Sarilumab meets primary endpoint in phase 3 rheumatoid arthritis trial

Regeneron Pharmaceuticals and Sanofi have announced sarilumab met its primary endpoints after 24 weeks in a phase 3 trial of patients with rheumatoid arthritis, according to a company press release.

The study comprised 546 patients with rheumatoid arthritis (RA) who were randomly assigned to self-administered, subcutaneous sarilumab at 200 mg or 150 mg every 2 weeks or placebo as an add-on therapy to non-biologic disease-modifying anti-rheumatic drugs (DMARDs). Patients selected for the trial had responded inadequately or were intolerant of prior therapy with tumor necrosis factor-alpha inhibitors (TNF-a) inhibitors, according to the release.

After 24 weeks, 61% of patients in the 200 mg group improved by American College of Rheumatology criteria by 20% (ACR20), and 56% in the 150 mg sarilumab group met ACR20, compared with 34% in the placebo group. Physical function improved based on the Health Assessment Question-Disability Index (HAQ-DI) score measured at week 12.

Infections were reported in 30%, 22% and 27% in the 200 mg, 150 mg and placebo groups, respectively, and injection site reactions were reported in 8%, 7% and 1% in the 200 mg, 150 mg and placebo groups, respectively.

Detailed results of the trial will be presented at a future medical conference, according to the release.

Referenc e: www.regeneron.com.