Difficult-To-Treat and Severe Asthma: Can Real-World Studies On Effectiveness of Biological Treatments Change the Lives of Patients?

References

• Holgate ST, Wenzel S, Postma DS, et al. Asthma. Nat Rev Dis Primers. 2015;1:15025. doi:10.1038/nrdp.2015.25
   PubMed Web of Science ®Google Scholar
• Stern J, Pier J, Litonjua AA. Asthma epidemiology and risk factors. Semin Immunopathol. 2020;42:5–15. doi:10.1007/s00281-020-00785-1
   PubMed Web of Science ®Google Scholar
• Soremekun S, Heaney LG, Skinner D, et al. Asthma exacerbations are associated with a decline in lung function: a longitudinal population-based study. Thorax. 2023;78(7):643–652. doi:10.1136/thorax-2021-217032
   PubMed Web of Science ®Google Scholar
• Chen W, Sadatsafavi M, Tran TN, et al. Characterization of patients in the international severe asthma registry with high steroid exposure who did or did not initiate biologic therapy. J Asthma Allergy. 2022;15:1491–1510. doi:10.2147/JAA.S377174
   PubMed Web of Science ®Google Scholar
• Perez-de-Llano L, Scelo G, Canonica GW, et al. Impact of pre-biologic impairment on meeting domain-specific biologic responder definitions in patients with severe asthma. Ann Allergy Asthma Immunol. 2023;S1081–1206(23):1508–1509.
   Google Scholar
• Papi A, Brightling C, Pedersen SE, Reddel HK. Asthma. Lancet. 2018;391:783–800. doi:10.1016/S0140-6736(17)33311-1
   PubMed Web of Science ®Google Scholar
• Pelaia C, Pelaia G, Crimi C, et al. Tezepelumab: a potential new biological therapy for severe refractory asthma. Int J Mol Sci. 2021;22(9):4369. doi:10.3390/ijms22094369
   PubMed Web of Science ®Google Scholar
• Pelaia C, Heffler E, Crimi C, et al. Interleukins 4 and 13 in asthma: key pathophysiologic cytokines and druggable molecular targets. Front Pharmacol. 2022;13:851940. doi:10.3389/fphar.2022.851940
   PubMed Web of Science ®Google Scholar
• Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention; 2023. Available from: www.ginasthma.org. Accessed February 29, 2024.
   Google Scholar
• Bousquet J, Rabe K, Humbert M, et al. Predicting and evaluating response to omalizumab in patients with severe allergic asthma. Respir Med. 2007;101(7):1483–1492. doi:10.1016/j.rmed.2007.01.011
   PubMed Web of Science ®Google Scholar
• Pfeffer PE, Ali N, Murray R, et al. Comparative effectiveness of anti-IL5 and anti-IgE biologic classes in patients with severe asthma eligible for both. Allergy. 2023;78(7):1934–1948. doi:10.1111/all.15711
   PubMed Web of Science ®Google Scholar
• 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 Web of Science ®Google Scholar
• 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(5):1202–1216.e23. doi:10.1016/j.jaip.2021.12.027
   PubMed Web of Science ®Google Scholar
• Chen W, Tran TN, Sadatsafavi M, et al. Impact of initiating biologics in patients with severe asthma on long-term oral corticosteroids or frequent rescue steroids (GLITTER): data from the international severe asthma registry. J Allergy Clin Immunol Pract. 2023;11(9):2732–2747. doi:10.1016/j.jaip.2023.05.044
   PubMed Web of Science ®Google Scholar
• Nagase H, Suzukawa M, Oishi K, Matsunaga K. Biologics for severe asthma: the real-world evidence, effectiveness of switching, and prediction factors for the efficacy. Allergol Int. 2023;72(1):11–23. doi:10.1016/j.alit.2022.11.008
   PubMed Web of Science ®Google Scholar
• Brusselle GG, Koppelman GH. Biologic therapies for severe asthma. N Engl J Med. 2022;386(2):157–171. doi:10.1056/NEJMra2032506
   PubMed Web of Science ®Google Scholar
• Kardas G, Kuna P, Panek M. Biological therapies of severe asthma and their possible effects on airway remodeling. Front Immunol. 2020;11:1134. doi:10.3389/fimmu.2020.01134
   PubMed Web of Science ®Google Scholar
• Cushen B, Koh MS, Tran TN, et al. Adult severe asthma registries: a global and growing inventory. Pragmat Obs Res. 2023;14:127–147. doi:10.2147/POR.S399879
   PubMed Web of Science ®Google Scholar
• Scelo G, Torres-Duque CA, Maspero J, et al. Analysis of comorbidities and multimorbidity in adult patients in the international severe asthma registry. Ann Allergy Asthma Immunol. 2024;132(1):42–53. doi:10.1016/j.anai.2023.08.021
   PubMedGoogle Scholar
• Wechsler ME, Scelo G, Larenas-Linnemann DES, et al. Association between T2-related comorbidities and effectiveness of biologics in severe asthma. Am J Respir Crit Care Med. 2024;209(3):262–272. doi:10.1164/rccm.202305-0808OC
   PubMedGoogle Scholar
• Coleman C, Khaleva E, Rattu A, et al. Narrative review to capture patients’ perceptions and opinions about non-response and response to biological therapy for severe asthma. Eur Respir J. 2023;61(1):2200837. doi:10.1183/13993003.00837-2022
   PubMed Web of Science ®Google Scholar
• Juniper EF, Guyatt GH, Cox FM, Ferrie PJ, King DR. Development and validation of the mini asthma quality of life questionnaire. Eur Respir J. 1999;14(1):32–38. doi:10.1034/j.1399-3003.1999.14a08.x
   PubMed Web of Science ®Google Scholar
• Nathan RA, Sorkness CA, Kosinski M, et al. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004;113(1):59–65. doi:10.1016/j.jaci.2003.09.008
   PubMed Web of Science ®Google Scholar
• Su N, Zhi L, Liu F, et al. Real-world safety and effectiveness of omalizumab in moderate to severe allergic asthma patients in china: a post-authorization study. J Asthma Allergy. 2023;16:625–636. doi:10.2147/JAA.S406628
   PubMed Web of Science ®Google Scholar
• Rojo-Tolosa S, González-Gutiérrez MV, Sánchez-Martínez JA, et al. Impact of omalizumab in patients with severe uncontrolled asthma and possible predictive biomarkers of response: a real-life study. Pharmaceutics. 2023;15(2):523. doi:10.3390/pharmaceutics15020523
   PubMed Web of Science ®Google Scholar
• Menzella F, Galeone C, Formisano D, et al. Real-life efficacy of omalizumab after 9 years of follow-up. Allergy Asthma Immunol Res. 2017;9(4):368–372. doi:10.4168/aair.2017.9.4.368
   PubMed Web of Science ®Google Scholar
• 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 Web of Science ®Google Scholar
• Campisi R, Crimi C, Intravaia R, et al. Adherence to omalizumab: a multicenter ”real-world” study. World Allergy Organ J. 2020;13(2):100103. doi:10.1016/j.waojou.2020.100103
   PubMed Web of Science ®Google Scholar
• Pilette C, Canonica GW, Chaudhuri R, et al. REALITI-A study: real-world oral corticosteroid-sparing effect of mepolizumab in severe asthma. J Allergy Clin Immunol Pract. 2022;10(10):2646–2656. doi:10.1016/j.jaip.2022.05.042
   PubMed Web of Science ®Google Scholar
• Pavord I, Gardiner F, Heaney LG, et al. Remission outcomes in severe eosinophilic asthma with mepolizumab therapy: analysis of the REDES study. Front Immunol. 2023;14:1150162. doi:10.3389/fimmu.2023.1150162
   PubMed Web of Science ®Google Scholar
• Rojo-Tolosa S, González-Gutiérrez MV, Jiménez-Gálvez G, et al. Impact of Anti-IL5 therapies on patients with severe uncontrolled asthma and possible predictive biomarkers of response: a real-life study. Int J Mol Sci. 2023;24(3):2011. doi:10.3390/ijms24032011
   PubMed Web of Science ®Google Scholar
• Korn S, Milger K, Skowasch D, et al. Real-world experience on the use of mepolizumab from the severe asthma registry of the German asthma net (MepoGAN-Study). J Asthma Allergy. 2023;16:541–552. doi:10.2147/JAA.S403286
   PubMed Web of Science ®Google Scholar
• González-Pérez R, Poza-Guedes P, Mederos-Luis E, Sánchez-Machín I. Real-life performance of mepolizumab in T2-high severe refractory asthma with the overlapping eosinophilic-allergic phenotype. Biomedicines. 2022;10(10):2635. doi:10.3390/biomedicines10102635
   PubMed Web of Science ®Google Scholar
• Jackson DJ, Burhan H, Menzies-Gow A, et al. Benralizumab effectiveness in severe asthma is independent of previous biologic use. J Allergy Clin Immunol Pract. 2022;10(6):1534–1544.e4. doi:10.1016/j.jaip.2022.02.014
   PubMed Web of Science ®Google Scholar
• Di Bona D, Minenna E, Albanesi M, Nettis E, Caiaffa MF, Macchia L. Benralizumab improves patient reported outcomes and functional parameters in difficult-to-treat patients with severe asthma: data from a real-life cohort. Pulm Pharmacol Ther. 2020;64:101974. doi:10.1016/j.pupt.2020.101974
   PubMed Web of Science ®Google Scholar
• Martínez-Moragón E, García-Moguel I, Nuevo J, Resler G. ORBE study investigators. Real-world study in severe eosinophilic asthma patients refractory to anti-IL5 biological agents treated with benralizumab in Spain (ORBE study). BMC Pulm Med. 2021;21(1):417. doi:10.1186/s12890-021-01785-z
   PubMed Web of Science ®Google Scholar
• Vultaggio A, Aliani M, Altieri E, et al. Long-term effectiveness of benralizumab in severe eosinophilic asthma patients treated for 96-weeks: data from the ANANKE study. Respir Res. 2023;24(1):135. doi:10.1186/s12931-023-02439-w
   PubMed Web of Science ®Google Scholar
• Scioscia G, Carpagnano GE, Quarato CMI, et al. Effectiveness of benralizumab in improving the quality of life of severe eosinophilic asthmatic patients: our real-life experience. Front Pharmacol. 2021;12:631660. doi:10.3389/fphar.2021.631660
   PubMed Web of Science ®Google Scholar
• Dupin C, Belhadi D, Guilleminault L, et al. Effectiveness and safety of dupilumab for the treatment of severe asthma in a real-life French multi-centre adult cohort. Clin Exp Allergy. 2020;50(7):789–798. doi:10.1111/cea.13614
   PubMed Web of Science ®Google Scholar
• Campisi R, Crimi C, Nolasco S, et al. Real-world experience with dupilumab in severe asthma: one-year data from an Italian named patient program. J Asthma Allergy. 2021;14:575–583. doi:10.2147/JAA.S312123
   PubMed Web of Science ®Google Scholar
• Fukunaga K, Tagaya E, Ishida M, Sunaga Y, Koshiba R, Yokoyama A. Real-world impact of dupilumab on asthma disease burden in Japan: the CROSSROAD study. Allergol Int. 2023;72(4):537–544. doi:10.1016/j.alit.2023.04.001
   PubMed Web of Science ®Google Scholar
• Pelaia C, Lombardo N, Busceti MT, et al. Short-term evaluation of dupilumab effects in patients with severe asthma and nasal polyposis. J Asthma Allergy. 2021;14:1165–1172. doi:10.2147/JAA.S328988
   PubMed Web of Science ®Google Scholar
• Pelaia C, Benfante A, Busceti MT, et al. Real-life effects of dupilumab in patients with severe type 2 asthma, according to atopic trait and presence of chronic rhinosinusitis with nasal polyps. Front Immunol. 2023;14:1121237. doi:10.3389/fimmu.2023.1121237
   PubMed Web of Science ®Google Scholar
• Pelaia C, Calabrese C, Terracciano R, de Blasio F, Vatrella A, Pelaia G. Omalizumab, the first available antibody for biological treatment of severe asthma: more than a decade of real-life effectiveness. Ther Adv Respir Dis. 2018;12:1753466618810192. doi:10.1177/1753466618810192
   Web of Science ®Google Scholar
• Pelaia G, Canonica GW, Matucci A, Paolini R, Triggiani M, Paggiaro P. Targeted therapy in severe asthma today: focus on immunoglobulin E. Drug Des Devel Ther. 2017;11:1979–1987. doi:10.2147/DDDT.S130743
   PubMed Web of Science ®Google Scholar
• Samitas K, Delimpoura V, Zervas E, Gaga M. Anti-IgE treatment, airway inflammation and remodelling in severe allergic asthma: current knowledge and future perspectives. Eur Respir Rev. 2015;24(138):594–601. doi:10.1183/16000617.00001715
   PubMed Web of Science ®Google Scholar
• Buhl R, Marco AG, Cohen D, Canonica GW. Eligibility for treatment with omalizumab in Italy and Germany. Respir Med. 2014;108(1):50–56. doi:10.1016/j.rmed.2013.10.026
   PubMed Web of Science ®Google Scholar
• Al Ahmad M, Borboa Olivares LM, Cardoso AP, et al. Real-life effectiveness of omalizumab in patients with severe allergic asthma: RELIEF study. Open Respir Med J. 2022;16:e187430642206130.
   Google Scholar
• Cabrejos S, Moreira A, Ramirez A, et al. FENOMA Study: achieving Full Control in Patients with Severe Allergic Asthma. J Asthma Allergy. 2020;13:159–166. doi:10.2147/JAA.S246902
   PubMed Web of Science ®Google Scholar
• Pelaia C, Calabrese C, Barbuto S, et al. Omalizumab lowers asthma exacerbations, oral corticosteroid intake and blood eosinophils: results of a 5-YEAR single-centre observational study. Pulm Pharmacol Ther. 2019;54:25–30. doi:10.1016/j.pupt.2018.11.002
   PubMed Web of Science ®Google Scholar
• Domínguez-Ortega J, Mullol J, Álvarez Gutiérrez FJ, et al. The effect of biologics in lung function and quality of life of patients with united airways disease: a systematic review. J Allergy Clin Immunol Glob. 2023;3(1):100174. doi:10.1016/j.jacig.2023.100174
   PubMedGoogle Scholar
• Israel E, Canonica GW, Brusselle G, et al. Real-life effectiveness of mepolizumab in severe asthma: a systematic literature review. J Asthma. 2022;59(11):2201–2217. doi:10.1080/02770903.2021.2008431
   PubMed Web of Science ®Google Scholar
• Harrison T, Canonica GW, Chupp G, et al. Real-world mepolizumab in the prospective severe asthma REALITI-A study: initial analysis. Eur Respir J. 2020;56(4):2000151. doi:10.1183/13993003.00151-2020
   PubMed Web of Science ®Google Scholar
• Casale T, Molfino NA, Silver J, et al. Real-world effectiveness of mepolizumab in patients with severe asthma and associated comorbidities. Ann Allergy Asthma Immunol. 2021;127(3):354–362.e2. doi:10.1016/j.anai.2021.05.021
   PubMed Web of Science ®Google Scholar
• Crimi C, Campisi R, Cacopardo G, et al. Real-life effectiveness of mepolizumab in patients with severe refractory eosinophilic asthma and multiple comorbidities. World Allergy Organ J. 2020;13(9):100462. doi:10.1016/j.waojou.2020.100462
   PubMed Web of Science ®Google Scholar
• Menzella F, Lusuardi M, Galeone C, Facciolongo N, Zucchi L. The clinical profile of benralizumab in the management of severe eosinophilic asthma. Ther Adv Respir Dis. 2016;10(6):534–548. doi:10.1177/1753465816667659
   PubMed Web of Science ®Google Scholar
• Castro M, Corren J, Pavord ID, et al. Dupilumab efficacy and safety in moderate-to-severe uncontrolled asthma. N Engl J Med. 2018;378(26):2486–2496. doi:10.1056/NEJMoa1804092
   PubMed Web of Science ®Google Scholar
• Menzies-Gow A, Mansur AH, Brightling CE. Clinical utility of fractional exhaled nitric oxide in severe asthma management. Eur Respir J. 2020;55(3):1901633. doi:10.1183/13993003.01633-2019
   PubMed Web of Science ®Google Scholar
• Wechsler ME, Klion AD, Paggiaro P, et al. Effect of dupilumab on blood eosinophil counts in patients with asthma, chronic rhinosinusitis with nasal polyps, atopic dermatitis, or eosinophilic esophagitis. J Allergy Clin Immunol Pract. 2022;10(10):2695–2709. doi:10.1016/j.jaip.2022.05.019
   PubMed Web of Science ®Google Scholar
• Guttman-Yassky E, Bissonnette R, Ungar B, et al. Dupilumab progressively improves systemic and cutaneous abnormalities in patients with atopic dermatitis. J Allergy Clin Immunol. 2019;143(1):155–172. doi:10.1016/j.jaci.2018.08.022
   PubMed Web of Science ®Google Scholar