The most , according to a review published in the British Journal of Dermatology.
These findings underscore the mechanistic elegance of interleukin (IL)-13 inhibition and highlight potential advantages of flexible dosing, according to the study’s lead author, Eric Simpson, MD, MCR. Overall, the pooled analysis of safety data from five phase 2 and 3 trials shows that “blockade of a single cytokine provides excellent short- and long-term safety, which is useful for a severe chronic disease,” said Dr. Simpson, professor of dermatology at Oregon Health & Science University in Portland.
Dr. Eric Simpson
Most patients with AD require years of treatment. “So for clinicians to confidently report to patients the low rates of serious adverse events (AEs) and lack of immune suppression side-effect profile is very encouraging for both the provider and patient,” Dr. Simpson said, noting there were no new signals or concerning short-term AEs.
Tralokinumab (Adbry), an IL-13 antagonist administered subcutaneously, was approved by the Food and Drug Administration for treatment of moderate to severe AD in adults in December 2021.
Minor differences vs. placebo
In the pooled analysis involving 1,605 patients treated for 16 weeks with tralokinumab and 680 who received placebo, frequency of any AE was 65.7% and 67.2%, respectively. Severe AEs occurred in 4.6% and 6.3% of patients, respectively.
The most common AE overall was AD, which occurred less often in tralokinumab-treated patients (15.4%) than those on placebo (26.2%). Other common AEs that occurred more frequently with tralokinumab included viral upper respiratory tract infections (15.7% vs. 12.2%), upper respiratory tract infections (URTI, 5.6% vs. 4.8%), conjunctivitis (5.4% vs. 1.9%), and injection-site reactions (3.5% vs. 0.3%).
AEs that occurred less often with tralokinumab than placebo included skin infections (3.7% vs. 9.2%, respectively) and infected dermatitis (1.6% vs. 6.4%).
Regarding safety areas of special interest, eye disorders classified as conjunctivitis, keratoconjunctivitis, or keratitis occurred more commonly with tralokinumab (7.9%) than placebo (3.4%). Most eye disorders were mild or moderate and resolved during the study. During maintenance treatment up to 52 weeks, AE rates mirrored those in the initial treatment period and did not increase with treatment duration.
In fact, Dr. Simpson said, the low rate of AEs that are known to accompany type 2 blockade, such as conjunctivitis, do not increase but rather appear to drop with longer-term use. The fact that skin infections were reduced vs. placebo and decreased over time suggests that long-term IL-13 blockade with tralokinumab positively impacts skin infections, a well-known comorbidity in uncontrolled AD, he added.
Raj Chovatiya, MD, PhD, who was asked to comment on the study, said, “These findings provide additional data supporting the safety and tolerability of tralokinumab and support my personal real-world experience with tralokinumab as a safe and effective biologic therapy for patients with moderate to severe AD.”
Dr. Raj Chovatiya
Dr. Chovatiya is assistant professor, director of the Center for Eczema and Itch, and medical director of clinical trials at Northwestern University in Chicago.