Sarilumab

(Kevzara®)

Kevzara®

Drug updated on 9/4/2024

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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  • Kevzara (sarilumab) 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 for the treatment of adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper.
  • This summary is based on the review of seven systematic review(s)/meta-analysis(es). [1-7]
  • Fatigue Reduction in RA: Sarilumab demonstrated significant effectiveness in reducing fatigue at 24 weeks compared to placebo (MD=-3.15, p<0.001). Other drugs, including adalimumab, golimumab, baricitinib, tocilizumab, and tofacitinib, also effectively reduced fatigue in RA patients.
  • ACR50 Response in RA: Sarilumab showed a high probability of achieving ACR50 response at 24 weeks as monotherapy, ranking second only to tocilizumab. No significant differences were found in ACR50 response compared to other drugs like adalimumab, sirukumab, baricitinib, and tocilizumab.
  • Disease Activity Score (DAS28): Sarilumab effectively reduced DAS28, with its 200 mg dose showing superiority over baricitinib 2 mg, tofacitinib, and certolizumab at 24 weeks in csDMARD-IR patients. Overall, its efficacy in reducing DAS28 was similar to other targeted DMARDs.
  • Sarilumab's safety profile was comparable to other targeted DMARDs, with no significant difference in the incidence of adverse reactions, serious adverse reactions, or withdrawal due to adverse reactions.
  • There was no significant increase in the risk of serious infections with sarilumab compared to csDMARDs, and its safety outcomes, including the risk of serious infections, were similar to those of other bDMARDs.
  • Sarilumab demonstrated consistent efficacy and safety across different RA subgroups, including csDMARD-IR and TNFi-IR populations, with similar effectiveness in achieving ACR20/50/70 responses and reducing DAS28, and a comparable safety profile, including serious adverse events and infections, to other targeted therapies in these populations.

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