Sanofi RA Drug Improves MTX Response

Sanofi and Regeneron Pharmaceuticals have announced results from the Phase III trial of sarilumab in adult patients with active rheumatoid arthritis (RA) who were inadequate responders to methotrexate (MTX) therapy. The treatment, in combination with MTX, improved disease signs and symptoms as well as physical function, and inhibited progression of joint damage.

The 52-week trial enrolled approximately 1,200 patients with active, moderate-to-severe RA, who were inadequate responders to MTX therapy. Patients were randomized to one of three subcutaneous treatment groups, all in combination with MTX and dosed every other week: sarilumab 200 mg, sarilumab 150 mg, or placebo.

Both sarilumab groups showed clinically relevant and statistically significant improvements compared to the placebo group in all three co-primary endpoints. There was a higher incidence of treatment emergent adverse events leading to withdrawal in the sarilumab treatment groups compared to placebo — 13.9% in 200 mg, 12.5% in 150 mg and 4.7% in placebo) — with infections the most frequently reported adverse events.