RA: Sarilumab Deemed Safe for Long-Term Use

Treatment with sarilumab remains safe and effective through 2 years of use in adults with rheumatoid arthritis (RA) with inadequate response to methotrexate, according to a new study.

For their study, researchers evaluated 1197 patients with RA who were enrolled in the MOBILITY trial. During this phase of the trial, patients with inadequate response to methotrexate were treated with 150 mg or 200 mg subcutaneous sarilumab or placebo ever 2 weeks plus methotrexate for up to 1 year.
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Of these participants, 901 entered EXTEND, a long-term extension study, upon completion of the MOBILITY trial. During EXTEND, all patients were treated with 200 mg sarilumab every 2 weeks plus methotrexate.

Dose reduction to 150 mg sarilumab twice weekly was permitted in cases of abnormal laboratory findings and per investigator’s discretion.

Results of EXTEND revealed that disease activity reached similar levels, regardless of initial treatment, during the extension period. The researchers found that modified total Sharp scores at year 1 had been maintained through year 2.

In particular, patients treated with twice-weekly 200 mg sarilumab demonstrated the best radiographic outcomes.

Approximately 89.4% of patients continued the study through 2 years following dose reduction. Treatment-emergent adverse events (TEAEs) occurred at a rate of 279.6 events per 100 patient-years, and serious AEs at a rate of 16.6 events per 100 patient-years.

The most commonly reported TEAEs included neutropenia and injection site erythema, among others.

“Sarilumab safety through year 2 was consistent with IL-6 receptor blockade,” the researchers wrote. “Clinical response was similar irrespective of initial treatment, and radiographic progression stabilized.”

—Christina Vogt

Reference:

Genovese MC, van Adelserg J, Fan C, et al. Two years of sarilumab in patients with rheumatoid arthritis and an inadequate response to MTX: safety, efficacy and radiographic outcomes [Published online May 9, 2018]. Rheumatology. https://doi.org/10.1093/rheumatology/key121

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