1. Comparative Safety and Effectiveness of Vedolizumab to Tumor Necrosis Factor Antagonist Therapy for Ulcerative Colitis
- Author
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Yiran Zhang, Satimai Aniwan, A Weiss, Gursimran Kochhar, Sunanda V. Kane, Bo Shen, Matthew Bohm, Siddharth Singh, Eugenia Shmidt, Jean-Frederic Colombel, Corey A. Siegel, David Faleck, Edward V. Loftus, James P. Campbell, Mahmoud A. Rahal, Siri Kadire, Ronghui Xu, William J. Sandborn, David Hudesman, Arun Swaminath, Joseph Meserve, Robert Hirten, Vipul Jairath, Ryan C. Ungaro, Bruce E. Sands, Karen Lasch, Jenna L. Koliani-Pace, Brigid S. Boland, Parambir S. Dulai, Dana J. Lukin, Shreya Chablaney, Monika Fischer, Adam Winters, Gloria Tran, Shannon Chang, and Sashidhar Varma
- Subjects
Ulcerative ,Gastroenterology ,0302 clinical medicine ,Monoclonal ,Humanized ,Cancer ,Hazard ratio ,Colitis ,Ulcerative colitis ,Treatment Outcome ,6.1 Pharmaceuticals ,030220 oncology & carcinogenesis ,030211 gastroenterology & hepatology ,Patient Safety ,medicine.drug ,Cohort study ,medicine.medical_specialty ,Clinical Sciences ,Biologics ,Antibodies, Monoclonal, Humanized ,Autoimmune Disease ,Antibodies ,Article ,Vedolizumab ,03 medical and health sciences ,Gastrointestinal Agents ,Clinical Research ,Internal medicine ,medicine ,Humans ,Adverse effect ,Retrospective Studies ,Gastroenterology & Hepatology ,Hepatology ,Tumor Necrosis Factor-alpha ,business.industry ,Inflammatory Bowel Disease ,Evaluation of treatments and therapeutic interventions ,medicine.disease ,Health Outcomes ,Confidence interval ,Infliximab ,Propensity score matching ,Comparative Research ,Colitis, Ulcerative ,Tumor Necrosis Factor Inhibitors ,Digestive Diseases ,business - Abstract
Background & 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–naive 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–naive 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−naive 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−naive patients.
- Published
- 2022