FDA Approves New Treatment for Rheumatoid Arthritis

The US Food and Drug Administration recently approved Kevzara (sarilumab) for the treatment of moderate to severe rheumatoid arthritis in adult patients who are not responding to or have an intolerance to one or more disease modifying antirheumatic drugs (DMARD). The drug is a human monoclonal antibody that has been shown to inhibit interleukin-6 receptor mediated signaling by binding to the receptor, which is associated with rheumatoid arthritis inflammation.

Kevzara can be used alone or in combination with other DMARD, and is recommended to be administered as a subcutaneous injection at a dose of 200 mg once every 2 weeks, which can be self-administered. If necessary, the dosage can be reduced from 200 mg to 150 mg every 2 weeks to manage certain laboratory abnormalities, such as neutropenia, thrombocytopenia, and liver enzyme elevations.
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The efficacy of Kevzara was evaluated using data from clinical trials that included approximately 2900 adult patients with moderate to severe rheumatoid arthritis who had an inadequate response to previous treatment. In 2 phase 3 clinical trials, the MOBILITY STUDY and TARGET study, patients who received Kevzara with a DMARD experienced improvement in signs and symptoms of rheumatoid arthritis based on the American College of Rheumatology Criteria, greater improvement in baseline physical function, and less radiographic progression of structural damage.

Common adverse reactions to Kevzara included neutropenia, increased alanine aminotransferase, injection site erythema, upper respiratory infections, and urinary tract infections. In addition, Kevzara can increase the risk for serious infections that can result in hospitalization and death.

—Melissa Weiss

Reference:

Sanofi and Regeneron announce FDA approval of Kevzara (sarilumab) for the treatment of moderately to severely active rheumatoid arthritis in adult patients [Press Release]. Paris and Tarrytown, NJ: Sanofi Genzyme; May 22, 2017. http://news.genzyme.com/press-release/sanofi-and-regeneron-announce-fda-approval-kevzara-sarilumab-treatment-moderately-seve. Accessed May 23, 2017.