Background: Real-world data on the effectiveness of upadacitinib for inflammatory bowel disease (IBD) are limited.
Aims: To assess upadacitinib persistence, effectiveness, and safety in a real-world scenario.
Methods: Retrospective multicentre study of IBD patients who received upadacitinib before 31st December 2022 and at least 12 weeks before the recruitment date. Clinical effectiveness was assessed based on partial Mayo score for ulcerative colitis (UC) and Harvey-Bradshaw index for Crohn's disease (CD).
Results: We included 100 patients (68 with CD, and 32 with UC). Patients had previously received a median of four advanced therapies. Twenty-three discontinued the treatment (median follow-up 7.6 months). CD (vs. UC) (Hazard Ratio[HR] 3.7;95%Confidence Interval (CI):1.04-12.9), and age below 40 years at upadacitinib initiation (HR 2.4;95%CI:1.0-5.8) were associated with treatment discontinuation in multivariable analysis. Clinical remission for IBD was achieved in 59% of patients at week 8, 64% at week 12, and 42% at week 52. The proportion of patients with UC previously exposed to tofacitinib (n=25) who achieved clinical remission was 78% at week 12, and 50% at week 52. Factors associated with clinical remission at week 12 were UC diagnosis (Odds Ratio[OR] 4.6;95%CI:1.3-17), mild or moderate activity at baseline (OR 8;95%CI:1.1-56) and not smoking (OR 4.4;95%CI:1.5-13). Dose escalation recaptured remission in 60% of patients with relapse. Eighty percent of patients with active immune-mediated diseases or extraintestinal manifestations improved with upadacitinib. Forty-three patients reported adverse events, 11 of them serious.
Conclusion: Upadacitinib is effective and safe for treating highly refractory IBD patients, even in previously treated with JAK inhibitors.
Copyright © 2024 by The American College of Gastroenterology.