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Regeneron and Sanofi's sarilumab beats AbbVie's Humira in late-stage RA study

Published 11/16/2016, 09:13 AM
Regeneron and Sanofi's sarilumab beats AbbVie's Humira in late-stage RA study
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  • Results from a Phase 3 clinical trial, SARIL-RA-MONARCH, assessing Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi 's (NYSE:SNY) sarilumab compared to AbbVie's (NYSE:ABBV) HUMIRA (adalimumab) in adult patients with rheumatoid arthritis (RA) showed sarilumab to be superior in improving RA symptoms. The data will be presented today at the American College of Rheumatology Annual Meeting in Washington, D.C.
  • SARIL-RA-MONARCH enrolled 369 adults with active RA who failed to respond adequately or were intolerant of or were inappropriate candidates for methotrexate. They were randomized to receive either sarilumab monotherapy (200 mg every two weeks subcutaneously) or adalimumab (40 mg every two weeks subcutaneously). The primary endpoint was the change from baseline to week 24 in a scale called DAS28-ESR, a measure of RA activity via the evaluation of 28 joints for tenderness and swelling, a general health assessment and ESR (erythrocyte sedimentation rate), a simple laboratory test for inflammation.
  • Sarilumab demonstrated superiority to adalimumab as measured by DAS28-ESR (-3.28 vs. -2.20; p<0.0001). The rates of DAS28-ESR remission also favored sarilumab (26% vs. 7%; p<0.0001).
  • It also beat adalimumab in terms of the proportion of patients who achieved ACR20 (20% improvement in RA symtoms) (72% vs. 58%; p<0.01), ACR50 (45% vs. 29%; p=0.0017) and ACR70 (23% vs. 11%; p=0.0036).
  • The incidence of adverse events were 64% for both groups. Serious adverse events were observed in 5% of the sarilumab subjects and 7% in the adalimumab subjects. The incidence of infections were similar (29% for sarilumab vs. 28% for adalimumab). Neutropenia (low level of a type of white blood cell called neutrophils) was more common with sarilumab (14%) than adalimumab (1%).
  • Sarilumab in a human monoclonal antibody that inhibits the inflammatory activity of RA by binding to the interleukin-6 (IL-6) receptor. IL-6 is the most abundant cytokine in the serum and synovial fluid of RA sufferers and is correlated with disease activity and joint destruction.
  • Regeneron's U.S. marketing application is currently under review. The FDA issued a CRL last month citing manufacturing deficiencies at the Sanofi site that will "fill and finish" the product. Sanofi has responded to the agency and is working with the regulator to promptly address the issues.

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