Vedolizumab (Entyvio; Takeda), an integrin receptor antagonist, was found to be superior to adalimumab (Humira; AbbVie), a tumor necrosis factor-alpha (TNFα) antagonist, in achieving clinical remission in patients with moderately to severely active ulcerative colitis (UC), according to results from a phase 3b head-to-head trial.



Patients in the VARSITY study were randomized to receive either vedolizumab intravenous (IV) and placebo subcutaneous (SC) (N=383) or adalimumab SC and placebo IV (N=386) over a 52-week treatment period; the primary endpoint of the study was the percentage of patients achieving clinical remission at Week 52 (defined as a complete Mayo score of ≤2 points and no individual subscore >1 point).



Results showed that a statistically significantly greater percentage of patients achieved clinical remission in the vedolizumab group vs the adalimumab group (31.3% vs 22.5%, respectively; P =.0061) at Week 52. In addition, 39.7% of vedolizumab-treated patients achieved mucosal healing (secondary endpoint defined as Mayo endoscopic subscore of ≤1 point) compared with 27.7% of patients treated with adalimumab (P =.0005). While not powered to compare safety, the study findings demonstrated a lower rate of infections in patients treated with vedolizumab compared with those who received adalimumab (33.5% vs 43.5%, respectively).



“The goal of treatment in ulcerative colitis is to achieve clinical remission and mucosal healing, and these results clearly highlight the benefits seen with vedolizumab versus adalimumab on these important outcomes,” said Dr Bruce E. Sands, primary investigator of the VARSITY study and Chief of the Dr Henry D. Janowitz Division of Gastroenterology at Mount Sinai Hospital and the Icahn School of Medicine at Mount Sinai in New York. “The results also showed lower rates of overall and serious adverse events including infections in patients treated with vedolizumab than adalimumab.”



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