can be challenging,” Dr. Kroumpouzos added. “This makes the recognition of zoom dysmorphia during telehealth visits even more difficult.”

Individuals who may have zoom dysmorphia may fear being misunderstood, judged, or ridiculed because of a perceived flaw in appearance, he said, making establishing rapport and eye contact difficult. “There’s a reticence and silence due to the individual’s avoidant characteristics,” he said. “Patients may become easily distracted or disengaged during telehealth visits in case of technical issues. Psychiatric comorbidities can mask symptoms related to dysmorphic concerns.”

To bridge this gap, Dr. Kroumpouzos and colleagues have proposed a screening tool, a questionnaire related to features of zoom dysmorphia, to facilitate recognition of zoom dysmorphia in virtual settings.

[embed:render:related:node:266374]

The first component consists of open-ended questions such as “Are you comfortable with being interviewed in a virtual appointment?” and “How do you feel about your appearance during virtual meetings?” Such questions “aim to start the dialogue, to facilitate the discussion with a patient who may be shy or avoidant,” Dr. Kroumpouzos explained.

The second component of the tool consists of questions more specific to screening for zoom dysmorphia, starting with “Are you concerned about facial flaws?” If the patient answers no, they don’t qualify for any others, he said. “But, if they answer yes to that question and yes to at least one more [question], they may have zoom dysmorphia.”

Other questions include, “Do you think that your face is not friendly to the camera?” “Do you hesitate to open the camera?” “Have you tried to hide or camouflage your flaw with your hands, hair, makeup, or clothing?” “Have you sought advice from others to improve your appearance or image?” “Do you often use the filter features of the video conferencing platform?” “Did you consider buying a new camera or equipment that helps improve your image?”

If the clinician deems the patient a candidate for the diagnosis of zoom dysmorphia, the tool recommends asking a BDD-focused question: “In the past month, have you been very concerned that there is something wrong with your physical appearance or the way one or more parts of your body look?” If the patient answers yes, “that individual should be invited to fill out a questionnaire specifically for BDD or come to the office for further evaluation,” Dr. Kroumpouzos said.

In his view, the brevity of the proposed screening tool makes it easy to incorporate into clinical practice, and the “yes or no” questions are practical. “It is crucial to elicit the presence of zoom dysmorphia in its early stage,” he said. “Zoom dysmorphia may trigger an increase in BDD, [so] it is essential to identify the presence of BDD in zoom dysmorphia sufferers and treat it appropriately.”

Dr. Kroumpouzos reported having no relevant financial disclosures.

SAN DIEGO — While the concept of zoom dysmorphia is well accepted in today’s clinical practice, diagnostic criteria are lacking, especially in virtual settings, according to George Kroumpouzos, MD, PhD, who, with colleagues, recently proposed a screening tool to help identify patients with zoom dysmorphia.

The term, coined in 2020 by dermatologist Shadi Kourosh, MD, MPH, and colleagues at Harvard Medical School, Boston, refers to an altered or skewed negative perception of one’s body image that results from spending extended amounts of time on video calls. Speaking at the annual meeting of the American Academy of Dermatology, Dr. Kroumpouzos, clinical associate professor of dermatology at Brown University, Providence Rhode Island, explained that most people believe that zoom dysmorphia falls within the spectrum of body dysmorphic disorder (BDD). He described zoom dysmorphia as “a facial dysmorphia triggered or aggravated by frequent virtual meetings. Frequent use of videoconferencing platforms is linked to a distorted perception of facial images, which leads to dysmorphic concerns.”

Kroumpouzos_George_RI_web.jpg

Individuals with zoom dysmorphia tend to scrutinize their facial features and fixate on what they think needs to improve, he continued. They experience anxiety about attending video conferences with the camera on and feel pressured to appear perfect before virtual meetings. “They find facial flaws during virtual meetings, and they believe others notice their perceived flaws,” he said. “This all has drastic effects on body dissatisfaction and self-esteem, which leads to a desire to seek cosmetic procedures. It interferes with an individual’s life and can trigger or aggravate body dysmorphic disorder.”

While several tools have been validated in cosmetic settings to screen for BDD, such as the 9-item Body Dysmorphic Disorder Questionnaire–Dermatology questionnaire, the 7-item Body Dysmorphic Disorder Questionnaire–Aesthetic Surgery questionnaire, the Cosmetic Procedure Screening Questionnaire, and the Body Dysmorphic Disorder Symptom Scale, no formal screening tools exist to identify zoom dysmorphia. To complicate matters, “identifying dysmorphic concerns in virtual settings can be challenging,” Dr. Kroumpouzos added. “This makes the recognition of zoom dysmorphia during telehealth visits even more difficult.”

Individuals who may have zoom dysmorphia may fear being misunderstood, judged, or ridiculed because of a perceived flaw in appearance, he said, making establishing rapport and eye contact difficult. “There’s a reticence and silence due to the individual’s avoidant characteristics,” he said. “Patients may become easily distracted or disengaged during telehealth visits in case of technical issues. Psychiatric comorbidities can mask symptoms related to dysmorphic concerns.”

To bridge this gap, Dr. Kroumpouzos and colleagues have proposed a screening tool, a questionnaire related to features of zoom dysmorphia, to facilitate recognition of zoom dysmorphia in virtual settings.

[embed:render:related:node:266374]

The first component consists of open-ended questions such as “Are you comfortable with being interviewed in a virtual appointment?” and “How do you feel about your appearance during virtual meetings?” Such questions “aim to start the dialogue, to facilitate the discussion with a patient who may be shy or avoidant,” Dr. Kroumpouzos explained.

The second component of the tool consists of questions more specific to screening for zoom dysmorphia, starting with “Are you concerned about facial flaws?” If the patient answers no, they don’t qualify for any others, he said. “But, if they answer yes to that question and yes to at least one more [question], they may have zoom dysmorphia.”

Other questions include, “Do you think that your face is not friendly to the camera?” “Do you hesitate to open the camera?” “Have you tried to hide or camouflage your flaw with your hands, hair, makeup, or clothing?” “Have you sought advice from others to improve your appearance or image?” “Do you often use the filter features of the video conferencing platform?” “Did you consider buying a new camera or equipment that helps improve your image?”

If the clinician deems the patient a candidate for the diagnosis of zoom dysmorphia, the tool recommends asking a BDD-focused question: “In the past month, have you been very concerned that there is something wrong with your physical appearance or the way one or more parts of your body look?” If the patient answers yes, “that individual should be invited to fill out a questionnaire specifically for BDD or come to the office for further evaluation,” Dr. Kroumpouzos said.

In his view, the brevity of the proposed screening tool makes it easy to incorporate into clinical practice, and the “yes or no” questions are practical. “It is crucial to elicit the presence of zoom dysmorphia in its early stage,” he said. “Zoom dysmorphia may trigger an increase in BDD, [so] it is essential to identify the presence of BDD in zoom dysmorphia sufferers and treat it appropriately.”

Dr. Kroumpouzos reported having no relevant financial disclosures.

SAN DIEGO — While the concept of zoom dysmorphia is well accepted in today’s clinical practice, diagnostic criteria are lacking, especially in virtual settings, according to George Kroumpouzos, MD, PhD, who, with colleagues, recently proposed a screening tool to help identify patients with zoom dysmorphia.

The term, coined in 2020 by dermatologist Shadi Kourosh, MD, MPH, and colleagues at Harvard Medical School, Boston, refers to an altered or skewed negative perception of one’s body image that results from spending extended amounts of time on video calls. Speaking at the annual meeting of the American Academy of Dermatology, Dr. Kroumpouzos, clinical associate professor of dermatology at Brown University, Providence Rhode Island, explained that most people believe that zoom dysmorphia falls within the spectrum of body dysmorphic disorder (BDD). He described zoom dysmorphia as “a facial dysmorphia triggered or aggravated by frequent virtual meetings. Frequent use of videoconferencing platforms is linked to a distorted perception of facial images, which leads to dysmorphic concerns.”

Kroumpouzos_George_RI_web.jpg

Individuals with zoom dysmorphia tend to scrutinize their facial features and fixate on what they think needs to improve, he continued. They experience anxiety about attending video conferences with the camera on and feel pressured to appear perfect before virtual meetings. “They find facial flaws during virtual meetings, and they believe others notice their perceived flaws,” he said. “This all has drastic effects on body dissatisfaction and self-esteem, which leads to a desire to seek cosmetic procedures. It interferes with an individual’s life and can trigger or aggravate body dysmorphic disorder.”

While several tools have been validated in cosmetic settings to screen for BDD, such as the 9-item Body Dysmorphic Disorder Questionnaire–Dermatology questionnaire, the 7-item Body Dysmorphic Disorder Questionnaire–Aesthetic Surgery questionnaire, the Cosmetic Procedure Screening Questionnaire, and the Body Dysmorphic Disorder Symptom Scale, no formal screening tools exist to identify zoom dysmorphia. To complicate matters, “identifying dysmorphic concerns in virtual settings can be challenging,” Dr. Kroumpouzos added. “This makes the recognition of zoom dysmorphia during telehealth visits even more difficult.”

Individuals who may have zoom dysmorphia may fear being misunderstood, judged, or ridiculed because of a perceived flaw in appearance, he said, making establishing rapport and eye contact difficult. “There’s a reticence and silence due to the individual’s avoidant characteristics,” he said. “Patients may become easily distracted or disengaged during telehealth visits in case of technical issues. Psychiatric comorbidities can mask symptoms related to dysmorphic concerns.”

To bridge this gap, Dr. Kroumpouzos and colleagues have proposed a screening tool, a questionnaire related to features of zoom dysmorphia, to facilitate recognition of zoom dysmorphia in virtual settings.

[embed:render:related:node:266374]

The first component consists of open-ended questions such as “Are you comfortable with being interviewed in a virtual appointment?” and “How do you feel about your appearance during virtual meetings?” Such questions “aim to start the dialogue, to facilitate the discussion with a patient who may be shy or avoidant,” Dr. Kroumpouzos explained.

The second component of the tool consists of questions more specific to screening for zoom dysmorphia, starting with “Are you concerned about facial flaws?” If the patient answers no, they don’t qualify for any others, he said. “But, if they answer yes to that question and yes to at least one more [question], they may have zoom dysmorphia.”

Other questions include, “Do you think that your face is not friendly to the camera?” “Do you hesitate to open the camera?” “Have you tried to hide or camouflage your flaw with your hands, hair, makeup, or clothing?” “Have you sought advice from others to improve your appearance or image?” “Do you often use the filter features of the video conferencing platform?” “Did you consider buying a new camera or equipment that helps improve your image?”

If the clinician deems the patient a candidate for the diagnosis of zoom dysmorphia, the tool recommends asking a BDD-focused question: “In the past month, have you been very concerned that there is something wrong with your physical appearance or the way one or more parts of your body look?” If the patient answers yes, “that individual should be invited to fill out a questionnaire specifically for BDD or come to the office for further evaluation,” Dr. Kroumpouzos said.

In his view, the brevity of the proposed screening tool makes it easy to incorporate into clinical practice, and the “yes or no” questions are practical. “It is crucial to elicit the presence of zoom dysmorphia in its early stage,” he said. “Zoom dysmorphia may trigger an increase in BDD, [so] it is essential to identify the presence of BDD in zoom dysmorphia sufferers and treat it appropriately.”

Dr. Kroumpouzos reported having no relevant financial disclosures.

SAN DIEGO — In his role as chief medical officer for Ascension Medical Group–Texas, which employs about 1,000 physicians across every medical specialty, dermatologist Jason S. Reichenberg, MD, MBA, has heard his share of stories about patients who treat medical staff aggressively, incessantly complain, or threaten to file lawsuits for the care or treatment they’ve received.

At the annual meeting of the American Academy of Dermatology, Dr. Reichenberg, professor of dermatology at the University of Texas at Austin, shared several tips for managing such difficult patients:

Look for ‘red flags’ that raise concerns. This may include patients’ unrealistic expectations for a cure, “which could be because of their cultural or educational background,” he said. Difficult patients also may view physicians as enemies.

Reichenberg_Jason_TX_2024_web.jpg

“They may quote legal jargon or threaten consequences if there is a bad outcome,” he explained. “They may say, ‘I’m a great reviewer on Yelp and I look forward to giving you a great Yelp review when we finish today.’ They may also have previously sued physicians, or they may tell you that their last physician was horrible.”

Shift into robot mode. In other words, don’t stray from your practice’s protocol by offering special treatment to difficult patients. For example, if a difficult patient shows up 15 minutes late and the office has a policy that patients should be rescheduled if they arrive 10 minutes late, “do not break that policy no matter what, because that’s your protocol,” he advised. “You also do not promise anything you don’t know or that nobody could know. If a difficult patient asks, ‘what is the statistical chance that I’ll get better with this treatment,’ you either say, ‘studies have shown that this is the exact percentage,’ or ‘I don’t know. We’re going to do our best.’”

Set expectations at the outset. “If I walk into the room and the nurse has been in there for 25 minutes doing the intake and I know it’s going to be a long visit, I’ll start by saying, ‘I have 8 minutes to see you today,’ ” Dr. Reichenberg said. “ ‘Whatever we don’t finish today we’ll have to do during a follow-up visit, so let’s please prioritize what we need to do.’ ” Sometimes he sets his smartphone alarm to 8 minutes and when the timer goes off, he’ll say, “I’m so sorry, but I have to go.” For talkative patients, he continued, “I’ll ask, ‘is it okay if I interrupt you if I have a clarifying question?’ That gives you permission to interrupt.”

Blame a third “party” or policy. When patients express anger, find an “enemy” that you can be angry at together. “You might say something like, ‘I’m as frustrated as you are; I can’t believe how broken our health care system is that I have only 8 minutes with you today,’ ” he advised. “Show that you’re on the same side as them.” You could also blame a policy by saying something like, “I’m sorry; I can’t do that for you. My practice has strict rules about that. I’m as frustrated as you are.”

[embed:render:related:node:196325]

Practice self-regulation. Here, the goal is to delay the time between being triggered by the patient who gets under your skin and your response to that person, such as saying you received “a page or an important text before you walk out of the exam room,” he said. This principle also applies to messages that unreasonable individuals send by e-mail or through messages on their patient portal. “Probably the biggest mistakes I’ve seen from physicians is when they get really angry and they write an angry portal message or e-mail and send it out,” Dr. Reichenberg said. “If I feel triggered, I wait to respond. I’ll sometimes forward [the response] it to my nurse and request that person to send it out the next morning, so the reply reads, ‘Dr. Reichenberg said…’ That gives me the chance to calm down. It also gives the patient a chance to calm down.”

Never worry alone. When struggling to communicate effectively with a difficult patient, he recommends seeking input from a trusted physician colleague. “Better yet, pick up the phone and call the patient’s primary care doctor or another specialist who takes care of that person, and talk about it,” he said. “Figure out if this is your problem or the patient’s problem. They may offer advice on how to handle that person.”

Know when the conflict is untenable. Sometimes it’s best to resign from providing care to difficult patients. “I might write or say something like, ‘I resign from your care. I do not have any expertise to help you with your problem,’ ” Dr. Reichenberg said. “Or, ‘I don’t know that I have the infrastructure to handle the kind of problems you have. I’m not sure we’re the best fit.’ I would suggest that you not give every single detail about why you’re firing them, because the patients could write a step-by-step response, arguing against that.” If you decide to terminate the relationship with a patient, make sure that he or she is not in an acute phase of their illness. “You do not want to get sued for patient abandonment,” he said. “Know your state laws. In general, you’re going to give them a statement of intent to terminate — usually in 30 days — but you have to agree to treat them emergently.” Dr. Reichenberg also provides them with a referral source so they can find a new physician and waives the fee for sending medical records to the new provider. “Also, though it’s not required, I’ll include a statement about the consequences of not receiving care, if I think that they’re [neglecting] their own care,” he said.

Dr. Reichenberg reported having no financial disclosures.

SAN DIEGO — In his role as chief medical officer for Ascension Medical Group–Texas, which employs about 1,000 physicians across every medical specialty, dermatologist Jason S. Reichenberg, MD, MBA, has heard his share of stories about patients who treat medical staff aggressively, incessantly complain, or threaten to file lawsuits for the care or treatment they’ve received.

At the annual meeting of the American Academy of Dermatology, Dr. Reichenberg, professor of dermatology at the University of Texas at Austin, shared several tips for managing such difficult patients:

Look for ‘red flags’ that raise concerns. This may include patients’ unrealistic expectations for a cure, “which could be because of their cultural or educational background,” he said. Difficult patients also may view physicians as enemies.

Reichenberg_Jason_TX_2024_web.jpg

“They may quote legal jargon or threaten consequences if there is a bad outcome,” he explained. “They may say, ‘I’m a great reviewer on Yelp and I look forward to giving you a great Yelp review when we finish today.’ They may also have previously sued physicians, or they may tell you that their last physician was horrible.”

Shift into robot mode. In other words, don’t stray from your practice’s protocol by offering special treatment to difficult patients. For example, if a difficult patient shows up 15 minutes late and the office has a policy that patients should be rescheduled if they arrive 10 minutes late, “do not break that policy no matter what, because that’s your protocol,” he advised. “You also do not promise anything you don’t know or that nobody could know. If a difficult patient asks, ‘what is the statistical chance that I’ll get better with this treatment,’ you either say, ‘studies have shown that this is the exact percentage,’ or ‘I don’t know. We’re going to do our best.’”

Set expectations at the outset. “If I walk into the room and the nurse has been in there for 25 minutes doing the intake and I know it’s going to be a long visit, I’ll start by saying, ‘I have 8 minutes to see you today,’ ” Dr. Reichenberg said. “ ‘Whatever we don’t finish today we’ll have to do during a follow-up visit, so let’s please prioritize what we need to do.’ ” Sometimes he sets his smartphone alarm to 8 minutes and when the timer goes off, he’ll say, “I’m so sorry, but I have to go.” For talkative patients, he continued, “I’ll ask, ‘is it okay if I interrupt you if I have a clarifying question?’ That gives you permission to interrupt.”

Blame a third “party” or policy. When patients express anger, find an “enemy” that you can be angry at together. “You might say something like, ‘I’m as frustrated as you are; I can’t believe how broken our health care system is that I have only 8 minutes with you today,’ ” he advised. “Show that you’re on the same side as them.” You could also blame a policy by saying something like, “I’m sorry; I can’t do that for you. My practice has strict rules about that. I’m as frustrated as you are.”

[embed:render:related:node:196325]

Practice self-regulation. Here, the goal is to delay the time between being triggered by the patient who gets under your skin and your response to that person, such as saying you received “a page or an important text before you walk out of the exam room,” he said. This principle also applies to messages that unreasonable individuals send by e-mail or through messages on their patient portal. “Probably the biggest mistakes I’ve seen from physicians is when they get really angry and they write an angry portal message or e-mail and send it out,” Dr. Reichenberg said. “If I feel triggered, I wait to respond. I’ll sometimes forward [the response] it to my nurse and request that person to send it out the next morning, so the reply reads, ‘Dr. Reichenberg said…’ That gives me the chance to calm down. It also gives the patient a chance to calm down.”

Never worry alone. When struggling to communicate effectively with a difficult patient, he recommends seeking input from a trusted physician colleague. “Better yet, pick up the phone and call the patient’s primary care doctor or another specialist who takes care of that person, and talk about it,” he said. “Figure out if this is your problem or the patient’s problem. They may offer advice on how to handle that person.”

Know when the conflict is untenable. Sometimes it’s best to resign from providing care to difficult patients. “I might write or say something like, ‘I resign from your care. I do not have any expertise to help you with your problem,’ ” Dr. Reichenberg said. “Or, ‘I don’t know that I have the infrastructure to handle the kind of problems you have. I’m not sure we’re the best fit.’ I would suggest that you not give every single detail about why you’re firing them, because the patients could write a step-by-step response, arguing against that.” If you decide to terminate the relationship with a patient, make sure that he or she is not in an acute phase of their illness. “You do not want to get sued for patient abandonment,” he said. “Know your state laws. In general, you’re going to give them a statement of intent to terminate — usually in 30 days — but you have to agree to treat them emergently.” Dr. Reichenberg also provides them with a referral source so they can find a new physician and waives the fee for sending medical records to the new provider. “Also, though it’s not required, I’ll include a statement about the consequences of not receiving care, if I think that they’re [neglecting] their own care,” he said.

Dr. Reichenberg reported having no financial disclosures.

SAN DIEGO — In his role as chief medical officer for Ascension Medical Group–Texas, which employs about 1,000 physicians across every medical specialty, dermatologist Jason S. Reichenberg, MD, MBA, has heard his share of stories about patients who treat medical staff aggressively, incessantly complain, or threaten to file lawsuits for the care or treatment they’ve received.

At the annual meeting of the American Academy of Dermatology, Dr. Reichenberg, professor of dermatology at the University of Texas at Austin, shared several tips for managing such difficult patients:

Look for ‘red flags’ that raise concerns. This may include patients’ unrealistic expectations for a cure, “which could be because of their cultural or educational background,” he said. Difficult patients also may view physicians as enemies.

Reichenberg_Jason_TX_2024_web.jpg

“They may quote legal jargon or threaten consequences if there is a bad outcome,” he explained. “They may say, ‘I’m a great reviewer on Yelp and I look forward to giving you a great Yelp review when we finish today.’ They may also have previously sued physicians, or they may tell you that their last physician was horrible.”

Shift into robot mode. In other words, don’t stray from your practice’s protocol by offering special treatment to difficult patients. For example, if a difficult patient shows up 15 minutes late and the office has a policy that patients should be rescheduled if they arrive 10 minutes late, “do not break that policy no matter what, because that’s your protocol,” he advised. “You also do not promise anything you don’t know or that nobody could know. If a difficult patient asks, ‘what is the statistical chance that I’ll get better with this treatment,’ you either say, ‘studies have shown that this is the exact percentage,’ or ‘I don’t know. We’re going to do our best.’”

Set expectations at the outset. “If I walk into the room and the nurse has been in there for 25 minutes doing the intake and I know it’s going to be a long visit, I’ll start by saying, ‘I have 8 minutes to see you today,’ ” Dr. Reichenberg said. “ ‘Whatever we don’t finish today we’ll have to do during a follow-up visit, so let’s please prioritize what we need to do.’ ” Sometimes he sets his smartphone alarm to 8 minutes and when the timer goes off, he’ll say, “I’m so sorry, but I have to go.” For talkative patients, he continued, “I’ll ask, ‘is it okay if I interrupt you if I have a clarifying question?’ That gives you permission to interrupt.”

Blame a third “party” or policy. When patients express anger, find an “enemy” that you can be angry at together. “You might say something like, ‘I’m as frustrated as you are; I can’t believe how broken our health care system is that I have only 8 minutes with you today,’ ” he advised. “Show that you’re on the same side as them.” You could also blame a policy by saying something like, “I’m sorry; I can’t do that for you. My practice has strict rules about that. I’m as frustrated as you are.”

[embed:render:related:node:196325]

Practice self-regulation. Here, the goal is to delay the time between being triggered by the patient who gets under your skin and your response to that person, such as saying you received “a page or an important text before you walk out of the exam room,” he said. This principle also applies to messages that unreasonable individuals send by e-mail or through messages on their patient portal. “Probably the biggest mistakes I’ve seen from physicians is when they get really angry and they write an angry portal message or e-mail and send it out,” Dr. Reichenberg said. “If I feel triggered, I wait to respond. I’ll sometimes forward [the response] it to my nurse and request that person to send it out the next morning, so the reply reads, ‘Dr. Reichenberg said…’ That gives me the chance to calm down. It also gives the patient a chance to calm down.”

Never worry alone. When struggling to communicate effectively with a difficult patient, he recommends seeking input from a trusted physician colleague. “Better yet, pick up the phone and call the patient’s primary care doctor or another specialist who takes care of that person, and talk about it,” he said. “Figure out if this is your problem or the patient’s problem. They may offer advice on how to handle that person.”

Know when the conflict is untenable. Sometimes it’s best to resign from providing care to difficult patients. “I might write or say something like, ‘I resign from your care. I do not have any expertise to help you with your problem,’ ” Dr. Reichenberg said. “Or, ‘I don’t know that I have the infrastructure to handle the kind of problems you have. I’m not sure we’re the best fit.’ I would suggest that you not give every single detail about why you’re firing them, because the patients could write a step-by-step response, arguing against that.” If you decide to terminate the relationship with a patient, make sure that he or she is not in an acute phase of their illness. “You do not want to get sued for patient abandonment,” he said. “Know your state laws. In general, you’re going to give them a statement of intent to terminate — usually in 30 days — but you have to agree to treat them emergently.” Dr. Reichenberg also provides them with a referral source so they can find a new physician and waives the fee for sending medical records to the new provider. “Also, though it’s not required, I’ll include a statement about the consequences of not receiving care, if I think that they’re [neglecting] their own care,” he said.

Dr. Reichenberg reported having no financial disclosures.

SAN DIEGO — In the next few years, expect intradermal injections of botulinum toxin A for the improvement in the appearance of pores, sebum, skin texture, and rosacea to gain a foothold in dermatology practices, Jeremy B. Green, MD, predicts.

“This technique is more popular in Asia than it is here in the US,” Dr. Green, who practices dermatology in Coral Gables, Florida, said at the annual meeting of the American Academy of Dermatology. As opposed to intramuscular injections, “it’s an intradermal delivery, so you use numbing cream prior, and you’re injecting botulinum toxin A nearly parallel to the skin surface with the bevel of the needle up,” he said. “You want to use a precise product. It’s uncomfortable delivering volume so superficially due to the tissue distention, so I also use a massager. I inject approximately 0.05 mL to 0.1 mL per point. This does really work.”

Green_Jeremy_B_FL_web.jpg

This mode of delivery was evaluated in a prospective, double-blind, split-face study in South Korea, which enrolled 18 volunteers who received an intradermal injection of botulinum toxin A into one cheek and normal saline into the contralateral side as a control. Participants were between 30 and 54 years of age and were seen at the clinic 2, 4, 8, and 12 weeks after the injection. At each visit, investigators took photographs, used a facial analyzer to evaluate the pores and wrinkles of the infraorbital area, and used a Sebumeter to evaluate sebum secretions from both cheeks. Improvement or aggravation in skin texture was evaluated by both volunteers and clinicians on a numeric scale from –4 (severe aggravation) to +4 (marked improvement) at each visit, and following photographic review, the wrinkle score of the nasolabial fold was graded on a 5-point scale.

The researchers observed no significant effects on the wrinkles of the infraorbital area and on sebum secretion. However, on the side where botulinum toxin A was injected, there were significant improvements in the wrinkles of the nasolabial fold and skin texture, they reported. The effects on nasolabial fold wrinkles lasted 12 weeks, effects on skin texture lasted 8 weeks, and improvement in pore size was only observed at week 2, they wrote. One serious adverse event occurred: a case of facial palsy after the injection of 30 units of botulinum toxin A in one cheek. However, injection of 20 units of botulinum toxin A in one cheek was not associated with any adverse events.

“The duration of these treatments is yet to be determined, but I think this is definitely going to gain popularity in the US,” said Dr. Green, clinical assistant professor of dermatology at the University of Miami Department of Dermatology and Cutaneous Surgery.
 

Recently Approved Neurotoxin

He also discussed letibotulinumtoxinA-wlbg (Letybo), an injectable neurotoxin long used in South Korea, which the US Food and Drug Administration (FDA) approved for the temporary improvement in the appearance of moderate to severe glabellar (frown) lines in adults on March 4, 2024. Approval was based on positive results from three phase 3 trials of letibotulinumtoxinA-wlbg that enrolled more than 1,000 individuals in the United States and Europe.

“This is the sixth approved neurotoxin in the US,” Dr. Green said. “It is derived from the CBFC26 strain of Clostridium botulinum, and it’s a purified 900 kDa type A toxin complex with human serum albumin and sodium chloride as its excipients.” It comes in a 50-unit or 100-unit vial and requires refrigeration. “To me, the most fascinating thing about this product is that it has been the number-one selling botulinum toxin on the South Korea market for the last 5 years,” he said. “But what do we know about its characteristics?”

In a non-inferiority trial, Chinese researchers enrolled 500 patients with moderate to severe glabellar wrinkles to investigate the efficacy and safety of letibotulinumtoxinA-wlbg and onabotulinumtoxinA. Participants were randomized 3:1 to receive 20 U of letibotulinumtoxinA-wlbg or onabotulinumtoxinA and then observed them for 16 weeks. The primary endpoint was noninferiority in the proportion of study participants who received a score of 0 or 1 for glabellar wrinkles on a four-point photographic evaluation scale, as assessed by an evaluator at maximum frown at 4 weeks.

At week 4, 88.49% of participants in the letibotulinumtoxinA-wlbg arm achieved a score of 0 or 1 for glabellar wrinkles, compared with 87.39% of those in the onabotulinumtoxinA arm (P = .7469). No significant differences were observed for secondary efficacy or safety endpoints between the two treatments. “It will be interesting to see how this product does when it’s available to us,” Dr. Green said.

Another potential newcomer is ready-to-use liquid botulinum neurotoxin. RelabotulinumtoxinA is a complex, protein-free, ready-to-use liquid botulinum toxin A designed to avoid the traditional requirement to reconstitute it from powder, according to Galderma. It features a saline phosphate buffer solution, so it contains no human or animal-derived excipients, Dr. Green pointed out, and it eliminates the variability, errors, and risks associated with reconstitution.

[embed:render:related:node:268502]

“There was a report in the neurology literature of botulinum toxin being reconstituted with sterile water for cervical dystonia,” he noted. “When this was injected, it was excruciatingly painful, because it created an osmotic gradient within the muscle. So, if we can take a step away from human error, that would be a good thing.”

To date, Dr. Green said, four phase 3 trials of relabotulinumtoxinA involving more than 1,900 patients have been conducted in the United States and Canada evaluating its use for glabellar frown lines and lateral canthal lines, “and the data is impressive,” he said. This product is still investigational, said Dr. Green, who has not had experience injecting it in the clinical trial program.

The idea of a rapid onset botulinum toxin is also emerging. TrenibotulinumtoxinE, which is being developed by Allergan, “is similar to a type A neurotoxin,” Dr. Green said. “It inhibits neuromuscular transmission via presynaptic vesicular protein synaptosomal-associated protein (SNAP)-25 but at a different cleavage site. It has a faster onset — within one day — but a shorter duration — 3-4 weeks.”

In a dose escalation study of its use for glabellar frown lines, 80% of participants achieved a two-grade investigator-rated improvement in glabellar frown line severity at maximum frown at the highest dose. The maximum clinical effect of trenibotulinumtoxinE was seen within 24 hours and lasted between 14 and 30 days.

“The question is, if it is approved by the FDA, where would this product fit in our practices?” Dr. Green asked. “The effect is gone in 3 weeks as opposed to 4 months,” so this may be an option to recommend for someone who is reticent to try neurotoxins, he said, “or a patient who comes to you on a Friday and says, ‘I have a gala tomorrow night.’ ”

Dr. Green disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for many pharmaceutical companies, including Allergan and Galderma.

SAN DIEGO — In the next few years, expect intradermal injections of botulinum toxin A for the improvement in the appearance of pores, sebum, skin texture, and rosacea to gain a foothold in dermatology practices, Jeremy B. Green, MD, predicts.

“This technique is more popular in Asia than it is here in the US,” Dr. Green, who practices dermatology in Coral Gables, Florida, said at the annual meeting of the American Academy of Dermatology. As opposed to intramuscular injections, “it’s an intradermal delivery, so you use numbing cream prior, and you’re injecting botulinum toxin A nearly parallel to the skin surface with the bevel of the needle up,” he said. “You want to use a precise product. It’s uncomfortable delivering volume so superficially due to the tissue distention, so I also use a massager. I inject approximately 0.05 mL to 0.1 mL per point. This does really work.”

Green_Jeremy_B_FL_web.jpg

This mode of delivery was evaluated in a prospective, double-blind, split-face study in South Korea, which enrolled 18 volunteers who received an intradermal injection of botulinum toxin A into one cheek and normal saline into the contralateral side as a control. Participants were between 30 and 54 years of age and were seen at the clinic 2, 4, 8, and 12 weeks after the injection. At each visit, investigators took photographs, used a facial analyzer to evaluate the pores and wrinkles of the infraorbital area, and used a Sebumeter to evaluate sebum secretions from both cheeks. Improvement or aggravation in skin texture was evaluated by both volunteers and clinicians on a numeric scale from –4 (severe aggravation) to +4 (marked improvement) at each visit, and following photographic review, the wrinkle score of the nasolabial fold was graded on a 5-point scale.

The researchers observed no significant effects on the wrinkles of the infraorbital area and on sebum secretion. However, on the side where botulinum toxin A was injected, there were significant improvements in the wrinkles of the nasolabial fold and skin texture, they reported. The effects on nasolabial fold wrinkles lasted 12 weeks, effects on skin texture lasted 8 weeks, and improvement in pore size was only observed at week 2, they wrote. One serious adverse event occurred: a case of facial palsy after the injection of 30 units of botulinum toxin A in one cheek. However, injection of 20 units of botulinum toxin A in one cheek was not associated with any adverse events.

“The duration of these treatments is yet to be determined, but I think this is definitely going to gain popularity in the US,” said Dr. Green, clinical assistant professor of dermatology at the University of Miami Department of Dermatology and Cutaneous Surgery.
 

Recently Approved Neurotoxin

He also discussed letibotulinumtoxinA-wlbg (Letybo), an injectable neurotoxin long used in South Korea, which the US Food and Drug Administration (FDA) approved for the temporary improvement in the appearance of moderate to severe glabellar (frown) lines in adults on March 4, 2024. Approval was based on positive results from three phase 3 trials of letibotulinumtoxinA-wlbg that enrolled more than 1,000 individuals in the United States and Europe.

“This is the sixth approved neurotoxin in the US,” Dr. Green said. “It is derived from the CBFC26 strain of Clostridium botulinum, and it’s a purified 900 kDa type A toxin complex with human serum albumin and sodium chloride as its excipients.” It comes in a 50-unit or 100-unit vial and requires refrigeration. “To me, the most fascinating thing about this product is that it has been the number-one selling botulinum toxin on the South Korea market for the last 5 years,” he said. “But what do we know about its characteristics?”

In a non-inferiority trial, Chinese researchers enrolled 500 patients with moderate to severe glabellar wrinkles to investigate the efficacy and safety of letibotulinumtoxinA-wlbg and onabotulinumtoxinA. Participants were randomized 3:1 to receive 20 U of letibotulinumtoxinA-wlbg or onabotulinumtoxinA and then observed them for 16 weeks. The primary endpoint was noninferiority in the proportion of study participants who received a score of 0 or 1 for glabellar wrinkles on a four-point photographic evaluation scale, as assessed by an evaluator at maximum frown at 4 weeks.

At week 4, 88.49% of participants in the letibotulinumtoxinA-wlbg arm achieved a score of 0 or 1 for glabellar wrinkles, compared with 87.39% of those in the onabotulinumtoxinA arm (P = .7469). No significant differences were observed for secondary efficacy or safety endpoints between the two treatments. “It will be interesting to see how this product does when it’s available to us,” Dr. Green said.

Another potential newcomer is ready-to-use liquid botulinum neurotoxin. RelabotulinumtoxinA is a complex, protein-free, ready-to-use liquid botulinum toxin A designed to avoid the traditional requirement to reconstitute it from powder, according to Galderma. It features a saline phosphate buffer solution, so it contains no human or animal-derived excipients, Dr. Green pointed out, and it eliminates the variability, errors, and risks associated with reconstitution.

[embed:render:related:node:268502]

“There was a report in the neurology literature of botulinum toxin being reconstituted with sterile water for cervical dystonia,” he noted. “When this was injected, it was excruciatingly painful, because it created an osmotic gradient within the muscle. So, if we can take a step away from human error, that would be a good thing.”

To date, Dr. Green said, four phase 3 trials of relabotulinumtoxinA involving more than 1,900 patients have been conducted in the United States and Canada evaluating its use for glabellar frown lines and lateral canthal lines, “and the data is impressive,” he said. This product is still investigational, said Dr. Green, who has not had experience injecting it in the clinical trial program.

The idea of a rapid onset botulinum toxin is also emerging. TrenibotulinumtoxinE, which is being developed by Allergan, “is similar to a type A neurotoxin,” Dr. Green said. “It inhibits neuromuscular transmission via presynaptic vesicular protein synaptosomal-associated protein (SNAP)-25 but at a different cleavage site. It has a faster onset — within one day — but a shorter duration — 3-4 weeks.”

In a dose escalation study of its use for glabellar frown lines, 80% of participants achieved a two-grade investigator-rated improvement in glabellar frown line severity at maximum frown at the highest dose. The maximum clinical effect of trenibotulinumtoxinE was seen within 24 hours and lasted between 14 and 30 days.

“The question is, if it is approved by the FDA, where would this product fit in our practices?” Dr. Green asked. “The effect is gone in 3 weeks as opposed to 4 months,” so this may be an option to recommend for someone who is reticent to try neurotoxins, he said, “or a patient who comes to you on a Friday and says, ‘I have a gala tomorrow night.’ ”

Dr. Green disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for many pharmaceutical companies, including Allergan and Galderma.

SAN DIEGO — In the next few years, expect intradermal injections of botulinum toxin A for the improvement in the appearance of pores, sebum, skin texture, and rosacea to gain a foothold in dermatology practices, Jeremy B. Green, MD, predicts.

“This technique is more popular in Asia than it is here in the US,” Dr. Green, who practices dermatology in Coral Gables, Florida, said at the annual meeting of the American Academy of Dermatology. As opposed to intramuscular injections, “it’s an intradermal delivery, so you use numbing cream prior, and you’re injecting botulinum toxin A nearly parallel to the skin surface with the bevel of the needle up,” he said. “You want to use a precise product. It’s uncomfortable delivering volume so superficially due to the tissue distention, so I also use a massager. I inject approximately 0.05 mL to 0.1 mL per point. This does really work.”

Green_Jeremy_B_FL_web.jpg

This mode of delivery was evaluated in a prospective, double-blind, split-face study in South Korea, which enrolled 18 volunteers who received an intradermal injection of botulinum toxin A into one cheek and normal saline into the contralateral side as a control. Participants were between 30 and 54 years of age and were seen at the clinic 2, 4, 8, and 12 weeks after the injection. At each visit, investigators took photographs, used a facial analyzer to evaluate the pores and wrinkles of the infraorbital area, and used a Sebumeter to evaluate sebum secretions from both cheeks. Improvement or aggravation in skin texture was evaluated by both volunteers and clinicians on a numeric scale from –4 (severe aggravation) to +4 (marked improvement) at each visit, and following photographic review, the wrinkle score of the nasolabial fold was graded on a 5-point scale.

The researchers observed no significant effects on the wrinkles of the infraorbital area and on sebum secretion. However, on the side where botulinum toxin A was injected, there were significant improvements in the wrinkles of the nasolabial fold and skin texture, they reported. The effects on nasolabial fold wrinkles lasted 12 weeks, effects on skin texture lasted 8 weeks, and improvement in pore size was only observed at week 2, they wrote. One serious adverse event occurred: a case of facial palsy after the injection of 30 units of botulinum toxin A in one cheek. However, injection of 20 units of botulinum toxin A in one cheek was not associated with any adverse events.

“The duration of these treatments is yet to be determined, but I think this is definitely going to gain popularity in the US,” said Dr. Green, clinical assistant professor of dermatology at the University of Miami Department of Dermatology and Cutaneous Surgery.
 

Recently Approved Neurotoxin

He also discussed letibotulinumtoxinA-wlbg (Letybo), an injectable neurotoxin long used in South Korea, which the US Food and Drug Administration (FDA) approved for the temporary improvement in the appearance of moderate to severe glabellar (frown) lines in adults on March 4, 2024. Approval was based on positive results from three phase 3 trials of letibotulinumtoxinA-wlbg that enrolled more than 1,000 individuals in the United States and Europe.

“This is the sixth approved neurotoxin in the US,” Dr. Green said. “It is derived from the CBFC26 strain of Clostridium botulinum, and it’s a purified 900 kDa type A toxin complex with human serum albumin and sodium chloride as its excipients.” It comes in a 50-unit or 100-unit vial and requires refrigeration. “To me, the most fascinating thing about this product is that it has been the number-one selling botulinum toxin on the South Korea market for the last 5 years,” he said. “But what do we know about its characteristics?”

In a non-inferiority trial, Chinese researchers enrolled 500 patients with moderate to severe glabellar wrinkles to investigate the efficacy and safety of letibotulinumtoxinA-wlbg and onabotulinumtoxinA. Participants were randomized 3:1 to receive 20 U of letibotulinumtoxinA-wlbg or onabotulinumtoxinA and then observed them for 16 weeks. The primary endpoint was noninferiority in the proportion of study participants who received a score of 0 or 1 for glabellar wrinkles on a four-point photographic evaluation scale, as assessed by an evaluator at maximum frown at 4 weeks.

At week 4, 88.49% of participants in the letibotulinumtoxinA-wlbg arm achieved a score of 0 or 1 for glabellar wrinkles, compared with 87.39% of those in the onabotulinumtoxinA arm (P = .7469). No significant differences were observed for secondary efficacy or safety endpoints between the two treatments. “It will be interesting to see how this product does when it’s available to us,” Dr. Green said.

Another potential newcomer is ready-to-use liquid botulinum neurotoxin. RelabotulinumtoxinA is a complex, protein-free, ready-to-use liquid botulinum toxin A designed to avoid the traditional requirement to reconstitute it from powder, according to Galderma. It features a saline phosphate buffer solution, so it contains no human or animal-derived excipients, Dr. Green pointed out, and it eliminates the variability, errors, and risks associated with reconstitution.

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“There was a report in the neurology literature of botulinum toxin being reconstituted with sterile water for cervical dystonia,” he noted. “When this was injected, it was excruciatingly painful, because it created an osmotic gradient within the muscle. So, if we can take a step away from human error, that would be a good thing.”

To date, Dr. Green said, four phase 3 trials of relabotulinumtoxinA involving more than 1,900 patients have been conducted in the United States and Canada evaluating its use for glabellar frown lines and lateral canthal lines, “and the data is impressive,” he said. This product is still investigational, said Dr. Green, who has not had experience injecting it in the clinical trial program.

The idea of a rapid onset botulinum toxin is also emerging. TrenibotulinumtoxinE, which is being developed by Allergan, “is similar to a type A neurotoxin,” Dr. Green said. “It inhibits neuromuscular transmission via presynaptic vesicular protein synaptosomal-associated protein (SNAP)-25 but at a different cleavage site. It has a faster onset — within one day — but a shorter duration — 3-4 weeks.”

In a dose escalation study of its use for glabellar frown lines, 80% of participants achieved a two-grade investigator-rated improvement in glabellar frown line severity at maximum frown at the highest dose. The maximum clinical effect of trenibotulinumtoxinE was seen within 24 hours and lasted between 14 and 30 days.

“The question is, if it is approved by the FDA, where would this product fit in our practices?” Dr. Green asked. “The effect is gone in 3 weeks as opposed to 4 months,” so this may be an option to recommend for someone who is reticent to try neurotoxins, he said, “or a patient who comes to you on a Friday and says, ‘I have a gala tomorrow night.’ ”

Dr. Green disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for many pharmaceutical companies, including Allergan and Galderma.

SAN DIEGO — In the clinical opinion of Jenny E. Murase, MD, caring for patients with delusional infestation — the conviction that one is infested by animate or inanimate pathogens without medical or microbiological evidence of a true infestation — puts a dermatologist’s communication skills to the ultimate test.

“The fact that delusional infestation is a fixed, false belief [means] we will never agree with patients on the etiology by definition,” Dr. Murase, a dermatologist with the Palo Alto Foundation Medical Group, Mountain View, California, said at the annual meeting of the American Academy of Dermatology. “But somehow, we must come to some kind of an agreement on how to approach this therapeutically.”

Murase_Jenny_CA_web.jpg

Patients with delusional infestation (DI) often describe a cutaneous sensation of itching or crawling, biting, stinging — a pins and needles sensation. “Formication is when there’s a crawling sensation on the surface of the skin,” she said. “That’s something we can agree on — the fact that there is a shared understanding that they’re experiencing some kind of sensation in their skin.”

First described in 1894, several different terms have been used to describe DI in the past, including acarophobia, delusions of parasitosis, Ekbom syndrome, and Morgellons disease. The current term used for DI includes other animate or inanimate pathogens besides parasites.

The average dermatologist manages two to three patients with DI every 5 years, “so it’s not uncommon,” said Dr. Murase, who also holds a faculty position in the department of dermatology at the University of California, San Francisco. Females are about 2.5 times more likely to be affected compared with males, she said, and 8%-12% of patients with DI have a friend or relative who shares the symptom, and they often accompany them to the office visit. “Initially, you’re trying to determine if this a primary condition where it’s only the cutaneous condition the patient is experiencing, or if there is a secondary condition like an underlying psychiatric disorder or medical condition or drug use that contributes to the sensation,” she said.

According to a descriptive study of 115 patients with DI, 50% had at least one drug detected in hair samples, and nearly 60% had evidence of some cognitive impairment that could not be explained by deficits in IQ. Another study of 147 patients with DI seen at the Mayo Clinic between 2001 and 2007 found that 81% had a prior psychiatric condition and 26% had a shared psychotic disorder.
 

Phased Approach to Treatment

Dr. Murase discussed her phased approach to caring for patients with DI, based on a review article that she and colleagues published in the International Journal of Dermatology. Phase 1 involves preparing for the visit by asking staff to refer to patients with DI as VIPs and allowing them to talk freely about the sensation they’re experiencing. “The goal is to improve the patient’s condition, not to convince the patient that he or she is delusional,” Dr. Murase explained. “Many patients can’t distinguish between when they’re talking to the doctor and when they’re talking to a nurse or a nurse practitioner; they like to feel that they’re being heard and listened to.”

She also recommends scheduling patients with DI for the end of the day and arranging frequent follow-up visits. “Making them feel valued is the bottom line,” she emphasized. “Remember: They’re less likely to respect socially defined boundaries like time constraints, so you do have to set boundaries, and don’t take what they may say to you personally. You’re not going to be able to care for that individual unless you do that. They may appear defiant, frustrated, and angry, but the fact that they showed up in your office means that you can help that person.”

Phase 2 of care for these patients consists of building a therapeutic rapport by greeting them with a smile and positive attitude and using welcoming body language such as sitting side-by-side during the office visit as opposed to face-to-face, “so it’s a less aggressive approach,” she said. Next, ask about their goal with a question such as, “Is it more important for you to find the bug/virus or to improve your condition?”

During the visit, “you’re continually shifting from etiology — which they are desperate to understand — to a shared desire for treatment,” Dr. Murase said. “No one knows what causes DI and remember, in medicine we treat patients when the exact etiology is unknown. So, we’re not doing anything that differently. Focus on the effect that the symptoms are having on their life. Say something like, ‘it must be so miserable to be living this way. I really want to help you.’ ”

Phase 3 of care for patients with DI involves performing a thorough history and physical exam. The initial office visit should include a full body exam to rule out any underlying dermatologic condition that may be causing the sensation they’re complaining about. She cited a retrospective study of 108 patients who presented to the Mayo Clinic with DI as the main reason for their office visit. Of the 80 patients who had a biopsy, 61% had chronic dermatitis; 48% had excoriation, ulceration, or erosion; and 31% had nonspecific dermal inflammation.

Whether to perform a biopsy or not is controversial, Dr. Murase added, because it’s probably not going to change the clinical impression or diagnosis. “If you agree to do the biopsy, get a verbal contract with the patient,” she advised. “You might say, ‘We’re going to do this. You’re going to choose the site, we’re going to do a biopsy, but we are going to be in agreement here that, if we can’t find the etiology, that you will still be open to going on therapy.’ This is important because it establishes a therapeutic alliance.”

Since patients with DI often bring in their own specimens, she also recommends providing them with microscope glass slides without cover slips and asking them to use clear tape, not tape that is opaque or matted, to cover the specimen.

To rule out other illnesses and conditions that could be triggering the perceived DI, she said lab tests to consider include a complete blood count, comprehensive metabolic panel, thyroid-stimulating hormone, calcium, hemoglobin A1c, vitamin B12, urinalysis, toxicology screen, HIV/hepatitis C, and rapid plasma reagin.
 

Starting Treatment

Phase 4 of care for patients with DI involves initiating therapy, which includes demonstrating empathy by reflecting on the detrimental effects of the patient’s reported sensations on their quality of life. “Emphasize that you are not questioning their experience, and that you don’t doubt that they feel things on their skin,” Dr. Murase said. “Recommend medications on an empirical or ‘trial and error’ pragmatic basis. I often tell patients, ‘I will never give up on you if you will never give up on me.’”

For treating patients with DI, her first-generation antipsychotic of choice is pimozide. She starts at a dose of 0.5 mg, building up to 2-3 mg once a day. Haloperidol is another option: 0.5 mg to start, building up to 1-5 mg every night at bedtime. “This requires monitoring for bone suppression via CBC and hypermetabolic complications via fasting lipids and HbA1c,” she said. “There is also an increased risk of prolonged QT with pimozide and risk of extrapyramidal symptoms and tardive dyskinesia.”

Second-generation antipsychotics to consider include risperidone (0.5 mg to start, building up to 102 mg at bedtime); olanzapine (2.5 mg to start, building up to 5-10 mg at bedtime); aripiprazole (2-5 mg to start, building up to 10-15 mg a day), and quetiapine (12.5 mg to start, building up to 200 mg at bedtime).

For all medical therapy she recommends starting patients with a low dose, increasing by 0.5 mg every 2-3 weeks, and let them be “stable and comfortable” for 3-4 months, and then taper down the dose by 0.5 mg every 2-4 weeks or more slowly. In the medical chart, Dr. Murase recommends avoiding use of the terms “psychosis” and “delusions.” Instead, “formication” (tactile hallucination of insects crawling on or within the skin) or “cutaneous dysesthesia” are better terms if patients access their records, she said.

Dr. Murase reported having no relevant disclosures.

SAN DIEGO — In the clinical opinion of Jenny E. Murase, MD, caring for patients with delusional infestation — the conviction that one is infested by animate or inanimate pathogens without medical or microbiological evidence of a true infestation — puts a dermatologist’s communication skills to the ultimate test.

“The fact that delusional infestation is a fixed, false belief [means] we will never agree with patients on the etiology by definition,” Dr. Murase, a dermatologist with the Palo Alto Foundation Medical Group, Mountain View, California, said at the annual meeting of the American Academy of Dermatology. “But somehow, we must come to some kind of an agreement on how to approach this therapeutically.”

Murase_Jenny_CA_web.jpg

Patients with delusional infestation (DI) often describe a cutaneous sensation of itching or crawling, biting, stinging — a pins and needles sensation. “Formication is when there’s a crawling sensation on the surface of the skin,” she said. “That’s something we can agree on — the fact that there is a shared understanding that they’re experiencing some kind of sensation in their skin.”

First described in 1894, several different terms have been used to describe DI in the past, including acarophobia, delusions of parasitosis, Ekbom syndrome, and Morgellons disease. The current term used for DI includes other animate or inanimate pathogens besides parasites.

The average dermatologist manages two to three patients with DI every 5 years, “so it’s not uncommon,” said Dr. Murase, who also holds a faculty position in the department of dermatology at the University of California, San Francisco. Females are about 2.5 times more likely to be affected compared with males, she said, and 8%-12% of patients with DI have a friend or relative who shares the symptom, and they often accompany them to the office visit. “Initially, you’re trying to determine if this a primary condition where it’s only the cutaneous condition the patient is experiencing, or if there is a secondary condition like an underlying psychiatric disorder or medical condition or drug use that contributes to the sensation,” she said.

According to a descriptive study of 115 patients with DI, 50% had at least one drug detected in hair samples, and nearly 60% had evidence of some cognitive impairment that could not be explained by deficits in IQ. Another study of 147 patients with DI seen at the Mayo Clinic between 2001 and 2007 found that 81% had a prior psychiatric condition and 26% had a shared psychotic disorder.
 

Phased Approach to Treatment

Dr. Murase discussed her phased approach to caring for patients with DI, based on a review article that she and colleagues published in the International Journal of Dermatology. Phase 1 involves preparing for the visit by asking staff to refer to patients with DI as VIPs and allowing them to talk freely about the sensation they’re experiencing. “The goal is to improve the patient’s condition, not to convince the patient that he or she is delusional,” Dr. Murase explained. “Many patients can’t distinguish between when they’re talking to the doctor and when they’re talking to a nurse or a nurse practitioner; they like to feel that they’re being heard and listened to.”

She also recommends scheduling patients with DI for the end of the day and arranging frequent follow-up visits. “Making them feel valued is the bottom line,” she emphasized. “Remember: They’re less likely to respect socially defined boundaries like time constraints, so you do have to set boundaries, and don’t take what they may say to you personally. You’re not going to be able to care for that individual unless you do that. They may appear defiant, frustrated, and angry, but the fact that they showed up in your office means that you can help that person.”

Phase 2 of care for these patients consists of building a therapeutic rapport by greeting them with a smile and positive attitude and using welcoming body language such as sitting side-by-side during the office visit as opposed to face-to-face, “so it’s a less aggressive approach,” she said. Next, ask about their goal with a question such as, “Is it more important for you to find the bug/virus or to improve your condition?”

During the visit, “you’re continually shifting from etiology — which they are desperate to understand — to a shared desire for treatment,” Dr. Murase said. “No one knows what causes DI and remember, in medicine we treat patients when the exact etiology is unknown. So, we’re not doing anything that differently. Focus on the effect that the symptoms are having on their life. Say something like, ‘it must be so miserable to be living this way. I really want to help you.’ ”

Phase 3 of care for patients with DI involves performing a thorough history and physical exam. The initial office visit should include a full body exam to rule out any underlying dermatologic condition that may be causing the sensation they’re complaining about. She cited a retrospective study of 108 patients who presented to the Mayo Clinic with DI as the main reason for their office visit. Of the 80 patients who had a biopsy, 61% had chronic dermatitis; 48% had excoriation, ulceration, or erosion; and 31% had nonspecific dermal inflammation.

Whether to perform a biopsy or not is controversial, Dr. Murase added, because it’s probably not going to change the clinical impression or diagnosis. “If you agree to do the biopsy, get a verbal contract with the patient,” she advised. “You might say, ‘We’re going to do this. You’re going to choose the site, we’re going to do a biopsy, but we are going to be in agreement here that, if we can’t find the etiology, that you will still be open to going on therapy.’ This is important because it establishes a therapeutic alliance.”

Since patients with DI often bring in their own specimens, she also recommends providing them with microscope glass slides without cover slips and asking them to use clear tape, not tape that is opaque or matted, to cover the specimen.

To rule out other illnesses and conditions that could be triggering the perceived DI, she said lab tests to consider include a complete blood count, comprehensive metabolic panel, thyroid-stimulating hormone, calcium, hemoglobin A1c, vitamin B12, urinalysis, toxicology screen, HIV/hepatitis C, and rapid plasma reagin.
 

Starting Treatment

Phase 4 of care for patients with DI involves initiating therapy, which includes demonstrating empathy by reflecting on the detrimental effects of the patient’s reported sensations on their quality of life. “Emphasize that you are not questioning their experience, and that you don’t doubt that they feel things on their skin,” Dr. Murase said. “Recommend medications on an empirical or ‘trial and error’ pragmatic basis. I often tell patients, ‘I will never give up on you if you will never give up on me.’”

For treating patients with DI, her first-generation antipsychotic of choice is pimozide. She starts at a dose of 0.5 mg, building up to 2-3 mg once a day. Haloperidol is another option: 0.5 mg to start, building up to 1-5 mg every night at bedtime. “This requires monitoring for bone suppression via CBC and hypermetabolic complications via fasting lipids and HbA1c,” she said. “There is also an increased risk of prolonged QT with pimozide and risk of extrapyramidal symptoms and tardive dyskinesia.”

Second-generation antipsychotics to consider include risperidone (0.5 mg to start, building up to 102 mg at bedtime); olanzapine (2.5 mg to start, building up to 5-10 mg at bedtime); aripiprazole (2-5 mg to start, building up to 10-15 mg a day), and quetiapine (12.5 mg to start, building up to 200 mg at bedtime).

For all medical therapy she recommends starting patients with a low dose, increasing by 0.5 mg every 2-3 weeks, and let them be “stable and comfortable” for 3-4 months, and then taper down the dose by 0.5 mg every 2-4 weeks or more slowly. In the medical chart, Dr. Murase recommends avoiding use of the terms “psychosis” and “delusions.” Instead, “formication” (tactile hallucination of insects crawling on or within the skin) or “cutaneous dysesthesia” are better terms if patients access their records, she said.

Dr. Murase reported having no relevant disclosures.

SAN DIEGO — In the clinical opinion of Jenny E. Murase, MD, caring for patients with delusional infestation — the conviction that one is infested by animate or inanimate pathogens without medical or microbiological evidence of a true infestation — puts a dermatologist’s communication skills to the ultimate test.

“The fact that delusional infestation is a fixed, false belief [means] we will never agree with patients on the etiology by definition,” Dr. Murase, a dermatologist with the Palo Alto Foundation Medical Group, Mountain View, California, said at the annual meeting of the American Academy of Dermatology. “But somehow, we must come to some kind of an agreement on how to approach this therapeutically.”

Murase_Jenny_CA_web.jpg

Patients with delusional infestation (DI) often describe a cutaneous sensation of itching or crawling, biting, stinging — a pins and needles sensation. “Formication is when there’s a crawling sensation on the surface of the skin,” she said. “That’s something we can agree on — the fact that there is a shared understanding that they’re experiencing some kind of sensation in their skin.”

First described in 1894, several different terms have been used to describe DI in the past, including acarophobia, delusions of parasitosis, Ekbom syndrome, and Morgellons disease. The current term used for DI includes other animate or inanimate pathogens besides parasites.

The average dermatologist manages two to three patients with DI every 5 years, “so it’s not uncommon,” said Dr. Murase, who also holds a faculty position in the department of dermatology at the University of California, San Francisco. Females are about 2.5 times more likely to be affected compared with males, she said, and 8%-12% of patients with DI have a friend or relative who shares the symptom, and they often accompany them to the office visit. “Initially, you’re trying to determine if this a primary condition where it’s only the cutaneous condition the patient is experiencing, or if there is a secondary condition like an underlying psychiatric disorder or medical condition or drug use that contributes to the sensation,” she said.

According to a descriptive study of 115 patients with DI, 50% had at least one drug detected in hair samples, and nearly 60% had evidence of some cognitive impairment that could not be explained by deficits in IQ. Another study of 147 patients with DI seen at the Mayo Clinic between 2001 and 2007 found that 81% had a prior psychiatric condition and 26% had a shared psychotic disorder.
 

Phased Approach to Treatment

Dr. Murase discussed her phased approach to caring for patients with DI, based on a review article that she and colleagues published in the International Journal of Dermatology. Phase 1 involves preparing for the visit by asking staff to refer to patients with DI as VIPs and allowing them to talk freely about the sensation they’re experiencing. “The goal is to improve the patient’s condition, not to convince the patient that he or she is delusional,” Dr. Murase explained. “Many patients can’t distinguish between when they’re talking to the doctor and when they’re talking to a nurse or a nurse practitioner; they like to feel that they’re being heard and listened to.”

She also recommends scheduling patients with DI for the end of the day and arranging frequent follow-up visits. “Making them feel valued is the bottom line,” she emphasized. “Remember: They’re less likely to respect socially defined boundaries like time constraints, so you do have to set boundaries, and don’t take what they may say to you personally. You’re not going to be able to care for that individual unless you do that. They may appear defiant, frustrated, and angry, but the fact that they showed up in your office means that you can help that person.”

Phase 2 of care for these patients consists of building a therapeutic rapport by greeting them with a smile and positive attitude and using welcoming body language such as sitting side-by-side during the office visit as opposed to face-to-face, “so it’s a less aggressive approach,” she said. Next, ask about their goal with a question such as, “Is it more important for you to find the bug/virus or to improve your condition?”

During the visit, “you’re continually shifting from etiology — which they are desperate to understand — to a shared desire for treatment,” Dr. Murase said. “No one knows what causes DI and remember, in medicine we treat patients when the exact etiology is unknown. So, we’re not doing anything that differently. Focus on the effect that the symptoms are having on their life. Say something like, ‘it must be so miserable to be living this way. I really want to help you.’ ”

Phase 3 of care for patients with DI involves performing a thorough history and physical exam. The initial office visit should include a full body exam to rule out any underlying dermatologic condition that may be causing the sensation they’re complaining about. She cited a retrospective study of 108 patients who presented to the Mayo Clinic with DI as the main reason for their office visit. Of the 80 patients who had a biopsy, 61% had chronic dermatitis; 48% had excoriation, ulceration, or erosion; and 31% had nonspecific dermal inflammation.

Whether to perform a biopsy or not is controversial, Dr. Murase added, because it’s probably not going to change the clinical impression or diagnosis. “If you agree to do the biopsy, get a verbal contract with the patient,” she advised. “You might say, ‘We’re going to do this. You’re going to choose the site, we’re going to do a biopsy, but we are going to be in agreement here that, if we can’t find the etiology, that you will still be open to going on therapy.’ This is important because it establishes a therapeutic alliance.”

Since patients with DI often bring in their own specimens, she also recommends providing them with microscope glass slides without cover slips and asking them to use clear tape, not tape that is opaque or matted, to cover the specimen.

To rule out other illnesses and conditions that could be triggering the perceived DI, she said lab tests to consider include a complete blood count, comprehensive metabolic panel, thyroid-stimulating hormone, calcium, hemoglobin A1c, vitamin B12, urinalysis, toxicology screen, HIV/hepatitis C, and rapid plasma reagin.
 

Starting Treatment

Phase 4 of care for patients with DI involves initiating therapy, which includes demonstrating empathy by reflecting on the detrimental effects of the patient’s reported sensations on their quality of life. “Emphasize that you are not questioning their experience, and that you don’t doubt that they feel things on their skin,” Dr. Murase said. “Recommend medications on an empirical or ‘trial and error’ pragmatic basis. I often tell patients, ‘I will never give up on you if you will never give up on me.’”

For treating patients with DI, her first-generation antipsychotic of choice is pimozide. She starts at a dose of 0.5 mg, building up to 2-3 mg once a day. Haloperidol is another option: 0.5 mg to start, building up to 1-5 mg every night at bedtime. “This requires monitoring for bone suppression via CBC and hypermetabolic complications via fasting lipids and HbA1c,” she said. “There is also an increased risk of prolonged QT with pimozide and risk of extrapyramidal symptoms and tardive dyskinesia.”

Second-generation antipsychotics to consider include risperidone (0.5 mg to start, building up to 102 mg at bedtime); olanzapine (2.5 mg to start, building up to 5-10 mg at bedtime); aripiprazole (2-5 mg to start, building up to 10-15 mg a day), and quetiapine (12.5 mg to start, building up to 200 mg at bedtime).

For all medical therapy she recommends starting patients with a low dose, increasing by 0.5 mg every 2-3 weeks, and let them be “stable and comfortable” for 3-4 months, and then taper down the dose by 0.5 mg every 2-4 weeks or more slowly. In the medical chart, Dr. Murase recommends avoiding use of the terms “psychosis” and “delusions.” Instead, “formication” (tactile hallucination of insects crawling on or within the skin) or “cutaneous dysesthesia” are better terms if patients access their records, she said.

Dr. Murase reported having no relevant disclosures.

SAN DIEGO — In the opinion of Patricia A. Treadwell, MD, providing health equity in dermatology means providing support for everyone, regardless of their financial circumstances or their skin color.

It also means embracing diversity, which she defined as diversity of thinking. “If you look at the literature, diversity in higher education and health profession training settings is associated with better educational outcomes for all students,” Dr. Treadwell, professor emeritus of dermatology and pediatrics at Indiana University School of Medicine, Indianapolis, said in a presentation on health equity during the plenary session at the annual meeting of the American Academy of Dermatology. “Each person brings a variety of experiences and perspectives. This provides a wide range of opinions and different ways to look at things. Racial and ethnic minority providers can help health organization reduce cultural and linguistic barriers and improve cultural competence.”

Treadwell_ Patricia_A_IN_web.jpg

Such efforts matter, she continued, because according to the United States Census, Black individuals make up 13.6% of the population, while Latinx individuals represent 19.1% of the population. “So, melanin matters,” she said. “If you look at a dermatology textbook, a high percentage [of cases] are identified as Caucasian individuals, which results in an overrepresentation of Caucasians in photographs. That can result in delayed or missed diagnoses [in different skin types]. If you are contributing to cases in textbooks, make sure you have a variety of different skin types so that individuals who are referring to the textbooks will be more equipped.”

Practicing dermatologists can support diversity by offering opportunities to underrepresented in medicine (URM) students, “African-American students, Hispanic students, and Native American students,” said Dr. Treadwell, who was chief of pediatric dermatology at Riley Hospital for Children in Indianapolis from 1987 to 2004. “You also want to be encouraging,” she said.

Dermatologists can also support diversity by providing precepting opportunities, “because many [medical] students may not have connections and networks. Providing those opportunities is important,” she said. Another way to help is to be a mentor to young dermatologists. “I certainly have had mentors in my career who have been very helpful,” she said. “They’ve given me advice about things I was not familiar with.”

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Dr. Treadwell suggested the Skin of Color Society as an organization that can assist with networking, mentoring, and research efforts. She also cited the Society for Pediatric Dermatology’s Equity, Diversity, and Inclusion Committee, formed in 2020. One of its initiatives was assembling a special issue of Pediatric Dermatology dedicated to DEI issues, which was published in November 2021.

Dr. Treadwell concluded her presentation by encouraging dermatologists to find ways to care for uninsured or underinsured patients, particularly those with skin of color. This might involve work at a county hospital “to provide access, to serve the patients ... and helping to decrease some the issues in terms of health equity,” she said.

Dr. Treadwell reported having no relevant disclosures. At the plenary session, she presented the John Kenney Jr., MD Lifetime Achievement Award and Lectureship.

SAN DIEGO — In the opinion of Patricia A. Treadwell, MD, providing health equity in dermatology means providing support for everyone, regardless of their financial circumstances or their skin color.

It also means embracing diversity, which she defined as diversity of thinking. “If you look at the literature, diversity in higher education and health profession training settings is associated with better educational outcomes for all students,” Dr. Treadwell, professor emeritus of dermatology and pediatrics at Indiana University School of Medicine, Indianapolis, said in a presentation on health equity during the plenary session at the annual meeting of the American Academy of Dermatology. “Each person brings a variety of experiences and perspectives. This provides a wide range of opinions and different ways to look at things. Racial and ethnic minority providers can help health organization reduce cultural and linguistic barriers and improve cultural competence.”

Treadwell_ Patricia_A_IN_web.jpg

Such efforts matter, she continued, because according to the United States Census, Black individuals make up 13.6% of the population, while Latinx individuals represent 19.1% of the population. “So, melanin matters,” she said. “If you look at a dermatology textbook, a high percentage [of cases] are identified as Caucasian individuals, which results in an overrepresentation of Caucasians in photographs. That can result in delayed or missed diagnoses [in different skin types]. If you are contributing to cases in textbooks, make sure you have a variety of different skin types so that individuals who are referring to the textbooks will be more equipped.”

Practicing dermatologists can support diversity by offering opportunities to underrepresented in medicine (URM) students, “African-American students, Hispanic students, and Native American students,” said Dr. Treadwell, who was chief of pediatric dermatology at Riley Hospital for Children in Indianapolis from 1987 to 2004. “You also want to be encouraging,” she said.

Dermatologists can also support diversity by providing precepting opportunities, “because many [medical] students may not have connections and networks. Providing those opportunities is important,” she said. Another way to help is to be a mentor to young dermatologists. “I certainly have had mentors in my career who have been very helpful,” she said. “They’ve given me advice about things I was not familiar with.”

[embed:render:related:node:268460]

Dr. Treadwell suggested the Skin of Color Society as an organization that can assist with networking, mentoring, and research efforts. She also cited the Society for Pediatric Dermatology’s Equity, Diversity, and Inclusion Committee, formed in 2020. One of its initiatives was assembling a special issue of Pediatric Dermatology dedicated to DEI issues, which was published in November 2021.

Dr. Treadwell concluded her presentation by encouraging dermatologists to find ways to care for uninsured or underinsured patients, particularly those with skin of color. This might involve work at a county hospital “to provide access, to serve the patients ... and helping to decrease some the issues in terms of health equity,” she said.

Dr. Treadwell reported having no relevant disclosures. At the plenary session, she presented the John Kenney Jr., MD Lifetime Achievement Award and Lectureship.

SAN DIEGO — In the opinion of Patricia A. Treadwell, MD, providing health equity in dermatology means providing support for everyone, regardless of their financial circumstances or their skin color.

It also means embracing diversity, which she defined as diversity of thinking. “If you look at the literature, diversity in higher education and health profession training settings is associated with better educational outcomes for all students,” Dr. Treadwell, professor emeritus of dermatology and pediatrics at Indiana University School of Medicine, Indianapolis, said in a presentation on health equity during the plenary session at the annual meeting of the American Academy of Dermatology. “Each person brings a variety of experiences and perspectives. This provides a wide range of opinions and different ways to look at things. Racial and ethnic minority providers can help health organization reduce cultural and linguistic barriers and improve cultural competence.”

Treadwell_ Patricia_A_IN_web.jpg

Such efforts matter, she continued, because according to the United States Census, Black individuals make up 13.6% of the population, while Latinx individuals represent 19.1% of the population. “So, melanin matters,” she said. “If you look at a dermatology textbook, a high percentage [of cases] are identified as Caucasian individuals, which results in an overrepresentation of Caucasians in photographs. That can result in delayed or missed diagnoses [in different skin types]. If you are contributing to cases in textbooks, make sure you have a variety of different skin types so that individuals who are referring to the textbooks will be more equipped.”

Practicing dermatologists can support diversity by offering opportunities to underrepresented in medicine (URM) students, “African-American students, Hispanic students, and Native American students,” said Dr. Treadwell, who was chief of pediatric dermatology at Riley Hospital for Children in Indianapolis from 1987 to 2004. “You also want to be encouraging,” she said.

Dermatologists can also support diversity by providing precepting opportunities, “because many [medical] students may not have connections and networks. Providing those opportunities is important,” she said. Another way to help is to be a mentor to young dermatologists. “I certainly have had mentors in my career who have been very helpful,” she said. “They’ve given me advice about things I was not familiar with.”

[embed:render:related:node:268460]

Dr. Treadwell suggested the Skin of Color Society as an organization that can assist with networking, mentoring, and research efforts. She also cited the Society for Pediatric Dermatology’s Equity, Diversity, and Inclusion Committee, formed in 2020. One of its initiatives was assembling a special issue of Pediatric Dermatology dedicated to DEI issues, which was published in November 2021.

Dr. Treadwell concluded her presentation by encouraging dermatologists to find ways to care for uninsured or underinsured patients, particularly those with skin of color. This might involve work at a county hospital “to provide access, to serve the patients ... and helping to decrease some the issues in terms of health equity,” she said.

Dr. Treadwell reported having no relevant disclosures. At the plenary session, she presented the John Kenney Jr., MD Lifetime Achievement Award and Lectureship.

SAN DIEGO — When Jennifer Adams, MD, recently entered the search term “warts” on the ClinicalTrials.gov web site, nearly 240 results popped up.

“There is a lot of research activity around this topic,” Dr. Adams, vice chair of the department of dermatology at the University of Nebraska Medical Center, said at the annual meeting of the American Academy of Dermatology. “We just don’t have fantastic, well-run trials on many of the currently available treatments.”

In a 2012 Cochrane review on the topical treatment of non-genital cutaneous warts, authors drew from 85 trials involving 8,815 randomized patients. They found that most warts spontaneously resolved, and the authors determined salicylic acid to be safe and modestly beneficial. Specifically, trials of salicylic acid (SA) versus placebo showed that the former significantly increased the chance of clearance of warts at all sites (risk ratio, 1.56, 95% confidence interval [CI], 1.20-2.03). A meta-analysis of cryotherapy versus placebo for warts at all sites favored neither intervention nor control (RR, 1.45, 95% CI, 0.65-3.23).

“The authors determined that there is less evidence for cryotherapy but stated that it may work when salicylic acid does not, or in combination with salicylic acid,” Dr. Adams said. “However, salicylic acid and cryotherapy don’t do enough for our patients [with warts]. There are a lot of situations where we need to reach further into the toolbox.”

A 2021 review article listed many options for managing difficult-to-treat warts, including intralesional Candida antigen, intralesional measles-mumps-rubella (MMR), intralesional HPV vaccine, intralesional vitamin D, intralesional cidofovir, intralesional bleomycin, and intralesional 5-FU injections, and topical vitamin D, topical cidofovir, and topical bleomycin. According to Dr. Adams, clinical data exist for cidofovir and vitamin D but studies evaluated different formulations, doses, sites of administration, and limited randomized controlled trials.

“Intralesional cidofovir is more effective than the topical form, but intralesional cidofovir can be painful and both forms are expensive,” she said. “Topical vitamin D is less likely to cause dyspigmentation compared to other available treatments, so it’s a great option in skin of color, but it has been less effective compared to some of our other topical treatments.”

[embed:render:related:node:261488]

Newer Options Promising

On the horizon, berdazimer gel was approved in January of 2024 for the treatment of molluscum but results from trials of its use for extragenital warts are encouraging. Another promising option is topical ionic contraviral therapy (ICVT) with digoxin and furosemide combined, which inhibits cellular potassium influx. A phase 2a randomized controlled trial of 80 adults found a statistically significant reduction in the diameter of cutaneous warts among those who received ICVT compared with those who received placebo (P = .002). “It’s cheap and well tolerated,” Dr. Adams added.

Intralesional approaches to treating warts offer another alternative. A 2020 review of 43 articles concluded that intralesional treatments for warts have equal or superior efficacy to first-line salicylic acid or cryotherapy.

Dr. Adams said that she considers intralesional treatments such as vitamin D, MMR vaccine antigen, and Candida antigen for refractory, numerous, or distant site warts. “Injecting the MMR vaccine into the largest wart every 2 weeks has been found to lead to complete clearance in 60%-68% of cases in one study,” she said. “The benefit is that it’s $21 per dose, which is nice, but as with any vaccination, patients can develop flu-like symptoms as side effects.”

Use of the HPV vaccine for treating cutaneous warts remains controversial, she continued, but it seems to work better in younger patients. In one open-label study that evaluated the HPV vaccine for the treatment of multiple recalcitrant warts, with doses administered at 0. 2, and 6 months, the response rate 3 months after the third dose was 55% among those older than age 26, compared with 84% among those ages 9-26 years.

Another option, intralesional cidofovir, has been shown to be especially effective for refractory warts. “It has also been shown to work for warts in immunocompetent and immunocompromised patients,” Dr. Adams said.

In the realm of adjuvant treatments, microneedling has been found to have similar efficacy to needling, Dr. Adams said, but with minimal pain. “When we combine it with topical treatments like 5-FU, it’s even more efficacious,” she said.

One study found that combining microneedling with topical 5-FU had clearance similar to that of intralesional 5-FU or microneedling alone, but involved fewer treatment sessions and less pain in the combination group.

Autoinoculation has been used to stimulate an immune response in patients with warts, leading to clearance rates of 4% (mild clearance) to 66% (complete clearance) in one study. “We would expect this to work better in immunocompetent patients, but it’s something to keep in mind if you’re limited in the medications you can get for a patient,” Dr. Adams said. Also, results from a systematic review and meta-analysis suggest that systemic retinoids combined with intralesional immunotherapy leads to higher clearance rates and lower rates of recurrence of warts. The top performer among those tested was acitretin plus Candida antigen.

Dr. Adams advised dermatologists who try alternatives to salicylic acid and cryotherapy for warts to be “wary of a lack of high-level evidence” for their use. “They can be helpful for patients who have failed traditional therapies or have a contraindication to the usual go-tos.”

She reported having no relevant financial disclosures.

SAN DIEGO — When Jennifer Adams, MD, recently entered the search term “warts” on the ClinicalTrials.gov web site, nearly 240 results popped up.

“There is a lot of research activity around this topic,” Dr. Adams, vice chair of the department of dermatology at the University of Nebraska Medical Center, said at the annual meeting of the American Academy of Dermatology. “We just don’t have fantastic, well-run trials on many of the currently available treatments.”

In a 2012 Cochrane review on the topical treatment of non-genital cutaneous warts, authors drew from 85 trials involving 8,815 randomized patients. They found that most warts spontaneously resolved, and the authors determined salicylic acid to be safe and modestly beneficial. Specifically, trials of salicylic acid (SA) versus placebo showed that the former significantly increased the chance of clearance of warts at all sites (risk ratio, 1.56, 95% confidence interval [CI], 1.20-2.03). A meta-analysis of cryotherapy versus placebo for warts at all sites favored neither intervention nor control (RR, 1.45, 95% CI, 0.65-3.23).

“The authors determined that there is less evidence for cryotherapy but stated that it may work when salicylic acid does not, or in combination with salicylic acid,” Dr. Adams said. “However, salicylic acid and cryotherapy don’t do enough for our patients [with warts]. There are a lot of situations where we need to reach further into the toolbox.”

A 2021 review article listed many options for managing difficult-to-treat warts, including intralesional Candida antigen, intralesional measles-mumps-rubella (MMR), intralesional HPV vaccine, intralesional vitamin D, intralesional cidofovir, intralesional bleomycin, and intralesional 5-FU injections, and topical vitamin D, topical cidofovir, and topical bleomycin. According to Dr. Adams, clinical data exist for cidofovir and vitamin D but studies evaluated different formulations, doses, sites of administration, and limited randomized controlled trials.

“Intralesional cidofovir is more effective than the topical form, but intralesional cidofovir can be painful and both forms are expensive,” she said. “Topical vitamin D is less likely to cause dyspigmentation compared to other available treatments, so it’s a great option in skin of color, but it has been less effective compared to some of our other topical treatments.”

[embed:render:related:node:261488]

Newer Options Promising

On the horizon, berdazimer gel was approved in January of 2024 for the treatment of molluscum but results from trials of its use for extragenital warts are encouraging. Another promising option is topical ionic contraviral therapy (ICVT) with digoxin and furosemide combined, which inhibits cellular potassium influx. A phase 2a randomized controlled trial of 80 adults found a statistically significant reduction in the diameter of cutaneous warts among those who received ICVT compared with those who received placebo (P = .002). “It’s cheap and well tolerated,” Dr. Adams added.

Intralesional approaches to treating warts offer another alternative. A 2020 review of 43 articles concluded that intralesional treatments for warts have equal or superior efficacy to first-line salicylic acid or cryotherapy.

Dr. Adams said that she considers intralesional treatments such as vitamin D, MMR vaccine antigen, and Candida antigen for refractory, numerous, or distant site warts. “Injecting the MMR vaccine into the largest wart every 2 weeks has been found to lead to complete clearance in 60%-68% of cases in one study,” she said. “The benefit is that it’s $21 per dose, which is nice, but as with any vaccination, patients can develop flu-like symptoms as side effects.”

Use of the HPV vaccine for treating cutaneous warts remains controversial, she continued, but it seems to work better in younger patients. In one open-label study that evaluated the HPV vaccine for the treatment of multiple recalcitrant warts, with doses administered at 0. 2, and 6 months, the response rate 3 months after the third dose was 55% among those older than age 26, compared with 84% among those ages 9-26 years.

Another option, intralesional cidofovir, has been shown to be especially effective for refractory warts. “It has also been shown to work for warts in immunocompetent and immunocompromised patients,” Dr. Adams said.

In the realm of adjuvant treatments, microneedling has been found to have similar efficacy to needling, Dr. Adams said, but with minimal pain. “When we combine it with topical treatments like 5-FU, it’s even more efficacious,” she said.

One study found that combining microneedling with topical 5-FU had clearance similar to that of intralesional 5-FU or microneedling alone, but involved fewer treatment sessions and less pain in the combination group.

Autoinoculation has been used to stimulate an immune response in patients with warts, leading to clearance rates of 4% (mild clearance) to 66% (complete clearance) in one study. “We would expect this to work better in immunocompetent patients, but it’s something to keep in mind if you’re limited in the medications you can get for a patient,” Dr. Adams said. Also, results from a systematic review and meta-analysis suggest that systemic retinoids combined with intralesional immunotherapy leads to higher clearance rates and lower rates of recurrence of warts. The top performer among those tested was acitretin plus Candida antigen.

Dr. Adams advised dermatologists who try alternatives to salicylic acid and cryotherapy for warts to be “wary of a lack of high-level evidence” for their use. “They can be helpful for patients who have failed traditional therapies or have a contraindication to the usual go-tos.”

She reported having no relevant financial disclosures.

SAN DIEGO — When Jennifer Adams, MD, recently entered the search term “warts” on the ClinicalTrials.gov web site, nearly 240 results popped up.

“There is a lot of research activity around this topic,” Dr. Adams, vice chair of the department of dermatology at the University of Nebraska Medical Center, said at the annual meeting of the American Academy of Dermatology. “We just don’t have fantastic, well-run trials on many of the currently available treatments.”

In a 2012 Cochrane review on the topical treatment of non-genital cutaneous warts, authors drew from 85 trials involving 8,815 randomized patients. They found that most warts spontaneously resolved, and the authors determined salicylic acid to be safe and modestly beneficial. Specifically, trials of salicylic acid (SA) versus placebo showed that the former significantly increased the chance of clearance of warts at all sites (risk ratio, 1.56, 95% confidence interval [CI], 1.20-2.03). A meta-analysis of cryotherapy versus placebo for warts at all sites favored neither intervention nor control (RR, 1.45, 95% CI, 0.65-3.23).

“The authors determined that there is less evidence for cryotherapy but stated that it may work when salicylic acid does not, or in combination with salicylic acid,” Dr. Adams said. “However, salicylic acid and cryotherapy don’t do enough for our patients [with warts]. There are a lot of situations where we need to reach further into the toolbox.”

A 2021 review article listed many options for managing difficult-to-treat warts, including intralesional Candida antigen, intralesional measles-mumps-rubella (MMR), intralesional HPV vaccine, intralesional vitamin D, intralesional cidofovir, intralesional bleomycin, and intralesional 5-FU injections, and topical vitamin D, topical cidofovir, and topical bleomycin. According to Dr. Adams, clinical data exist for cidofovir and vitamin D but studies evaluated different formulations, doses, sites of administration, and limited randomized controlled trials.

“Intralesional cidofovir is more effective than the topical form, but intralesional cidofovir can be painful and both forms are expensive,” she said. “Topical vitamin D is less likely to cause dyspigmentation compared to other available treatments, so it’s a great option in skin of color, but it has been less effective compared to some of our other topical treatments.”

[embed:render:related:node:261488]

Newer Options Promising

On the horizon, berdazimer gel was approved in January of 2024 for the treatment of molluscum but results from trials of its use for extragenital warts are encouraging. Another promising option is topical ionic contraviral therapy (ICVT) with digoxin and furosemide combined, which inhibits cellular potassium influx. A phase 2a randomized controlled trial of 80 adults found a statistically significant reduction in the diameter of cutaneous warts among those who received ICVT compared with those who received placebo (P = .002). “It’s cheap and well tolerated,” Dr. Adams added.

Intralesional approaches to treating warts offer another alternative. A 2020 review of 43 articles concluded that intralesional treatments for warts have equal or superior efficacy to first-line salicylic acid or cryotherapy.

Dr. Adams said that she considers intralesional treatments such as vitamin D, MMR vaccine antigen, and Candida antigen for refractory, numerous, or distant site warts. “Injecting the MMR vaccine into the largest wart every 2 weeks has been found to lead to complete clearance in 60%-68% of cases in one study,” she said. “The benefit is that it’s $21 per dose, which is nice, but as with any vaccination, patients can develop flu-like symptoms as side effects.”

Use of the HPV vaccine for treating cutaneous warts remains controversial, she continued, but it seems to work better in younger patients. In one open-label study that evaluated the HPV vaccine for the treatment of multiple recalcitrant warts, with doses administered at 0. 2, and 6 months, the response rate 3 months after the third dose was 55% among those older than age 26, compared with 84% among those ages 9-26 years.

Another option, intralesional cidofovir, has been shown to be especially effective for refractory warts. “It has also been shown to work for warts in immunocompetent and immunocompromised patients,” Dr. Adams said.

In the realm of adjuvant treatments, microneedling has been found to have similar efficacy to needling, Dr. Adams said, but with minimal pain. “When we combine it with topical treatments like 5-FU, it’s even more efficacious,” she said.

One study found that combining microneedling with topical 5-FU had clearance similar to that of intralesional 5-FU or microneedling alone, but involved fewer treatment sessions and less pain in the combination group.

Autoinoculation has been used to stimulate an immune response in patients with warts, leading to clearance rates of 4% (mild clearance) to 66% (complete clearance) in one study. “We would expect this to work better in immunocompetent patients, but it’s something to keep in mind if you’re limited in the medications you can get for a patient,” Dr. Adams said. Also, results from a systematic review and meta-analysis suggest that systemic retinoids combined with intralesional immunotherapy leads to higher clearance rates and lower rates of recurrence of warts. The top performer among those tested was acitretin plus Candida antigen.

Dr. Adams advised dermatologists who try alternatives to salicylic acid and cryotherapy for warts to be “wary of a lack of high-level evidence” for their use. “They can be helpful for patients who have failed traditional therapies or have a contraindication to the usual go-tos.”

She reported having no relevant financial disclosures.

SAN DIEGO — A novel formulation of polidocanol, an injectable synthetic non-ionic detergent that is approved by the US Food and Drug Administration (FDA) for sclerotherapy, may have a role in excess submental fat reduction, results from a phase 2b trial demonstrated.

The solution, also known as 10XB101, “has been demonstrated to cause adipolysis,” Kavita Darji, MD, an American Society for Dermatologic Surgery (ASDS) cosmetic and dermatologic laser surgery fellow at a practice in San Diego, said during a late-breaking session at the annual meeting of the American Academy of Dermatology. “It shows less inflammation and release of cytokines TNF-alpha and MCP-1 by macrophages than deoxycholic acid, which is currently used for submental fat reduction.”

Darji_Kavita_SANDIEGO_web.jpg

In a phase 2b clinical trial conducted at four sites, investigators enrolled 51 patients and assigned them to one of four dose cohorts: 2%, 3%, or 4.5% 10XB101, or vehicle. Each treatment consisted of up to 50 injections at 0.2 mL per injection, and they were administered up to six times 4 weeks apart. Study endpoints included a composite of the Clinician Submental Fat Score (CSFS) and Patient Submental Fat Score (PSFS) on a 0-4–point scale. The researchers graded local skin reactions such as erythema, edema, tenderness on palpation, bruising, pain, and burning/stinging as 0 (none), 1 (mild), 2 (moderate), or 3 (severe). They also obtained lab tests and performed electrocardiograms.

Dr. Darji and colleagues analyzed two populations: the intent to treat (ITT) population, which included all 51 enrolled subjects who received any injection of the test agent, and a completer population of 40 subjects. “These patients had at least four treatments or completed the treatments per protocol, completed the 4 weeks after final treatment assessments, or did not have any significant protocol deviations that would impact the evaluation of efficacy,” she explained.

To compare how 10XB101 performed compared with deoxycholic acid (Kybella), which is approved by the FDA to improve the appearance of moderate to severe submental fat, the researchers drew from pooled findings of Refine 1 and 2, in which adults received up to six treatment sessions with deoxycholic acid or placebo.

The ITT analysis of the 3% and 4.5% 10XB101 dose groups showed about a fourfold increase in a 2-grade or better improvement in the composite endpoint relative to the pooled findings of deoxycholic acid (62% vs. 16%, respectively). In addition, 80% of the completer population achieved a 2-grade improvement in the composite endpoint. “Importantly, 10% to 33% also received a 3-grade improvement, depending on the dose they were assigned to,” Dr. Darji said.

On average, patients in both cohorts achieved a 1-grade improvement after two treatments, and about 50% achieved a 2-grade improvement after four treatments — which is consistent with a more rapid onset when compared with deoxycholic acid, she said.

[embed:render:related:node:267078]

Both study endpoints were achieved by 31% of patients in the ITT group vs. 33% of completers, respectively, with the 2% dose; 62% vs. 80% with the 3% dose; and 54% vs. 79% for the 4.5% dose. “This is a 2- to 5-times increase in success” when compared with the results of deoxycholic acid in the published pooled analysis, Dr. Darji said. The researchers measured adverse events by spontaneous and elicited reports and by assessments of recorded local skin reactions. They found that 80% of all measured local skin reactions rated as 0 while 98% of all measured local skin reactions rated as a 0 or 1. One myocardial infarction occurred, which was mild and resolved. This case was not related to the study drug, Dr. Darji said in an interview after the meeting. Otherwise, no safety laboratory or ECG signals were noted.

In findings limited to the 3% dose of 10XB101, mild bruising occurred in 8% of patients at postinjection visit 2, 18% of those at postinjection visit 3, 20% of those at postinjection visit 4, and in 20% of those at postinjection visit 5. Reports of mild pain/burning/stinging occurred in 8% of patients at postinjection visit 2 but at no other subsequent visits. Meanwhile, edema occurred in 42% of patients at postinjection visit 2, 45% of those at postinjection visit 3, 50% of those at postinjection visits 4 and 5, and 38% of those at postinjection visit 6.

“Patients resumed normal activity within 1-3 days and had fewer side effects that lasted longer than 30 days,” Dr. Darji concluded, adding that the results “imply a potential opportunity to expand the treatment to other anatomic areas, which is a future direction.”

One of the session moderators, Andrew Blauvelt, MD, MBA, of Oregon Medical Research Center, Portland, noted that the study was not a head-to-head trial of polidocanol vs. deoxycholic acid, so he cautioned against drawing strong conclusions about the comparative data presented.

Asked to comment on the results Lawrence J. Green, MD, of the department of dermatology at George Washington University, Washington, said that 10XB101 “showed excellent efficacy with much fewer adverse events when compared to what we found in studies with Kybella, the only currently FDA-approved injection for submental fat reduction.”

Green_Lawrence_J_MD_web.jpg

In addition, “much less pain after injection was to me the most obvious differentiator between this and Kybella studies. I look forward to seeing if larger studies confirm the efficacy and safety from this phase 2 study, as 10XB101 has potential to be a more effective, and safer option to reduce submental fat,” he added. He was not involved with the study.

Dr. Darji reported having no disclosures. Mitchel P. Goldman, MD, the study’s lead investigator, is a minority investor in 10XBio, which is developing 10XB101. Dr. Blauvelt and Dr. Green disclosed conflicts of interest from many pharmaceutical companies.

SAN DIEGO — A novel formulation of polidocanol, an injectable synthetic non-ionic detergent that is approved by the US Food and Drug Administration (FDA) for sclerotherapy, may have a role in excess submental fat reduction, results from a phase 2b trial demonstrated.

The solution, also known as 10XB101, “has been demonstrated to cause adipolysis,” Kavita Darji, MD, an American Society for Dermatologic Surgery (ASDS) cosmetic and dermatologic laser surgery fellow at a practice in San Diego, said during a late-breaking session at the annual meeting of the American Academy of Dermatology. “It shows less inflammation and release of cytokines TNF-alpha and MCP-1 by macrophages than deoxycholic acid, which is currently used for submental fat reduction.”

Darji_Kavita_SANDIEGO_web.jpg

In a phase 2b clinical trial conducted at four sites, investigators enrolled 51 patients and assigned them to one of four dose cohorts: 2%, 3%, or 4.5% 10XB101, or vehicle. Each treatment consisted of up to 50 injections at 0.2 mL per injection, and they were administered up to six times 4 weeks apart. Study endpoints included a composite of the Clinician Submental Fat Score (CSFS) and Patient Submental Fat Score (PSFS) on a 0-4–point scale. The researchers graded local skin reactions such as erythema, edema, tenderness on palpation, bruising, pain, and burning/stinging as 0 (none), 1 (mild), 2 (moderate), or 3 (severe). They also obtained lab tests and performed electrocardiograms.

Dr. Darji and colleagues analyzed two populations: the intent to treat (ITT) population, which included all 51 enrolled subjects who received any injection of the test agent, and a completer population of 40 subjects. “These patients had at least four treatments or completed the treatments per protocol, completed the 4 weeks after final treatment assessments, or did not have any significant protocol deviations that would impact the evaluation of efficacy,” she explained.

To compare how 10XB101 performed compared with deoxycholic acid (Kybella), which is approved by the FDA to improve the appearance of moderate to severe submental fat, the researchers drew from pooled findings of Refine 1 and 2, in which adults received up to six treatment sessions with deoxycholic acid or placebo.

The ITT analysis of the 3% and 4.5% 10XB101 dose groups showed about a fourfold increase in a 2-grade or better improvement in the composite endpoint relative to the pooled findings of deoxycholic acid (62% vs. 16%, respectively). In addition, 80% of the completer population achieved a 2-grade improvement in the composite endpoint. “Importantly, 10% to 33% also received a 3-grade improvement, depending on the dose they were assigned to,” Dr. Darji said.

On average, patients in both cohorts achieved a 1-grade improvement after two treatments, and about 50% achieved a 2-grade improvement after four treatments — which is consistent with a more rapid onset when compared with deoxycholic acid, she said.

[embed:render:related:node:267078]

Both study endpoints were achieved by 31% of patients in the ITT group vs. 33% of completers, respectively, with the 2% dose; 62% vs. 80% with the 3% dose; and 54% vs. 79% for the 4.5% dose. “This is a 2- to 5-times increase in success” when compared with the results of deoxycholic acid in the published pooled analysis, Dr. Darji said. The researchers measured adverse events by spontaneous and elicited reports and by assessments of recorded local skin reactions. They found that 80% of all measured local skin reactions rated as 0 while 98% of all measured local skin reactions rated as a 0 or 1. One myocardial infarction occurred, which was mild and resolved. This case was not related to the study drug, Dr. Darji said in an interview after the meeting. Otherwise, no safety laboratory or ECG signals were noted.

In findings limited to the 3% dose of 10XB101, mild bruising occurred in 8% of patients at postinjection visit 2, 18% of those at postinjection visit 3, 20% of those at postinjection visit 4, and in 20% of those at postinjection visit 5. Reports of mild pain/burning/stinging occurred in 8% of patients at postinjection visit 2 but at no other subsequent visits. Meanwhile, edema occurred in 42% of patients at postinjection visit 2, 45% of those at postinjection visit 3, 50% of those at postinjection visits 4 and 5, and 38% of those at postinjection visit 6.

“Patients resumed normal activity within 1-3 days and had fewer side effects that lasted longer than 30 days,” Dr. Darji concluded, adding that the results “imply a potential opportunity to expand the treatment to other anatomic areas, which is a future direction.”

One of the session moderators, Andrew Blauvelt, MD, MBA, of Oregon Medical Research Center, Portland, noted that the study was not a head-to-head trial of polidocanol vs. deoxycholic acid, so he cautioned against drawing strong conclusions about the comparative data presented.

Asked to comment on the results Lawrence J. Green, MD, of the department of dermatology at George Washington University, Washington, said that 10XB101 “showed excellent efficacy with much fewer adverse events when compared to what we found in studies with Kybella, the only currently FDA-approved injection for submental fat reduction.”

Green_Lawrence_J_MD_web.jpg

In addition, “much less pain after injection was to me the most obvious differentiator between this and Kybella studies. I look forward to seeing if larger studies confirm the efficacy and safety from this phase 2 study, as 10XB101 has potential to be a more effective, and safer option to reduce submental fat,” he added. He was not involved with the study.

Dr. Darji reported having no disclosures. Mitchel P. Goldman, MD, the study’s lead investigator, is a minority investor in 10XBio, which is developing 10XB101. Dr. Blauvelt and Dr. Green disclosed conflicts of interest from many pharmaceutical companies.

SAN DIEGO — A novel formulation of polidocanol, an injectable synthetic non-ionic detergent that is approved by the US Food and Drug Administration (FDA) for sclerotherapy, may have a role in excess submental fat reduction, results from a phase 2b trial demonstrated.

The solution, also known as 10XB101, “has been demonstrated to cause adipolysis,” Kavita Darji, MD, an American Society for Dermatologic Surgery (ASDS) cosmetic and dermatologic laser surgery fellow at a practice in San Diego, said during a late-breaking session at the annual meeting of the American Academy of Dermatology. “It shows less inflammation and release of cytokines TNF-alpha and MCP-1 by macrophages than deoxycholic acid, which is currently used for submental fat reduction.”

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In a phase 2b clinical trial conducted at four sites, investigators enrolled 51 patients and assigned them to one of four dose cohorts: 2%, 3%, or 4.5% 10XB101, or vehicle. Each treatment consisted of up to 50 injections at 0.2 mL per injection, and they were administered up to six times 4 weeks apart. Study endpoints included a composite of the Clinician Submental Fat Score (CSFS) and Patient Submental Fat Score (PSFS) on a 0-4–point scale. The researchers graded local skin reactions such as erythema, edema, tenderness on palpation, bruising, pain, and burning/stinging as 0 (none), 1 (mild), 2 (moderate), or 3 (severe). They also obtained lab tests and performed electrocardiograms.

Dr. Darji and colleagues analyzed two populations: the intent to treat (ITT) population, which included all 51 enrolled subjects who received any injection of the test agent, and a completer population of 40 subjects. “These patients had at least four treatments or completed the treatments per protocol, completed the 4 weeks after final treatment assessments, or did not have any significant protocol deviations that would impact the evaluation of efficacy,” she explained.

To compare how 10XB101 performed compared with deoxycholic acid (Kybella), which is approved by the FDA to improve the appearance of moderate to severe submental fat, the researchers drew from pooled findings of Refine 1 and 2, in which adults received up to six treatment sessions with deoxycholic acid or placebo.

The ITT analysis of the 3% and 4.5% 10XB101 dose groups showed about a fourfold increase in a 2-grade or better improvement in the composite endpoint relative to the pooled findings of deoxycholic acid (62% vs. 16%, respectively). In addition, 80% of the completer population achieved a 2-grade improvement in the composite endpoint. “Importantly, 10% to 33% also received a 3-grade improvement, depending on the dose they were assigned to,” Dr. Darji said.

On average, patients in both cohorts achieved a 1-grade improvement after two treatments, and about 50% achieved a 2-grade improvement after four treatments — which is consistent with a more rapid onset when compared with deoxycholic acid, she said.

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Both study endpoints were achieved by 31% of patients in the ITT group vs. 33% of completers, respectively, with the 2% dose; 62% vs. 80% with the 3% dose; and 54% vs. 79% for the 4.5% dose. “This is a 2- to 5-times increase in success” when compared with the results of deoxycholic acid in the published pooled analysis, Dr. Darji said. The researchers measured adverse events by spontaneous and elicited reports and by assessments of recorded local skin reactions. They found that 80% of all measured local skin reactions rated as 0 while 98% of all measured local skin reactions rated as a 0 or 1. One myocardial infarction occurred, which was mild and resolved. This case was not related to the study drug, Dr. Darji said in an interview after the meeting. Otherwise, no safety laboratory or ECG signals were noted.

In findings limited to the 3% dose of 10XB101, mild bruising occurred in 8% of patients at postinjection visit 2, 18% of those at postinjection visit 3, 20% of those at postinjection visit 4, and in 20% of those at postinjection visit 5. Reports of mild pain/burning/stinging occurred in 8% of patients at postinjection visit 2 but at no other subsequent visits. Meanwhile, edema occurred in 42% of patients at postinjection visit 2, 45% of those at postinjection visit 3, 50% of those at postinjection visits 4 and 5, and 38% of those at postinjection visit 6.

“Patients resumed normal activity within 1-3 days and had fewer side effects that lasted longer than 30 days,” Dr. Darji concluded, adding that the results “imply a potential opportunity to expand the treatment to other anatomic areas, which is a future direction.”

One of the session moderators, Andrew Blauvelt, MD, MBA, of Oregon Medical Research Center, Portland, noted that the study was not a head-to-head trial of polidocanol vs. deoxycholic acid, so he cautioned against drawing strong conclusions about the comparative data presented.

Asked to comment on the results Lawrence J. Green, MD, of the department of dermatology at George Washington University, Washington, said that 10XB101 “showed excellent efficacy with much fewer adverse events when compared to what we found in studies with Kybella, the only currently FDA-approved injection for submental fat reduction.”

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In addition, “much less pain after injection was to me the most obvious differentiator between this and Kybella studies. I look forward to seeing if larger studies confirm the efficacy and safety from this phase 2 study, as 10XB101 has potential to be a more effective, and safer option to reduce submental fat,” he added. He was not involved with the study.

Dr. Darji reported having no disclosures. Mitchel P. Goldman, MD, the study’s lead investigator, is a minority investor in 10XBio, which is developing 10XB101. Dr. Blauvelt and Dr. Green disclosed conflicts of interest from many pharmaceutical companies.

The Food and Drug Administration (FDA) has approved spesolimab-sbzo, an interleukin (IL)-36 receptor antagonist, for the treatment of generalized pustular psoriasis (GPP) in adults and in pediatric patients aged ≥ 12 years who weigh ≥ 40 kg, according to an announcement from the manufacturer. 

This is an expanded indication for spesolimab-sbzo, first approved in September 2022 for treating GPP flares. Developed by Boehringer Ingelheim and marketed under the name Spevigo, the product is an injectable antibody that blocks the IL-36 receptor, a key part of the pathway shown to be involved in the cause of GPP, which is rare and is a potentially-life-threatening disease.

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According to a press release from the company, the FDA’s approval of the expanded indication was based on the results of a 48-week clinical trial of 123 patients (Effisayil 2), which showed that individuals who received spesolimab experienced a significant 84% reduction in GPP flares compared with those who received placebo. Among 30 study participants who received a high treatment dose, no flares were observed after week 4. Among all patients who received spesolimab-sbzo, treatment was associated with an increased incidence (defined as ≥ 9 cases per 100 patient-years) of injection site reactions, urinary tract infections, arthralgia, and pruritus compared with placebo. 

Spesolimab-sbzo is currently available in 48 countries, according to the Boehringer Ingelheim release, which states that the approval makes it the first targeted therapy that is available for the acute and chronic treatment of patients with GPP.

A version of this article appeared on Medscape.com.

The Food and Drug Administration (FDA) has approved spesolimab-sbzo, an interleukin (IL)-36 receptor antagonist, for the treatment of generalized pustular psoriasis (GPP) in adults and in pediatric patients aged ≥ 12 years who weigh ≥ 40 kg, according to an announcement from the manufacturer. 

This is an expanded indication for spesolimab-sbzo, first approved in September 2022 for treating GPP flares. Developed by Boehringer Ingelheim and marketed under the name Spevigo, the product is an injectable antibody that blocks the IL-36 receptor, a key part of the pathway shown to be involved in the cause of GPP, which is rare and is a potentially-life-threatening disease.

[embed:render:related:node:266450]

According to a press release from the company, the FDA’s approval of the expanded indication was based on the results of a 48-week clinical trial of 123 patients (Effisayil 2), which showed that individuals who received spesolimab experienced a significant 84% reduction in GPP flares compared with those who received placebo. Among 30 study participants who received a high treatment dose, no flares were observed after week 4. Among all patients who received spesolimab-sbzo, treatment was associated with an increased incidence (defined as ≥ 9 cases per 100 patient-years) of injection site reactions, urinary tract infections, arthralgia, and pruritus compared with placebo. 

Spesolimab-sbzo is currently available in 48 countries, according to the Boehringer Ingelheim release, which states that the approval makes it the first targeted therapy that is available for the acute and chronic treatment of patients with GPP.

A version of this article appeared on Medscape.com.

The Food and Drug Administration (FDA) has approved spesolimab-sbzo, an interleukin (IL)-36 receptor antagonist, for the treatment of generalized pustular psoriasis (GPP) in adults and in pediatric patients aged ≥ 12 years who weigh ≥ 40 kg, according to an announcement from the manufacturer. 

This is an expanded indication for spesolimab-sbzo, first approved in September 2022 for treating GPP flares. Developed by Boehringer Ingelheim and marketed under the name Spevigo, the product is an injectable antibody that blocks the IL-36 receptor, a key part of the pathway shown to be involved in the cause of GPP, which is rare and is a potentially-life-threatening disease.

[embed:render:related:node:266450]

According to a press release from the company, the FDA’s approval of the expanded indication was based on the results of a 48-week clinical trial of 123 patients (Effisayil 2), which showed that individuals who received spesolimab experienced a significant 84% reduction in GPP flares compared with those who received placebo. Among 30 study participants who received a high treatment dose, no flares were observed after week 4. Among all patients who received spesolimab-sbzo, treatment was associated with an increased incidence (defined as ≥ 9 cases per 100 patient-years) of injection site reactions, urinary tract infections, arthralgia, and pruritus compared with placebo. 

Spesolimab-sbzo is currently available in 48 countries, according to the Boehringer Ingelheim release, which states that the approval makes it the first targeted therapy that is available for the acute and chronic treatment of patients with GPP.

A version of this article appeared on Medscape.com.