Regeneron and Sanofi announced the results from a Phase 3 trial for sarilumab, a fully humanized anti-IL-6Rα monoclonal antibody. Testing with 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 (ACR) 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.
This article originally appeared on MPR