SARIL-RA-TARGET evaluated the efficacy and safety of two subcutaneous sarilumab doses vs. 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). TNF-IR patients (n=546) were randomized to one of three treatments given subcutaneously: sarilumab 200mg, sarilumab 150mg, or placebo, in addition to DMARD therapy.
The co-primary efficacy endpoints of a greater improvement in signs and symptoms of RA at 24 weeks and physical function at 12 weeks, compared to placebo were met. Both sarilumab groups showed clinically relevant and statistically significant improvements compared to the placebo group in both co-primary endpoints (P>0.001). Improvement in signs and symptoms of RA at 24 weeks was observed in 61% of patients in the sarilumab 200mg group; 56% in the sarilumab 150mg group; and 34% in the placebo group, all in combination with DMARD therapy.
Sarilumab is the first fully human monoclonal antibody that binds with high affinity to the IL-6 receptor. It blocks the binding of IL-6 to its receptor and interrupts the resultant cytokine-mediated inflammatory signaling.