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Positive Results Reported for Sarilumab in Late-Stage Arthritis Trial

FDA submission planned for Q4 2015

A phase III study of sarilumab (Sanofi/Regeneron Pharmaceuticals), an investigational, fully human interleukin-6 receptor (IL-6R) antibody, has met its co-primary efficacy endpoints of a greater improvement in the signs and symptoms of rheumatoid arthritis (RA) at 24 weeks and in physical function at 12 weeks compared with placebo.

The SARIL-RA-TARGET trial evaluated the efficacy and safety of two subcutaneous sarilumab doses compared with placebo, added to nonbiologic disease-modifying antirheumatic drug (DMARD) therapy, in RA patients who were inadequate responders to or intolerant of tumor necrosis factor-alpha inhibitors (TNF-IR).

The SARIL-RA-TARGET trial enrolled 546 TNF-IR patients who were randomly assigned to one of three treatments, which were self-administered subcutaneously every other week: sarilumab 200 mg, sarilumab 150 mg, or placebo, in addition to DMARD therapy.

Improvement in the 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. These differences were statistically significant in favor of the two sarilumab groups (P < 0.001).

Both sarilumab groups also showed statistically significant improvements in physical function, as measured by the change from baseline in the Health Assessment Question–Disability Index (HAQ-DI) at week 12, compared with the placebo group (P < 0.001).

The most common adverse events included infections (30%, 22%, and 27% for sarilumab 200 mg, sarilumab 150 mg, and placebo, respectively) and injection-site reactions (8%, 7%, and 1%, respectively). Serious infections were uncommon (1%, 0.6%, and 1%, respectively). A reduction in the neutrophil count was the most common laboratory abnormality.

Two additional trials from the phase III program, SARIL-RA-EASY and SARIL-RA-ASCERTAIN, also met their primary endpoints.

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.

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

Sarilumab (REGN88/SAR153191) is the first fully human monoclonal antibody directed against IL-6R. Sarilumab binds with high affinity to IL-6R, thereby blocking the binding of IL-6 to its receptor and interrupting the resultant cytokine-mediated inflammatory signalling.

Sarilumab is an investigational compound, and its safety and efficacy have not been evaluated by any regulatory authority.

Source: Regeneron Pharmaceuticals; May 21, 2015.


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