Heterogeneity in the use of biologics for severe asthma in Europe: a SHARP ERS study

. 2022 Oct ; 8 (4) : . [epub] 20221024

Status PubMed-not-MEDLINE Jazyk angličtina Země Anglie, Velká Británie Médium electronic-ecollection

Typ dokumentu časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/pmid36299366

INTRODUCTION: Treatment with biologics for severe asthma is informed by international and national guidelines and defined by national regulating bodies, but how these drugs are used in real-life is unknown. MATERIALS AND METHODS: The European Respiratory Society (ERS) SHARP Clinical Research Collaboration conducted a three-step survey collecting information on asthma biologics use in Europe. Five geographically distant countries defined the survey questions, focusing on seven end-points: biologics availability and financial issues, prescription and administration modalities, inclusion criteria, continuation criteria, switching biologics, combining biologics and evaluation of corticosteroid toxicity. The survey was then sent to SHARP National Leads of 28 European countries. Finally, selected questions were submitted to a broad group of 263 asthma experts identified by national societies. RESULTS: Availability of biologics varied between countries, with 17 out of 28 countries having all five existing biologics. Authorised prescribers (pulmonologists and other specialists) also differed. In-hospital administration was the preferred deliverance modality. While exacerbation rate was used as an inclusion criterion in all countries, forced expiratory volume in 1 s was used in 46%. Blood eosinophils were an inclusion criterion in all countries for interleukin-5 (IL-5)-targeted and IL-4/IL-13-targeted biologics, with varying thresholds. There were no formally established criteria for continuing biologics. Reduction in exacerbations represented the most important benchmark, followed by improvement in asthma control and quality of life. Only 73% (191 out of 263) of surveyed clinicians assessed their patients for corticosteroid-induced toxicity. CONCLUSION: Our study reveals important heterogeneity in the use of asthma biologics across Europe. To what extent this impacts on clinical outcomes relevant to patients and healthcare services needs further investigation.

Allergy Centre Tampere University Hospital and Faculty of Medicine and Health Technology Tampere University Tampere Finland

Centre for Experimental Medicine School of Medicine Dentistry and Biomedical Sciences Queen's University Belfast Belfast UK

Department of Allergology and Immunology Russian Medical Academy of Continuous Professional Education Moscow Russia

Department of Allergy Respiratory Medicine and Sleep Landspitali University Hospital Reykjavik Iceland University of Iceland Reykjavik Iceland

Department of Pneumology University Hospital and Charles University Faculty of Medicine Hradec Kralove Czech Republic

Department of Pulmonary Diseases Istanbul University Cerrahpasa Cerrahpasa Faculty of Medicine Istanbul Turkey

Department of Pulmonology Lithuanian University of Health Sciences Kaunas Lithuania

Department of Respiratory Medicine Amsterdam University Medical Center University of Amsterdam Amsterdam the Netherlands

Department of Respiratory Medicine and Allergy Karolinska University Hospital Stockholm Sweden

Department of Respiratory Medicine Liège University Hospital Liège Belgium

Department of Respiratory Medicine Medical Center Leeuwarden Leeuwarden the Netherlands

Department of Respiratory Medicine University Hospital of Liège Liège Belgium

Division of Internal Medicine Asthma and Allergy Barlicki University Hospital Medical University of Lodz Lodz Poland

Faculty of Medical Sciences University of Kragujevac and Clinic for Pulmonology Clinical Centre Kragujevac Serbia

Faculty of Medicine University of Southampton Southampton UK

Institute of Technology University of Tartu Tartu Estonia

Latvian Association of Allergists Center of Tuberculosis and Lung Diseases Riga Latvia

National Institute of Pneumology M Nasta Bucharest Romania

National Korányi Institute of Pulmonology Budapest Hungary

NIHR Southampton Biomedical Research Centre Southampton UK

Personalized Medicine Asthma and Allergy Humanitas Clinical and Research Center IRCCS Milan Italy

PhyMedExp Univ Montpellier CNRS INSERM CHU Montpellier Montpellier France

Pulmonology Department Hospitais da Universidade de Coimbra Centro Hospitalar e Universitário de Coimbra Coimbra Portugal

Respiratory Medicine Department and Asthma Center Athens Chest Hospital Sotiria Athens Greece

Respiratory Medicine Unit Department of Medicine Solna Campus and Center for Molecular Medicine Karolinska Institute Stockholm Sweden

Respiratory Research Unit Bispebjerg University Hospital Copenhagen Denmark

Respiratory Research Unit Complexo Hospitalario Universitario and Instituto de Investigación Biomédica de A Coruña Spain

School of Medicine University College Dublin Dublin Ireland

St Vincent's University Hospital University College Dublin Dublin Ireland

The Clinic for Lung Diseases Jordanovac University Hospital Centre Zagreb Zagreb Croatia

Universitätsmedizin Mainz Mainz Germany

University Clinic of Medicine Cantonal Hospital Basel Liestal Switzerland

University Clinic of Respiratory and Allergic Diseases Golnik Slovenia

University of Basel Basel Switzerland

Zobrazit více v PubMed

Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention. 2021. Available from: http://ginasthma.org/

Hekking PPW, Wener RR, Amelink M, et al. . The prevalence of severe refractory asthma. J Allergy Clin Immunol 2015; 135: 896–902. doi:10.1016/j.jaci.2014.08.042 PubMed DOI

Chung KF, Wenzel SE, Brozek JL, et al. . International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J 2014; 43: 343–373. doi:10.1183/09031936.00202013 PubMed DOI

Israel E, Reddel HK. Severe and difficult-to-treat asthma in adults. N Engl J Med 2017; 377: 965–976. doi:10.1056/NEJMra1608969 PubMed DOI

Pavord ID, Beasley R, Agusti A, et al. . After asthma: redefining airways diseases. Lancet 2018; 391: 350–400. doi:10.1016/S0140-6736(17)30879-6 PubMed DOI

Brusselle GG, Koppelman GH. Biologic therapies for severe asthma. N Engl J Med 2022; 386: 157–171. doi:10.1056/NEJMra2032506 PubMed DOI

Djukanovic R, Adcock IM, Anderson G, et al. . The severe heterogeneous asthma research collaboration, patient-centred (SHARP) ERS clinical research collaboration: a new dawn in asthma research. Eur Respir J 2018; 52: 1801671. doi:10.1183/13993003.01671-2018 PubMed DOI

van Bragt JJMH, Adcock IM, Bel EHD, et al. . Characteristics and treatment regimens across ERS SHARP severe asthma registries. Eur Respir J 2020; 55: 1901163. doi:10.1183/13993003.01163-2019 PubMed DOI

Porsbjerg CM, Menzies-Gow AN, Tran TN, et al. . Global variability in administrative approval prescription criteria for biologic therapy in severe asthma. J Allergy Clin Immunol Pract 2022; 10: 1202–1216.e23. doi:10.1016/j.jaip.2021.12.027 PubMed DOI

Calzetta L, Matera MG, Rogliani P. Monoclonal antibodies in severe asthma: is it worth it? Expert Opin Drug Metab Toxicol 2019; 15: 517–520. doi:10.1080/17425255.2019.1621837 PubMed DOI

Canonica GW, Harrison TW, Chanez P, et al. . Benralizumab improves symptoms of patients with severe, eosinophilic asthma with a diagnosis of nasal polyposis. Allergy 2022; 77: 150–161. doi:10.1111/all.14902 PubMed DOI

Menzella F, Fontana M, Contoli M, et al. . Efficacy and safety of omalizumab treatment over a 16-year follow-up: when a clinical trial meets real-life. J Asthma Allergy 2022; 15: 505–515. doi:10.2147/JAA.S363398 PubMed DOI PMC

Graff S, Brusselle G, Hanon S, et al. . Anti-interleukin-5 therapy is associated with attenuated lung function decline in severe eosinophilic asthma patients from the Belgian severe asthma registry. J Allergy Clin Immunol Pract 2022; 10: 467–477. doi:10.1016/j.jaip.2021.09.023 PubMed DOI

Wechsler ME, Ford LB, Maspero JF, et al. . Long-term safety and efficacy of dupilumab in patients with moderate-to-severe asthma (TRAVERSE): an open-label extension study. Lancet Respir Med 2022; 10: 11–25. doi:10.1016/S2213-2600(21)00322-2 PubMed DOI

Hansen S, Ulrik C, Hilberg O, et al. . The effectiveness of anti-IL5 biologics is comparable in previous-smokers and never-smokers with severe asthma. Eur Respir J 2021; 58: Suppl. 65, PA3742.

Buhl R, Humbert M, Bjermer L, et al. . Severe eosinophilic asthma: a roadmap to consensus. Eur Respir J 2017; 49: 1700634. doi:10.1183/13993003.00634-2017 PubMed DOI

Frix AN, Schleich F, Paulus V, et al. . Effectiveness of omalizumab on patient reported outcomes, lung function, and inflammatory markers in severe allergic asthma. Biochem Pharmacol 2020; 179: 113944. doi:10.1016/j.bcp.2020.113944 PubMed DOI

Schleich F, Graff S, Nekoee H, et al. . Real-world experience with mepolizumab: does it deliver what it has promised? Clin Exp Allergy 2020; 50: 687–695. doi:10.1111/cea.13601 PubMed DOI

Upham JW, Le Lievre C, Jackson DJ, et al. . Defining a severe asthma super-responder: findings from a Delphi process. J Allergy Clin Immunol Pract 2021; 9: 3997–4004. doi:10.1016/j.jaip.2021.06.041 PubMed DOI

Pelaia C, Crimi C, Nolasco S, et al. . Switch from omalizumab to benralizumab in allergic patients with severe eosinophilic asthma: a real-life experience from southern Italy. Biomedicines 2021; 9: 1822. doi:10.3390/biomedicines9121822 PubMed DOI PMC

Carpagnano GE, Pelaia C, D'Amato M, et al. . Switching from omalizumab to mepolizumab: real-life experience from Southern Italy. Ther Adv Respir Dis 2020; 14: 175346662092923. doi:10.1177/1753466620929231 PubMed DOI PMC

Numata T, Araya J, Miyagawa H, et al. . Effectiveness of switching biologics for severe asthma patients in Japan: a single-center retrospective study. J Asthma Allergy 2021; 14: 609–618. doi:10.2147/JAA.S311975 PubMed DOI PMC

Ortega G, Tongchinsub P, Carr T. Combination biologic therapy for severe persistent asthma. Ann Allergy Asthma Immunol 2019; 123: 309–311. doi:10.1016/j.anai.2019.06.013 PubMed DOI

Dedaj R, Unsel L. Case study: a combination of Mepolizumab and Omaluzimab injections for severe asthma. J Asthma 2019; 56: 473–474. doi:10.1080/02770903.2018.1471706 PubMed DOI

Wechsler ME, Ruddy MK, Pavord ID, et al. . Efficacy and safety of Itepekimab in patients with moderate-to-severe asthma. N Engl J Med 2021; 385: 1656–1668. doi:10.1056/NEJMoa2024257 PubMed DOI

Menzies-Gow AN, McBrien C, Unni B, et al. . Real world biologic use and switch patterns in severe asthma: data from the international severe asthma registry and the US CHRONICLE study. J Asthma Allergy 2022; 15: 63–78. doi:10.2147/JAA.S328653 PubMed DOI PMC

Bel EH, Wenzel SE, Thompson PJ, et al. . Oral glucocorticoid-sparing effect of Mepolizumab in eosinophilic asthma. N Engl J Med 2014; 371: 1189–1197. doi:10.1056/NEJMoa1403291 PubMed DOI

Nair P, Wenzel S, Rabe KF, et al. . Oral glucocorticoid–sparing effect of benralizumab in severe asthma. N Engl J Med 2017; 376: 2448–2458. doi:10.1056/NEJMoa1703501 PubMed DOI

Rabe KF, Nair P, Brusselle G, et al. . Efficacy and safety of dupilumab in glucocorticoid-dependent severe asthma. N Engl J Med 2018; 378: 2475–2485. doi:10.1056/NEJMoa1804093 PubMed DOI

McDowell PJ, Stone JH, Zhang Y, et al. . Quantification of glucocorticoid-associated morbidity in severe asthma using the glucocorticoid toxicity index. J Allergy Clin Immunol Pract 2021; 9: 365–372. doi:10.1016/j.jaip.2020.08.032 PubMed DOI

E uropean Medicines Agency. XOLAIR (omalizumab). www.ema.europa.eu/en/medicines/human/EPAR/xolair

Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2016/103976s5225lbl.pdf XOLAIR (omalizumab) for injection, for subcutaneous use.

European Medicines Agency. NUCALA (mepolizumab). www.ema.europa.eu/en/medicines/human/EPAR/nucala

Food and Drug Administration. NUCALA (mepolizumab) for injection, for subcutaneous use. www.accessdata.fda.gov/drugsatfda_docs/label/2015/125526Orig1s000Lbl.pdf

European Medicines Agency. CINQAERO (reslizumab). www.ema.europa.eu/en/documents/overview/cinqaero-epar-summary-public_en.pdf

Food and Drug Administration. CINQAIR (reslizumab) injection, for intravenous use. www.accessdata.fda.gov/drugsatfda_docs/label/2016/761033lbl.pdf

European Medicines Agency. www.ema.europa.eu/en/documents/overview/fasenra-epar-medicine-overview_en.pdf FASENRA (benralizumab). An overview of Fasenra and why it is authorized in the EU.

Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2017/761070s000lbl.pdf FASENRA (benralizumab) injection, for subcutaneous use.

Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/761055s007lbl.pdf DUPIXENT (dupilumab) injection, for subcutaneous use.

European Medicines Agency. www.ema.europa.eu/en/documents/product-information/dupixent-epar-product-information_en.pdf DUPIXENT (dupilumab).

Najít záznam

Citační ukazatele

Nahrávání dat ...

    Možnosti archivace