Published online Oct 16, 2026. doi: 10.4253/wjge.125564
Revised: August 13, 2026
Accepted: October 9, 2026
Published online: October 16, 2026
Processing time: 95 Days and 14 Hours
Upadacitinib has been approved for the treatment of patients with moderate-to-severe Crohn’s disease (CD) and ulcerative colitis (UC). Observational studies on the use of upadacitinib in inflammatory bowel disease (IBD) outside regulatory trials remain limited.
To evaluate real-world effectiveness and adverse events (AEs) profile of upa
This is an observational cohort study in patients with refractory IBD [CD: 43; UC: 42; indefinite colitis: 1; pouchitis: 1; mean age: 40.1 years (SD = 12.9); median disease duration: 6 years (interquartile range: 2.5-13); extra-intestinal manifestations: 44 (50.6%)], who received treatment with upadacitinib. Our primary endpoint was treatment persistence. Secondary endpoints included clinical remission, corticosteroid- and intensification-free treatment persistence and endoscopic remission rates. AEs were also reported.
Eighty-six patients were exposed to ≥ 1 advanced therapy and 40.2% received concomitant corticosteroids at baseline. Seventy patients (80.5%) remained on upadacitinib (median duration: 66 weeks, interquartile range: 30-88) by the end of follow-up. Treatment persistence was higher in UC (88.1% vs 72.1% in CD, P = 0.046). Clinical remission at one-year was achieved in 63.3%, corticosteroid-free remission in 51.7%, and intensification-free remission in 58.3%. In patients with UC, smoking (P = 0.014) and baseline C-reactive protein (P = 0.029) were associated with earlier treatment discontinuation, whereas, male sex (P = 0.037) and extensive disease (P = 0.045) with earlier discontinuation or need for intensification. Endoscopic remission was achieved in 41.2% (7/17) of CD and 65.2% (15/23) of UC patients. In multivariate regression, endoscopic remission was associated with female sex (P = 0.039) and UC (P = 0.041). AEs were reported in 48 patients, primarily infections (24.1%) and acne (21.8%).
In this real-world cohort of patients with IBD who were refractory to multiple prior advanced therapies, upada
Core Tip: Our real-world study demonstrates that upadacitinib is an effective and well-tolerated treatment for patients with advanced therapy-refractory inflammatory bowel disease. Over a median follow-up of 66 weeks, upadacitinib showed high treatment persistence and clinical remission rates, particularly in patients with ulcerative colitis. Moreover, our study identifies baseline predictors for treatment discontinuation or intensification of upadacitinib in patients with ulcerative colitis, as well as predictors of endoscopic remission in both ulcerative colitis and Crohn’s disease, thus, providing insights into personalized management of patients.