학술논문
Comparative Safety and Effectiveness of Vedolizumab to Tumor Necrosis Factor Antagonist Therapy for Ulcerative Colitis
Document Type
article
Author
Lukin, Dana; Faleck, David; Xu, Ronghui; Zhang, Yiran; Weiss, Aaron; Aniwan, Satimai; Kadire, Siri; Tran, Gloria; Rahal, Mahmoud; Winters, Adam; Chablaney, Shreya; Koliani-Pace, Jenna L; Meserve, Joseph; Campbell, James P; Kochhar, Gursimran; Bohm, Matthew; Varma, Sashidhar; Fischer, Monika; Boland, Brigid; Singh, Siddharth; Hirten, Robert; Ungaro, Ryan; Lasch, Karen; Shmidt, Eugenia; Jairath, Vipul; Hudesman, David; Chang, Shannon; Swaminath, Arun; Shen, Bo; Kane, Sunanda; Loftus, Edward V; Sands, Bruce E; Colombel, Jean-Frederic; Siegel, Corey A; Sandborn, William J; Dulai, Parambir S
Source
Clinical Gastroenterology and Hepatology. 20(1)
Subject
Language
Abstract
Background & aimsWe aimed to compare safety and effectiveness of vedolizumab to tumor necrosis factor (TNF)-antagonist therapy in ulcerative colitis in routine practice.MethodsA 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.ResultsA 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).ConclusionsTreatment 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.