SARIL-RA-TARGET study of sarilumab positive Phase III results for rheumatoid arthritis- Sanofi + Regeneron

Sanofi and Regeneron Pharmaceuticals, Inc. announced that a Phase III study (SARIL-RA-TARGET) of sarilumab, an investigational, fully-human IL6 receptor antibody, met its co-primary efficacy endpoints of a greater improvement in signs and symptoms of rheumatoid arthritis (RA) at 24 weeks, and physical function at 12 weeks compared to placebo. The study, evaluated the efficacy and safety of two subcutaneous sarilumab doses versus placebo, added to non-biologic disease modifying anti-rheumatic drugs (DMARD) therapy in RA patients who were inadequate 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 (SC) every other week (Q2W): sarilumab 200 milligrams (mg), sarilumab 150 mg, 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 (p < 0.001): (1) Improvement in signs and symptoms of RA at 24 weeks, as measured by the American College of Rheumatology (ACR20) score of 20 percent improvement, were as follows: 61 percent in the sarilumab 200 mg group; 56 percent in the sarilumab 150 mg group; and 34 percent in the placebo group, all in combination with DMARD therapy. (2) Improvement in physical function, as measured by change from baseline in the Health Assessment Question-Disability Index (HAQ-DI) at week 12.The most frequently reported adverse events included infections (30, 22 and 27 percent in the 200 mg, 150 mg and placebo groups respectively) and injection site reactions (8, 7, 1 percent in the 200 mg, 150 mg and placebo groups respectively). Serious infections were uncommon (1, 0.6 and 1 percent in the 200 mg, 150 mg and placebo groups respectively.

Comment: Sarilumab is in the same class as Actemra/RoActemra (tocilizumab)from Roche/Genentech and is in competition with another fully human anti-IL-6R antibody, Johnson & Johnson/ GlaxoSmithKline's sirukumab, a subcutaneous injection, which is also in Phase III for rheumatoid arthritis and other autoimmune diseases.

The drug is likely to be positioned for those who fail in disease modifying anti rheumatic drugs (DMARDs) and anti TNF agents.