Sarilumab

(Kevzara®)

Sarilumab

Drug updated on 5/17/2024

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

Indication

  • Indicated for treatment of adult patients with moderately to severely active rheumatoid arthritis 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.

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Summary
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  • Sarilumab (Kevzara) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs), and also for those with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or cannot tolerate corticosteroid taper.
  • A total of seven studies were reviewed, which provided insights into sarilumab's efficacy in reducing fatigue in inflammatory rheumatic and musculoskeletal diseases, its comparative safety profile among other DMARDs, as well as its role in managing rheumatoid arthritis.
  • The studies revealed that sarilumab showed superior efficacy compared to placebo in reducing fatigue. It was found comparable with other DMARDs such as adalimumab, golimumab, baricitinib, etc., both regarding effectiveness and safety profiles.
  • In terms of population types and subgroup considerations, moderate-to-severe rheumatoid arthritis patients along with conventional synthetic DMARD-Inadequate Response (csDMARD-IR) patients and TNF inhibitor-Inadequate Response (TNFi-IR) populations were studied. These findings are pivotal for understanding how different patient demographics respond differently towards this therapy.
  • When used alongside conventional synthetic DMARDs (csDMARDs), sarilumab demonstrated superior efficacy while maintaining a similar safety profile when compared against placebo+csDMARDs. This highlights the competitive therapeutic potential it holds within challenging treatment landscapes like these where multiple therapies are often required simultaneously.
  • Sarilumab's monotherapy at 200mg every two weeks showcased better results than adalimumab's monotherapy whilst having a similar safety record. This further supports sarilumab’s use as an effective standalone option as well, especially amongst csDMARD IR Patients.

Product Monograph / Prescribing Information

Document TitleYearSource
Kevzara (sarilumab) Prescribing Information. 2023Sanofi-Aventis U.S. LLC., Bridgewater, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy of pharmacological interventions: a systematic review informing the 2023 EULAR recommendations for the management of fatigue in people with inflammatory rheumatic and musculoskeletal diseases.2023Rheumatic & Musculoskeletal Diseases
Comparison of adalimumab to other targeted therapies in rheumatoid arthritis: results from systematic literature review and meta-analysis.2022Journal of Personalized Medicine
Comparison of the efficacy and safety indicators of DMARDs for rheumatoid arthritis: a network meta-analysis 2021Medicine
Efficacy of pharmacological treatment in rheumatoid arthritis: a systematic literature research informing the 2019 update of the EULAR recommendations for management of rheumatoid arthritis.2020Annals of the Rheumatic Diseases
Safety of synthetic and biological DMARDs: a systematic literature review informing the 2019 update of the EULAR recommendations for the management of rheumatoid arthritis.2020Annals of the Rheumatic Diseases
Evaluation of the efficacy and safety of sarilumab combination therapy in patients with rheumatoid arthritis with inadequate response to conventional disease-modifying antirheumatic drugs or tumour necrosis factor α inhibitors: systematic literature review and network meta-analyses.2019Rheumatic & Musculoskeletal Diseases
Indirect treatment comparison of the efficacy and safety of sarilumab monotherapy in rheumatoid arthritis patients with inadequate response to conventional disease-modifying antirheumatic drugs.2019Advances in Therapy

Clinical Practice Guidelines