Evaluation of real-life data in patients with severe eosinophilic asthma treated with mepolizumab

Year 2022, , 275 - 279, 26.09.2022

Hale Ateş , Kurtuluş Aksu , İlkay Koca Kalkan , Musa Topel , Senay Demir , Selma Yesilkaya , Sakine Nazik Bahcecioglu

https://doi.org/10.47582/jompac.1167677

Abstract

Aim: We aimed to evaluate the efficacy of mepolizumab on asthma exacerbations, blood eosinophils, oral steroid dependence, and asthma control.
Material and Method: This study is a clinical observational study created from real-life data obtained by retrospective analysis. Patients who were initiated subcutaneous mepolizumab at a dose of 100 mg every four weeks in our clinic and received treatment for at least 16 weeks were included in the study.
Result: Thirty-four patients with severe eosinophilic asthma were included in the study. We found that mepolizumab treatment resulted in a decrease in the number of asthma exacerbations, the need for maintenance oral corticosteroid, blood eosinophil counts, and improvement in lung functions and asthma control test scores in patients with severe eosinophilic asthma. At 6 months the rate of responders and super responders to mepolizumab treatment was 75% and 17.9%, respectively, and the overall response rate was 92.9% as a result. In the first year of treatment, the rate of super-responders increased to 58.3%, and the overall response rate was 91.7%. The rate of second-year responders and super-responders was 7.7% and 84.6%, respectively, and the overall response rate was 92.3%. At 3 years, the overall response rate had increased to 100%.
Conclusion: The results of our single-center study, in which we evaluated the results of mepolizumab treatment in patients with severe eosinophilic asthma, confirmed the clinical, hematological and functional findings published by previous studies in a real-life setting.

Keywords

Asthma control test, blood eosinophil counts, corticosteroid, interleukin – 5

Mepolizumab ile tedavi edilen ağır eozinofilik astımlı hastalarda gerçek yaşam verilerinin değerlendirilmesi

Abstract

Amaç: Mepolizumabın astım alevlenmeleri, kan eozinofilleri, oral steroid bağımlılığı ve astım kontrolü üzerindeki etkinliğini değerlendirmeyi amaçladık.
Gereç ve Yöntem: Bu çalışma, retrospektif analiz ile elde edilen gerçek yaşam verilerinden oluşturulmuş klinik gözlemsel bir çalışmadır. Kliniğimizde dört haftada bir 100 mg deri altı mepolizumab başlanan ve en az 16 hafta tedavi gören hastalar çalışmaya alındı.
Bulgular: Ağır eozinofilik astımı olan 34 hasta çalışmaya dahil edildi. Ağır eozinofilik astımı olan hastalarda mepolizumab tedavisinin astım alevlenmelerinin sayısında, oral kortikosteroid idame ihtiyacında, kan eozinofil sayılarında ve akciğer fonksiyonlarında ve astım kontrol testi puanlarında iyileşme ile sonuçlandığını bulduk. 6 ayda mepolizumab tedavisine yanıt verenlerin ve süper yanıt verenlerin oranı sırasıyla %75 ve %17,9’du ve sonuç olarak genel yanıt oranı %92,9’du. Tedavinin ilk yılında, süper yanıt verenlerin oranı %58,3’e yükseldi ve genel yanıt oranı %91,7 oldu. İkinci yılda yanıt verenlerin ve süper yanıt verenlerin oranı sırasıyla %7,7 ve %84,6 ve genel yanıt oranı %92,3’tü. 3 yılda, genel yanıt oranı %100’e yükselmişti.
Sonuç: Ağır eozinofilik astımı olan hastalarda mepolizumab tedavisinin sonuçlarını değerlendirdiğimiz tek merkezli çalışmamızın sonuçları, gerçek yaşam ortamında önceki çalışmalarda yayınlanan klinik, hematolojik ve fonksiyonel bulguları doğruladı.

Keywords

Astım kontrol testi, interlökin–5, kan eozinofil sayıları, kortikosteroid

References

• Pelaia C, Crimi C, Pelaia G, et al. Real‐life evaluation of mepolizumab efficacy in patients with severe eosinophilic asthma, according to atopic trait and allergic phenotype. Clin Experiment Allergy 2020; 50: 780-8.
• Pelaia C, Busceti MT, Solinas S, Terracciano R, Pelaia G. 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. Pulmonary Pharmacology Therapeutics 2018; 53: 1-5.
• Morjaria JB, Emma R, Fuochi V, Polosa R, Caruso M. An evaluation of mepolizumab for the treatment of severe asthma. Expert Opinion on Biological Therapy 2019; 19: 491-500.
• Cameli P, Bergantini L, d’Alessandro M, et al. A comprehensive evaluation of mepolizumab effectiveness in a real-life setting. Int Arch Allerg Immunol 2020; 181: 606-12.
• Bagnasco D, Ferrando M, Varricchi G, Puggioni F, Passalacqua G, Canonica GW. Anti-interleukin 5 (IL-5) and IL-5Ra biological drugs: efficacy, safety, and future perspectives in severe eosinophilic asthma. Front Med 2017; 4: 135.
• Pavord ID, Korn S, Howarth P, et al. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet 2012; 380: 651-9.
• Ortega HG, Liu MC, Pavord ID, et al. Mepolizumab treatment in patients with severe eosinophilic asthma. New Engl J Med 2014; 371: 1198-207.
• Bel EH, Wenzel SE, Thompson PJ, et al. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med 2014; 371: 1189-97.
• Chupp GL, Bradford ES, Albers FC, et al. Efficacy of mepolizumab add-on therapy on health-related quality of life and markers of asthma control in severe eosinophilic asthma (MUSCA): a randomised, double-blind, placebo-controlled, parallel-group, multicentre, phase 3b trial. Lancet Respir Med 2017; 5: 390-400.
• Holguin F, Cardet JC, Chung KF, et al. Management of severe asthma: a European respiratory society/American thoracic society guideline. Eur Respir J 2020; 55: 1.
• Öztürk BÖ, Yavuz Z, Eraslan D, et al. Mepolizumab is an effective option in severe eosinophilic asthma regardless of baseline features: single-center real-life data. Int Arch Allerg Immunol 2022; 183: 526-38.
• Bakakos A, Loukides S, Bakakos P. Severe eosinophilic asthma. J Clin Med 2019; 8: 1375.
• Drick N, Seeliger B, Welte T, Fuge J, Suhling H. Anti-IL-5 therapy in patients with severe eosinophilic asthma–clinical efficacy and possible criteria for treatment response. BMC Pulm Med 2018; 18: 1-9.
• Bagnasco D, Caminati M, Menzella F, et al. One year of mepolizumab. Efficacy and safety in real-life in Italy. Pulm Pharmacol Ther 2019; 58: 101836.
• Enríquez-Rodríguez AI, Hermida Valverde T, Romero Alvarez P, et al. Results in clinical practice in the treatment of severe eosinophilic asthma with mepolizumab: a real-life study. J Asthma 2022; 59: 1005-11.
• Renner A, Marth K, Patocka K, Idzko M, Pohl W. Effectiveness of mepolizumab therapy in patients with severe eosinophilic asthma: Austrian real-life data. Pulm Pharmacol Ther 2020; 64: 101946.
• Harvey ES, Langton D, Katelaris C, et al. Mepolizumab effectiveness and identification of super-responders in severe asthma. Eur Respir J 2020; 55: 5.
• Crimi C, Campisi R, Cacopardo G, et al. Real-life effectiveness of mepolizumab in patients with severe refractory eosinophilic asthma and multiple comorbidities. World Allergy Organization J 2020; 13: 100462.
• Numata T, Nakayama K, Utsumi H, et al. Efficacy of mepolizumab for patients with severe asthma and eosinophilic chronic rhinosinusitis. BMC Pulmonary Med 2019; 19: 1-9.
• Caminati M, Cegolon L, Vianello A, et al. Mepolizumab for severe eosinophilic asthma: a real-world snapshot on clinical markers and timing of response. Expert Rev Respir Med 2019; 13: 1205-12.
• Leckie MJ, ten Brinke A, Khan J. et al. Effects of an interleukin-5 blocking monoclonal antibody on eosinophils, airway hyper-responsiveness, and the late asthmatic response. Lancet 2000; 356: 2144-8.
• Schleich F, Graff S, Nekoee H, et al. Real‐world experience with mepolizumab: Does it deliver what it has promised? Clin Experiment Allergy 2020; 50: 687-95.
• Yancey SW, Keene ON, Albers FC, et al. Biomarkers for severe eosinophilic asthma. J Allergy Clin Immunol 2017; 140: 1509-18.
• Pertzov B, Unterman A, Shtraichman O, Shitenberg D, Rosengarten D, Kramer MR. Efficacy and safety of mepolizumab in a real-world cohort of patients with severe eosinophilic asthma. J Asthma 2021; 58: 79-84.
• Ortega HG, Yancey SW, Mayer B, et al. Severe eosinophilic asthma treated with mepolizumab stratified by baseline eosinophil thresholds: a secondary analysis of the DREAM and MENSA studies. Lancet Respir Med 2016; 4: 549-56.