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Sarilumab trial generates positive results among patients with RA
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Sanofi and Regeneron Pharmaceuticals’ rheumatoid arthritis treatment, sarilumab, demonstrated promising results, meeting the three co-primary endpoints of a phase 3 trial.
Data presented at the June European League Against Rheumatism Annual Congress in Paris, France, pointed to improved clinical response for at least 24 weeks, improved function at 16 weeks and persistent relief of symptoms and suspension of joint damage at 52 weeks, according to a press release.
The phase 3 SARIL-RA-MOBILITY trial included 1,197 adult patients with active, moderate-to-severe rheumatoid arthritis (RA) who were inadequate responders to methotrexate therapy. Patients were randomly assigned to receive sarilumab 150 mg, sarilumab 200 mg or placebo given subcutaneously every other week. Each patient also received concurrent methotrexate treatment during the trial.
Clinical response was measured by attaining 20% and 70% improvement in RA signs and symptoms according to the American College of Rheumatology scoring levels (ACR20 and ACR70, respectively) for a minimum of 24 weeks.
Both sarilumab groups had statistically significant improvements compared with placebo at all three co-primary endpoints, according to the release.
SARIL-RA, the phase 3 sarilumab program, currently has six ongoing clinical studies, targeted to enroll a total of approximately 2,800 patients with RA.
Sarilumab is the first fully-human monoclonal antibody directed against the IL-6 receptor, according to the release.