Sustained Corticosteroid-Free Clinical Remission During Vedolizumab Maintenance Therapy in Patients with Ulcerative Colitis on Stable Concomitant Corticosteroids During Induction Therapy: A Post Hoc Analysis of GEMINI 1

Edward V Loftus Jr,1 Bruce E Sands,2 Jean-Frédéric Colombel,2 Iris Dotan,3 Javaria Mona Khalid,4 David Tudor,5 Parnia Geransar5 1Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, MN, USA; 2The Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai Hospital, New York, NY, USA; 3Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel, and the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; 4Takeda International – UK Branch, London, UK; 5Takeda Pharmaceuticals International AG, Zurich, SwitzerlandCorrespondence: Edward V Loftus JrDivision of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, 200 First Street SW, Rochester, MN 55905, USATel +1-507-284-2511Email loftus.edward@mayo.eduBackground: Corticosteroid-free clinical remission is important in ulcerative colitis.Objective: This GEMINI 1 post hoc analysis evaluated vedolizumab efficacy in achieving sustained corticosteroid-free clinical remission in moderately to severely active ulcerative colitis.Materials and Methods: GEMINI 1 included a 6-week induction period followed by a 46-week maintenance period. Patients received stable corticosteroid dosing at baseline/during induction and tapered dosing during maintenance. Analysis groups included vedolizumab (induction and maintenance); vedolizumab/placebo (vedolizumab induction, placebo maintenance); and placebo (induction and maintenance). The primary endpoint was sustained corticosteroid-free clinical remission (partial Mayo score ≤ 2, no individual subscore > 1, for ≥ 32 weeks). Multivariate analyses identified covariates associated with the primary endpoint. Safety endpoints included adverse events.Results: Baseline demographics and concomitant corticosteroid use were similar across groups (n=454). A greater proportion (95% confidence interval) of the vedolizumab group achieved sustained corticosteroid-free clinical remission (10.2% [6.9 to 13.6]) vs the placebo group (1.4% [0.0 to 7.3]; difference 8.9% [– 3.8 to 21.4]). Proportions were similar between the vedolizumab/placebo and placebo groups. Covariates associated with sustained corticosteroid-free clinical remission (odds ratio [95% confidence interval]) were treatment (vedolizumab vs placebo: 9.35 [1.25 to 71.43]; p=0.0605), anti-tumor necrosis factor alpha exposure (yes vs no: 0.26 [0.12 to 0.57]; p=0.0008), and disease duration (≤ 2 vs > 2 years: 2.66 [0.99– 7.19]; p=0.0531). Adverse events were similar across groups.Conclusion: A numerically greater proportion of vedolizumab-treated patients with ulcerative colitis achieved sustained corticosteroid-free clinical remission. Vedolizumab treatment, no previous anti-tumor necrosis factor alpha exposure, and shorter disease duration were associated with sustained corticosteroid-free clinical remission.Clinicaltrials.gov: NCT00783718.Keywords: vedolizumab, ulcerative colitis, corticosteroid, anti-tumor necrosis factor alpha, clinical remission