Sarilumab

(Kevzara®)

Sarilumab

Drug updated on 10/30/2024

Dosage FormInjection (subcutaneous; 150 mg/1.14 mL, 200 mg/1.14 mL)
Drug ClassInterleukin-6 (IL-6) receptor antagonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs)
  • Indicated for treatment of adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper
  • Indicated for treatment of patients who weigh 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA).

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Summary
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  • This summary is based on the review of seven systematic review(s)/meta-analysis(es). [1-7]
  • Sarilumab demonstrated significant efficacy in rheumatoid arthritis (RA) patients with inadequate response to tumor necrosis factor (TNF) inhibitors, achieving American College of Rheumatology (ACR) 20%, ACR50, and ACR70 responses. Sarilumab was comparable in overall efficacy to other biologics, including adalimumab and tocilizumab, but slightly less effective than tocilizumab in some comparisons.
  • In polymyalgia rheumatica (PMR), Sarilumab was shown to be an approved corticosteroid-sparing therapy, effectively targeting the IL-6 signaling pathway. Additionally, Sarilumab was effective in managing non-infectious non-anterior uveitis (NINA uveitis).
  • Sarilumab was superior to placebo in reducing fatigue in patients with inflammatory rheumatic and musculoskeletal diseases (I-RMDs), demonstrating efficacy in reducing fatigue over 24 weeks in RA patients.
  • Sarilumab demonstrated a favorable safety profile across various inflammatory conditions, including RA and I-RMDs, with no significant safety concerns reported. It showed no notable differences in the incidence of adverse events or serious adverse events when compared to other biologic agents such as abatacept, rituximab, tocilizumab, and adalimumab.
  • Sarilumab exhibited a comparable safety profile to other biologics in RA patients with inadequate response to TNF inhibitors, with no significant differences observed in adverse reactions, serious adverse reactions, or withdrawal due to adverse effects.
  • Sarilumab was evaluated across various populations, including patients with RA who had an inadequate response to TNF inhibitors, showing significant improvement in ACR responses. It was also effective in reducing fatigue in adults with I-RMDs and demonstrated efficacy in managing NINA uveitis. Additionally, Sarilumab was highlighted as a corticosteroid-sparing option in PMR and giant cell arteritis (GCA), reflecting its potential across diverse inflammatory conditions.

Product Monograph / Prescribing Information

Document TitleYearSource
Kevzara (sarilumab) Prescribing Information.2024Sanofi-Aventis U.S. LLC., Bridgewater, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines