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Crohn’s disease patients with prior anti-TNF failure achieved response, remission with vedolizumab
Vedolizumab safely induced clinical response after 6 weeks and clinical remission after 10 weeks in patients with Crohn’s disease who had previous tumor necrosis factor antagonist therapy failure, according to trial results.
In a placebo-controlled, phase 3, double blind multinational trial (GEMINI 3), Bruce E. Sands, MD, MS, chief of the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, and colleagues 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.
Bruce E. Sands
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.
“Vedolizumab was not statistically superior to placebo in achieving clinical remission at week 6 among patients with moderately to severely active CD and previous TNF antagonist failure,” the researchers concluded. “Several prespecified outcomes suggest that vedolizumab may lead to clinical remission in TNF antagonist-naive patients with CD and at 10 weeks in TNF antagonist-failure patients.”
“Physicians and patients need to have appropriate expectations about time to reaching full effect when treating patients whose Crohn’s disease has already been treated with anti-TNF antibodies,” Sands told Healio.com/Gastroenterology. “This study suggests that such patients need to complete their third induction infusion at week 6 and wait until at least week 10 to see what vedolizumab can achieve.”
Disclosure: See the study for a full list of relevant financial disclosures.