Drug updated on 5/17/2024
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
- 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 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 |