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Sanofi and Regeneron Report Positive Results with Sarilumab in First Phase 3 Rheumatoid Arthritis Registration Trial
Date:11/22/2013

PARIS and TARRYTOWN, N.Y., Nov. 22, 2013 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that in the SARIL-RA-MOBILITY Phase 3 clinical trial in adult patients with active rheumatoid arthritis (RA) who were inadequate responders to methotrexate (MTX) therapy, sarilumab (the first fully-human anti-IL-6R monoclonal antibody) treatment in combination with MTX improved disease signs and symptoms as well as physical function, and inhibited progression of joint damage.

"IL-6 blockade is emerging as an important therapeutic approach for rheumatoid arthritis," said Neil Graham, M.B.B.S., M.D., M.P.H., Vice President, Program Direction, Immunology and Inflammation, Regeneron Pharmaceuticals.  "We are encouraged with these Phase 3 results, which demonstrated efficacy at both doses of sarilumab, each administered every other week."

The 52 week SARIL-RA-MOBILITY Phase 3 trial enrolled approximately 1,200 patients with active, moderate-to-severe rheumatoid arthritis, and who were inadequate responders to MTX therapy. Patients were randomized to one of three subcutaneous treatment groups, all in combination with MTX and dosed every other week: sarilumab 200 milligrams (mg), sarilumab 150 mg, or placebo.

Both sarilumab groups showed clinically relevant and statistically significant improvements compared to the placebo group in all three co-primary endpoints (p<0.0001).

(1) Improvement in signs and symptoms of RA at 24 weeks, as measured by the American College of Rheumatology score of 20 percent improvement (ACR20).

  • 66 percent, 58 percent, and 33 percent in the sarilumab 200 mg, sarilumab 150 mg, and placebo groups respectively, all in combination with MTX.
  • (2) Improvement in physical function, as measured by change from baseline in the Health Assessm
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    SOURCE Regeneron Pharmaceuticals, Inc.
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