Real-World Effectiveness and Safety of Upadacitinib in Crohn's Disease: A Multicenter Study.

Abstract

Background & aims: We aimed to describe the real-world effectiveness and safety of upadacitinib (UPA), an oral Janus kinase 1 inhibitor, in patients with Crohn's disease (CD).

Methods: A retrospective analysis was conducted across 9 centers in the United States, focusing on adults with CD treated with UPA, 45 mg, as induction therapy for active luminal disease. The coprimary end points were clinical remission at 12 weeks (Harvey Bradshaw Index ≤4 or absence of symptoms on physician's global assessment) and endoscopic remission at 6 months (Simplified Endoscopic Mucosal Assessment for Crohn's Disease score of 0-1 or absence of ulcers). Secondary outcomes included clinical, radiographic, and histologic outcomes, and adverse events.

Results: The study included 334 patients with CD (median age, 34 years; disease duration, 12 years; 44.6% female). Clinical remission was achieved in 52.1% at 12 weeks and 55.9% at 6 months. Endoscopic remission at 6 months was observed in 42.7% of patients. Advanced therapy-naive patients achieved a higher proportion of clinical remission at 12 weeks (58.6%) and 6 months (97.7%) compared with patients with 1 prior advanced therapy (53.3% and 66.7%) and 2 or more prior advanced therapy exposures (50.2% and 40.5%), respectively. Body mass index and longer disease duration was associated with lower odds of clinical remission at 12 weeks. Adverse events were reported in 13.5% and UPA discontinued in 19.1%.

Conclusions: UPA was effective at inducing clinical and endoscopic remission in a real-world group of patients with CD, even with prior exposure to multiple prior advanced therapies. No new safety concerns were identified.