IL-6 inhibitor shows positive clinical benefit in RA patients

Sarilumab may be an effective option for patients with moderately-to-severely active rheumatoid arthritis (RA)-including those who have had an inadequate response to, or were intolerant of, 1 or more TNF-alpha inhibitors (TNF-IR) or inadequate response to methotrexate, according to topline results from a new study.

SARIL-RA-TARGET trial enrolled 546 TNF-IR and evaluated the efficacy and safety of 2 subcutaneous sarilumab doses versus placebo, added to non-biologic disease-modifying antirheumatic drug (DMARD) therapy in patients who were inadequate responders to or intolerant of TNF-alpha inhibitors (TNF-IR). Patients (n=546) were randomly assigned to 1 of 3 treatment groups every other week (Q2W): sarilumab 200 mg, sarilumab 150 mg, or placebo, self-administered subcutaneously (SC) in addition to DMARD therapy. The study met its co-primary efficacy end points showing that sarilumab + DMARDs had greater improvement in signs and symptoms of RA at 24 weeks and physical function as 12 weeks compared to placebo + DMARDs:

• Improvement in signs and symptoms of RA at 24 weeks, as measured by the American College of Rheumatology score of 20% improvement (ACR20), were as follows: 61% in the sarilumab 200 mg group; 56% in the sarilumab 150 mg group; and 34% in the placebo group, all in combination with DMARD therapy.

• Improvement in physical function, as measured by change from baseline in the Health Assessment Question-Disability Index (HAQ-DI) at week 12. 

Dr van Adelsberg“Despite the availability of a wide range of synthetic and biologic DMARDs and biologic treatments for RA, new agents are still needed to address issues including failure to respond, an initial response which diminishes over time and intolerance to current therapies,” said Janet van Adelsberg, MD, senior director, immunology and inflammation at Regeneron.

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Studies have generated evidence that inhibition of IL-6 can reduce the signs and symptoms of RA and help to stop the destruction of joints in patients with RA, according to van Adelsberg.

NEXT: Endpoints for SARIL-RA-EASY and SARIL-RA-ASCERTAIN trials

Most frequently reported adverse events included infections and injection-site reactions. Serious infections were uncommon.

Two additional trials from the phase 3 program, SARIL-RA-EASY and SARIL-RA-ASCERTAIN, also met their primary end points:

• SARIL-RA-EASY enrolled 217 patients and was designed to evaluate the technical performance and usability of the sarilumab autoinjector device. There were no product technical failures with the autoinjector, the primary end point of the study. 
   

• SARIL-RA-ASCERTAIN was a 202 patient safety calibrator study, designed to assess the safety of two subcutaneous doses of sarilumab and tocilizumab infusion in combination with DMARDs in patients with RA who were TNF-IR. There were no clinically meaningful differences between the treatment groups in serious adverse events and serious infections.

The studies were sponsored by the Regeneron and Sanofi Alliance.

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