Mepolizumab

(Nucala®)

Mepolizumab

Drug updated on 6/5/2025

Dosage FormInjection (subcutaneous; 100 mg single dose vial, 100 mg/mL single-dose prefilled autoinjector or single-dose; prefilled syringe, 40 mg/0.4 mL single-dose prefilled syringe)
Drug ClassInterleukin-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 aged 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP)
  • Indicated for add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype
  • 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 greater than or equal to 6 months without an identifiable non-hematologic secondary cause

Latest News

loading GIF

Summary
This AI-generated content is provided without warranty, with no liability accepted for reliance on it. Learn more.

  • This summary is based on the review of 31 systematic review(s)/meta-analysis(es). [1-31]
  • In patients with asthma, mepolizumab reduced annualized asthma exacerbation rates by 56% for exacerbations requiring hospitalization or emergency department (ED) visits; in an Italian real-world cohort, clinically significant exacerbations decreased from 3.74 to 0.67 clinically significant exacerbations (CSEs)/patient/year.
  • Dupilumab reduced asthma exacerbations more effectively than mepolizumab (relative risk (RR) 0.74 \[95% confidence interval (CI) 0.62 to 0.89]); benralizumab and reslizumab showed inconsistent efficacy in reducing annualized asthma exacerbation rate (AAER).
  • In asthma populations, mepolizumab significantly improved Asthma Control Test (ACT) scores and showed variable forced expiratory volume in one second (FEV1) improvement, particularly in those with higher eosinophil counts; dupilumab generally produced greater lung function and quality of life improvements.
  • For patients with chronic rhinosinusitis with nasal polyps (CRSwNP), mepolizumab significantly improved nasal polyp score and 22-item Sinonasal Outcome Test (SNOT-22) scores in real-world settings; dupilumab demonstrated superior efficacy, while omalizumab was less effective than dupilumab.
  • Mepolizumab was generally well-tolerated with low discontinuation rates due to adverse events; commonly reported adverse events included headache and injection site reactions.
  • Dupilumab showed a higher incidence of injection-site reactions compared to placebo and lower discontinuation rates due to adverse events compared to benralizumab.
  • Benralizumab had a higher incidence of antidrug antibodies than other biologics and a higher risk of serious adverse events leading to discontinuation compared to placebo.
  • Mepolizumab was particularly effective in patients with severe eosinophilic asthma, showed consistent benefits in real-world chronic rhinosinusitis with nasal polyps (CRSwNP) populations, and demonstrated limited efficacy in eosinophilic chronic obstructive pulmonary disease (COPD); in comparison, dupilumab and tezepelumab showed greater efficacy in patients with higher eosinophil counts for asthma, while dupilumab showed superior outcomes in CRSwNP and eosinophilic COPD subgroups.

Product Monograph / Prescribing Information

Document TitleYearSource
Nucala (mepolizumab) Prescribing Information2025GlaxoSmithKline, Philadelphia, PA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy and Safety of Biologics for Chronic Rhinosinusitis With Nasal Polyps: A Meta-Analysis of Real-World Evidence2025Allergy
Meta-Analysis of Randomized, Controlled Trials Assessing the Effectiveness and Safety of Biological Treatments in Chronic Obstructive Pulmonary Disease Patients2025Clinical Therapeutics
Biologic Therapies for Chronic Obstructive Pulmonary Disease: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials2025COPD
Efficacy of Biologics in Reducing Exacerbations Requiring Hospitalization or an Emergency Department Visit in Patients with Moderate or Severe, Uncontrolled Asthma2025Advances in Therapy
Real-world effectiveness of mepolizumab in asthma: a systematic review and meta-analysis2025The Journal of Asthma
Dupilumab Versus Mepolizumab for Chronic Rhinosinusitis With Nasal Polyposis: An Indirect Treatment Comparison2024The Journal of Allergy and Clinical Immunology: In Practice
The effect of biologics in lung function and quality of life of patients with united airways disease: A systematic review2024The Journal of Allergy and Clinical Immunology
Comparative safety of monoclonal antibodies in chronic inflammatory airway diseases (chronic sinusitis with nasal polyposis and asthma): A network meta-analysis2024International Immunopharmacology
Advanced Biologic Therapies in the Management of Asthma in Children and Adolescents: A Comprehensive Network Meta-Analysis2024International Archives of Allergy and Immunology
Rheumatic adverse events associated with biologic therapy for chronic rhinosinusitis: A systematic review and meta-analysis2024International Forum of Allergy & Rhinology
The role of anti-eosinophilic therapies in eosinophilic granulomatosis with polyangiitis: a systematic review2023Rheumatology International
Efficacy and Safety of Mepolizumab in the Management of Severe Eosinophilic Asthma: A Systematic Review2023Cureus
Improvement in Smell Using Monoclonal Antibodies Among Patients With Chronic Rhinosinusitis With Nasal Polyps: A Systematic Review2023Journal of Investigational Allergology & Clinical Immunology
Effect of Biologic Therapies on Airway Hyperresponsiveness and Allergic Response: A Systematic Literature Review2023Journal of Asthma and Allergy
Incidence of Anti-Drug Antibodies to Monoclonal Antibodies in Asthma: A Systematic Review and Meta-Analysis2023The Journal of Allergy and Clinical Immunology
Tezepelumab compared with other biologics for the treatment of severe asthma: a systematic review and indirect treatment comparison2022Journal of Medical Economics
Anti-IL-5 therapies for asthma2022The Cochrane Database of Systematic Reviews
Comparative efficacy of mepolizumab, benralizumab, and dupilumab in eosinophilic asthma: A Bayesian network meta-analysis2022The Journal of Allergy and Clinical Immunology
Efficacy and safety of anti-interleukin-5 therapy in patients with chronic obstructive pulmonary disease: A meta-analysis of randomized, controlled trials2022Journal of Microbiology, Immunology, and Infection
Comparative efficacy and safety of monoclonal antibodies and aspirin desensitization for chronic rhinosinusitis with nasal polyposis: A systematic review and network meta-analysis2022The Journal of Allergy and Clinical Immunology
Real-life effectiveness of mepolizumab in severe asthma: a systematic literature review2022The Journal of Asthma
Comparative Efficacy and Safety of Tezepelumab and Other Biologics in Patients with Inadequately Controlled Asthma According to Thresholds of Type 2 Inflammatory Biomarkers: A Systematic Review and Network Meta-Analysis2022Cells
A systematic review and integrated analysis of biologics that target Type 2 inflammation to treat COPD with increased peripheral blood eosinophils2022Heliyon
The Impact of Monoclonal Antibodies on Airway Smooth Muscle Contractility in Asthma: A Systematic Review2021Biomedicines
Clinical effects of mepolizumab in patients with severe eosinophilic asthma according to background therapy: A meta-analysis2021The Journal of Allergy and Clinical Immunology
Mepolizumab improves clinical outcomes in patients with severe asthma and comorbid conditions2021Respiratory Research
Real-world Effectiveness of Mepolizumab in Severe Eosinophilic Asthma: A Systematic Review and Meta-analysis2021Clinical Therapeutics
Biologics for chronic rhinosinusitis2021The Cochrane Database of Systematic Reviews
Efficacy and safety of treatment with biologicals for severe chronic rhinosinusitis with nasal polyps: A systematic review for the EAACI guidelines2021Allergy
Mepolizumab in Hypereosinophilic Syndrome: A Systematic Review and Meta-analysis2021Clinics (Sao Paulo, Brazil)
Monoclonal Antibodies Targeting IL-5 or IL-5Ralpha in Eosinophilic Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-Analysis2021Frontiers in Pharmacology

Clinical Practice Guidelines