Sanofi and Regeneron's sarilumab meets co-primary endpoints in rheumatoid arthritis

French drug major Sanofi (Euronext: SAN) and US biotech firm Regeneron (Nasdaq: REGN) have announced that a Phase III study of sarilumab met its co-primary efficacy endpoints.

Sarilumab, an investigational, fully-human interleukin( IL) 6 receptor antibody, met the endpoints of a greater improvement in signs and symptoms of rheumatoid arthritis at 24 weeks, and physical function at 12 weeks, compared to placebo. The SARIL-RA-TARGET study evaluated the efficacy and safety of two subcutaneous sarilumab doses versus placebo, added to non-biologic disease-modifying anti-rheumatic drug therapy in rheumatoid arthritis who were in adequate responders to, or intolerant of, TNF-alpha inhibitors (TNF-IR).

The SARIL-RA-TARGET trial enrolled 546 TNF-IR patients who were randomized to one of three treatment groups self-administered subcutaneously every other week: sarilumab 200mg, sarilumab 150mg, or placebo, in addition to DMARD therapy. Both sarilumab groups showed clinically relevant and statistically significant improvements compared to the placebo group in both co-primary endpoints. Signs and symptoms of rheumatoid arthritis showed a 61% improvement in the sarilumab 200mg group, 56% in the sarilumab 150mg group, and 34% in placebo, all in combination with DMARD therapy.