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

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

Abstract

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.