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The following is a summary of “Real-World Effectiveness and Safety of Upadacitinib in Crohn’s Disease: A Multi-Centre Study,” published in the March 2025 issue of Clinical Gastroenterology and Hepatology by Devi et al.

This study evaluates the real-world effectiveness and safety of upadacitinib (UPA), a selective Janus kinase 1 (JAK1) inhibitor, in patients with Crohn’s disease (CD), providing insights into its role in clinical and endoscopic remission. A retrospective analysis was conducted across nine medical centers in the United States, including older adult patients with active luminal CD who received UPA 45 mg as induction therapy. The co-primary endpoints were clinical remission at 12 weeks, defined as a Harvey-Bradshaw Index score ≤ 4 or absence of symptoms based on the physician’s global assessment, and endoscopic remission at 6 months, defined by a Simplified Endoscopic Mucosal Assessment for Crohn’s Disease score of 0-1 or absence of ulcers. 

Secondary outcomes encompassed clinical, radiographic, and histologic responses, as well as adverse events. A total of 334 patients were included, with a median age of 34 years, median disease duration of 12 years, and 44.6% female representation. Clinical remission was observed in 52.1% of patients at 12 weeks and 55.9% at 6 months, while endoscopic remission at 6 months was achieved in 42.7% of cases. The response to UPA varied based on prior exposure to advanced therapies, with patients with AT-naïve achieving superior clinical remission rates at both 12 weeks (58.6%) and 6 months (97.7%) compared to those with prior AT exposure—53.3% and 66.7% for patients with one prior AT, and 50.2% and 40.5% for those with two or more prior ATs, respectively. Furthermore, a higher body mass index (BMI) and longer disease duration were associated with lower odds of achieving clinical remission at 12 weeks. The overall safety profile was consistent with prior clinical trial data, with AEs reported in 13.5% of patients and UPA discontinuation in 19.1%. No new safety concerns were identified. 

These findings reinforce the efficacy of UPA in achieving clinical and endoscopic remission in a diverse CD population, including those previously exposed to multiple advanced therapies. The study highlights the potential role of UPA in the evolving treatment landscape of CD, though further research is warranted to refine patient selection criteria and optimize therapeutic strategies.

Source: sciencedirect.com/science/article/pii/S1542356525001545