Vedolizumab superior to adalimumab in ulcerative colitis

One of the most anticipated events of ECCO 2019 was the presentation of the head-to-head trial comparing the efficacy and safety of two biological agents [1]. In patients with moderately to severely active ulcerative colitis, vedolizumab was found to be superior to adalimumab in achieving clinical remission and endoscopic mucosal healing after 1 year. Both treatments were generally safe and well tolerated.

VARSITY was a phase 3b randomised, double-blind, double-dummy, multicentre, active-controlled trial. The 771 participants were randomised to: 1) active vedolizumab intravenous (IV) infusions (300 mg)/placebo subcutaneous injections; or 2) placebo IV infusions/active adalimumab subcutaneous injections (160 mg, 80 mg, 40 mg). The primary endpoint was clinical remission.

The results were presented by Dr Stefan Schreiber (University-Hospital Schleswig-Holstein, Germany), who showed that the percentage of patients who completed the study was 74.5% in the vedolizumab group vs 61.9% in the adalimumab group. Overall clinical remission rates at week 52 were 31.3% for vedolizumab and 22.5% for adalimumab (P=0.0061). Mucosal healing at week 52 was achieved in 39.7% and 27.7% of patients, respectively (P=0.0005). Overall, 62.7% and 69.2% of patients experienced an adverse event. Serious adverse events occurred in 11.0% and 13.7% of patients, respectively.

Dr Schreiber noted that the clinical superiority of vedolizumab was most pronounced in the anti-TNF naïve subpopulation in a subgroup analysis. Treatment differences in clinical response appeared to emerge between week 6 and week 14. Corticosteroid-free remission rates numerically favoured adalimumab, while the absolute reduction of corticosteroid use was greater with vedolizumab; however, treatment group differences were not significant. Both drugs were found to be generally safe and well-tolerated. Dr Schreiber concluded: “These results support the use of vedolizumab prior to adalimumab in patients with moderately tot severely active ulcerative colitis.”

1. Schreiber S, et al. ECCO 2019, OP34.

Posted on 9 May, 20198 April, 2024