Real-world outcomes of mepolizumab treatment in severe eosinophilic asthma patients - retrospective cohort study in Slovakia.
Slovakia
exacerbations
mepolizumab
real world evidence
severe eosinophilic asthma
Journal
Biomedical papers of the Medical Faculty of the University Palacky, Olomouc, Czechoslovakia
ISSN: 1804-7521
Titre abrégé: Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub
Pays: Czech Republic
ID NLM: 101140142
Informations de publication
Date de publication:
Sep 2023
Sep 2023
Historique:
received:
24
02
2023
accepted:
16
06
2023
medline:
3
11
2023
pubmed:
13
7
2023
entrez:
13
7
2023
Statut:
ppublish
Résumé
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. 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. 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 0.6x10 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.
Substances chimiques
mepolizumab
90Z2UF0E52
Anti-Asthmatic Agents
0
Adrenal Cortex Hormones
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
272-280Déclaration de conflit d'intérêts
The authors report no conflicts of interest in this work.
Références
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: 28651591
doi: 10.1186/s12931-017-0614-x
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: 28918400
doi: 10.1136/thoraxjnl-2017-210531
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: 30190274
doi: 10.1183/13993003.00703-2018
Patel SS, Casale TB, Cardet JC. Biological therapies for eosinophilic asthma. Expert Opin Biol Ther 2018;18(7):747-54.
pubmed: 29938543
doi: 10.1080/14712598.2018.1492540
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: 22901886
doi: 10.1016/S0140-6736(12)60988-X
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: 25199060
doi: 10.1056/NEJMoa1403291
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: 25199059
doi: 10.1056/NEJMoa1403290
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: 30217438
doi: 10.1016/j.pupt.2018.09.006
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: 31472296
doi: 10.1016/j.jaip.2019.08.023
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: 32817259
doi: 10.1183/13993003.00151-2020
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: 34586602
doi: 10.1007/s40265-021-01597-9
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: 34951336
doi: 10.1080/02770903.2021.2008431
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: 34098955
doi: 10.1186/s12931-021-01746-4
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: 34038773
doi: 10.1016/j.anai.2021.05.021
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: 32060069
doi: 10.1183/13993003.01874-2019
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: 30359681
doi: 10.1016/j.jaci.2018.09.033
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: 32112573
doi: 10.1111/all.14253
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: 33872587
doi: 10.1016/S2213-2600(21)00097-7