Crohns disease patients with prior anti TNF failure, In a placebo-controlled, phase 3, double blind multinational trial, researchers assessed the safety and efficacy of vedolizumab in patients with moderately to severely active Crohn’s disease (CD) from November 2010 through April 2012.
Patients (n=416) from 107 centers were randomly assigned 300 mg vedolizumab or placebo at 0, 2 and 6 weeks. Initially 76% of the cohort who had inadequate response or intolerance to previous TNF antagonist therapy were evaluated at weeks 0, 2 and 6. Then the overall population, including the remaining TNF antagonist-naive patients, was assessed for outcomes at 6 and 10 weeks.
At 6 weeks 15.2% of vedolizumab patients who had previous TNF antagonist failure achieved remission vs. 12.1% of the placebo group (RR=1.2; 95% CI, 0.7-2.2), but 39.2% achieved clinical response compared with 22.3% of the placebo group (RR=1.8; 95% CI, 1.2-2.5). In the overall population at week 6, 19.1% of vedolizumab patients achieved remission compared with 12.1% of placebo (RR=1.6; 95% CI, 1-2.5). At 10 weeks 26.6% of the vedolizumab group achieved remission compared with 12.1% of the placebo group (RR=2.2; 95% CI, 1.3-3.6). Adverse events were similar between groups.
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