Vedolizumab led to higher rates of histologic remission and minimal histologic disease activity as well as more favorable histologic and endoscopic outcomes compared with adalimumab in patients with ulcerative colitis (UC), according to findings from the VARSITY trial published in Gastroenterology.
The study included 769 patients with UC who had either previously received anti-tumor necrosis factor (TNF) therapy (other than adalimumab) or were naïve to anti-TNF treatment. Participants were randomly assigned to either vedolizumab (n=383) or adalimumab (n=386).
Vedolizumab was administered via intravenous infusion at 300 mg on day 1 as well as at weeks 2, 6, 14, 22, 30, 38, and 46. Patients also received placebo injections on day 1, week 2, and then a single injection every 2 weeks until week 50.
In the adalimumab arm, patients received multiple injections of the therapy on days 1 through 2 (total dose of 160 mg). Week 2 included a total dose of 80 mg, followed by single injections of 40 mg of adalimumab every 2 weeks until week 50. Placebo infusions were also administered at day 1 as well as weeks 2, 6, 14, 22, 30, 38, and 46.
According to the Geboes and Robarts Histopathology Index (RHI) scores, patients who received vedolizumab had significantly greater histologic remission at weeks 14 (Geboes: 16.7% vs 7.3%, Δ9.4% [95% CI, 4.9-13.9] P <.0001; RHI: 25.6% vs 16.1%, Δ9.5% [95% CI, 3.8-15.2] P =.0011) and 52 (Geboes: 29.2% vs 8.3%, Δ20.9% [95% CI, 15.6-26.2] P <.0001; RHI: 37.6% vs 19.9%, Δ17.6% [95% CI, 11.3-23.8] P <.0001).
The minimal histologic disease activity rate was significantly higher for vedolizumab compared with adalimumab at week 14 (37.3% vs 24.4%, respectively; Δ12.9%; 95% CI, 6.5-19.4; P <.0001). Rates of minimal histologic disease activity were also higher in the vedolizumab arm at week 52 (42.3% vs 25.6%; Δ16.6%; 95% CI, 10.0-23.1; P <.0001).
A greater proportion of patients who received vedolizumab also experienced histologic remission plus endoscopic improvement (30.5% [RHI] and 25.6% [Geboes] vs 14.5% [RHI] and 6.7% [Geboes]).
Limitations of this study included the lack of dose escalation as well as the limited duration of follow up.
Investigators noted that the finding regarding histologic outcomes and endoscopic improvements “is important given the recent position statement from the European Crohn’s and Colitis Organisation (ECCO) supporting the need to consider mucosal healing based on endoscopy and histology.”
Disclosure: This clinical trial was supported by Takeda. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Peyrin-Biroulet L, Loftus EV Jr, Colombel JF, et al. Histologic outcomes with vedolizumab versus adalimumab in ulcerative colitis: results from VARSITY