Sarilumab, Alone or in Combination with Conventional Synthetic DMARDs, Safe and Effective for Most RA Patients

Researchers recently assessed the safety and efficacy of sarilumab either as a monotherapy or in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) in patients with varying severities of rheumatoid arthritis (RA).

“Characterization of subpopulations of patients most likely to respond favourably or unfavourably to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and/or biologic DMARDs (bDMARDs) could help guide appropriate use of the many therapies now available and improve patient outcomes,” the researchers explained.

To perform their analysis, researchers gathered data from phase 3 studies. This included two placebo-controlled trials of subcutaneous sarilumab 150 mg or 200 mg every two weeks (Q2W) in combination with either methotrexate in patients with an inadequate response to methotrexate alone (52 weeks) or csDMARDs in patients who had an inadequate response or intolerance to tumor necrosis factor inhibitors, and one of sarilumab 200 mg Q2W as monotherapy compared to adalimumab 40 mg Q2W in patients who had an inadequate response or intolerance to methotrexate (24 weeks). Patients were assessed by demographics, disease characteristics, and prior treatments. Clinical, radiographic, and physical function measures were all assessed as outcomes.

Overall, sarilumab was clinically superior as a monotherapy compared to adalimumab as well as in combination with csDMARDs compared to placebo plus csDMARDs across all patient demographic, disease characteristics, and prior treatments subgroups.

“Interaction p values of < 0.05 were consistently observed across studies only for baseline anti-cyclic citrullinated peptide antibody (ACPA) status for American College of Rheumatology 20% response, but not American College of Rheumatology 50% or 70% response,” the study authors did note.

Patients taking sarilumab, compared to those taking placebo, were more likely to experience adverse events and worsening laboratory parameters, as well as patients aged ≥65 years—which the authors noted was a small population of the study (n=289) compared to patients aged <65 years (n=1,819). Six patients aged ≥65 years experienced serious infections; however, patients aged ≥65 years in all treatment groups were more likely to sustain serious infections.

The study was published in Arthritis Research & Therapy.

“These data suggest that treatment with sarilumab is associated with beneficial effects across a broad spectrum of patients who have RA,” the authors summarized.