Nucala
Drug name: Nucala | Dosage form: Injection (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) | Approval year: 2015 | Company: GlaxoSmithKline, Philadelphia, PA | Class: Interleukin-5 (IL-5) antagonist monoclonal antibodies | System: Respiratory and Immune
Indications
- 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
Document title: Efficacy and Safety of Biologics for Chronic Rhinosinusitis With Nasal Polyps: A Meta-Analysis of Real-World Evidence Document link: https://onlinelibrary.wiley.com/doi/10.1111/all.16499 Document source: Allergy Document type: Systematic Reviews / Meta-Analyses Document year: 2025
Document title: Nucala (mepolizumab) Prescribing Information Document link: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Nucala/pdf/NUCALA-PI-PIL-IFU-COMBINED.PDF Document source: GlaxoSmithKline, Philadelphia, PA Document type: Product Monograph / Prescribing Information Document year: 2025
Document title: Meta-Analysis of Randomized, Controlled Trials Assessing the Effectiveness and Safety of Biological Treatments in Chronic Obstructive Pulmonary Disease Patients Document link: https://linkinghub.elsevier.com/retrieve/pii/S0149-2918(24)00374-6 Document source: Clinical Therapeutics Document type: Systematic Reviews / Meta-Analyses Document year: 2025
Document title: Biologic Therapies for Chronic Obstructive Pulmonary Disease: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials Document link: https://www.tandfonline.com/doi/abs/10.1080/15412555.2025.2449889?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed Document source: COPD Document type: Systematic Reviews / Meta-Analyses Document year: 2025
Document title: Efficacy of Biologics in Reducing Exacerbations Requiring Hospitalization or an Emergency Department Visit in Patients with Moderate or Severe, Uncontrolled Asthma Document link: https://link.springer.com/article/10.1007/s12325-025-03184-w Document source: Advances in Therapy Document type: Systematic Reviews / Meta-Analyses Document year: 2025
Document title: Real-world effectiveness of mepolizumab in asthma: a systematic review and meta-analysis Document link: https://www.tandfonline.com/doi/abs/10.1080/02770903.2024.2449229?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed Document source: The Journal of Asthma Document type: Systematic Reviews / Meta-Analyses Document year: 2025
Document title: Dupilumab Versus Mepolizumab for Chronic Rhinosinusitis With Nasal Polyposis: An Indirect Treatment Comparison Document link: https://linkinghub.elsevier.com/retrieve/pii/S2213-2198(24)00941-3 Document source: The Journal of Allergy and Clinical Immunology: In Practice Document type: Systematic Reviews / Meta-Analyses Document year: 2024
Document title: EULAR recommendations for the management of ANCA-associated vasculitis: 2022 update Document link: https://ard.bmj.com/content/annrheumdis/83/1/30.full.pdf?with-ds=yes Document source: Annals of the Rheumatic Diseases Document type: Clinical Practice Guidelines Document year: 2024
Document title: The effect of biologics in lung function and quality of life of patients with united airways disease: A systematic review Document link: https://pmc.ncbi.nlm.nih.gov/articles/PMC10616425/pdf/main.pdf Document source: The Journal of Allergy and Clinical Immunology Document type: Systematic Reviews / Meta-Analyses Document year: 2024
Document title: Comparative safety of monoclonal antibodies in chronic inflammatory airway diseases (chronic sinusitis with nasal polyposis and asthma): A network meta-analysis Document link: https://www.sciencedirect.com/science/article/abs/pii/S1567576924009834?via%3Dihub Document source: International Immunopharmacology Document type: Systematic Reviews / Meta-Analyses Document year: 2024
Document title: Advanced Biologic Therapies in the Management of Asthma in Children and Adolescents: A Comprehensive Network Meta-Analysis Document link: https://karger.com/article/doi/10.1159/000542797 Document source: International Archives of Allergy and Immunology Document type: Systematic Reviews / Meta-Analyses Document year: 2024
Document title: Rheumatic adverse events associated with biologic therapy for chronic rhinosinusitis: A systematic review and meta-analysis Document link: https://onlinelibrary.wiley.com/doi/epdf/10.1002/alr.23453 Document source: International Forum of Allergy & Rhinology Document type: Systematic Reviews / Meta-Analyses Document year: 2024
Document title: The role of anti-eosinophilic therapies in eosinophilic granulomatosis with polyangiitis: a systematic review Document link: https://pmc.ncbi.nlm.nih.gov/articles/PMC10185576/pdf/296_2023_Article_5326.pdf Document source: Rheumatology International Document type: Systematic Reviews / Meta-Analyses Document year: 2023
Document title: Efficacy and Safety of Mepolizumab in the Management of Severe Eosinophilic Asthma: A Systematic Review Document link: https://pmc.ncbi.nlm.nih.gov/articles/PMC10757760/pdf/cureus-0015-00000049781.pdf Document source: Cureus Document type: Systematic Reviews / Meta-Analyses Document year: 2023
Document title: Systematic literature review informing the 2022 update of the EULAR recommendations for the management of ANCA-associated vasculitis (AAV): Part 2 - Treatment of eosinophilic granulomatosis with polyangiitis and diagnosis and general management of AAV Document link: https://rmdopen.bmj.com/content/rmdopen/9/2/e003083.full.pdf Document source: RMD Open Document type: Clinical Practice Guidelines Document year: 2023
Document title: Improvement in Smell Using Monoclonal Antibodies Among Patients With Chronic Rhinosinusitis With Nasal Polyps: A Systematic Review Document link: https://www.jiaci.org/revistas/vol33issue6_1.pdf Document source: Journal of Investigational Allergology & Clinical Immunology Document type: Systematic Reviews / Meta-Analyses Document year: 2023
Document title: Evidence-Based Guideline for the diagnosis and management of eosinophilic granulomatosis with polyangiitis. Document link: https://www.nature.com/articles/s41584-023-00958-w Document source: Nature Reviews Rheumatology Document type: Clinical Practice Guidelines Document year: 2023
Document title: Effect of Biologic Therapies on Airway Hyperresponsiveness and Allergic Response: A Systematic Literature Review Document link: https://pmc.ncbi.nlm.nih.gov/articles/PMC10368134/pdf/jaa-16-755.pdf Document source: Journal of Asthma and Allergy Document type: Systematic Reviews / Meta-Analyses Document year: 2023
Document title: Incidence of Anti-Drug Antibodies to Monoclonal Antibodies in Asthma: A Systematic Review and Meta-Analysis Document link: https://pmc.ncbi.nlm.nih.gov/articles/PMC10601343/pdf/nihms-1938153.pdf Document source: The Journal of Allergy and Clinical Immunology Document type: Systematic Reviews / Meta-Analyses Document year: 2023
Document title: Tezepelumab compared with other biologics for the treatment of severe asthma: a systematic review and indirect treatment comparison Document link: https://www.tandfonline.com/doi/epdf/10.1080/13696998.2022.2074195?needAccess=true Document source: Journal of Medical Economics Document type: Systematic Reviews / Meta-Analyses Document year: 2022
Document title: Anti-IL-5 therapies for asthma Document link: https://pmc.ncbi.nlm.nih.gov/articles/PMC9285134/pdf/CD010834.pdf Document source: The Cochrane Database of Systematic Reviews Document type: Systematic Reviews / Meta-Analyses Document year: 2022
Document title: Comparative efficacy of mepolizumab, benralizumab, and dupilumab in eosinophilic asthma: A Bayesian network meta-analysis Document link: https://pmc.ncbi.nlm.nih.gov/articles/PMC9643621/pdf/nihms-1821100.pdf Document source: The Journal of Allergy and Clinical Immunology Document type: Systematic Reviews / Meta-Analyses Document year: 2022
Document title: Efficacy and safety of anti-interleukin-5 therapy in patients with chronic obstructive pulmonary disease: A meta-analysis of randomized, controlled trials Document link: https://pdf.sciencedirectassets.com/280178/1-s2.0-S1684118222X00029/1-s2.0-S168411822030253X/mainext.pdf?X-Amz-Security-Token=IQoJb3JpZ2luX2VjEHIaCXVzLWVhc3QtMSJGMEQCIBXFxGqdmTHR4%2F8JqpAXEErh2vCM5pviwcqSrhL2%2BVJEAiA%2BneZ7kR2kH1GjLT%2F4kQ3XHPnYI%2F4a005LoO5ZRyeiRSq8BQjb%2F%2F%2F%2F%2F%2F%2F%2F%2F%2F8BEAUaDDA1OTAwMzU0Njg2NSIMtHNuub8XR2dG%2B0L4KpAFZrqbXvRV8X7L3lKOG9egnNfF72SeN0tawolbUx%2BoSa34ZJ34lrnYV%2FmuM%2B1X6ASNVeLJfGO%2BCxUxImy2pN%2FBoUl2JmHk5Ccw9PtjdwJ39GJFzUYkykqF1JEXkTjXlSDO%2BjUpvvrgNrLRxwJGmRnwaarISsDeErfecRlAig4spaF2ncmk0fQe6uDfTu8iVFg6AsoHaqcMqqRna6LeppaO5hxCQkEpQUZe28TWghUyD9PIenGOGZgHsKlsJ82E5pZqJ%2FGJoQvnGhLny%2Bt483v5bzfhnTXEvavX3fOmCm4WL9WOu8hrgNf6sTJWggWQJ%2BThX3LIl%2BLPJ%2FqwDRrOvTm7AkGlW9LxHw6By0gb3Yd3nyU%2FrtMz4tAPHvgyTCKcai17%2BHgV0FEDrve0%2BuDO3PiLcAcqzY91ibtZxhFkoB8Ttcv8KZJocezGcwo27SyIEl80ruk38h9%2FAdGbFb9Z8K0bPwSAgAwGQiB2wrstp69VKM%2BvkCa6uE3%2Fcg%2Foe3YB7tdb%2F0Zcp1BtM0MRtFiyhW4baWOZMLQBMcEeUT6DmRUxWMNpcnUgzouI5MmRfX%2FOdWh%2BBS7XV9D4BG7aP0H1W6Pnxp3RRanF3FuS7LJ1w%2BLPBtIfylZWSZnEot%2BP2RjULKy%2BksrfGGTD%2B6PKAOaLwEkyBLS3%2BIzheY%2FLUt216XuF5EIJWGirVHjkIYk8Kxwxfn8cf8v4CvsXMohU6UmCFn0WwnBl%2Bb7u%2BWJK%2BnAxj%2FJgYGzNvnvwO69iofuLhlj8Ga1xqXMEUgD8bwV0JM9tvYv2h3qt1UQJACJDAdUnwFScnigSqKu5iZfdhnHgWRuSKtTviu9INDCDyBGxFXW94UgfJ3jdjPEX8UYskxaN%2FENgci0wgofquAY6sgG%2FZUgtYRPw86WoadX38jS9T8x4guvDwJ4YfbZhv1QikmGEnN4ygcXwaEwqYXsbMTvU53L9XjJ5eEwYRJZdFD5KSShL2RbVp3cWR7IILWMqTtR2aJkKilYzDgkzJ%2FqlCJZMOC%2BOrfKeE2xOhy0HG%2F97Z%2FxPtiODiBdXBr%2FNKNWEwrQmbG4quVbRC2KB6ZFb6mRK9%2FGOPeWKvqjy1kp8vFiYVIJKXN5PG%2BnOmdIiNwBoQnBu&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Date=20241024T175838Z&X-Amz-SignedHeaders=host&X-Amz-Expires=300&X-Amz-Credential=ASIAQ3PHCVTYR4YPHW6Q%2F20241024%2Fus-east-1%2Fs3%2Faws4_request&X-Amz-Signature=bbe126a46d88543985f3a543a1ee23cf5b48ffdc4333950fa02178ec43d47586&hash=0c679c288b43fde5d07bbcfbe9bb3b9afb8991e3a7281a8cfc3aa9b52480c519&host=68042c943591013ac2b2430a89b270f6af2c76d8dfd086a07176afe7c76c2c61&pii=S168411822030253X&tid=spdf-c399f37c-6e4c-4e45-bfda-10aede3bef0b&sid=f4200e6869b6814ee8081ea7adc7e351548dgxrqa&type=client&tsoh=d3d3LnNjaWVuY2VkaXJlY3QuY29t&ua=05075b0450000700515f&rr=8d7bdb291fefa316&cc=ca Document source: Journal of Microbiology, Immunology, and Infection Document type: Systematic Reviews / Meta-Analyses Document year: 2022
Document title: Comparative efficacy and safety of monoclonal antibodies and aspirin desensitization for chronic rhinosinusitis with nasal polyposis: A systematic review and network meta-analysis Document link: https://www.jacionline.org/action/showPdf?pii=S0091-6749%2821%2901393-2 Document source: The Journal of Allergy and Clinical Immunology Document type: Systematic Reviews / Meta-Analyses Document year: 2022
Document title: Real-life effectiveness of mepolizumab in severe asthma: a systematic literature review Document link: https://www.tandfonline.com/doi/epdf/10.1080/02770903.2021.2008431?needAccess=true Document source: The Journal of Asthma Document type: Systematic Reviews / Meta-Analyses Document year: 2022
Document title: 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 Document link: https://pmc.ncbi.nlm.nih.gov/articles/PMC8909778/pdf/cells-11-00819.pdf Document source: Cells Document type: Systematic Reviews / Meta-Analyses Document year: 2022
Document title: A systematic review and integrated analysis of biologics that target Type 2 inflammation to treat COPD with increased peripheral blood eosinophils Document link: https://pmc.ncbi.nlm.nih.gov/articles/PMC9218150/pdf/main.pdf Document source: Heliyon Document type: Systematic Reviews / Meta-Analyses Document year: 2022
Document title: The Impact of Monoclonal Antibodies on Airway Smooth Muscle Contractility in Asthma: A Systematic Review Document link: https://pmc.ncbi.nlm.nih.gov/articles/PMC8468486/pdf/biomedicines-09-01281.pdf Document source: Biomedicines Document type: Systematic Reviews / Meta-Analyses Document year: 2021
Document title: Clinical effects of mepolizumab in patients with severe eosinophilic asthma according to background therapy: A meta-analysis Document link: https://www.jaci-inpractice.org/action/showPdf?pii=S2213-2198%2821%2900647-4 Document source: The Journal of Allergy and Clinical Immunology Document type: Systematic Reviews / Meta-Analyses Document year: 2021
Document title: Mepolizumab improves clinical outcomes in patients with severe asthma and comorbid conditions Document link: https://pmc.ncbi.nlm.nih.gov/articles/PMC8182929/pdf/12931_2021_Article_1746.pdf Document source: Respiratory Research Document type: Systematic Reviews / Meta-Analyses Document year: 2021
Document title: Real-world Effectiveness of Mepolizumab in Severe Eosinophilic Asthma: A Systematic Review and Meta-analysis Document link: https://www.clinicaltherapeutics.com/article/S0149-2918(21)00158-2/abstract Document source: Clinical Therapeutics Document type: Systematic Reviews / Meta-Analyses Document year: 2021
Document title: Biologics for chronic rhinosinusitis Document link: https://pmc.ncbi.nlm.nih.gov/articles/PMC8094915/pdf/CD013513.pdf Document source: The Cochrane Database of Systematic Reviews Document type: Systematic Reviews / Meta-Analyses Document year: 2021
Document title: Efficacy and safety of treatment with biologicals for severe chronic rhinosinusitis with nasal polyps: A systematic review for the EAACI guidelines Document link: https://onlinelibrary.wiley.com/doi/epdf/10.1111/all.14809 Document source: Allergy Document type: Systematic Reviews / Meta-Analyses Document year: 2021
Document title: Mepolizumab in Hypereosinophilic Syndrome: A Systematic Review and Meta-analysis Document link: https://pmc.ncbi.nlm.nih.gov/articles/PMC8478134/pdf/cln-76-3271.pdf Document source: Clinics (Sao Paulo, Brazil) Document type: Systematic Reviews / Meta-Analyses Document year: 2021
Document title: Monoclonal Antibodies Targeting IL-5 or IL-5Ralpha in Eosinophilic Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-Analysis Document link: https://pmc.ncbi.nlm.nih.gov/articles/PMC8594629/pdf/fphar-12-754268.pdf Document source: Frontiers in Pharmacology Document type: Systematic Reviews / Meta-Analyses Document year: 2021
Document title: 2021 American College of Rheumatology/Vasculitis Foundation guideline for the management of antineutrophil cytoplasmic antibody–associated vasculitis Document link: https://acrjournals.onlinelibrary.wiley.com/doi/epdf/10.1002/art.41773 Document source: Arthritis & Rheumatology Document type: Clinical Practice Guidelines Document year: 2021
Document title: 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 asthma Document link: https://onlinelibrary.wiley.com/doi/epdf/10.1111/all.14221 Document source: Allergy Document type: Clinical Practice Guidelines Document year: 2020