Sarilumab is safe, well-tolerated, and efficacious in the treatment of moderate to severe rheumatoid arthritis (RA), according to a review published in Therapeutics and Clinical Risk Management.

Methotrexate (MTX) has been the conventional therapeutic mainstay for the first-line treatment of RA, with tumor necrosis factor (TNF) inhibitors prescribed as an alternative to patients who cannot tolerate MTX or among whom the medication is ineffective. Despite the widespread use of MTX in RA, TNF inhibitors are not effective in all patients, and alternate avenues are needed.

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Cytokine inhibitors, including interleukin (IL)-6 antagonists such as sarilumab, have been approved for the treatment of RA, either as monotherapy or in combination with MTX; sarilumab has been indicated for patients with RA who responded poorly or were intolerant of prior treatment with disease-modifying antirheumatic drugs. Recommended dosing for sarilumab is known to be 150 mg or 200 mg injected subcutaneously every 2 weeks, with peak and steady state concentrations achieved at 2 to 4 days and 14 to 16 weeks, respectively.

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In this review, of the 16 studies evaluated, 3 clinical trials provided good evidence of the safety, tolerability and efficacy of sarilumab in the treatment of RA, with significant reductions in structural damage progression and an acceptable adverse event profile; infections and neutropenia were the 2 most commonly reported adverse events.

Results from the MOBILITY trial (phase 2, n=306; phase 3, n=1369; Identifier: NCT01061736 Part A and B, respectively) indicated that sarilumab plus MTX was superior to placebo and placebo plus MTX. In the TARGET (n=546; placebo-controlled; Identifier: NCT01709578) and MONARCH (n=369; double dummy design; Identifier: NCT02332590) trials, 2 multicenter double-blind phase 3 clinical trials, treatment of RA with sarilumab was found to be more efficacious than with its comparators (TARGET, sarilumab plus MTX vs placebo plus MTX; MONARCH, sarilumab plus placebo vs adalimumab plus placebo).

“Sarilumab is beyond any doubt another molecule that can be added to the clinicians’ armamentarium for the treatment of patients with moderate to severe RA with a good safety and efficacy profile,” the researchers noted. They also recommended that future research focus on elucidation of the precise IL-6 pathophysiology involved in RA progression and further compare IL-6 and TNF inhibitors in terms of superiority when used immediately following RA diagnosis.


Pelechas E, Voulgari PV, Drosos AA. Clinical evaluation of the safety, efficacy and tolerability of sarilumab in the treatment of moderate to severe rheumatoid arthritis. Ther Clin Risk Manag. 2019;15:1073-1079.