Regeneron and Sanofi announced their Phase 3 study for sarilumab has met its primary endpoint, demonstrating superiority over adalimumab in improving symptoms in patients with active rheumatoid arthritis (RA) at Week 24, in the SARIL-RA-MONARCH trials.
A total of 369 patients with active RA were randomized in the study to receive either subcutaneous sarilumab monotherapy (200mg every 2 weeks) or adalimumab monotherapy (40mg every 2 weeks). Primary endpoint was change from baseline in DAS28-ESR at 24 weeks. The sarilumab group showed significantly more change at -3.25 compared to -2.22 for adalimumab. Patients also displayed improvements in signs and symptoms by 20% according to the American College of Rheumatology criteria (72% vs. 58% for sarilumab and adalimumab, respectively).
There was an increased rate of neutropenia associated with sarilumab compared to adalimumab, 14% vs. 1%, respectively. The rate of other adverse events was generally similar between both treatments.
Sarilumab is an investigational, human monoclonal antibody directed against the IL-6 receptor. It inhibits the inflammatory activity in RA mediated by the IL-6 signaling pathway. The FDA accepted for review the biologics license application (BLA) for sarilumab in January. The submission is based on findings from the SARIL-RA-MONARCH trial.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date for sarilumab of October 30, 2016.
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