Real-life effectiveness of mepolizumab in severe asthma: a systematic literature review

References

• Vos T, Abajobir AA, Abate KH, Abbafati C, Abbas KM, Abd-Allah F, Abdulkader RS, Abdulle AM, Abebo TA, Abera SF, et al. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. The Lancet. 2017; 390(10100):1211–1259. doi:10.1016/S0140-6736(17)32154-2.
   PubMed Web of Science ®Google Scholar
• Wenzel S. Severe asthma: from characteristics to phenotypes to endotypes. Clin Exp Allergy. 2012; 42(5):650–658. doi:10.1111/j.1365-2222.2011.03929.x.
   PubMed Web of Science ®Google Scholar
• Chung KF, Wenzel SE, Brozek JL, Bush A, Castro M, Sterk PJ, Adcock IM, Bateman ED, Bel EH, Bleecker ER, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014; 43(2):343–373. doi:10.1183/09031936.00202013.
   PubMed Web of Science ®Google Scholar
• Global Initiative for Asthma. Global Strategy for Asthma management and prevention. 2021. Available from: https://ginasthma.org/wp-content/uploads/2021/05/GINA-Main-Report-2021-V2-WMS.pdf. Accessed Oct 2021
   Google Scholar
• Menzella F, Lusuardi M, Galeone C, Taddei S, Zucchi L. Profile of anti-IL-5 mAb mepolizumab in the treatment of severe refractory asthma and hypereosinophilic diseases. J Asthma Allergy. 2015; 8:105–114. doi:10.2147/JAA.S40244.
   PubMed Web of Science ®Google Scholar
• Busse WW. Biological treatments for severe asthma: a major advance in asthma care. Allergol Int. 2019; 68(2):158–166. doi:10.1016/j.alit.2019.01.004.
   PubMedGoogle Scholar
• European Medicines Agency. Nucala summary of product characteristics. 2021. Available from: https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf. Accessed Jan 2021
   Google Scholar
• Food and Drug Administration. Mepolizumab (NUCALA) prescribing information. 2020. Available from: https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Nucala/pdf/NUCALA-PI-PIL.PDF. Accessed Jan 2021
   Google Scholar
• GlaxoSmithKline. Nucala: basic product information. 2020. Available from: https://gskpro.com/ja-jp/products-info/nucala/index/. Accessed Jan 2021
   Google Scholar
• 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):1189–1197. doi:10.1056/NEJMoa1403291.
   PubMed Web of Science ®Google Scholar
• Chupp GL, Bradford ES, Albers FC, Bratton DJ, Wang-Jairaj J, Nelsen LM, Trevor JL, Magnan A, ten Brinke A. Efficacy of mepolizumab add-on therapy on health-related quality of life and markers of asthma control in severe eosinophilic asthma (MUSCA): a randomised, double-blind, placebo-controlled, parallel-group, multicentre, phase 3b trial. Lancet Respir Med. 2017; 5(5):390–400. doi:10.1016/S2213-2600(17)30125-X.
   PubMed Web of Science ®Google Scholar
• Ortega HG, Liu MC, Pavord ID, Brusselle GG, FitzGerald JM, Chetta A, Humbert M, Katz LE, Keene ON, Yancey SW, et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014; 371(13):1198–1207. doi:10.1056/NEJMoa1403290.
   PubMed Web of Science ®Google Scholar
• 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. 2012; 380(9842):651–659. doi:10.1016/S0140-6736(12)60988-X.
   PubMed Web of Science ®Google Scholar
• Llanos J-P, Ortega H, Bogart M, Packnett ER, Manjelievskaia J, Bell CF, Hahn B. Real-World Effectiveness of Mepolizumab in Patients with Severe Asthma: An Examination of Exacerbations and Costs. JAA. 2020;Volume 13:77–87. doi:10.2147/JAA.S236609.
   Web of Science ®Google Scholar
• Pertzov B, Unterman A, Shtraichman O, Shitenberg D, Rosengarten D, Kramer MR. Efficacy and safety of mepolizumab in a real-world cohort of patients with severe eosinophilic asthma. J Asthma. 2021; 58(1):79–84. doi:10.1080/02770903.2019.1658208.
   PubMed Web of Science ®Google Scholar
• van Toor JJ, van der Mark SC, Kappen JH, In ‘t Veen JCCM, Braunstahl GJ. Mepolizumab add-on therapy in a real world cohort of patients with severe eosinophilic asthma: response rate, effectiveness, and safety. J Asthma. 2021; 58(5):651–658. doi:10.1080/02770903.2020.1723623.
   PubMed Web of Science ®Google Scholar
• Boulet LP. Influence of comorbid conditions on asthma. Eur Respir J. 2009; 33(4):897–906. doi:10.1183/09031936.00121308.
   PubMed Web of Science ®Google Scholar
• Battaglia S, Basile M, Spatafora M, Scichilone N. Are asthmatics enrolled in randomized trials representative of real-life outpatients? Respiration. 2015; 89(5):383–389. doi:10.1159/000375314.
   PubMed Web of Science ®Google Scholar
• Chatkin JM, Dullius CR. The management of asthmatic smokers. Asthma Res Pract. 2016; 2(1):10–18. doi:10.1186/s40733-016-0025-7.
   PubMedGoogle Scholar
• Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JPA, Clarke M, Devereaux PJ, Kleijnen J, Moher D, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. J Clin Epidemiol. 2009; 62(10):e1–e34. doi:10.1016/j.jclinepi.2009.06.006.
   PubMed Web of Science ®Google Scholar
• Cook DJ, Mulrow CD, Haynes RB. Systematic reviews: synthesis of best evidence for clinical decisions. Ann Intern Med. 1997; 126(5):376–380. doi:10.7326/0003-4819-126-5-199703010-00006.
   PubMed Web of Science ®Google Scholar
• Higgins JP, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA. Cochrane handbook for systematic reviews of interventions. Sheffield, UK: John Wiley & Sons, 2019.
   Google Scholar
• Farah CS, Badal T, Reed N, Rogers PG, King GG, Thamrin C, Peters MJ, Seccombe LM. Mepolizumab improves small airway function in severe eosinophilic asthma. Respir Med. 2019; 148:49–53. doi:10.1016/j.rmed.2019.01.016.
   PubMed Web of Science ®Google Scholar
• Harvey ES, Langton D, Katelaris C, Stevens S, Farah CS, Gillman A, Harrington J, Hew M, Kritikos V, Radhakrishna N, et al. Mepolizumab effectiveness and identification of super-responders in severe asthma. Eur Respir J. 2020; 55(5):1902420. doi:10.1183/13993003.02420-2019.
   PubMed Web of Science ®Google Scholar
• Langton D, Sha J, Guo S, Sharp J, Banks C, Wang W, Plummer V, Thien F. Bronchial thermoplasty versus mepolizumab: Comparison of outcomes in a severe asthma clinic. Respirology. 2020; 25(12):1243–1249. doi:10.1111/resp.13830.
   PubMed Web of Science ®Google Scholar
• Schleich F, Graff S, Nekoee H, Moermans C, Henket M, Sanchez C, Paulus V, Guissard F, Donneau A‐F, Louis R, et al. Real-word experience with mepolizumab: Does it deliver what it has promised? Clin Exp Allergy. 2020; 50(6):687–695. doi:10.1111/cea.13601.
   PubMed Web of Science ®Google Scholar
• Drick N, Seeliger B, Welte T, Fuge J, Suhling H. Anti-IL-5 therapy in patients with severe eosinophilic asthma - clinical efficacy and possible criteria for treatment response. BMC Pulm Med. 2018; 18(1):119. doi:10.1186/s12890-018-0689-2.
   PubMed Web of Science ®Google Scholar
• 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. doi:10.1016/j.pupt.2018.09.006.
   PubMed Web of Science ®Google Scholar
• Bagnasco D, Caminati M, Menzella F, Milanese M, Rolla G, Lombardi C, Bucca C, Heffler E, Paoletti G, Testino E, et al. One year of mepolizumab. Efficacy and safety in real-life in Italy. Pulm Pharmacol Ther. 2019; 58:101836. doi:10.1016/j.pupt.2019.101836.
   PubMed Web of Science ®Google Scholar
• Caminati M, Cegolon L, Vianello A, Chieco Bianchi F, Festi G, Marchi MR, Micheletto C, Mazza F, Tognella S, Senna G, et al. Mepolizumab for severe eosinophilic asthma: a real-world snapshot on clinical markers and timing of response. Expert Rev Respir Med. 2019; 13(12):1205–1212. doi:10.1080/17476348.2019.1676734.
   PubMed Web of Science ®Google Scholar
• Lombardi C, Bagnasco D, Caruso C, D’Amato M, Menzella F, Milanese M, Senna G, Canonica GW, Passalacqua G. Analysis of the drop-out rate in patients receiving mepolizumab for severe asthma in real life. Pulm Pharmacol Ther. 2019; 54:87–89. doi:10.1016/j.pupt.2018.12.003.
   PubMed Web of Science ®Google Scholar
• Montero-Perez O, Contreras-Rey MB, Sanchez-Gomez E. Effectiveness and safety of mepolizumab in severe refractory eosinophilic asthma: results in clinical practice. Drugs Context. 2019; 8:212584. doi:10.7573/dic.212584.
   PubMedGoogle Scholar
• Cameli P, Bergantini L, d’Alessandro M, Perruzza M, Cekorja B, Perillo F, Massa E, Ruzza A, Fossi A, Beltrami V, et al. A Comprehensive Evaluation of Mepolizumab Effectiveness in a Real-Life Setting. Int Arch Allergy Immunol. 2020; 181(8):606–612. doi:10.1159/000507996.
   PubMed Web of Science ®Google Scholar
• d’Ancona G, Kavanagh J, Roxas C, Green L, Fernandes M, Thomson L, Dhariwal J, Nanzer AM, Jackson DJ, Kent BD, et al. Adherence to corticosteroids and clinical outcomes in mepolizumab therapy for severe asthma. Eur Respir J. 2020; 55(5):1902259. doi:10.1183/13993003.02259-2019.
   PubMed Web of Science ®Google Scholar
• Kavanagh JE, d’Ancona G, Elstad M, Green L, Fernandes M, Thomson L, Roxas C, Dhariwal J, Nanzer AM, Kent BD, et al. Real-World Effectiveness and the Characteristics of a "Super-Responder" to Mepolizumab in Severe Eosinophilic Asthma. Chest. 2020; 158(2):491–500. doi:10.1016/j.chest.2020.03.042.
   PubMed Web of Science ®Google Scholar
• Numata T, Miyagawa H, Kawamoto H, Yoshida M, Utsumi H, Hashimoto M, Minagawa S, Hara H, Araya J, Kuwano K, et al. Predictors of the enhanced response to mepolizumab treatment for severe eosinophilic asthma: A retrospective, long-term study. Cogent Medicine. 2020; 7(1):1776468. doi:10.1080/2331205X.2020.1776468.
   Google Scholar
• Pelaia C, Crimi C, Pelaia G, Nolasco S, Campisi R, Heffler E, Valenti G, Crimi N. Real-life evaluation of mepolizumab efficacy in patients with severe eosinophilic asthma, according to atopic trait and allergic phenotype. Clin Exp Allergy. 2020; 50(7):780–788. doi:10.1111/cea.13613.
   PubMed Web of Science ®Google Scholar
• Sousa J, Taborda-Barata L, Monteiro C. Biological therapy-associated adverse reactions in asthma: analysis of reporting to the Portuguese pharmacovigilance system. Expert Opin Drug Saf. 2020; 19(1):99–106. doi:10.1080/14740338.2020.1686481.
   PubMed Web of Science ®Google Scholar
• Sposato B, Camiciottoli G, Bacci E, Scalese M, Carpagnano GE, Pelaia C, Santus P, Maniscalco M, Masieri S, Corsico A, et al. Mepolizumab effectiveness on small airway obstruction, corticosteroid sparing and maintenance therapy step-down in real life. Pulm Pharmacol Ther. 2020; 61:101899. doi:10.1016/j.pupt.2020.101899.
   PubMed Web of Science ®Google Scholar
• Taillé C, Chanez P, Devouassoux G, Didier A, Pison C, Garcia G, Charriot J, Bouée S, Gruber A, Pribil C, et al. Mepolizumab in a population with severe eosinophilic asthma and corticosteroid dependence: results from a French early access programme. Eur Respir J. 2020; 55(6):1902345. doi:10.1183/13993003.02345-2019.
   PubMed Web of Science ®Google Scholar
• Yilmaz İ, Türk M, Bahçecioğlu S, Tutar N, Gülmez İ. Efficacy of mepolizumab treatment in oral corticosteroid-dependent severe eosinophilic asthma patients with chronic rhinosinusitis with nasal polyps: single center, real life study. Turk J Med Sci. 2020; 44(2):433–441. doi:10.3906/sag-1912-62.
   Web of Science ®Google Scholar
• Juniper EF, Guyatt GH, Willan A, et al. Determining a minimal important change in a disease-specific Quality of Life Questionnaire. J Clin Epidemiol. 1994; 47(1):81–87. doi:10.1016/0895-4356(94)90036-1.
   PubMed Web of Science ®Google Scholar
• Schatz M, Kosinski M, Yarlas AS, Hanlon J, Watson ME, Jhingran P. The minimally important difference of the Asthma Control Test. J Allergy Clin Immunol. 2009; 124(4):719–723. e711. doi:10.1016/j.jaci.2009.06.053.
   PubMed Web of Science ®Google Scholar
• Chowdhury NI, Mace JC, Bodner TE, Alt JA, Deconde AS, Levy JM, Smith TL. Investigating the minimal clinically important difference for SNOT-22 symptom domains in surgically managed chronic rhinosinusitis. Int Forum Allergy Rhinol. 2017; 7(12):1149–1155. doi:10.1002/alr.22028.
   PubMed Web of Science ®Google Scholar
• Roche N, Anzueto A, Bosnic Anticevich S, Kaplan A, Miravitlles M, Ryan D, Soriano JB, Usmani O, Papadopoulos NG, Canonica GW, et al. The importance of real-life research in respiratory medicine: manifesto of the Respiratory Effectiveness Group: Endorsed by the International Primary Care Respiratory Group and the World Allergy Organization. Eur Respir J. 2019; 54(3):1901511. doi:10.1183/13993003.01511-2019.
   PubMed Web of Science ®Google Scholar
• Lugogo N, Domingo C, Chanez P, Leigh R, Gilson MJ, Price RG, Yancey SW, Ortega HG. Long-term efficacy and safety of mepolizumab in patients with severe eosinophilic asthma: a multi-center, open-label, phase IIIb study. Clin Ther. 2016; 38(9):2058–2070.e2051. doi:10.1016/j.clinthera.2016.07.010.
   PubMed Web of Science ®Google Scholar
• Khatri S, Moore W, Gibson PG, Leigh R, Bourdin A, Maspero J, Barros M, Buhl R, Howarth P, Albers FC, et al. 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. e1747. doi:10.1016/j.jaci.2018.09.033.
   PubMed Web of Science ®Google Scholar
• Suehs CM, Menzies-Gow A, Price D, Bleecker ER, Canonica GW, Gurnell M, Bourdin A. Expert Consensus on the Tapering of Oral Corticosteroids for the Treatment of Asthma: A Delphi Study. Am J Respir Crit Care Med. 2021;203(7):871–881. doi:10.1164/rccm.202007-2721OC.
   PubMed Web of Science ®Google Scholar
• Nicolaides NC, Pavlaki AN, Alexandra M, Chrousos GP. Glucocorticoid therapy and adrenal suppression. In Endotext. South Dartmouth (MA): MDText.com, Inc.; 2018.
   Google Scholar
• Hartl S, Breyer M-K, Burghuber OC, Ofenheimer A, Schrott A, Urban MH, Agusti A, Studnicka M, Wouters EFM, Breyer-Kohansal R, et al. Blood eosinophil count in the general population: typical values and potential confounders. Eur Respir J. 2020; 55(5):1901874. doi:10.1183/13993003.01874-2019.
   PubMed Web of Science ®Google Scholar
• Ortega H, Chupp G, Bardin P, Bourdin A, Garcia G, Hartley B, Yancey S, Humbert M. The role of mepolizumab in atopic and nonatopic severe asthma with persistent eosinophilia. Eur Respir J. 2014; 44(1):239–241. doi:10.1183/09031936.00220413.
   PubMed Web of Science ®Google Scholar
• Lacombe D, O’Morain C, Casadei B, Hill K, Mateus E, Lories R, Brusselle G. Moving forward from drug-centred to patient-centred research: a white paper initiated by EORTC and developed together with the BioMed Alliance members. Eur Respir J. 2019; 53(2):1801870. doi:10.1183/13993003.01870-2018.
   PubMed Web of Science ®Google Scholar
• Crimi C, Campisi R, Nolasco S, Cacopardo G, Intravaia R, Porto M, Impellizzeri P, Pelaia C, Crimi N. Mepolizumab effectiveness in patients with severe eosinophilic asthma and co-presence of bronchiectasis: A real-world retrospective pilot study. Respir Med. 2021; 185:106491. doi:10.1016/j.rmed.2021.106491.
   PubMed Web of Science ®Google Scholar
• Kayser MZ, Drick N, Milger K, Fuge J, Kneidinger N, Korn S, Buhl R, Behr J, Welte T, Suhling H, et al. Real-World Multicenter Experience with Mepolizumab and Benralizumab in the Treatment of Uncontrolled Severe Eosinophilic Asthma Over 12 Months. J Asthma Allergy. 2021; 14:863–871. doi:10.2147/JAA.S319572.
   PubMed Web of Science ®Google Scholar
• Li H, Zhang Q, Wang J, Gao S, Li C, Wang J, Zhang S, Lin J. Real-world Effectiveness of Mepolizumab in Severe Eosinophilic Asthma: A Systematic Review and Meta-analysis. Clin Ther. 2021; 43(6):e192–e208. doi:10.1016/j.clinthera.2021.03.023.
   PubMed Web of Science ®Google Scholar