Comparative Effectiveness and Safety of Upadacitinib and Vedolizumab in Biologic-Experienced Patients With Ulcerative...

Upadacitinib (UPA) and vedolizumab (VDZ) have been approved to treat moderate-to-severe ulcerative colitis (UC); however, direct comparative data between these two regimens are lacking. We aimed to compare the effectiveness and safety of UPA and VDZ among patients with moderate-to-severe UC who had previously been treated with advanced therapies.

Patients with moderate-to-severe UC receiving VDZ or UPA for at least 14 weeks following advanced therapy failure, including at least one anti-tumor necrosis factor (TNF) agent, between 2015 and 2024, were retrospectively recruited. Clinical response and remission were defined by the Partial Mayo Score and the Simple Clinical Colitis Activity Index. The safety profile during the treatment was also compared.

Altogether 66 patients treated with VDZ and 22 patients with UPA were included. The median age of the VDZ and UPA groups was 38 and 37 years, respectively. Patients receiving UPA achieved significantly higher rates of corticosteroid-free remission after 52-week therapy (75.0% vs. 25.0%; adjusted odds ratio [aOR] 5.68, 95% confidence interval [CI] 1.50-21.00, p = 0.011); however, these patients were more likely to experience adverse events (AEs) (40.9% vs. 9.1%; aOR 4.60, 95% CI 1.20-17.00, p = 0.02), although medication discontinuation due to AEs was only noted in two (3.0%) patients receiving VDZ. No patients were hospitalized during the treatment period.

UC patients receiving UPA achieved significantly higher rates of corticosteroid-free clinical remission but with more AEs, suggesting that decision-making based on disease severity and comorbidities can help guide the positioning of these therapies in UC.