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• W2157094187 abstract "Recently, GEMINI 1 investigators examined the efficacy of vedolizumab for induction and maintenance of remission in active ulcerative colitis (Mayo score of 6-12 and unsuccessful previous treatment with azathioprine, steroids or biologic therapy) in two integrated randomized controlled trials (RCTs) [1]. In the induction phase, 521 patients received open-label IV vedolizumab 300 mg at weeks 0 and 2 while 374 patients were blinded and randomized to receive vedolizumab or placebo at weeks 0 and 2. Any of these patients who had a response (defined as a 30% and at least 3 score drop from baseline Mayo Clinic Score) to vedolizumab at week 6 were re-randomized to receive placebo or vedolizumab every 4 or 8 weeks up to week 52. At week 6, clinical remission rate was significantly higher in the vedolizumab treatment group (47.1%) compared with patients in the placebo group (25.5%; P<0.001). At week 52, 44.8% of patients who continued to receive vedolizumab every 4 weeks and 41.8% of patients who continued to receive vedolizumab every 8 weeks remained in clinical remission as compared to 15.9% of patients who transitioned to the placebo arm (P<0.001). After one year, more than half of the patients receiving vedolizumab had mucosal healing compared to 20% of patients in the placebo cohort. At week 52, adverse events were similar among all groups.In the same issue of the New England Journal of Medicine, Sandborn et al [2] (GEMINI 2 study group) examined the efficacy of vedolizumab for induction and maintenance of remission in active Crohn’s disease (Crohn’s Disease Activity Index (CDAI) of 220-450 and unsuccessful previous treatment with azathioprine, methotrexate, steroids or biologic therapy) in two integrated RCTs. In the induction phase, 747 patients received open-label IV vedolizumab 300 mg at weeks 0 and 2 while 368 patients were blinded and randomized to receive vedolizumab or placebo at weeks 0 and 2. Any of these patients who had a response (a drop of 100 points in CDAI) to vedolizumab at week 6 were re-randomized to receive placebo or vedolizumab every 4 or 8 weeks up to week 52. At week 6, clinical remission rate (CDAI ≤150) was significantly higher in the vedolizumab treatment group (14.5%) compared with patients in the placebo group (6.8%; P=0.02); however, response rates were not statistically different (31.4% vs. 25.7%, P=0.23). At week 52, 36.4% of patients who continued to receive vedolizumab every 4 weeks and 39.0% of patients who continued to receive vedolizumab every 8 weeks remained in clinical remission as compared to 21.6% of patients who transitioned to the placebo arm (P<0.01). Higher rates of serious adverse events (24.4% vs. 15.3%) and infections (44.1% vs. 40.2%) were seen in patients who were treated with vedolizumab." @default.
• W2157094187 created "2016-06-24" @default.
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• W2157094187 date "2014-01-01" @default.
• W2157094187 modified "2023-09-23" @default.
• W2157094187 title "Vedolizumab, a gut-specific monoclonal antibody, renews hope for an alternative to anti-TNF therapy in inflammatory bowel diseases." @default.
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