Bruce E. Sands
SAN DIEGO – The VARSITY study results showed that clinical and endoscopic outcomes of Entyvio treatment were superior to those of Humira in moderately to severely active ulcerative colitis at 1 year, according to a researcher at Digestive Disease Week.
“We all know that biologic therapy is a very important part of the management of patients with ulcerative colitis, but unfortunately there has been a paucity of direct comparative clinical data to inform the choice of biologic options. VARSITY is the first head-to-head trial comparing two biologic therapies for ulcerative colitis,” Bruce E. Sands, MD, from Icahn School of Medicine at Mount Sinai, said during his Distinguished Abstract Plenary Lecture.
VARSITY was a phase 3b, randomized, double-blind, double-dummy, active-controlled, multi-center study that compared the efficacy and safety of Humira (adalimumab, AbbVie) and Entyvio (vedolizumab, Takeda).
Adult patients aged up to 85 years who had a diagnosis for more than 3 months (n = 769) were randomized 1:1 to receive either vedolizumab IV (300 mg) and placebo subcutaneous or adalimumab subcutaneous (160 mg) and placebo IV, Sands said. The primary endpoint was clinical remission at week 52 and secondary endpoints were endoscopic improvement and corticosteroid-free clinical remission at week 52 among patients who had entered the study on baseline corticosteroids.
“It is worth commenting ... steroid tapering was requested to be initiated starting at week 6 if the patient had achieved response; however, this was left up to the treating physician and there was no forced taper,” he said.
At week 52, 31.3% of patients receiving vedolizumab IV achieved the primary endpoint of clinical remission compared with 22.5% of patients treated with adalimumab subcutaneous (P = .0061). Further, 39.7% of patients treated with vedolizumab achieved the secondary endpoint of mucosal healing at week 52, compared to 27.7% receiving adalimumab (P = .0005), according to Sands.
Additionally, exploratory data showed a greater proportion of patients receiving vedolizumab intravenous (67.1%) achieved clinical response at week 14 compared with those treated with adalimumab subcutaneous (45.9%), according to the abstract.
Sands noted that a separation between treatment groups was seen as early as week 6.
“In terms of safety and tolerability, I would say that both drugs behaved in a very safe way according to what we already know about their excellent safety profiles,” Sands said noting there was one death “that was thought to be unrelated” and was a post-surgical complication.
“Vedolizumab showed superior clinical and endoscopic efficacy over adalimumab,” Sands said. “The treatment effects were most pronounced in TNF inhibitor naive subpopulation. ... These results, I think, provide the most direct evidence to date on the comparative efficacy of biologics to support clinical decision-making in the management of moderately to severely active ulcerative colitis.”– by Joan-Marie Stiglich, ELS
Sands BE. Abstract 416a. Presented at: Digestive Disease Week 2019. May 18-21; San Diego, California.
Disclosure: Sands reports financial support for research for Celgene, Janssen, Pfizer and Takeda.