AIMS: Mepolizumab, a fully-humanized recombinant IgG1 kappa monoclonal antibody directed against IL-5, has shown improved asthma control and lung function in randomised controlled trials. The aim of this study was to evaluate real-world clinical experience in patients with severe eosinophilic asthma treated with mepolizumab in Slovakia. METHODS: A retrospective, non-interventional study based on medical records of all adult asthma patients initiating mepolizumab between November 1, 2017 and January 31, 2019, completing 12 months of treatment. At baseline, general and clinical profile data were recorded 12 months prior to treatment. Primary and secondary endpoints described the results of mepolizumab use at 2, 6, and 12 months after the initiation and compared to baseline. Statistical testing of individual change (in each patient) in selected parameters was performed. RESULTS: The cohort included 17 patients with particularly severe asthma at baseline, with frequent severe exacerbations (SE, median 5 [IQR 4-6]/patient/year), high blood eosinophil counts (median 0.6x109/L), frequent oral corticosteroid (OCS) dependence (82.35%), median dose 15 (IQR 7.5-20) mg/day, impaired lung function, and a spectrum of comorbidities. In a one-year follow-up, the data showed reductions in median SE (0 [IQR 0-1] patient/year, eosinophilia (median 0.175x109/L) and OCS maintenance dose (median 6.25 [IQR 2.5-20] mg/day), all statistically significant after 12 months on mepolizumab. Improved and stabilised lung functions throughout the cohort and a reduced incidence of nasal polyposis were observed. CONCLUSIONS: The results provide clinical evidence of mepolizumab efficacy in a real sample of patients with severe asthma when administered in routine care settings in Slovakia.

Allergology and Immunology Clinic Department of Internal Medicine F D Roosevelt Hospital Banska Bystrica Slovakia

Department of Clinical Immunology and Allergology University Teaching Hospital in Martin Martin Slovakia

Department of Paediatrics Jessenius Faculty of Medicine in Martin Comenius University in Bratislava University Teaching Hospital in Martin Martin Slovakia

Department of Pulmonology and Phthisiology Jessenius Faculty of Medicine in Martin Comenius University in Bratislava University Teaching Hospital in Martin Martin Slovakia

Faculty of Public Health Slovak Medical University Bratislava Slovakia

GlaxoSmithKline Medical Department Prague Czech Republic

Pharm In Ltd Bratislava Slovakia

Pulmonology Outpatient Clinic Rockmed Bratislava Slovakia

See more in PubMed

Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention [Internet]. 2021 [cited 2022 Apr 13]. Available from: www.ginasthma.org

Barry LE, Sweeney J, O'Neill C, Price D, Heaney LG. The cost of systemic corticosteroid-induced morbidity in severe asthma: a health economic analysis. Respir Res 2017;18(1):129. PubMed DOI

Kerkhof M, Tran TN, Soriano JB, Golam S, Gibson D, Hillyer EV, Price DB. Healthcare resource use and costs of severe, uncontrolled eosinophilic asthma in the UK general population. Thorax 2018;73(2):116-24. PubMed DOI

NCZI. Zdravotnícka ročenka Slovenskej republiky [Internet]. Bratislava: Národné centrum zdravotníckych informácií; 2019. 278 p. Available from: http://www.nczisk.sk/statisticke_vystupy/publikacie_statisticke_prehlady/zdravotnicke_rocenky/Pages/default.aspx (In Slovak)

Volmer T, Effenberger T, Trautner C, Buhl R. Consequences of long-term oral corticosteroid therapy and its side-effects in severe asthma in adults: a focused review of the impact data in the literature. Eur Respir J 2018;52(4):1800703. PubMed DOI

Patel SS, Casale TB, Cardet JC. Biological therapies for eosinophilic asthma. Expert Opin Biol Ther 2018;18(7):747-54. PubMed DOI

Pavord ID, Korn S, Howarth P, Bleecker ER, Buhl R, Keene ON, Ortega H, Chanez P. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet Lond Engl 2012;380(9842):651-9. PubMed DOI

Bel EH, Wenzel SE, Thompson PJ, Prazma CM, Keene ON, Yancey SW, Ortega HG, Pavord ID, SIRIUS Investigators. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med 2014;371(13):1189-97. PubMed DOI

Ortega HG, Liu MC, Pavord ID, Brusselle GG, FitzGerald JM, Chetta A, Humbert M, Katz LE, Keene ON, Yancey SW, Chanez P. Mepolizumab Treatment in Patients with Severe Eosinophilic Asthma. N Engl J Med 2014;371(13):1198-207. PubMed DOI

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. Pulm Pharmacol Ther 2018;53:1-5. PubMed DOI

Akenroye A, Keet C. Underrepresentation of blacks, smokers, and obese patients in studies of monoclonal antibodies for asthma. J Allergy Clin Immunol Pract 2020;8(2):739-741.e6. PubMed DOI

Harrison T, Canonica GW, Chupp G, Lee J, Schleich F, Welte T, Valero A, Gemzoe K, Maxwell A, Joksaite S, Yang S, Howarth P, Van Dyke MK. Real-world mepolizumab in the prospective severe asthma REALITI-A study: initial analysis. Eur Respir J 2020;56(4):2000151. PubMed DOI

Domingo Ribas C, Carrillo Díaz T, Blanco Aparicio M, Martínez Moragón E, Banas Conejero D, Sánchez Herrero MG, REDES Study Group. REal worlD Effectiveness and Safety of Mepolizumab in a Multicentric Spanish Cohort of Asthma Patients Stratified by Eosinophils: The REDES Study. Drugs 2021;81(15):1763-74. PubMed DOI

Israel E, Canonica GW, Brusselle G, Yang S, Howarth PH, Martin AL, Koufopoulou M, Smith SG, Alfonso-Cristancho R. Real-life effectiveness of mepolizumab in severe asthma: a systematic literature review. J Asthma 2022;59(11):2201-17. doi: 10.1080/02770903.2021.2008431 PubMed DOI

Gibson PG, Prazma CM, Chupp GL, Bradford ES, Forshag M, Mallett SA, Yancey SW, Smith SG, Bel EH. Mepolizumab improves clinical outcomes in patients with severe asthma and comorbid conditions. Respir Res 2021;22(1):171. PubMed DOI

Casale T, Molfino NA, Silver J, Bogart M, Packnett E, McMorrow D, Wu J, Hahn B. Real-world effectiveness of mepolizumab in patients with severe asthma and associated comorbidities. Ann Allergy Asthma Immunol Off Publ Am Coll Allergy Asthma Immunol 2021;127(3):354-362.e2. PubMed DOI

Hartl S, Breyer MK, Burghuber OC, Ofenheimer A, Schrott A, Urban MH, Agusti A, Studnicka M, Wouters EFM, Breyer-Kohansal R. Blood eosinophil count in the general population: typical values and potential confounders. Eur Respir J 2020;55(5):1901874. PubMed DOI

Khatri S, Moore W, Gibson PG, Leigh R, Bourdin A, Maspero J, Barros M, Buhl R, Howarth P, Albers FC, Bradford ES, Gilson M, Price RG, Yancey SW, Ortega H. Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma. J Allergy Clin Immunol 2019;143(5):1742-1751.e7. PubMed DOI

Jesenak M, Diamant Z. Blood eosinophils: In quest of a Holy Grail for personalized asthma treatment with biologicals. Allergy 2020;75(6):1294-7. PubMed DOI

Han JK, Bachert C, Fokkens W, Desrosiers M, Wagenmann M, Lee SE, Smith SG, Martin N, Mayer B, Yancey SW, Sousa AR, Chan R, Hopkins C, SYNAPSE study investigators. Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med 2021;9(10):1141-53. PubMed DOI

The effect of mepolizumab dosage form on treatment outcomes in severe asthma