Sarilumab Receives FDA Approval for Rheumatoid Arthritis

Sarilumab plus DMARDs demonstrated statistically significant improvements in patients with moderate to severe RA.

The FDA granted approval to sarilumab (Kevzara) for the treatment of adult patients with moderate to severe active rheumatoid arthritis (RA) who had an inadequate response or intolerance to 1 or more disease modifying antirheumatic drugs (DMARDs).

Sarilumab is a human monoclonal antibody designed to bind to the interleukin-6 receptor, according to a press release. It has been shown to inhibit IL-6R mediated signaling, which in excess can contribute to inflammation associated with RA.

“Despite the many advances made in the treatment of rheumatoid arthritis, patients continue to need new treatment options,” Olivier Brandicourt, MD, CEO of Sanofi, said in a release. “Today’s approval in the US not only underscores our ongoing commitment to making a difference in the lives of patients, but also demonstrates our drive to accelerate science and medicine in immunology.”

The approval was based on data from 2 pivotal phase 3 clinical trials MOBILITY and TARGET, which included approximately 2900 adults with moderate to severe active RA who had an inadequate response to prior treatments.

In the MOBILITY study, patients who received sarilumab plus methotrexate (MTX) experienced reduced signs and symptoms, improved physical function, and demonstrated significantly less radiographic progression of structural damage compared with patients who received placebo plus MTX.

Additional study highlights included: patients in the sarilumab plus MTX arm achieved a greater improvement in the primary endpoint of signs and symptoms at 24 weeks, achieving a 20% improvement in the American College of Rheumatology Criteria.

At 52 weeks, patients in the sarilumab plus MTX arm experienced significantly less radiographic progression of structural damage as measured by the change in modified Total Sharp Score. At 16 weeks, those in the sarilumab plus MTX arm also demonstrated greater improvement from baseline in physical function, according to the release.

In the TARGET study, patients administered sarilumab plus DMARD experienced reduced signs and symptoms and improved physical function compared with placebo plus DMARD.

Patients treated with sarilumab plus DMARD achieved a greater improvement in the primary endpoint of signs and symptoms at 24 weeks. At 12 weeks, patients in the sarilumab plus DMARD arm demonstrated greater improvement from baseline in physical function.

The most common adverse events reported were neutropenia, increased alanine aminotransferase, injection site erythema, upper respiratory infections, and urinary tract infections.

“Today’s milestone with [sarilumab], which follows closely on the heels of our recent approval of dupilumab (Dupixent), showcases the ability of our internal discovery and science engine to deliver important new medicines by leveraging our leading technologies, such as VelocImmune,” George D. Yancopoulos, MD, PhD, founding scientist, president, and chief scientific officer at Regeneron, said in the release. “This milestone would not have been possible without our important ongoing collaboration with Sanofi, and most importantly, the patients and physicians who participated in our SARIL-RA clinical program, and worked with us to make sarilumab available to those in the US RA community in need of new options.”

Sarilumab can be used as a monotherapy or in combination with MTX or other conventional DMARDs. The recommended dose is 200-mg subcutaneous injection of sarilumab once every 2 weeks. Dosing can be reduced from 200 mg to 150 mg once every 2 weeks as needed, according to the release.