Drug updated on 9/4/2024
Dosage Form | Injection (subcutaneous; 150 mg/1.14 mL, 200 mg/1.14 mL) |
Drug Class | Interleukin-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.
Latest News
Summary
- 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 Title | Year | Source |
---|---|---|
Kevzara (sarilumab) Prescribing Information. | 2023 | Sanofi-Aventis U.S. LLC., Bridgewater, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. | 2021 | Arthritis Care & Research |
EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. | 2020 | Annals of the Rheumatic Diseases |
Clinical practice guidelines management of patients with rheumatoid arthritis. | 2019 | Spanish Society of Rheumatology |