Abstract | BACKGROUND: OBJECTIVE: 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: CLINICALTRIALSGOV: NCT00783718.
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Authors | Edward V Loftus Jr, Bruce E Sands, Jean-Frédéric Colombel, Iris Dotan, Javaria Mona Khalid, David Tudor, Parnia Geransar |
Journal | Clinical and experimental gastroenterology
(Clin Exp Gastroenterol)
Vol. 13
Pg. 211-220
( 2020)
ISSN: 1178-7023 [Print] New Zealand |
PMID | 32606883
(Publication Type: Journal Article)
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Copyright | © 2020 Loftus Jr et al. |