New exploratory data published in the New England Journal of Medicine further provide evidence of the benefits of vedolizumab (Entyvio; Takeda), an integrin receptor antagonist, when compared with adalimumab (Humira; AbbVie), a tumor necrosis factor-alpha (TNFα) antagonist, in patients with moderately to severely active ulcerative colitis.
In the phase 3b VARSITY study, patients 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).
Among anti-TNFα-naïve and experienced patients, 34.2% and 20.3% achieved clinical remission with vedolizumab vs 24.3% and 16.0% with adalimumab, respectively. Moreover, at Week 14, findings from the exploratory data showed 26.6% of vedolizumab-treated patients achieved clinical remission compared with 21.2% of adalimumab-treated patients. Additionally, durable clinical remission (defined as clinical remission at week 52 among patients in clinical remission at week 14) was achieved in 18.3% of patients with vedolizumab and 11.9% of patients with adalimumab, respectively.
With regard to corticosteroid use, 12.6% of patients treated with vedolizumab were observed to be in corticosteroid-free clinical remission at Week 52 vs 21.8% of those treated with adalimumab; the median change in oral corticosteroid use from baseline to week 52 was -10mg in the vedolizumab group compared with -7mg in the adalimumab group.
Additional findings from the exploratory data showed that treatment with vedolizumab was associated with greater improvements in quality of life, as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) score; 52% of vedolizumab-treated patients reported a ≥16-point improvement vs 42.2% of adalimumab-treated patients. A greater percentage of patients in the vedolizumab group also achieved clinical response at Week 14 and had absence of active histologic disease at Week 52 when compared with adalimumab.
Commenting on the results, Dr Bruce E. Sands, primary investigator of the VARSITY study and Chief of the Dr. Henry D. Janowitz Division of Gastroenterology at The Mount Sinai Hospital and the Icahn School of Medicine at Mount Sinai in New York said, “The VARSITY results provide physicians with valuable insights to support their treatment decisions when initiating biologic therapy in patients with ulcerative colitis.”
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