An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis
Summary
The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment period.
Timeline
- Start
- 2015-06-29
- Primary completion
- 2018-09-26
- Completion
- 2019-01-18
Outcome
Met primary endpoint
registry analysis (superiority test); Adalimumab SC, 160/80/40 mg vs Vedolizumab IV 300 mg; p = 0.0061; Adjusted Difference 8.8 (95% CI 2.5 to 15.0) NCT02497469 ↗
paper At week 52, clinical remission was observed in a higher percentage of patients in the vedolizumab group than in the adalimumab group PMID 31553834 ↗
paper vedolizumab was superior to adalimumab with respect to achievement of clinical remission and endoscopic improvement PMID 31553834 ↗
release “Data showed that 31.3% (n=120/383) of patients receiving vedolizumab intravenous (IV) achieved the primary endpoint of clinical remission” takeda.com ↗
Publications
- Dulai PS, Feagan BG, Sands BE, Chen J, Lasch K, Lirio RA. Prognostic Value of Fecal Calprotectin to Inform Treat-to-Target Monitoring in Ulcerative Colitis. Clin Gastroenterol Hepatol. 2023 Feb;21(2):456-466.e7. doi: 10.1016/j.cgh.2022.07.027. Epub 2022 Aug 4.
- Peyrin-Biroulet L, Loftus EV Jr, Colombel JF, Danese S, Rogers R, Bornstein JD, Chen J, Schreiber S, Sands BE, Lirio RA. Histologic Outcomes With Vedolizumab Versus Adalimumab in Ulcerative Colitis: Results From An Efficacy and Safety Study of Vedolizumab Intravenous Compared to Adalimumab Subcutaneous in Participants With Ulcerative Colitis (VARSITY). Gastroenterology. 2021 Oct;161(4):1156-1167.e3. doi: 10.1053/j.gastro.2021.06.015. Epub 2021 Jun 16.
- Sands BE, Peyrin-Biroulet L, Loftus EV Jr, Danese S, Colombel JF, Toruner M, Jonaitis L, Abhyankar B, Chen J, Rogers R, Lirio RA, Bornstein JD, Schreiber S; VARSITY Study Group. Vedolizumab versus Adalimumab for Moderate-to-Severe Ulcerative Colitis. N Engl J Med. 2019 Sep 26;381(13):1215-1226. doi: 10.1056/NEJMoa1905725.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Adalimumab | Monoclonal antibody | 40 mg | Subcutaneous |
| Subject | Vedolizumab | Monoclonal antibody | 300 mg | Intravenous |