Vedolizumab as induction and maintenance therapy for ulcerative colitis

Brian G. Feagan, Paul Rutgeerts, Bruce E. Sands, Stephen Hanauer, Jean Frédéric Colombel, William J. Sandborn, Gert Van Assche, Jeffrey Axler, Hyo Jong Kim, Silvio Danese, Irving Fox, Catherine Milch, Serap Sankoh, Tim Wyant, Jing Xu, Asit Parikh

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND: Gut-selective blockade of lymphocyte trafficking by vedolizumab may constitute effective treatment for ulcerative colitis. METHODS: We conducted two integrated randomized, double-blind, placebo-controlled trials of vedolizumab in patients with active disease. In the trial of induction therapy, 374 patients (cohort 1) received vedolizumab (at a dose of 300 mg) or placebo intravenously at weeks 0 and 2, and 521 patients (cohort 2) received open-label vedolizumab at weeks 0 and 2, with disease evaluation at week 6. In the trial of maintenance therapy, patients in either cohort who had a response to vedolizumab at week 6 were randomly assigned to continue receiving vedolizumab every 8 or 4 weeks or to switch to placebo for up to 52 weeks. A response was defined as a reduction in the Mayo Clinic score (range, 0 to 12, with higher scores indicating more active disease) of at least 3 points and a decrease of at least 30% from baseline, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1. RESULTS: Response rates at week 6 were 47.1% and 25.5% among patients in the vedolizumab group and placebo group, respectively (difference with adjustment for stratification factors, 21.7 percentage points; 95% confidence interval [CI], 11.6 to 31.7; P1), as compared with 15.9% of patients who switched to placebo (adjusted difference, 26.1 percentage points for vedolizumab every 8 weeks vs. placebo [95% CI, 14.9 to 37.2; P

Original languageEnglish
Pages (from-to)699-710
Number of pages12
JournalNew England Journal of Medicine
Volume369
Issue number8
DOIs
Publication statusPublished - 2013

ASJC Scopus subject areas

  • Medicine(all)

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