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Upadacitinib Improves Outcomes in Fistulizing Crohn’s Disease

Rebecca Mashaw
09/04/2025

In a post hoc analysis of the phase 3 U-EXCEL, U-EXCEED, and U-ENDURE trials, upadacitinib demonstrated significant efficacy in patients with fistulizing Crohn’s disease, particularly perianal disease, investigators reported.

The induction trials randomized patients 2:1 to receive once-daily upadacitinib 45 mg or placebo for 12 weeks. Clinical responders to upadacitinib were rerandomized to receive 15 mg, 30 mg, or placebo for 52 weeks during the maintenance phase. Efficacy outcomes included resolution of drainage, closure of external openings, clinical remission, endoscopic response, and safety.

Of 1021 trial participants, 143 (14.0%) had fistulas at baseline, with most (n = 128) presenting with perianal fistulas (56 draining). During induction, upadacitinib 45 mg achieved significantly greater resolution of drainage of perianal fistulas compared with placebo (44.7% [17/38] vs 5.6% [1/18]; P = .003). In maintenance, rates of drainage resolution were higher with upadacitinib 15 mg (28.6% [4/14]) and 30 mg (23.1% [3/13]) compared with placebo (0%), though not all differences reached statistical significance.

Closure of perianal fistula external openings was also superior with upadacitinib. During induction, closure was achieved in 22.1% (19/86) of patients receiving 45 mg versus 4.8% (2/42) with placebo (P = .013). In maintenance, closure rates were significantly greater with upadacitinib 15 mg (18.8% [6/32]; P = .024) and 30 mg (16.0% [4/25]; P = .037) compared with placebo (0%).© 2025 HMP Global. All Rights Reserved.

Overall, upadacitinib treatment resulted in higher rates of drainage resolution, fistula closure, clinical remission, and endoscopic response compared with placebo in patients with fistulizing Crohn’s disease, suggesting it may offer meaningful therapeutic benefit for this difficult-to-treat population.

 

Reference:

Colombel JF, Lacerda AP, Irving PM, et al. Efficacy of upadacitinib in patients with fistulizing Crohn’s disease: post hoc analysis of phase 3 trials. Clin Gastroenterol Hepatol. 2025;23(6):1019-1029. doi:10.1016/j.cgh.2024.08.032

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