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).
COMMENT
When curious about the relative drug performance in IBD, direct comparison between different clinical trials is often difficult or impossible due to varying trial designs. VARSITY is one of the first head-to-head comparisons of two biologic agents for UC. I hope that more such trials will follow to better inform clinical decision-making regarding therapy choices.
Vedolizumab appears to be the best choice as the first biologic agent in UC due to its great efficacy and safety profile. Keep in mind, though, that it has a relatively slow onset of action and there is often a need for bridging steroid use until vedolizumab takes effect. Patients should be steroid responsive and able and willing to tolerate sometimes lengthy steroid exposure. However, coverage for vedolizumab as the first biologic for UC patients may be variable across different states. For example, in Indiana, about 90% of insurance companies will cover vedolizumab as the first biologic agent for UC patients.
Monika Fischer, MD, FASGE
CITATION(S )
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)
