Efficacy and Safety of Subcutaneous Vedolizumab in Patients With Moderately to Severely Active Crohn's Disease: Results From the VISIBLE 2 Randomised Trial

J Crohns Colitis. 2022 Jan 28;16(1):27-38. doi: 10.1093/ecco-jcc/jjab133.


Séverine Vermeire 1Geert D'Haens 2Filip Baert 3Silvio Danese 4Taku Kobayashi 5Edward V Loftus 6Siddharth Bhatia 7Christian Agboton 8Maria Rosario 7Chunlin Chen 7Wenwen Zhang 7Krisztina Kisfalvi 7William J Sandborn 9


Author information

1Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.

2Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam, The Netherlands.

3Department of Gastroenterology, AZ Delta, Roeselare, Belgium.

4Humanitas Clinical and Research Center - IRCCS, and Department of Biomedical Sciences, Humanitas University, Milan, Italy.

5Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.

6Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, MN, USA.

7Takeda, Cambridge, MA, USA.

8Takeda, Zurich, Switzerland.

9Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA.


Background and aims: To report results from VISIBLE 2, a randomised, double-blind, placebo-controlled, phase 3 trial evaluating a new subcutaneous [SC] vedolizumab formulation as maintenance treatment in adults with moderately to severely active Crohn's disease [CD].

Methods: Following open-label vedolizumab 300 mg intravenous induction therapy at Weeks 0 and 2, Week 6 clinical responders (≥70-point decrease in CD Activity Index [CDAI] score from baseline) were randomised 2:1 to receive double-blind maintenance vedolizumab 108 mg SC or placebo every 2 weeks until Week 50. Assessments at Week 52 included clinical remission [primary endpoint; CDAI ≤150], enhanced clinical response [≥100-point decrease in CDAI from baseline], corticosteroid-free clinical remission among patients using a corticosteroid at baseline, clinical remission in anti-tumour necrosis factor [anti-TNF]-naïve patients, and safety.

Results: Following vedolizumab intravenous induction, 275 patients were randomised to vedolizumab SC and 135 to placebo maintenance. At Week 52, 48.0% of patients receiving vedolizumab SC versus 34.3% receiving placebo were in clinical remission [p = 0.008]. Enhanced clinical response at Week 52 was achieved by 52.0% versus 44.8% of patients receiving vedolizumab SC versus placebo, respectively [p = 0.167]. At Week 52, 45.3% and 18.2% of patients receiving vedolizumab SC and placebo, respectively, were in corticosteroid-free clinical remission, and 48.6% of anti-TNF-naïve patients receiving vedolizumab SC and 42.9% receiving placebo were in clinical remission. Injection site reaction was the only new safety finding observed for vedolizumab SC [2.9%].

Conclusions: Vedolizumab SC is an effective and safe maintenance therapy in patients with CD who responded to two infusions of vedolizumab intravenous induction therapy.

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