Mepolizumab

(Nucala®)

Nucala®

Drug updated on 12/11/2024

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 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 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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