Mepolizumab

(Nucala®)

Nucala®

Drug updated on 9/4/2024

Dosage FormInjection (subcutaneous; 100 mg, 100 mg/mL, 40 mg/0.4 mL)
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 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.

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Summary
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  • Nucala (mepolizumab) is indicated for add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype; add-on maintenance treatment of adult patients 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP); treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA); and 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.
  • This summary is based on the review of 33 systematic review(s)/meta-analysis(es). [1-33]
  • Asthma-Related Outcomes: Mepolizumab reduced asthma exacerbation rates by 47% to 52% compared to placebo, with similar efficacy to reslizumab and benralizumab. Improvements in lung function (FEV1) were observed but were generally small. Asthma control and quality of life showed improvements, though the degree varied across studies.
  • Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP): Mepolizumab significantly improved Nasal Polyp Score (NPS) and SNOT-22 scores, but its efficacy was lower compared to dupilumab. Improvements in the sense of smell were also noted but were less pronounced than with dupilumab.
  • Hypereosinophilic Syndrome (HES): Mepolizumab significantly reduced relapse rates and maintained eosinophil counts below 600/µL for extended periods in HES patients, demonstrating notable effectiveness.
  • Comparison to Other Drugs: While mepolizumab showed comparable efficacy to other anti-IL-5 agents in asthma and HES, dupilumab outperformed mepolizumab in CRSwNP for several key outcomes.
  • Common Adverse Events (AEs): Frequently reported AEs included nasopharyngitis, headache, and upper respiratory tract infections. Mild to moderate injection site reactions were also observed.
  • Serious Adverse Events (SAEs): Mepolizumab had a lower incidence rate of SAEs compared to placebo and other anti-IL-5 drugs.
  • Post-Marketing Safety Concerns: Notable safety issues included incomplete therapeutic effect, improper device usage, and specific concerns such as pulmonary mass and upper respiratory tract infections.
  • Mepolizumab demonstrated consistent efficacy across different age groups, including children, adolescents, and older adults, with no significant gender-specific differences in effectiveness or safety. It was particularly effective in patients with severe eosinophilic asthma, CRSwNP, and HES, including those with coexisting conditions like cardiovascular diseases. Safety data in pediatric populations with CRSwNP were limited, and long-term use showed no new safety concerns, highlighting its steroid-sparing effect.

Product Monograph / Prescribing Information

Document TitleYearSource
Nucala (mepolizumab) Prescribing Information.2023GlaxoSmithKline LLC., Philadelphia, PA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Biologic therapy in pediatric chronic rhinosinusitis: a systematic review.2024Otolaryngology - Head and Neck Surgery
Adverse events of anti-IL-5 drugs in patients with eosinophilic asthma: a meta-analysis of randomized controlled trials and real-world evidence-based assessments.2024BMC Pulmonary Medicine
Incidence of anti-drug antibodies to monoclonal antibodies in asthma: a systematic review and meta-analysis.2023The Journal of Allergy and Clinical Immunology: In Practice
Comparative efficacy of tezepelumab to mepolizumab, benralizumab, and dupilumab in eosinophilic asthma: a Bayesian network meta-analysis.2023The Journal of Allergy and Clinical Immunology
Chronic rhinosinusitis with nasal polyps (CRSwNP) treated with omalizumab, dupilumab, or mepolizumab: a systematic review of the current knowledge towards an attempt to compare agents' efficacy.2023International Forum of Allergy & Rhinology
Improvement in Smell Using Monoclonal Antibodies Among Patients With Chronic Rhinosinusitis With Nasal Polyps: A Systematic Review.2023Journal of Investigational Allergology & Clinical Immunology
Systemic and local medical or surgical therapies for ear, nose and/or throat manifestations in ANCA-associated vasculitis: a systematic literature review..2023Journal of Clinical Medicine
The role of anti-eosinophilic therapies in eosinophilic granulomatosis with polyangiitis: a systematic review.2023Rheumatology International
Real-life effectiveness of mepolizumab in severe asthma: a systematic literature review.2022Journal 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-analysis.2022Cells
Anti‐IL5 therapies for asthma.2022The Cochrane Database of Systematic Reviews
Which is the best biologic for nasal polyps: dupilumab, omalizumab, or mepolizumab? A network meta-analysis.2022International Archives of Allergy and Immunology
Comparative efficacy and safety of monoclonal antibodies and aspirin desensitization for chronic rhinosinusitis with nasal polyposis: a systematic review and network meta-analysis.2022The Journal of Allergy and Clinical Immunology
Adverse events of biological therapy in chronic rhinosinusitis with nasal polyps: a systematic review2022American Journal of Otolaryngology
Efficacy and safety of anti-interleukin-5 therapies in chronic rhinosinusitis with nasal polyps: a systematic review and meta-analysis of randomized controlled trials.2022International Archives of Allergy and Immunology
The clinical efficacy of type 2 inflammation-specific agents targeting interleukins in reducing exacerbations in severe asthma: a meta-analysis.2022Yonsei Medical Journal
Real-world efficacy of treatment with benralizumab, dupilumab, mepolizumab and reslizumab for severe asthma: a systematic review and meta-analysis.2022Clinical and Experimental Allergy
Mepolizumab improves work productivity, activity limitation, symptoms, and rescue medication use in severe eosinophilic asthma.2022Clinical Respiratory Journal
Oral corticosteroids dependence and biologic drugs in severe asthma: myths or facts? a systematic review of real-world evidence.2021International Journal of Molecular Sciences
Impact of baseline clinical asthma characteristics on the response to mepolizumab: a post hoc meta-analysis of two Phase III trials.2021Respiratory Research
Mepolizumab improves clinical outcomes in patients with severe asthma and comorbid conditions.2021Respiratory Research
A network meta-analysis of randomized controlled trials on the treatment of eosinophilic esophagitis in adults and children.2021Journal of Clinical Gastroenterology
Treatment of lymphocyte-variant hypereosinophilic syndrome (L-HES): what to consider after confirming the elusive diagnosis.2021British Journal of Haematology
Mepolizumab in hypereosinophilic syndrome: a systematic review and meta-analysis.2021Clinics
Real-world effectiveness of mepolizumab in severe eosinophilic asthma: a systematic review and meta-analysis.2021Clinical Therapeutics
Biologics for chronic rhinosinusitis.2021The Cochrane Database of Systematic Reviews
Monoclonal antibodies targeting IL-5 or IL-5Rα in eosinophilic chronic obstructive pulmonary disease: a systematic review and meta-analysis.2021Frontiers in Pharmacology
Matching-adjusted comparison of oral corticosteroid reduction in asthma: Systematic review of biologics.2020Clinical and Experimental Allergy: Journal of the British Society for Allergy and Clinical Immunology
Anti-cytokine targeted therapies for ANCA-associated vasculitis.2020The Cochrane Database of Systematic Reviews
The role of biologics in chronic rhinosinusitis: a systematic review.2020International Forum of Allergy & Rhinology
Monoclonal antibodies in type 2 asthma: a systematic review and network meta-analysis2019Immunotherapy
Safety and Efficacy of Mepolizumab in Patients with Eosinophilic Granulomatosis with Polyangiitis.2019Pulmonary Medicine
Reslizumab and mepolizumab for moderate-to-severe poorly controlled asthma: an indirect comparison meta-analysis.2019Immunotherapy

Clinical Practice Guidelines