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news.Sanofi and Regeneron Pharmaceuticals have revealed Phase 2b MOBILITY trial results of sarilumab (REGN88/SAR153191) in patients with in rheumatoid arthritis (RA) and Phase 2b ALIGN trial results in patients with ankylosing spondylitis (AS).
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The results of the trial suggested that the patients treated with sarilumab in conjunction with methotrexate (MTX) improved signs and symptoms of moderate-to-severe RA compared to patients treated with MTX alone.
The trials’ primary endpoint was the proportion of patients achieving at least a 20% improvement in RA symptoms (ACR20) after 12 weeks.
In the trial, the 49% of patients who were given the lowest sarilumab dose regimen showed ACR20 response after 12 weeks.
Additionally, 72% of patients receiving the highest dose regimen compared to 46.2% of patients receiving placebo and MTX.
The company said in the Phase 2b ALIGN trial, sarilumab failed to demonstrate improvements in in signs and symptoms of active AS compared to placebo in patients who had inadequate response to NSAIDs.
Sanofi Global Research & Development president Elias Zerhouni said following these encouraging Phase 2b results in RA, the companies are currently discussing the dose(s) of sarilumab to advance into the Phase 3 portion of the MOBILITY trial.