Vedolizumab Is More Efficacious Than Adalimumab for UC in a Head-to-Head Trial
Monika Fischer, MD, FASGE reviewing Sands BE, et al. N Engl J Med 2019 Sep 26.
A head-to-head phase 3 trial involving patients with moderately to severely active ulcerative colitis (UC) found that vedolizumab was superior to adalimumab in achieving clinical remission and endoscopic improvement at 52 weeks, but not corticosteroid-free clinical remission.
In the VARSITY trial (double blind, double dummy, using U.S.-label dosing), 9% more patients on vedolizumab (N=383) experienced clinical remission (31.3% vs 22.5%; 95% confidence interval [CI], 2.5-15.0; P=0.006) and 12% more achieved endoscopic improvement (39.7% vs 27.7%; 95% CI, 5.3-18.5; P<0.001) compared to those on adalimumab (N=386). Interestingly, among those who achieved and maintained clinical remission by week 52, 9% more patients from the adalimumab group were off steroids compared to vedolizumab recipients (26/119 vs 14/111, respectively). On vedolizumab, 10% more patients reported improved quality of life (52% vs 42%). Infections were slightly more common in patients on vedolizumab than on adalimumab (2.3 events vs 3.4 events per patient-year). Exposure-adjusted occurrence of severe adverse events were uncommon in both groups (0.016 on vedolizumab vs 0.022 on adalimumab per patient-year).
Monika Fischer, MD, FASGE
Sands BE, Peyrin-Biroulet L, Loftus EV Jr, et al. Vedolizumab versus adalimumab for moderate-to-severe ulcerative colitis. N Engl J Med. 2019;381:1215-1226. (https://doi.org/10.1056/NEJMoa1905725)