Mepolizumab

(Nucala®)

Mepolizumab

Drug updated on 10/31/2024

Dosage FormInjection (subcutaneous; 100 mg, 100 mg/mL, 40 mg/0.4 mL)
Drug ClassInterleukin-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

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Summary
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  • 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 TitleYearSource
Nucala (mepolizumab) Prescribing Information.2023GlaxoSmithKline, Philadelphia, PA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Rheumatic adverse events associated with biologic therapy for chronic rhinosinusitis: A systematic review and meta-analysis2024International Forum of Allergy & Rhinology
Superiority of Avacopan and Mepolizumab to Glucocorticoid Tapering in the Treatment of Anti-neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis: A Systematic Review2024Cureus
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
Systemic and Local Medical or Surgical Therapies for Ear, Nose and/or Throat Manifestations in ANCA-Associated Vasculitis: A Systematic Literature Review2023Journal of Clinical Medicine
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
Impact of baseline clinical asthma characteristics on the response to mepolizumab: a post hoc meta-analysis of two Phase III trials2021Respiratory Research
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
Systemic treatments in the management of atopic dermatitis: A systematic review and meta-analysis2021Allergy
Anti-IL-5 therapies for chronic obstructive pulmonary disease2020The Cochrane Database of Systematic Reviews
Effect of monoclonal antibody drug therapy on mucosal biomarkers in airway disease: A systematic review2020Clinical and Experimental Allergy
Efficacy and safety of treatment with biologicals (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) for severe eosinophilic asthma. A systematic review for the EAACI Guidelines - recommendations on the use of biologicals in severe asthma2020Allergy
Matching-adjusted comparison of oral corticosteroid reduction in asthma: Systematic review of biologics2020Clinical and Experimental Allergy
Effect of Anti-IL5, Anti-IL5R, Anti-IL13 Therapy on Asthma Exacerbations: A Network Meta-analysis2020Lung
The role of biologics in chronic rhinosinusitis: a systematic review2020International Forum of Allergy & Rhinology
Reslizumab and mepolizumab for moderate-to-severe poorly controlled asthma: an indirect comparison meta-analysis2019Immunotherapy

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