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Sanofi and Regeneron announce new data from positive phase 3 trial of sarilumab in rheumatoid arthritis


Thursday, 12 Jun 2014 01:02am EDT 

Sanofi SA:Sanofi and Regeneron Pharmaceuticals Inc present positive results from phase 3 trial of investigational drug sarilumab in rheumatoid arthritis (RA) patients who were inadequate responders to methotrexate (MTX) therapy.New data showed that sarilumab increased clinical response rates defined as achieving ACR70 for at least 24 consecutive weeks and showed sustained improvement in signs and symptoms of RA after 52 weeks, which were secondary endpoints of trial.In this study, called SARIL-RA-MOBILITY, sarilumab met all three co-primary endpoints, demonstrating improvement in disease signs and symptoms at 24 weeks, physical function at 16 weeks and inhibition of joint damage progression at 52 weeks.Patients were randomized to one of three treatment groups dosed subcutaneously every other week, sarilumab 150 milligrams (mg), sarilumab 200 mg, or placebo, all in combination with MTX.Both sarilumab groups showed statistically improvements compared to placebo group in all three co-primary endpoints (p < 0.0001): improvement in signs and symptoms of RA at 24 weeks, improvement in physical function at Week 16 and inhibition of progression of structural damage at Week 52. 

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