Management of Uncontrolled Asthma: A Framework for Novel and Legacy Biologic Treatments

References

• Tan LD, Alismail A, Ariue B. Asthma guidelines: comparison of the national heart, lung, and blood institute expert panel report 4 with global initiative for asthma 2021. Curr Opin Pulm Med. 2022;28(3):234–244. doi:10.1097/MCP.0000000000000867
   PubMed Web of Science ®Google Scholar
• Reddel HK, Bacharier LB, Bateman ED, et al. Global Initiative for Asthma Strategy 2021: executive summary and rationale for key changes. Eur Respir J. 2021;59(1):2102730.
   Google Scholar
• Yaghoubi M, Adibi A, Safari A, FitzGerald JM, Sadatsafavi M. The projected economic and health burden of uncontrolled asthma in the United States. Am J Respir Crit Care Med. 2019;200(9):1102–1112. doi:10.1164/rccm.201901-0016OC
   PubMed Web of Science ®Google Scholar
• Chipps BE, Murphy KR, Oppenheimer J. 2020 NAEPP guidelines update and GINA 2021-asthma care differences, overlap, and challenges. J Allergy Clin Immunol Pract. 2022;10(1S):S19–S30. doi:10.1016/j.jaip.2021.10.032
   PubMed Web of Science ®Google Scholar
• Cloutier MM, Baptist AP, Blake KV; Expert Panel Working Group of the National Heart L, Blood Institute a, coordinated National Asthma E, et al. 2020 focused updates to the asthma management guidelines: a report from the national asthma education and prevention program coordinating Committee Expert Panel Working Group. J Allergy Clin Immunol. 2020;146(6):1217–1270. doi:10.1016/j.jaci.2020.10.003
   PubMed Web of Science ®Google Scholar
• Tan LD, Bratt JM, Godor D, Louie S, Kenyon NJ. Benralizumab: a unique IL-5 inhibitor for severe asthma. J Asthma Allergy. 2016;9:71–81. doi:10.2147/JAA.S78049
   PubMed Web of Science ®Google Scholar
• Settipane GA, Greisner WA 3rd, Settipane RJ. Natural history of asthma: a 23-year follow up of college students. Ann Allergy Asthma Immunol. 2000;84(5):499–503. doi:10.1016/S1081-1206(10)62512-4
   PubMed Web of Science ®Google Scholar
• Miranda C, Busacker A, Balzar S, Trudeau J, Wenzel SE. Distinguishing severe asthma phenotypes: role of age at onset and eosinophilic inflammation. J Allergy Clin Immunol. 2004;113(1):101–108. doi:10.1016/j.jaci.2003.10.041
   PubMed Web of Science ®Google Scholar
• Kuruvilla ME, Lee FE, Lee GB. Understanding asthma phenotypes, endotypes, and mechanisms of disease. Clin Rev Allergy Immunol. 2019;56(2):219–233. doi:10.1007/s12016-018-8712-1
   PubMed Web of Science ®Google Scholar
• Wenzel SE, Schwartz LB, Langmack EL, et al. Evidence that severe asthma can be divided pathologically into two inflammatory subtypes with distinct physiologic and clinical characteristics. Am J Respir Crit Care Med. 1999;160(3):1001–1008. doi:10.1164/ajrccm.160.3.9812110
   PubMed Web of Science ®Google Scholar
• Heijink IH, Kies PM, Kauffman HF, Postma DS, van Oosterhout AJ, Vellenga E. Down-regulation of E-cadherin in human bronchial epithelial cells leads to epidermal growth factor receptor-dependent Th2 cell-promoting activity. J Immunol. 2007;178(12):7678–7685. doi:10.4049/jimmunol.178.12.7678
   PubMed Web of Science ®Google Scholar
• Sweerus K, Lachowicz-Scroggins M, Gordon E, et al. Claudin-18 deficiency is associated with airway epithelial barrier dysfunction and asthma. J Allergy Clin Immunol. 2017;139(1):72–81 e71. doi:10.1016/j.jaci.2016.02.035
   PubMed Web of Science ®Google Scholar
• Hong H, Liao S, Chen F, Yang Q, Wang DY. Role of IL-25, IL-33, and TSLP in triggering united airway diseases toward type 2 inflammation. Allergy. 2020;75(11):2794–2804. doi:10.1111/all.14526
   PubMed Web of Science ®Google Scholar
• Boulet LP, FitzGerald JM, Reddel HK. The revised 2014 GINA strategy report: opportunities for change. Curr Opin Pulm Med. 2015;21(1):1–7. doi:10.1097/MCP.0000000000000125
   PubMed Web of Science ®Google Scholar
• Carpio-Escalona LV, Gonzalez-de-Olano D. Use of the Internet by patients attending allergy clinics and its potential as a tool that better meets patients’ needs. J Allergy Clin Immunol Pract. 2018;6(3):1064–1066. doi:10.1016/j.jaip.2017.10.034
   PubMed Web of Science ®Google Scholar
• Institute of Medicine (US) Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington (DC): National Academies Press (US); 2001. PMID: 25057539.
   Google Scholar
• Tan L, Chupp G, Castro M, Kraft M. Going beyond “Bio-markers,” Think “Life-markers”. Chest. 2020;157(3):503–505. doi:10.1016/j.chest.2019.08.2210
   PubMed Web of Science ®Google Scholar
• Reibman J, Tan L, Ambrose C, et al. Clinical and economic burden of severe asthma among US patients treated with biologic therapies. Ann Allergy Asthma Immunol. 2021;127(3):318–325 e312. doi:10.1016/j.anai.2021.03.015
   PubMed Web of Science ®Google Scholar
• Menzies-Gow A, Corren J, Bourdin A, et al. Tezepelumab in adults and adolescents with severe, uncontrolled asthma. N Engl J Med. 2021;384(19):1800–1809. doi:10.1056/NEJMoa2034975
   PubMed Web of Science ®Google Scholar
• Busse W, Spector S, Rosen K, Wang Y, Alpan O. High eosinophil count: a potential biomarker for assessing successful omalizumab treatment effects. J Allergy Clin Immunol. 2013;132(2):485–486 e411. doi:10.1016/j.jaci.2013.02.032
   PubMed Web of Science ®Google Scholar
• Hammad H, Lambrecht BN. The basic immunology of asthma. Cell. 2021;184(6):1469–1485. doi:10.1016/j.cell.2021.02.016
   PubMed Web of Science ®Google Scholar
• Patel SS, Casale TB, Cardet JC. Biological therapies for eosinophilic asthma. Expert Opin Biol Ther. 2018;18(7):747–754. doi:10.1080/14712598.2018.1492540
   PubMed Web of Science ®Google Scholar
• Christie L, Scadding J, Boyd J. CONTROLLED trial of effects of cortisone acetate in status asthmaticus; report to the medical research council by the subcommittee on clinical trials in asthma. Lancet. 1956;271(6947):803–806.
   PubMedGoogle Scholar
• Rowe BH, Spooner CH, Ducharme FM, Bretzlaff JA, Bota GW. Corticosteroids for preventing relapse following acute exacerbations of asthma. Cochrane Database Syst Rev. 2001;1:CD000195. doi:10.1002/14651858.CD000195
   PubMedGoogle Scholar
• Sweeney J, Patterson CC, Menzies-Gow A, et al. Comorbidity in severe asthma requiring systemic corticosteroid therapy: cross-sectional data from the optimum patient care research database and the British thoracic difficult asthma registry. Thorax. 2016;71(4):339–346. doi:10.1136/thoraxjnl-2015-207630
   PubMed Web of Science ®Google Scholar
• Dalal AA, Duh MS, Gozalo L, et al. Dose-response relationship between long-term systemic corticosteroid use and related complications in patients with severe asthma. J Manag Care Spec Pharm. 2016;22(7):833–847. doi:10.18553/jmcp.2016.22.7.833
   PubMedGoogle Scholar
• Price DB, Trudo F, Voorham J, et al. Adverse outcomes from initiation of systemic corticosteroids for asthma: long-term observational study. J Asthma Allergy. 2018;11:193–204. doi:10.2147/JAA.S176026
   PubMed Web of Science ®Google Scholar
• Sullivan PW, Ghushchyan VH, Globe G, Schatz M. Oral corticosteroid exposure and adverse effects in asthmatic patients. J Allergy Clin Immunol. 2018;141(1):110–116 e117. doi:10.1016/j.jaci.2017.04.009
   PubMed Web of Science ®Google Scholar
• Chung LP, Upham JW, Bardin PG, Hew M. Rational oral corticosteroid use in adult severe asthma: a narrative review. Respirology. 2020;25(2):161–172. doi:10.1111/resp.13730
   PubMed Web of Science ®Google Scholar
• Carr TF, Kraft M. Management of severe asthma before referral to the severe asthma specialist. J Allergy Clin Immunol Pract. 2017;5(4):877–886. doi:10.1016/j.jaip.2017.04.027
   PubMed Web of Science ®Google Scholar
• Tan LD, Yoneda KY, Louie S, Hogarth DK, Castro M. Bronchial thermoplasty: a decade of experience: state of the art. J Allergy Clin Immunol Pract. 2019;7(1):71–80. doi:10.1016/j.jaip.2018.08.017
   PubMed Web of Science ®Google Scholar
• McGregor MC, Krings JG, Nair P, Castro M. Role of biologics in asthma. Am J Respir Crit Care Med. 2019;199(4):433–445. doi:10.1164/rccm.201810-1944CI
   PubMed Web of Science ®Google Scholar
• Bernstein D, Pavord ID, Chapman KR, et al. Usability of mepolizumab single-use prefilled autoinjector for patient self-administration. J Asthma. 2020;57(9):987–998. doi:10.1080/02770903.2019.1630641
   PubMed Web of Science ®Google Scholar
• Vermeire S, D’Heygere F, Nakad A, et al. Preference for a prefilled syringe or an auto-injection device for delivering golimumab in patients with moderate-to-severe ulcerative colitis: a randomized crossover study. Patient Prefer Adherence. 2018;12:1193–1202. doi:10.2147/PPA.S154181
   PubMed Web of Science ®Google Scholar
• Zheng Y, Abuqayyas L, Megally A, et al. Tezepelumab pharmacokinetics, safety, and tolerability after administration via vial-and-syringe, accessorized prefilled syringe, or autoinjector: a randomized trial in healthy volunteers. Clin Ther. 2021;43(1):142–155 e145. doi:10.1016/j.clinthera.2020.11.014
   PubMed Web of Science ®Google Scholar
• Jin JF, Zhu LL, Chen M, et al. The optimal choice of medication administration route regarding intravenous, intramuscular, and subcutaneous injection. Patient Prefer Adherence. 2015;9:923–942. doi:10.2147/PPA.S87271
   PubMed Web of Science ®Google Scholar
• WHO Housing and Health Guidelines. Geneva: World Health Organization; 2018. Available from: https://www.ncbi.nlm.nih.gov/books/NBK535293/
   Google Scholar
• Marone G, Spadaro G, Braile M, et al. Tezepelumab: a novel biological therapy for the treatment of severe uncontrolled asthma. Expert Opin Investig Drugs. 2019;28(11):931–940. doi:10.1080/13543784.2019.1672657
   PubMedGoogle Scholar
• Corren J, Garcia Gil E, Griffiths JM, et al. Tezepelumab improves patient-reported outcomes in patients with severe, uncontrolled asthma in PATHWAY. Ann Allergy Asthma Immunol. 2021;126(2):187–193. doi:10.1016/j.anai.2020.10.008
   PubMed Web of Science ®Google Scholar
• Menzies-Gow A, Colice G, Griffiths JM, et al. NAVIGATOR: a phase 3 multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma. Respir Res. 2020;21(1):266. doi:10.1186/s12931-020-01526-6
   PubMed Web of Science ®Google Scholar
• Hoy SM. Tezepelumab: first approval. Drugs. 2022;82(4):461–468. doi:10.1007/s40265-022-01679-2
   PubMed Web of Science ®Google Scholar
• Wechsler ME, Colice G, Griffiths JM, et al. SOURCE: a phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of tezepelumab in reducing oral corticosteroid use in adults with oral corticosteroid dependent asthma. Respir Res. 2020;21(1):264. doi:10.1186/s12931-020-01503-z
   PubMed Web of Science ®Google Scholar
• Menzies-Gow A, Ponnarambil S, Downie J, Bowen K, Hellqvist A, Colice G. DESTINATION: a phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the long-term safety and tolerability of tezepelumab in adults and adolescents with severe, uncontrolled asthma. Respir Res. 2020;21(1):279. doi:10.1186/s12931-020-01541-7
   PubMed Web of Science ®Google Scholar
• NUCALA (mepolizumab) - HIGHLIGHTS OF PRESCRIBING INFORMATION. Food and Drug Administration. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103976s5225lbl.pdf. Accessed June 27, 2022.
   Google Scholar
• XOLAIR® (omalizumab) - HIGHLIGHTS OF PRESCRIBING INFORMATION. Food and Drug Administration. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761122s000lbl.pdf. Accessed June 27, 2022.
   Google Scholar
• CINQAIR® (reslizumab) - HIGHLIGHTS OF PRESCRIBING INFORMATION. Food and Drug Administration. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761033lbl.pdf. Accessed June 27, 2022.
   Google Scholar
• Fasenra (benralizumab) - HIGHLIGHTS OF PRESCRIBING INFORMATION. Food and Drug Administration. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761070Orig1s000TOC.cfm. Accessed June 27, 2022.
   Google Scholar
• DUPIXENT® (dupilumab) - HIGHLIGHTS OF PRESCRIBING INFORMATION. Food and Drug Administration. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761055s014lbl.pdf. Accessed June 27, 2022.
   Google Scholar
• TEZSPIRE™ (tezepelumab-ekko) - HIGHLIGHTS OF PRESCRIBING INFORMATION. Food and Drug Administration. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761224s000lbl.pdf. Accessed June 27, 2022.
   Google Scholar