SAN DIEGO — Clinical and endoscopic outcomes of Entyvio treatment were “superior” to those of Humira in cases of moderately to severely active ulcerative colitis at 1 year, a researcher at Digestive Disease Week said.
Data that directly compare these two biologic therapies for ulcerative colitis are scarce, according to Bruce E. Sands, MD, chief of the Dr. Henry D. Janowitz Division of Gastroenterology at the Icahn School of Medicine at Mount Sinai.
Researchers randomly assigned 769 adults aged 85 years or younger who had a diagnosis of ulcerative colitis for 3 months or longer in a 1:1 ratio to 300 mg Entyvio (vedolizumab IV, Takeda) and placebo subcutaneously or 160 mg Humira (adalimumab, AbbVie) subcutaneously and placebo IV for the phase 3b trial.
Sands and colleagues found that at week 52, 31.3% of the patients who received vedolizumab IV achieved clinical remission vs. 22.5% of those who received adalimumab subcutaneously (P = .0061). Further, 39.7% of the patients who received vedolizumab had mucosal healing at week 52 vs. 27.7% of those who received adalimumab (P = .0005). A separation between treatment groups was observed as early as week 6, according to researchers.
“Vedolizumab showed superior clinical and endoscopic efficacy over adalimumab,” Sands said. “The treatment effects were most pronounced in TNF inhibitor-naive subpopulation.” He added that the results “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.”
Click here for more Healio coverage of this clinical trial. – by Joan-Marie Stiglich, ELS, and Janel Miller
Reference: Sands BE. Abstract 416a. Presented at: Digestive Disease Week 2019. May 18-21; San Diego.
Disclosure: Sands reports financial support for research from Celgene, Janssen, Pfizer and Takeda.