Drug updated on 9/4/2024
Dosage Form | Injection (intravenous; 100 mg/10 mL) |
Drug Class | Interleukin-5 antagonist monoclonal antibodies |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype.
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Summary
- Cinqair (reslizumab) is indicated for add-on maintenance treatment of patients aged 18 years and older with severe asthma and an eosinophilic phenotype.
- This summary is based on the review of seven systematic review(s)/meta-analysis(es). [1-8]
- Reslizumab IV significantly reduced clinically significant asthma exacerbations by approximately 50% (Rate ratio: 0.43; 95% CI: 0.33 to 0.55) in patients with severe eosinophilic asthma.
- In real-world settings, reslizumab significantly reduced the annualized exacerbation rate by -6.72 (95% CI: -8.47 to -4.97) and showed improvements in FEV1 post-treatment.
- Network meta-analysis indicated reslizumab had favorable outcomes compared to mepolizumab, with significant improvements in FEV1 at 4 weeks and reductions in eosinophil counts at multiple time points (4, 16, and 24 weeks).
- No specific safety outcomes were reported for reslizumab in studies related to quality of life and lung function in severe asthma and CRSwNP, real-world efficacy, and the comparison of monoclonal antibodies.
- Reslizumab did not show an excess of serious adverse events, nor was there a difference in adverse events leading to discontinuation compared to placebo, and no significant safety concerns were observed in comparisons with mepolizumab and benralizumab.
- The population types and subgroups considered in the reviewed studies primarily focus on patients with severe eosinophilic asthma, including adults and children aged 6 to 17 years, as well as patients with combined asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). Real-world settings also included diverse participant groups reflective of clinical practice, particularly those with high eosinophil counts. The effectiveness of reslizumab was consistently noted in these populations, with significant reductions in exacerbations and improvements in lung function.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Cinqair (reslizumab) Prescribing Information. | 2019 | Teva Respiratory, LLC, West Chester, PA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Guidance for administering biologics for severe asthma and allergic conditions. | 2022 | Canadian Respiratory Journal |
EAACI Biologicals Guidelines—Recommendations for severe asthma. | 2021 | Allergy |
Global strategy for asthma management and prevention. | 2020 | Global Initiative for Asthma |
Severe asthma: adding new evidence – Latin American Thoracic Society. | 2020 | ERJ Open Research |
Management of severe asthma: a European Respiratory Society/American Thoracic Society guideline. | 2020 | European Respiratory Journal |
Asthma management guidelines. | 2020 | The National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group |