Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2023, 167(3):272-280 | DOI: 10.5507/bp.2023.029

Real-world outcomes of mepolizumab treatment in severe eosinophilic asthma patients - retrospective cohort study in Slovakia

Milos Jesenak^{1, 2, 3}, Vaclav Vanecek⁴, Martina Ondrusova^{5, 6}, Veronika Urdova^{2, 7}, Katarina Dostalova⁸, Ludek Hochmuth⁷

¹ Department of Clinical Immunology and Allergology, University Teaching Hospital in Martin, Martin, Slovakia

² Department of Pulmonology and Phthisiology, Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava, University Teaching Hospital in Martin, Martin, Slovakia

³ Department of Paediatrics, Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava, University Teaching Hospital in Martin, Martin, Slovakia

⁴ GlaxoSmithKline, Medical Department, Prague, Czech Republic

⁵ Pharm-In, Ltd, Bratislava, Slovakia

⁶ Faculty of Public Health, Slovak Medical University, Bratislava, Slovakia

⁷ Allergology and Immunology Clinic, Department of Internal Medicine, F. D. Roosevelt Hospital, Banska Bystrica, Slovakia

⁸ Pulmonology Outpatient Clinic Rockmed, Bratislava, Slovakia

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.

Keywords: severe eosinophilic asthma, exacerbations, mepolizumab, real world evidence, Slovakia

Received: February 24, 2023; Revised: May 23, 2023; Accepted: June 16, 2023; Prepublished online: July 10, 2023; Published: September 21, 2023  Show citation