Lukin, DanaFaleck, DavidXu, RonghuiZhang, YiranWeiss, AaronAniwan, SatimaiKadire, SiriTran, GloriaRahal, MahmoudWinters, AdamChablaney, ShreyaKoliani-Pace, Jenna L.Meserve, JosephCampbell, James P.Kochhar, GursimranBohm, MatthewVarma, SashidharFischer, MonikaBoland, BrigidSingh, SiddharthHirten, RobertUngaro, RyanLasch, KarenShmidt, EugeniaJairath, VipulHudesman, DavidChang, ShannonSwaminath, ArunShen, BoKane, SunandaLoftus, Edward V., Jr.Sands, Bruce E.Colombel, Jean-FredericSiegel, Corey A.Sandborn, William J.Dulai, Parambir S.2024-04-252024-04-252022Lukin D, Faleck D, Xu R, et al. Comparative Safety and Effectiveness of Vedolizumab to Tumor Necrosis Factor Antagonist Therapy for Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022;20(1):126-135. doi:10.1016/j.cgh.2020.10.003https://hdl.handle.net/1805/40243Background & aims: We aimed to compare safety and effectiveness of vedolizumab to tumor necrosis factor (TNF)-antagonist therapy in ulcerative colitis in routine practice. Methods: A multicenter, retrospective, observational cohort study (May 2014 to December 2017) of ulcerative colitis patients treated with vedolizumab or TNF-antagonist therapy. Propensity score weighted comparisons for development of serious adverse events and achievement of clinical remission, steroid-free clinical remission, and steroid-free deep remission. A priori determined subgroup comparisons in TNF-antagonist-naïve and -exposed patients, and for vedolizumab against infliximab and subcutaneous TNF-antagonists separately. Results: A total of 722 (454 vedolizumab, 268 TNF antagonist) patients were included. Vedolizumab-treated patients were more likely to achieve clinical remission (hazard ratio [HR], 1.651; 95% confidence interval [CI], 1.229-2.217), steroid-free clinical remission (HR, 1.828; 95% CI, 1.135-2.944), and steroid-free deep remission (HR, 2.819; 95% CI, 1.496-5.310) than those treated with TNF antagonists. Results were consistent across subgroup analyses in TNF-antagonist-naïve and -exposed patients, and for vedolizumab vs infliximab and vs subcutaneous TNF-antagonist agents separately. Overall, there were no statistically significant differences in the risk of serious adverse events (HR, 0.899; 95% CI, 0.502-1.612) or serious infections (HR, 1.235; 95% CI, 0.608-2.511) between vedolizumab-treated and TNF-antagonist-treated patients. However, in TNF-antagonist-naïve patients, vedolizumab was less likely to be associated with serious adverse events than TNF antagonists (HR, 0.192; 95% CI, 0.049-0.754). Conclusions: Treatment of ulcerative colitis with vedolizumab is associated with higher rates of remission than treatment with TNF-antagonist therapy in routine practice, and lower rates of serious adverse events in TNF-antagonist-naïve patients.en-USPublisher PolicyBiologicsComparative researchHealth outcomesArticle