Real-World Comparative Effectiveness and Safety of Upadacitinib Plus Vedolizumab Versus Upadacitinib Monotherapy During Induction in Moderate-to-Severe Ulcerative Colitis: A Multicenter Retrospective Cohort Study
This multicenter retrospective cohort study evaluates the real-world effectiveness and safety of upadacitinib used alone or in combination with vedolizumab in adult patients with moderate-to-severe ulcerative colitis (UC). UC is a chronic inflammatory bowel disease that often requires long-term management, and monotherapy may reach a therapeutic ceiling in clinical practice. Combination therapy with upadacitinib, a rapid-acting oral JAK inhibitor, and vedolizumab, a gut-selective biologic, may provide complementary benefits. The study uses existing clinical and laboratory data from six Chinese IBD centers to compare short-term outcomes, including clinical remission, clinical response, endoscopic remission, normalization of C-reactive protein, and occurrence of adverse events during the 8-week induction period. This study reflects routine clinical practice and aims to provide real-world evidence to support treatment decisions in patients with moderate-to-severe UC.
• Age ≥18 years at the time of treatment initiation.
• Established diagnosis of ulcerative colitis (UC) for at least 3 months prior to index date, confirmed by compatible clinical presentation, endoscopic findings, and histopathological evidence.
• Moderately to severely active disease at baseline, defined as a modified Mayo score ≥4 with an endoscopic subscore (ESS) ≥2.
• Initiation of treatment with upadacitinib, either as monotherapy or in combination with vedolizumab, in routine clinical practice at participating centers.
• Availability of baseline clinical assessment and follow-up data at 8 weeks after initiation of upadacitinib.