Drug updated on 10/31/2024
Dosage Form | Injection (subcutaneous; 100 mg, 100 mg/mL, 40 mg/0.4 mL) |
Drug Class | Interleukin-5 antagonists |
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.
Latest News
Summary
- This summary is based on the review of 34 systematic review(s)/meta-analysis(es). [1-35]
- Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): Mepolizumab may improve disease-specific quality of life and reduce disease severity in CRSwNP patients, although evidence remains uncertain for its impact on disease severity and serious adverse events.
- Severe Eosinophilic Asthma (SEA): Mepolizumab reduces exacerbations by approximately 50% in SEA patients, with long-term data showing sustained reductions; real-world studies reported consistent reductions in exacerbations (50%-90%) across varied patient groups over 6-24 months. The drug shows similar efficacy to other biologics like benralizumab and dupilumab in reducing exacerbation rates and enhancing lung function.
- Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis (AAV): Mepolizumab demonstrated efficacy in reducing sinonasal symptoms and relapse rates in eosinophilic granulomatosis with polyangiitis (EGPA), showing particular benefit in managing this subtype of ANCA-associated vasculitis.
- Combined Asthma and CRSwNP: For patients with combined asthma and CRSwNP, mepolizumab contributed to significant improvements in lung function and quality of life after 24 weeks of treatment.
- Safety in Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): Mepolizumab and other biologics increased the risk of rheumatic adverse events (AEs) compared to placebo, with arthralgia being the most frequently reported. Injection-site reactions were also more common with higher doses (100 mg every 4 weeks) than with lower doses (75 mg every 4 weeks).
- Safety in Severe Eosinophilic Asthma (SEA): Mepolizumab was associated primarily with mild injection site reactions and headaches, with a lower incidence of serious adverse events (SAEs) than placebo. Real-world data showed consistency with clinical trials, revealing no new safety concerns.
- General Safety Across Conditions: Anti-drug antibodies (ADAs) were observed at a rate of 3.63% in mepolizumab studies, with neutralizing antibodies present at approximately 0%. In COPD patients, mepolizumab's safety profile was comparable to placebo, with no significant differences in treatment discontinuation or serious adverse events.
- Studies on mepolizumab included diverse patient populations, demonstrating consistent efficacy across subgroups such as patients with severe eosinophilic asthma (SEA) with frequent exacerbations, chronic rhinosinusitis with nasal polyps (CRSwNP), and ANCA-associated vasculitis (AAV). Specifically, efficacy was observed across various demographic and clinical characteristics, including age of asthma onset, lung function levels, and presence of comorbidities such as upper respiratory and cardiovascular conditions.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Nucala (mepolizumab) Prescribing Information. | 2023 | GlaxoSmithKline, Philadelphia, PA |