Experimental Rheumatoid Arthritis Drug Improves Symptoms

Drug found to improve physical function.

Patients suffering from rheumatoid arthritis may soon be armed with a new treatment option.

During a recent phase 3 trial of the experimental fully human IL-6 receptor antibody sarilumab, the drug showed a greater improvement in the signs and symptoms of rheumatoid arthritis (RA) at 24 weeks and physical function at 12 weeks compared with placebo.

Sarilumab acts by binding with to the IL-6 receptor to block IL-6 from binding to its receptor, which interrupts the subsequent cytokine-mediated inflammatory signaling.

The SARIL-RA-TARGET trial analyzed the efficacy and safety profile for 2 subcutaneous sarilumab doses versus placebo. The drug was added to non-biologic disease modifying anti-rheumatic drugs (DMARD) therapy in RA patients who did not achieve an adequate response or who were intolerant of TNF-alpha inhibitors (TNF-IR).

The trial enrolled 546 TNF-IR patients randomized to 1 of 3 cohorts to subcutaneously self-administer every other week either sarilumab 200 mg, sarilumab 150 mg, or placebo, on top of DMARD therapy. Both of the sarilumab cohorts achieved clinically relevant and statistically significant improvements compared with the placebo cohort.

An evaluation using the American College of Rheumatology score of 20% improvement (ACR20) found that at 24 weeks 61% of patients in the sarilumab 200 mg group; 56% of patients in the sarilumab 150 mg group; and 34% of patients in the placebo group achieved ACR20, all in combination with DMARD therapy.

Physical function improvements measured by the change from baseline in the Health Assessment Question-Disability Index were achieved at week 12.

The most frequently reported side effects across all treatment groups included infections and injection site reactions, which occurred in 8% of the 200 mg group, 7% of the 150 mg group, and 1% of the placebo group.