Drug updated on 9/4/2024
Dosage Form | Injection (subcutaneous; 100 mg, 100 mg/mL, 40 mg/0.4 mL) |
Drug Class | Interleukin-5 (IL-5) antagonist monoclonal antibodies |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype.
- Indicated for add-on maintenance treatment of adult patients 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP).
- Indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
- Indicated for the treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for ≥6 months without an identifiable non-hematologic secondary cause.
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Summary
- Nucala (mepolizumab) is indicated for add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype; add-on maintenance treatment of adult patients 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP); treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA); and treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for ≥6 months without an identifiable non-hematologic secondary cause.
- This summary is based on the review of 33 systematic review(s)/meta-analysis(es). [1-33]
- Asthma-Related Outcomes: Mepolizumab reduced asthma exacerbation rates by 47% to 52% compared to placebo, with similar efficacy to reslizumab and benralizumab. Improvements in lung function (FEV1) were observed but were generally small. Asthma control and quality of life showed improvements, though the degree varied across studies.
- Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP): Mepolizumab significantly improved Nasal Polyp Score (NPS) and SNOT-22 scores, but its efficacy was lower compared to dupilumab. Improvements in the sense of smell were also noted but were less pronounced than with dupilumab.
- Hypereosinophilic Syndrome (HES): Mepolizumab significantly reduced relapse rates and maintained eosinophil counts below 600/µL for extended periods in HES patients, demonstrating notable effectiveness.
- Comparison to Other Drugs: While mepolizumab showed comparable efficacy to other anti-IL-5 agents in asthma and HES, dupilumab outperformed mepolizumab in CRSwNP for several key outcomes.
- Common Adverse Events (AEs): Frequently reported AEs included nasopharyngitis, headache, and upper respiratory tract infections. Mild to moderate injection site reactions were also observed.
- Serious Adverse Events (SAEs): Mepolizumab had a lower incidence rate of SAEs compared to placebo and other anti-IL-5 drugs.
- Post-Marketing Safety Concerns: Notable safety issues included incomplete therapeutic effect, improper device usage, and specific concerns such as pulmonary mass and upper respiratory tract infections.
- Mepolizumab demonstrated consistent efficacy across different age groups, including children, adolescents, and older adults, with no significant gender-specific differences in effectiveness or safety. It was particularly effective in patients with severe eosinophilic asthma, CRSwNP, and HES, including those with coexisting conditions like cardiovascular diseases. Safety data in pediatric populations with CRSwNP were limited, and long-term use showed no new safety concerns, highlighting its steroid-sparing effect.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Nucala (mepolizumab) Prescribing Information. | 2023 | GlaxoSmithKline LLC., Philadelphia, PA |