Histologic Outcomes With Vedolizumab Versus Adalimumab in Ulcerative Colitis: Results From VARSITY.
VARSITY showed superior clinical remission and endoscopic improvement in ulcerative colitis with vedolizumab versus adalimumab. This analysis compared histologic outcomes.Patients in VARSITY were randomized 1:1 to vedolizumab 300-mg intravenous infusions or adalimumab 40-mg subcutaneous injections. Geboes and Robarts Histopathology Index (RHI) scores were used to assess prespecified histologic exploratory endpoints (histologic remission [Geboes <2 or RHI ≤2] and minimal histologic disease activity [Geboes ≤3.1 or RHI ≤4]) at Weeks 14 and 52.In total 769 patients received vedolizumab (n=383) or adalimumab (n=386). Mean baseline histologic disease activity was similar between vedolizumab and adalimumab groups. Vedolizumab induced greater histologic remission than adalimumab at Weeks 14 (Geboes: 16.7% vs 7.3%, Δ9.4%, 95% CI, 4.9 to 13.9, P < .0001; RHI: 25.6% vs 16.1%, Δ9.5%, 95% CI, 3.8 to 15.2, P = .0011) and 52 (Geboes: 29.2% vs 8.3% Δ20.9%, 95% CI, 15.6 to 26.2, P < .0001; RHI: 37.6% vs 19.9%, Δ17.6%, 95% CI, 11.3 to 23.8, P < .0001) overall and in both anti-tumor necrosis factor (TNF)-naïve and -failure subgroups. Results were similar for minimal histologic disease activity. Histologic outcomes were generally better in anti-TNF-naïve versus -failure patients. At Week 52, rates of mucosal healing (composite endpoint of histologic plus endoscopic improvement) were also higher with vedolizumab than adalimumab (Geboes: 25.6% vs 6.7%; RHI: 30.5% vs 14.5%).Higher rates of histologic remission, minimal histologic disease activity, and combined histologic plus endoscopic outcomes were observed with vedolizumab versus adalimumab in ulcerative colitis in both anti-TNF-naïve and -failure subgroups.
Authors: Laurent Peyrin-Biroulet, Edward V Loftus, Jean-Frédéric Colombel, Silvio Danese, Raquel Rogers, Jeffrey D Bornstein, Jingjing Chen, Stefan Schreiber, Bruce E Sands, Richard A Lirio