Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis
Summary
The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) maintenance treatment on clinical remission at Week 52 in participants with moderately to severely active ulcerative colitis (UC) who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.
Timeline
- Start
- 2015-12-18
- Primary completion
- 2018-05-30
- Completion
- 2018-08-21
Outcome
Met primary endpoint
paper clinical remission at week 52 was achieved by 46.2%, 42.6%, and 14.3% of patients in the subcutaneous vedolizumab, intravenous vedolizumab, and placebo groups, respectively PMID 31470005 ↗
paper (subcutaneous vedolizumab vs placebo: Δ32.3%; 95% confidence interval, 19.7%-45.0%; P < .001). PMID 31470005 ↗
release “Meeting the primary endpoint of the VISIBLE 1 trial marks an exciting milestone” takeda.com ↗
release “VISIBLE 1, a statistically significant proportion of patients receiving vedolizumab SC 108 mg maintenance therapy administered every two weeks achieved clinical remission” takeda.com ↗
Publications
- D'Haens G, Baert F, Danese S, Kobayashi T, Loftus EV Jr, Sandborn WJ, Dornic Q, Lindner D, Kisfalvi K, Marins EG, Vermeire S. Efficacy of vedolizumab during intravenous induction therapy in ulcerative colitis and Crohn's disease: post hoc analysis of patient-reported outcomes from the VISIBLE 1 and 2 studies. Eur J Gastroenterol Hepatol. 2024 Apr 1;36(4):404-415. doi: 10.1097/MEG.0000000000002728. Epub 2024 Feb 21.
- Kobayashi T, Ito H, Ashida T, Yokoyama T, Nagahori M, Inaba T, Shikamura M, Yamaguchi T, Hori T, Pinton P, Watanabe M, Hibi T. Efficacy and safety of a new vedolizumab subcutaneous formulation in Japanese patients with moderately to severely active ulcerative colitis. Intest Res. 2021 Oct;19(4):448-460. doi: 10.5217/ir.2020.00026. Epub 2020 Aug 18.
- Sandborn WJ, Baert F, Danese S, Krznaric Z, Kobayashi T, Yao X, Chen J, Rosario M, Bhatia S, Kisfalvi K, D'Haens G, Vermeire S. Efficacy and Safety of Vedolizumab Subcutaneous Formulation in a Randomized Trial of Patients With Ulcerative Colitis. Gastroenterology. 2020 Feb;158(3):562-572.e12. doi: 10.1053/j.gastro.2019.08.027. Epub 2019 Aug 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vedolizumab | Monoclonal antibody | 108 mg | Intravenous |
| Subject | Vedolizumab | Monoclonal antibody | 300 mg | Intravenous |