Study: Vedolizumab in Crohn's Disease Patients with Previous TNF-Blocker Failure

the MPR take:

Although treatment of Crohn’s disease (CD) with tumor necrosis factor (TNF) antagonists has been beneficial in inducing and maintaining remission and decreasing hospitalization and surgery, controlled trials have found that about two-thirds of patients did not attain or maintain remission at one year post-TNF antagonist initiation. In a Phase 3, randomized, placebo-controlled, double-blind, multinational and multicenter trial, 315 patients with moderately to severely active CD and previous TNF antagonist failure were assigned to vedolizumab 300mg or placebo administered intravenously at weeks 0, 2, and 6 with evaluation outcomes at weeks 6 and 10. The vedolizumab group did not have significantly greater clinical remission at week 6 compared to the placebo group (15.2% vs. 12.1%, respectively), but did at week 10 (26.6% vs. 12.1%, respectively). These outcomes may have implications for induction and maintenance therapy with vedolizumab in these CD patients.

There is an increasing need for new treatments for patients with Crohn's disease (CD) in whom previous therapy with tumor necrosis factor (TNF) antagonists has failed. We performed a placebo-controlled, phase 3, double-blind trial to evaluate the efficacy and safety of vedolizumab, an antibody against the integrin α4β7, as induction therapy.