Long-Term Efficacy of Mepolizumab at 3 Years in Patients with Severe Asthma: Comparison with Clinical Trials and Super Responders

The efficacy mepolizumab in severe asthmatic patients is proven in the literature. Primarily to study the effect of mepolizumab on exacerbations, steroid dependence, and the continuation of efficacy in the long term. Secondarily to evaluate the effect of the drug on nasal polyps. Analyzing data from SANI (Severe Asthma Network Italy) clinics, we observed severe asthmatic patients treated with mepolizumab 100 mg/4 weeks, for a period of 3 years. 157 patients were observed. Exacerbations were reduced from the first year (−84.6%) and progressively to 90 and 95% in the second and third ones. Steroid-dependent patients decreased from 54% to 21% and subsequently to 11% in the second year and 6% in the third year. Patients with concomitant nasal polyps, assessed by SNOT-22, showed a 49% reduction in value from baseline to the third year. The study demonstrated the long-term efficacy of mepolizumab in a real-life setting.

[1]  J. Virchow,et al.  Biologics and airway remodeling in severe asthma , 2022, Allergy.

[2]  G. Canonica,et al.  REALITI-A study: Real-world oral corticosteroid-sparing effect of mepolizumab in severe asthma. , 2022, The journal of allergy and clinical immunology. In practice.

[3]  A. Matucci,et al.  Long-term retention rate of mepolizumab treatment in severe asthma: a 36-months real-life experience , 2022, The Journal of asthma : official journal of the Association for the Care of Asthma.

[4]  P. Howarth,et al.  Real-life effectiveness of mepolizumab in severe asthma: a systematic literature review , 2021, The Journal of asthma : official journal of the Association for the Care of Asthma.

[5]  G. Canonica,et al.  Prospective Italian real‐world study of mepolizumab in severe eosinophilic asthma validates retrospective outcome reports , 2021, Clinical and translational allergy.

[6]  M. Cosio,et al.  Innate lymphocytes -ILC2- might be the drivers of T2-high nonatopic asthma in children , 2021, Airway cell biology and immunopathology.

[7]  M. Humbert,et al.  Stopping versus continuing long-term mepolizumab treatment in severe eosinophilic asthma (COMET study) , 2021, European Respiratory Journal.

[8]  M. D’Amato,et al.  Mepolizumab improves sino-nasal symptoms and asthma control in severe eosinophilic asthma patients with chronic rhinosinusitis and nasal polyps: a 12-month real-life study , 2021, Therapeutic advances in respiratory disease.

[9]  G. Canonica,et al.  Economic impact of mepolizumab in uncontrolled severe eosinophilic asthma, in real life☆ , 2021, The World Allergy Organization journal.

[10]  P. Howarth,et al.  SARS-CoV2 infection in those on Mepolizumab therapy , 2021, Annals of Allergy, Asthma & Immunology.

[11]  B. Nageris,et al.  Mepolizumab for eosinophilic chronic sinusitis with nasal polyposis: real-life experience. , 2020, Rhinology.

[12]  P. Howarth,et al.  Real-world mepolizumab in the prospective severe asthma REALITI-A study: initial analysis , 2020, European Respiratory Journal.

[13]  G. Canonica,et al.  Minimal clinically important difference for asthma endpoints: an expert consensus report , 2020, European Respiratory Review.

[14]  J. Kavanagh,et al.  Real-World Effectiveness and the Characteristics of a 'Super-Responder' to Mepolizumab in Severe Eosinophilic Asthma. , 2020, Chest.

[15]  M. Mantero,et al.  Chronic rhinosinusitis with nasal polyps impact in severe asthma patients: Evidences from the Severe Asthma Network Italy (SANI) registry. , 2020, Respiratory medicine.

[16]  T. Casale,et al.  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 , 2020, Allergy.

[17]  D. P. Potaczek,et al.  Role of airway epithelial cells in the development of different asthma phenotypes. , 2020, Cellular signalling.

[18]  G. Passalacqua,et al.  Efficacy of mepolizumab in patients with previous omalizumab treatment failure: Real‐life observation , 2019, Allergy.

[19]  G. Canonica,et al.  The importance of being not significant: Blood eosinophils and clinical responses do not correlate in severe asthma patients treated with mepolizumab in real life , 2019, Allergy.

[20]  G. Canonica,et al.  One year of mepolizumab. Efficacy and safety in real-life in Italy. , 2019, Pulmonary pharmacology & therapeutics.

[21]  F. Albers,et al.  Long-term Safety and Clinical Benefit of Mepolizumab in Patients With the Most Severe Eosinophilic Asthma: the COSMEX Study. , 2019, Clinical therapeutics.

[22]  G. Canonica,et al.  The Severe Asthma Network in Italy: Findings and Perspectives. , 2019, The journal of allergy and clinical immunology. In practice.

[23]  J. Krings,et al.  Role of Biologics in Asthma , 2019, American journal of respiratory and critical care medicine.

[24]  G. Canonica,et al.  Shadow cost of oral corticosteroids-related adverse events: A pharmacoeconomic evaluation applied to real-life data from the Severe Asthma Network in Italy (SANI) registry , 2019, The World Allergy Organization journal.

[25]  G. Canonica,et al.  The North-Western Italian experience with anti IL-5 therapy amd comparison with regulatory trials , 2018, The World Allergy Organization journal.

[26]  R. Terracciano,et al.  Real-life evaluation of the clinical, functional, and hematological effects of mepolizumab in patients with severe eosinophilic asthma: Results of a single-centre observational study. , 2018, Pulmonary pharmacology & therapeutics.

[27]  D. Price,et al.  Healthcare resource utilization and costs associated with incremental systemic corticosteroid exposure in asthma , 2018, Allergy.

[28]  Kamlesh Khunti,et al.  Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician , 2018, Advances in Therapy.

[29]  D. Price,et al.  Adverse outcomes from initiation of systemic corticosteroids for asthma: long-term observational study , 2018, Journal of asthma and allergy.

[30]  Naweed I Chowdhury,et al.  Investigating the minimal clinically important difference for SNOT‐22 symptom domains in surgically managed chronic rhinosinusitis , 2017, International forum of allergy & rhinology.

[31]  Harald Renz,et al.  Epigenetics and allergy: from basic mechanisms to clinical applications. , 2017, Epigenomics.

[32]  H. Ortega,et al.  Long-term Efficacy and Safety of Mepolizumab in Patients With Severe Eosinophilic Asthma: A Multi-center, Open-label, Phase IIIb Study. , 2016, Clinical therapeutics.

[33]  C. Galeone,et al.  Profile of anti-IL-5 mAb mepolizumab in the treatment of severe refractory asthma and hypereosinophilic diseases , 2015, Journal of asthma and allergy.

[34]  J. Fahy Type 2 inflammation in asthma — present in most, absent in many , 2014, Nature Reviews Immunology.

[35]  Ian D Pavord,et al.  Mepolizumab treatment in patients with severe eosinophilic asthma. , 2014, The New England journal of medicine.

[36]  I. Pavord,et al.  Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. , 2014, The New England journal of medicine.

[37]  E. Bleecker,et al.  International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma , 2013, European Respiratory Journal.

[38]  Ian D Pavord,et al.  Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial , 2012, The Lancet.

[39]  Parameswaran Nair,et al.  Mepolizumab for prednisone-dependent asthma with sputum eosinophilia. , 2009, The New England journal of medicine.

[40]  V. Lund,et al.  Psychometric validity of the 22‐item Sinonasal Outcome Test , 2009, Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery.

[41]  Barmak Modrek,et al.  T-helper type 2-driven inflammation defines major subphenotypes of asthma. , 2009, American journal of respiratory and critical care medicine.

[42]  Ana Sousa,et al.  Mepolizumab and exacerbations of refractory eosinophilic asthma. , 2009, The New England journal of medicine.

[43]  R. Egan,et al.  Th2 cytokines and asthma — The role of interleukin-5 in allergic eosinophilic disease , 2001, Respiratory research.