Effectiveness and safety of mepolizumab in severe refractory eosinophilic asthma: results in clinical practice

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Abstract

Background: Asthma is an inflammatory disease of the airways with symptoms that vary over time and intensity, sometimes leading to disability or even death. Eosinophilic asthma accounts for 25% of cases of severe asthma. It is mediated by eosinophils regulated by interleukin-5 (IL-5), the target of mepolizumab, which has been recently licensed as an add-on treatment of severe refractory eosinophilic asthma. The aim of this study was to evaluate the effectiveness and safety of mepolizumab in clinical practice.

Methods: A multicentre, retrospective, and descriptive study covering a year was conducted in a province of Spain with more than 500,000 inhabitants. Every patient prescribed with mepolizumab since its introduction into the hospital was included in the study. Clinical parameters were collected from the pharmacists’ counselling reports from electronic prescription software and electronic patient records. Effectiveness was assessed as a decrease in the exacerbation frequency and/or a reduction in the use of oral corticosteroids (OCS) compared to the previous year.

Results: A total of 25 patients were studied, but only 23 could be evaluated by the cut-off date. A decrease in the exacerbation frequency was observed in 19 (82.6%) patients, 11 of them without any exacerbation during the treatment. A relative reduction of 87% in the exacerbation rate per year was obtained. A total of 15 patients were on regular OCS – 9 patients (60%) reduced their average dose, whilst 4 (26.7%) patients completely abandoned OCS. Safety was evaluated based on reported adverse effects. Adverse events were observed in 12 patients, the most common being headache, arthralgia, and dizziness/nausea.

Conclusion: Mepolizumab has been shown to be effective based on the high decrease in the exacerbation frequency and reduced use of OCS. Reported adverse effects were mostly mild and appeared in half of the patients; some of the adverse events had not been previously described in pivotal trials.

Keywords: adverse drug reaction, asthma, biological therapy, eosinophils, interleukin-5, medication therapy management, mepolizumab, treatment outcomes.

Citation: Montero-Pérez O, Contreras-Rey MB, Sánchez-Gómez E. Effectiveness and safety of mepolizumab in severe refractory eosinophilic asthma: results in clinical practice. Drugs in Context 2019; 8: 212584. DOI: 10.7573/dic.212584

Contributions: All authors contributed equally to the preparation of this review. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Disclosure and potential conflicts of interest: The authors declare that they have no conflicts of interest. The International Committee of Medical Journal Editors (ICMJE) Potential Conflicts of Interests form for the authors is available for download at https://www.drugsincontext.com/wp-content/uploads/2019/05/dic.212584-COI.pdf

Acknowledgements: Our most sincere appreciation to Patricia Monje, Pharmacist, at the Pharmacy Service of Rio Tinto Hospital (Huelva, Spain), who collaborated in the collection of data for this study. Funding declaration: There was no funding associated with the preparation of this article.

Copyright: Copyright © 2019 Montero-Pérez O, Contreras-Rey MB, Sánchez-Gómez E. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0 which allows anyone to copy, distribute, and transmit the article provided it is properly attributed in the manner specified below. No commercial use without permission.

Correct attribution: Copyright © 2019 Montero-Pérez O, Contreras-Rey MB, Sánchez-Gómez E. https://doi.org/10.7573/dic.212584. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0.

Article URL: https://drugsincontext.com/effectiveness-and-safety-of-mepolizumab-in-severe-refractory-eosinophilic-asthma-results-in-clinical-practice

Correspondence: Olalla Montero-Pérez, Unidad de Gestión Clínica de Farmacia, Hospital Juan Ramón Jiménez, Huelva, Spain. olallamontero@hotmail.es

Provenance: submitted; externally peer reviewed.

Submitted: 16 February 2019; Peer review comments to author: 20 March 2019; Revised manuscript received: 18 April 2019; Accepted: 24 April 2019; Publication date: 27 May 2019.

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