Sanofi and Regeneron announce positive Phase 3 monotherapy study results

Sanofi and Regeneron Pharmaceuticals recently announced that the Phase 3 study of monotherapies set to demonstrate the superiority of sarilumab to adalimumab when treating active rheumatoid arthritis (RA) has met its primary goal.

The study, which was named SARIL-RA-MONARCH, also saw its secondary goals met as well. This goal included improvements in physical function of patients with RA.

The SARIL-RA-MONARCH study saw 369 adult patients who currently have active RA enrolled. These patients all had adverse responses, were intolerant of, or were not candidates for methotrexate (MTX). The study was randomized, meaning patients were randomly given either subcutaneous sarilumab monotherapy, which included 200 mg every two weeks, or adalimumab monotherapy, 40 mg every two weeks. Patients who did not respond to adalimumab had the option of increasing their dosage to once a week.

The primary goal of the study was a change in baseline in DAS28-ESR 24 weeks into the dosing regimen. DAS28-ESR measures disease activity in RA, which includes the evaluation of 28 joints in the body for tenderness and swelling.

There was a drastic difference in favor of sarilumab, which was at -3.25 as opposed to -2.22 for patients who were given adalimumab. The study also met its secondary goal, which was the improvement of the signs and symptoms of RA in patients.