Sanofi and Regeneron Pharmaceuticals, Inc. have announced that a Phase 3 monotherapy study met its primary endpoint demonstrating that sarilumab was superior to adalimumab (marketed by AbbVie as HUMIRA) in improving signs and symptoms in patients with active rheumatoid arthritis (RA) at Week 24.
The study, called SARIL-RA-MONARCH, also met important secondary endpoints including other measures assessing improvements in signs and symptoms of RA and physical function. Sarilumab is an investigational, human IL-6 receptor antibody, stated Sanofi in it is annonunsement issued on Marc 11st.
“In this study, sarilumab monotherapy provided stronger efficacy than adalimumab monotherapy. Adalimumab is one of the most commonly used biologic medicines in RA,” said Janet van Adelsberg, M.D., Senior Director, Clinical Sciences, Immunology and Inflammation, Regeneron. “This is the first time an IL-6 receptor blocker delivered subcutaneously has demonstrated superiority over adalimumab monotherapy in RA.”
The SARIL-RA-MONARCH study enrolled 369 adult patients with active RA who were inadequate responders to, intolerant of, or inappropriate candidates for methotrexate (MTX). Patients were randomized to receive either subcutaneous sarilumab monotherapy (200 mg every 2 weeks) or adalimumab monotherapy (40 mg every 2 weeks); patients who did not respond adequately to adalimumab could increase to weekly dosing.
“Despite the availability of a wide range of treatment options, we believe that new therapies are needed to further address unmet needs of RA patients,” said Dr. Simon Cooper, MBBS VP, Global Project Head, Immunology and Inflammation, Sanofi. “These data suggest that sarilumab, if approved, may be an option for patients unable to tolerate or take methotrexate, and we look forward to sharing further details at an upcoming medical congress.”