Drug updated on 12/11/2024
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 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 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 chronic obstructive pulmonary disease (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 SEA with frequent exacerbations, CRSwNP, and ANCA-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 |