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Vedolizumab effective for Crohn’s disease, ulcerative colitis
Patients with ulcerative colitis or Crohn’s disease benefited from treatment with vedolizumab compared with placebo in recent studies.
In a phase 3, randomized, multicenter, double blind trial of vedolizumab as induction therapy, researchers administered 300 mg intravenous vedolizumab (n=225) or placebo (n=149) to patients with ulcerative colitis (UC) at baseline and after 2 weeks. An additional 521 patients received open-label vedolizumab at baseline and at 2 weeks, and participants in either cohort who responded to treatment after 6 weeks were randomly assigned maintenance therapy with vedolizumab every 4 (n=125) or 8 weeks (n=122) or placebo (n=126) for up to 52 weeks.
Treated patients in the blinded induction cohort had a response rate of 47.1% at 6 weeks, compared with 25.5% of placebo recipients (P<.01). After 52 weeks, clinical remission in the maintenance cohort was observed in 44.8% of patients treated at 4-week intervals and 41.8% treated at 8-week intervals, compared with 15.9% of placebo recipients (P<.001 for both comparisons). Efficacy was consistent across subgroups, and adverse events occurred similarly between treated and placebo patients.
In a similarly structured trial, patients with Crohn’s disease (CD) were randomly assigned induction therapy with 300 mg intravenous vedolizumab (n=220) or placebo (n=148) at baseline and at 2 weeks, while a second cohort of 747 patients received open-label vedolizumab. Patients who responded at 6 weeks then were randomly assigned maintenance therapy with vedolizumab or placebo in the same manner as the UC cohorts, with 154 patients each treated at 4- and 8-week intervals and 153 treated in the placebo group.
Clinical remission at 6 weeks occurred in 14.5% of treated patients in the blinded induction cohort, compared with 6.8% of placebo recipients (P=.02). Among maintenance therapy patients, 36.4% treated at 4-week intervals and 39% of the 8-week group achieved clinical remission at 52 weeks, compared with 21.6% of placebo patients (P=.004 for 4 weeks and P<.001 for 8 weeks). Efficacy was consistent across demographic subgroups.
Serious adverse events, infection and serious infection occurred more frequently among treated patients with CD than placebo recipients. While nasopharyngitis was observed more frequently in the treated group, headache and abdominal pain were less common than in the placebo group.
William J. Sandborn
“The two trials showed highly encouraging results for patients suffering from moderate-to-severe Crohn’s disease and ulcerative colitis when conventional therapy such as steroids, immune suppressive drugs and anti-tumor necrosis factor biologic drugs failed,” researcher William J. Sandborn, MD, chief of the gastroenterology division and director of the IBD Center at University of California, San Diego, said in a press release. “These latest findings will potentially lead to a new drug therapy that will improve a patient’s overall lifestyle.”
Disclosure: See the studies for full lists of relevant financial disclosures.