Sarilumab Shows Superiority to Humira Treating Rheumatoid Arthritis Symptoms
Sanofi and Regeneron Pharmaceuticals announce results of phase 3 trial showing efficacy of sarilumab in improving the signs and symptoms of active rheumatoid arthritis.
A phase 3 monotherapy study achieved its primary endpoint for sarilumab in the treatment of active rheumatoid arthritis (RA) at week 24.
Sarilumab was found superior to adalimumab (Humira) in improving the signs and symptoms in patients with active RA.
The SARIL-RA-MONARCH trial enrolled 269 adults suffering from active RA who are considered inadequate responders, intolerant, or inappropriate candidates for treatment with methotrexate (MTX).
Patients were randomized to receive either subcutaneous sarilumab monotherapy at 200-mg every 2 weeks or adalimumab monotherapy at 40-mg every 2 weeks.
Patients were allowed to increase the weekly dosage of Humira if they did not respond adequately to treatment.
“In this study, sarilumab monotherapy provided stronger efficacy than adalimumab monotherapy,” said Senior Director of Clinical Sciences, Janet van Adelsberg, MD. “Adalimumab is one of the most commonly used biologic medicines in RA. This is the first time an IL-6 receptor blocker delivered subcutaneously has demonstrated superiority over adalimumab monotherapy in RA.”
The primary endpoint of the study was a change from baseline in DAS28-ESR at 24 weeks. The results of the study showed a statistically significant difference that was favorable for sarilumab at -3.25 for sarilumab compared to -2.22 for adalimumab, p less than 0.0001.
The therapy was also able to meet clinically important secondary endpoints, as well as improvements in the signs and symptoms of RA, measured by patients who achieved a 20% improvement in the American College of Rheumatology (ACR) criteria, as 72% for sarilumab vs. 58% for adalimumab, p less than 0.01.
The drug also achieved positive secondary endpoints in ACR50 and ACR70 responses, and showed improved physical function, as measured by the Health Assessment Questionnaire, compared with Humira (p less than 0.01 for all of these measures).
Adverse events were 64% in both groups, while serious adverse events were 5% for sarilumab and 7% for Humira. Infections were found to be similar between the groups.
“Despite the availability of a wide range of treatment options, we believe that new therapies are needed to further address unmet needs of RA patients,” said Global Project Head of Sanofi, Simon Cooper, MBBS VP. “These data suggest that sarilumab, if approved, may be an option for patients unable to tolerate or take methotrexate, and we look forward to sharing further details at an upcoming medical congress.”