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RA patients improved symptoms with sarilumab/MTX treatment
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Adults with active rheumatoid arthritis who had inadequate response to methotrexate therapy displayed improved signs and symptoms when sarilumab was combined with methotrexate, according to phase 3 study results announced by Sanofi and Regeneron Pharmaceuticals.
Sarilumab, an experimental agent under clinical development, is the first fully human monoclonal antibody directed against the interleukin-6 receptor, according to a news release. It is delivered subcutaneously and blocks the binding of IL-6 to its receptor, interrupting the resultant cytokine-mediated inflammatory signaling.
Approximately 1,200 adults with moderate-to-severe rheumatoid arthritis who responded inadequately to methotrexate (MTX) therapy were enrolled in the 52-week, phase 3 trial. All were randomly assigned a biweekly combination of MTX with 200 mg sarilumab, 150 mg sarilumab or placebo.
Both sarilumab-treated groups displayed improvement in three primary endpoints compared with placebo patients (P<.001). Sixty-six percent and 58% of patients treated with 200 mg and 150 mg sarilumab, respectively, and 38% of placebo-treated patients showed gains in RA signs and symptoms at week 24 based on ACR20 score.
The other endpoints were improved physical function on the Health Assessment Question-Disability at week 16, and inhibition of structural damage at week 5, as measured by van der Heijde-modified Total Sharp Score (mTSS).
Measurements of mTSS were 0.25 and 0.90 for the 200-mg and 150-mg sarilumab groups, respectively, and 2.78 for placebo patients, all in combination with MTX. When compared with placebo/MTX at 52 weeks, patients receiving 200 mg sarilumab/MTX had an approximately 90% reduction in radiographic progression, as measured by mTSS.
Sarilumab-treated patients had a greater incidence of adverse events leading to treatment withdrawal when compared with those assigned placebo (13.9%, 200 mg sarilumab; 12.5%, 150 mg sarilumab; and 4.7%, placebo). The most frequent adverse events were infections, which occurred more often in the sarilumab arms.
“IL-6 blockade is emerging as an important therapeutic approach for rheumatoid arthritis,” Neil Graham, MBBS, MD, MPH, vice president, program direction, immunology and inflammation, Regeneron Pharmaceuticals, said in the release. “We are encouraged with these phase 3 results, which demonstrated efficacy at both doses of sarilumab.”