Sarilumab found superior to adalimumab in patients with active RA in phase 3 study

Sarilumab is being developed by Sanofi and Regeneron Pharmaceuticals, while adalimumab is marketed by AbbVie as Humira.

Sarilumab is a human monoclonal antibody directed against the interleukin-6 (IL-6) receptor that inhibits the inflammatory activity in RA mediated by the IL-6 signaling pathway.

The trial included 369 patients with active, moderate to severe rheumatoid arthritis (RA) who did not respond adequately to or were intolerant of methotrexate.

Patients were randomly assigned to received either subcutaneous sarilumab monotherapy at 200 mg every 2 weeks or adalimumab monotherapy at 40 mg every 2 weeks.

The primary endpoint was change from baseline in DAS28-ESR at 24 weeks, which demonstrated a statistically significant difference in favor of sarilumab.

The study also met important secondary endpoints, including other measures evaluating enhancements in the signs and symptoms of RA and physical function.

Regeneron Pharmaceuticals senior director, clinical sciences, immunology and inflammation Janet van Adelsberg said: "In this study, sarilumab monotherapy provided stronger efficacy than adalimumab monotherapy. 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."

In January, the companies submitted a biologics license application to the FDA with a target action date of 30 October 2016. The drug is also scheduled for filing in the European Union in the second half of this year.