Mepolizumab

(Nucala®)

Nucala®

Drug updated on 5/17/2024

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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  • Mepolizumab (Nucala) is indicated for add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES).
  • Thirty-three systematic reviews/meta-analyses were examined to gather information about the medication's effectiveness in treating these conditions.
  • In terms of safety, mepolizumab has a favorable profile. The rates of treatment-emergent adverse effects are similar to or lower than those of competitors such as benralizumab, dupilumab, and reslizumab.
  • For CRSwNP patients, mepolizumab offers significant improvement in polyp size reduction compared to baseline but may be less effective than dupilumab based on indirect comparisons.
  • Mepolizumab demonstrates efficacy in reducing disease exacerbations among EGPA patients while providing steroid-sparing effects, which improve patient outcomes. It is particularly effective for relapsing/refractory cases.
  • Common adverse events associated with mepolizumab include headache, upper respiratory tract infections, and injection-site reactions; however, no new safety concerns have been identified from pre-marketing or post-marketing data.
  • Across various subgroups, including pediatric, adult, and elderly populations suffering from severe asthma, CRSwNP, EGPA, and HES, mepolizumab's effectiveness has been validated. Its use as a maintenance treatment consistently benefits patients by decreasing exacerbation rates without causing significant safety issues.
  • The medication also shows positive results when used daily, reducing the need for oral corticosteroids while enhancing lung function parameters according to Phase III trials and real-world studies.

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
Smell improvement in chronic rhinosinusitis with nasal polyps with monoclonal antibodies: 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
Incidence of anti-drug antibodies to monoclonal antibodies in asthma: a systematic review and meta-analysis.2023Journal of Allergy and Clinical Immunology
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 review. https://linkinghub.elsevier.com/retrieve/pii/S0196-0709(22)00242-3 2022 American Journal of Otolaryngology2022American 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-life effectiveness of mepolizumab in severe asthma: a systematic literature review.2021Journal of Asthma
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
Reslizumab and mepolizumab for moderate-to-severe poorly controlled asthma: an indirect comparison meta-analysis.2019Immunotherapy
Safety and Efficacy of Mepolizumab in Patients with Eosinophilic Granulomatosis with Polyangiitis.2019Pulmonary Medicine
Monoclonal antibodies in type 2 asthma: a systematic review and network meta-analysis.2019Respiratory Research

Clinical Practice Guidelines