Sanofi and Regeneron Inc. have announced results from a pivotal Phase 3 study of sarilumab, an investigational, human antibody against the IL-6 receptor.
Sanofi says that the results of the study, SARIL-RA-TARGET, were presented on Sunday at an oral session during the American College of Rheumatology (ACR) Annual Meeting in San Francisco, California. The study met both its co-primary endpoints of improvements in signs and symptoms of rheumatoid arthritis (RA) and improvements in physical function, as well as secondary efficacy endpoints.1
“Rheumatoid arthritis can be a debilitating disease that has a significant impact on a patient, and despite the availability of a wide range of treatments, new agents are still needed to address unmet patient needs including failure to respond to therapy,” said Dr. Roy Fleischmann, clinical professor in the Department of Internal Medicine at the University of Texas Southwestern Medical Center and lead study author.
“These data suggest that sarilumab, if approved, may be a potential option for patients with moderate-to-severe RA.”
The SARIL-RA-TARGET trial enrolled 546 RA patients who were inadequate responders or intolerant of TNF-alpha inhibitors (TNF-IR). Patients were randomized to one of three treatment groups self-administered subcutaneously (SC) every other week (Q2W): sarilumab 200 milligrams (mg), sarilumab 150 mg, or placebo, in addition to non-biologic disease modifying anti-rheumatic drugs (DMARD) therapy. Top-line results were previously announced in May 2015, said Sanofi.
Both sarilumab groups showed clinically relevant and statistically significant improvements compared to placebo in both co-primary endpoints