Mepolizumab

(Nucala®)

Nucala®

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

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Summary
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  • 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 of Biologics in Reducing Exacerbations Requiring Hospitalization or an Emergency Department Visit in Patients with Moderate or Severe, Uncontrolled Asthma2025Advances in Therapy
Efficacy and Safety of Biologics for Chronic Rhinosinusitis With Nasal Polyps: A Meta-Analysis of Real-World Evidence2025Allergy
Biologic Therapies for Chronic Obstructive Pulmonary Disease: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials2025COPD
Real-world effectiveness of mepolizumab in asthma: a systematic review and meta-analysis2025The Journal of Asthma
Meta-Analysis of Randomized, Controlled Trials Assessing the Effectiveness and Safety of Biological Treatments in Chronic Obstructive Pulmonary Disease Patients2025Clinical Therapeutics
Advanced Biologic Therapies in the Management of Asthma in Children and Adolescents: A Comprehensive Network Meta-Analysis2024International Archives of Allergy and Immunology
Dupilumab Versus Mepolizumab for Chronic Rhinosinusitis With Nasal Polyposis: An Indirect Treatment Comparison2024The Journal of Allergy and Clinical Immunology: In Practice
Rheumatic adverse events associated with biologic therapy for chronic rhinosinusitis: A systematic review and meta-analysis2024International Forum of Allergy & Rhinology
Comparative safety of monoclonal antibodies in chronic inflammatory airway diseases (chronic sinusitis with nasal polyposis and asthma): A network meta-analysis2024International Immunopharmacology
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
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
The role of anti-eosinophilic therapies in eosinophilic granulomatosis with polyangiitis: a systematic review2023Rheumatology International
Incidence of Anti-Drug Antibodies to Monoclonal Antibodies in Asthma: A Systematic Review and Meta-Analysis2023The Journal of Allergy and Clinical Immunology
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
A systematic review and integrated analysis of biologics that target Type 2 inflammation to treat COPD with increased peripheral blood eosinophils2022Heliyon
Tezepelumab compared with other biologics for the treatment of severe asthma: a systematic review and indirect treatment comparison2022Journal of Medical Economics
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
Real-life effectiveness of mepolizumab in severe asthma: a systematic literature review2022The Journal of Asthma
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
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
Monoclonal Antibodies Targeting IL-5 or IL-5Ralpha in Eosinophilic Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-Analysis2021Frontiers in Pharmacology
Mepolizumab in Hypereosinophilic Syndrome: A Systematic Review and Meta-analysis2021Clinics (Sao Paulo, Brazil)
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

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