according to results from a real-world study at a Chicago treatment center.
The results suggest that upadacitinib may be an appropriate salvage treatment for patients who have failed other advanced therapies, including tofacitinib.
Dr. Scott Friedberg
For their research, published in Clinical Gastroenterology and Hepatology, Scott Friedberg, MD, and colleagues at the University of Chicago’s Inflammatory Bowel Disease Center, looked at results from 44 patients diagnosed with ulcerative colitis and 40 with Crohn’s disease, all with active luminal or perianal disease. All patients in the study had previous exposure to tumor necrosis factor inhibitors, and nearly 90% had exposure to two or more advanced therapies, including tofacitinib (n = 17), before being switched to upadacitinib.
Upadacitinib (Rinvoq, AbbVie) is the second small-molecule Janus kinase (JAK) inhibitor approved for ulcerative colitis by the Food and Drug Administration in March 2022 after tofacitinib (Xeljanz, Pfizer) in 2018. Upadacitinib received an additional indication in May 2023 as a treatment for Crohn’s disease. It selectively inhibits JAK1, while tofacitinib inhibits JAK1 and JAK3.
Among the ulcerative colitis patients in Dr. Friedberg and colleagues’ study (mean age, 39 years; 48% female), 85% had a clinical response and 82% achieved clinical remission by week 8. Of nine patients previously treated with tofacitinib, seven (78%) achieved remission at 8 weeks.
Some 76% of the Crohn’s disease patients in the study (mean age, 37 years; 53% female) saw clinical response by 8 weeks, and 71% achieved remission by that time. More than 60% of all participants who had increased fecal calprotectin and C-reactive protein levels at baseline saw normalization of these biomarkers by week 8.
Some patients saw an especially fast response, with 36% of the ulcerative colitis patients and 56% of the Crohn’s patients experiencing clinical remission by week 2.
Acne was the most common reported adverse event, occurring in 23% of patients. Only one serious adverse event, an anemia requiring hospitalization, occurred during the study.
No wash-out period occurred before starting patients on upadacitinib. There were no adverse events seen associated with this strategy, Dr. Friedberg and colleagues noted, a finding with important implications for real-world practice.
“When patients with active IBD are sick, starting a new therapy as soon as it is available is not only reasonable, it is required,” the investigators wrote. Additionally, the findings support the use of upadacitinib in ulcerative colitis patients with previous exposure to tofacitinib, as “selectivity of JAK targets may have different effectiveness profiles.”
Upadacitinib’s rapid onset “has multiple advantages,” the investigators wrote, “not only by being an option for severely active disease but also by allowing for a rapid taper or complete avoidance of corticosteroids.”
The authors noted their study’s small sample size as a key limitation. Several of Dr. Friedberg’s coauthors disclosed financial relationships with drug manufacturers, including AbbVie.
