Biological therapy management from the initial selection of biologics to switching between biologics in severe asthma
Yıl: 2023 Cilt: 71 Sayı: 1 Sayfa Aralığı: 75 - 93 Metin Dili: İngilizce DOI: 10.5578/tt.20239910 İndeks Tarihi: 30-05-2023
Biological therapy management from the initial selection of biologics to switching between biologics in severe asthma
Öz: The aim of this review is to elaborate the management of biologic therapy from initial selection to switching biologics in severe asthma. A nonsystematic review was performed for biological therapy management in severe asthma. Depending on clinical characteristics and biomarkers, selecting the preferred biologic based on super-responder criteria from previous studies may result in adequate clinical efficacy in most patients. On the other hand, no matter how carefully the choice is made, in some patients, it may be necessary to discon- tinue the drug due to suboptimal clinical response or even no response. This may result in the need to switch to a different biological therapy. How long the biological treatment of patients whose asthma is controlled with biologics will be continued and according to which criteria they will be terminated remains unclear. It has been shown that in patients with a long history of good response to biologics, asthma control may be impaired when biologics are discontinued, while it may persist in others. Therefore, discontinuation of biologics may be a viable strategy in a particular patient group. Clinicians should make the best use of all predictive factors to identify patients who will most benefit from each biologic. Patients who do not meet a predefined res- ponse criterion after sufficient time for response evaluation and who are eli- gible for one or more alternative biological agents should be offered the opportunity to switch to another biologic. There is no consensus on when the biologics used in severe asthma that produce favorable results should be dis- continued. In our opinion, treatment should continue for at least five years, as premature termination may potentially deteriorate asthma control.
Anahtar Kelime: Ağır astımda biyolojik ajanların ilk seçiminden biyolojikler arasında geçişe kadar biyolojik tedavi yönetimi
Öz: Bu derlemede ağır astımda, başlangıctaki biyolojik ajan seçiminden biyolojikler arasındaki gecişe kadar olan tedavi yönetiminin detay- lı bir şekilde gözden geçirilmesi amaçlanmıştır. Ağır astımda biyolojik tedavi yönetimi için sistematik olmayan bir inceleme yapıldı. Klinik özelliklere, biyobelirteçlere ve önceki çalışmalardan elde edilen süper yanıt verme kriterlerine dayalı olarak biyolojik ajanın seçilmesi, çoğu hastada yeterli klinik etkinlikle sonuçlanabilir. Öte yandan, seçim ne kadar dikkatli yapılırsa yapılsın, bazı hastalarda suboptimal klinik yanıt veya yanıt alınamaması nedeniyle ilacın kesilmesi gerekebilir. Bu, farklı bir biyolojik tedaviye geçme ihtiyacına neden olabilir. Biyolojik ajanlarla astımı kontrol altına alınan hastaların biyolojik tedavisine ne kadar devam edileceği, tedavinin hangi kriterlere göre sonlandırılacağı belirsizliğini korumaktadır. Biyolojik ajanlarla uzun vadede iyi yanıt alınan hastalarda bu ilaçlar kesildi- ğinde astım kontrolünün bozulabileceği, bazı hastalarda ise astım kontrolünün devam ettiği gösterilmiştir. Bu nedenle, belirli bir hasta grubunda biyolojik ilaçların kesilmesi geçerli bir strateji olabilir. Klinisyenler, her bir biyolojikten en fazla fayda sağlayacak hastaları belirlemek için tüm prediktif faktörleri en iyi şekilde kullanmalıdır. Yanıt değerlendirmesi için yeterli süre geçtikten sonra önceden tanımlanmış bir yanıt kriterini karşılamayan ve bir veya daha fazla alternatif biyolojik ajan için uygun olan hastalara başka bir biyolo- jik ajana geçme fırsatı sunulmalıdır. Ağır astımda kullanılan ve tedaviye iyi yanıt veren biyolojik ajanların ne zaman kesileceği konu- sunda fikir birliği yoktur. Erken sonlandırmalarda astım kontrolü bozulabileceği için en az beş yıl devam etmek mantıklı bir yaklaşım gibi görünmektedir.
Anahtar Kelime: Belge Türü: Makale Makale Türü: Derleme Erişim Türü: Erişime Açık
- 1. Food and Drug Administration. Highlight of prescribing information, benralizumab. Available from: www.access- data.fda.gov/drugsatfda_docs/label/2017/761070s000l- bl.pdf (Accessed date: June 2022).
- 2. Food and Drug Administration. Highlight of prescribing information, dupilumab. Available from: www.accessdata. fda.gov/drugsatfda_docs/label/2018/761055s007lbl.pdf. (Accessed date: June 2022).
- 3. Food and Drug Administration. Highlight of prescribing information, mepolizumab. Available from: www.access- data.fda.gov/drugsatfda_docs/nda/2015/125526Orig- 1s000MedR.pdf (Accessed date: June 2022).
- 4. Food and Drug Administration. Highlight of prescribing information, reslizumab. Available from: https://www. accessdat a.fda.gov/drugsatfda_docs/nda/2016/ 761033Orig1s000TOC.cfm (Accessed date: June 2022).
- 5. Food and Drug Administration. Highlight of prescribing information, omalizumab. Available from: www.accessda- ta.fda.gov/drugsatfda_docs/label/2016/103976s5225lbl. pdf (Accessed date: June 2022).
- 6. Food and Drug Administration. Highlight of prescribing information, tezeppelumab. Available from: www.access- data.fda.gov/drugsatfda_docs/label/2021/761224s000l- bl.pdf (Accessed date: June 2022).
- 7. Agache I, Akdis CA, Akdis M, Canonica GW, Casale T, Chivato T, et al. EAACI biologicals guidelines-Recommen- dations for severe asthma. Allergy 2021. 76(1): 14-44. https://doi.org/10.1111/all.14425
- 8. Hamada K, Oishi K, Murata Y, Hirano T, Matsunaga K. Feasibility of discontinuing biologics in severe asthma: An algorithmic approach. J Asthma Allergy 2021. 14: 1463. https://doi.org/10.2147/JAA.S340684
- 9. Global Inıtiative for Asthma. Global strategy for asthma management and prevention, 2022. Available from: www. ginasthma.org
- 10. Menzies-Gow AN, McBrien C, Unni B, Porsbjerg CM, Al-Ahmad M, Ambrose CS, 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. https://doi.org/10.2147/JAA.S328653
- 11. FASENRA (benralizumab) prescribing information. Wilmington, DE: AstraZeneca Pharmceuticals LP; 2019. Available from: https://www.fasenra.com/ (Accessed date: 16.07.2020).
- 12. DUPIXENT (dupilumab) prescribing information. Tarrytown, NY: Regeneron Pharmaceuticals, Inc; 2020. Available from: https://www.dupixent.com/ (Accessed date: 16.07.2020).
- 13. NUCALA (mepolizumab) prescribing information. Research Triangle Park, NC: GlaxoSmithKline; 2020. Available from: http://www.nucala.com/ (Accessed date: 19.10.2020).
- 14. XOLAIR (omalizumab) prescribing information. South San Francisco, Calif: Genentech, Inc; 2019. Available from: http://www.xolair.com/ (Accessed date: 16.07.2020).
- 15. CINQAIR (reslizumab) prescribing information. West Chester, Pa: Teva Respiratory, LLC; 2020. Available from: http://www.cinqair.com/ (Accessed date: 16.07.2020).
- 16. Tezspire (tezepelumab) prescribing information. Available from: https://www. https://www.tezspire.com/ (Accessed date: 25.06.2022).
- 17. Sosyal Güvenlik Kurumu Sağlık Uygulama Tebliği. Available from: www.mevzuat.gov.tr
- 18. Resmi Gazetede yayımlanan Sağlık Uygulama Tebliğinde Değişiklik Yapılmasına Dair Tebliğ. Available from: https:// www.resmigazete.gov.tr/eskiler/2014/08/20140830-8. htm
- 19. Gupta A, Pouliquen I, Austin D, Price RG, Kempsford R, Steinfeld J, et al. Subcutaneous mepolizumab in children aged 6 to 11 years with severe eosinophilic asthma. Pediatr pulmonol 2019; 54(12): 1957-67. https://doi. org/10.1002/ppul.24508
- 20. Omalizumab highlight of prescribing information. Available from: www.accessdata.fda.gov/drugsatfda_ docs/label/2021/103976s5238lbl.pdf
- 21. Menzella F, Ferrari E, Ferrucci SM, Lombardi E, Alfano S, Bonavita O, et al. Self-administration of omalizumab: Why not? A literature review and expert opinion. Expert Opin Biol Ther 2021; 21(4): 499-507. https://doi.org/10.1080/ 14712598.2021.1882990
- 22. Mepolizumab highlight of prescribing information. Available from: www.accessdata.fda.gov/drugsatfda_ docs/label/2022/761122s008,125526s019lbl.pdf
- 23. Bel EH, I Bernstein D, Bjermer L, Follows R, Bentley JH, Pouliquen I, et al. Usability of mepolizumab single-use prefilled syringe for patient self-administration. J Asthma 2020; 57(7): 755-64. https://doi.org/10.1080/02770903 .2019.1604745
- 24. Ferguson GT, Cole J, Aurivillius M, Roussel P, Barker P, Martin UJ; GRECO study investigators. Single-use autoin- jector functionality and reliability for at-home administra- tion of benralizumab for patients with severe asthma: GRECO trial results. J Asthma Allergy 2019; 12: 363. https://doi.org/10.2147/JAA.S224266
- 25. Cohen YZ, Zhang X, Xia B, Kosloski MP, Kamal MA, Davis JD, et al. Pharmacokinetics of Subcutaneous dupilumab injection with an autoinjector device or prefilled syringe. Clin Pharmacol Drug Dev 2022; 11(5): 675-81. https:// doi.org/10.1002/cpdd.1073
- 26. Wangberg H, Woessner K. Choice of biologics in asthma endotypes. Curr Opin Allergy Clin Immunol 2021; 21(1): 79-85. https://doi.org/10.1097/ACI.0000000000000708
- 27. U.S. Food and Drug Administration. Omalizumab. Available from: www.accessdata.fda.gov/drugsatfda_ docs/label/2020/103976s5235lbl.pdf
- 28. 28. U.S. Food and Drug Administration. Dupilumab. Available from: www.accessdata.fda.gov/drugsatfda_ docs/label/2019/761055s014lbl.pdf
- 29. U.S. Food and Drug Administration. Dupilumab, atopic dermatitis. Available from: www.accessdata.fda.gov/drug- satfda_docs/label/2017/761055lbl.pdf
- 30. U.S. Food and Drug Administration. Mepolizumab, EGPA. Available from: www.accessdata.fda.gov/drugsatfda_ docs/label/2021/761122s006,125526s018lbl.pdf
- 31. U.S. Food and Drug Administration. Mepolizumab, HES. Available from: www.accessdata.fda.gov/drugsatfda_ docs/label/2020/125526s017lbl.pdf
- 32. U.S. Food and Drug Administration. Mepolizumab, nasal polyps. Available from: www.accessdata.fda.gov/drugsatf- da_docs/label/2021/761122s006,125526s018lbl.pdf
- 33. Normansell R, Walker S, Milan SJ, Walters EH, Nair P. Omalizumab for asthma in adults and children. Cochrane Database of Syst Rev 2014; (1). https://doi. org/10.1002/14651858.CD003559.pub4
- 34. Hanania NA, Alpan O, Hamilos DL, Condemi JJ, Reyes- Rivera I, Zhu J, et al. Omalizumab in severe allergic asth- ma inadequately controlled with standard therapy: A randomized trial. Ann Inten Med 2011; 154(9): 573-82. https://doi.org/10.7326/0003-4819-154-9-201105030- 00002
- 35. Farne HA, Wilson A, Powell C, Bax L, Milan SJ. Anti IL5 therapies for asthma. Cochrane Database Syst Rev 2017; (9). https://doi.org/10.1002/14651858.CD010834.pub3
- 36. Chupp GL, Bradford ES, Albers FC, Bratton DJ, Wang-Jairaj J, Nelsen LM, et al. Efficacy of mepolizumab add-on ther- apy on health-related quality of life and markers of asthma control in severe eosinophilic asthma (MUSCA): A ran- domised, double-blind, placebo-controlled, parallel-group, multicentre, phase 3b trial. Lancet Respir Med 2017; 5(5): 390-400. https://doi.or g/10.1016/S2213- 2600(17)30125-X
- 37. Nair P, Pizzichini MM, Kjarsgaard M, Inman MD, Efthimiadis A, Pizzichini E, et al. Mepolizumab for predni- sone-dependent asthma with sputum eosinophilia. N Engl J Med 2009; 360(10): 985-93. https://doi.org/10.1056/ NEJMoa0805435
- 38. Nair P, Pizzichini MM, Kjarsgaard M, Inman MD, Efthimiadis A, Pizzichini E, et al. Efficacy and safety of treatment with biologicals (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) for severe eosinophilic asthma. A systematic review for the EAACI guidelines recommendations on the use of biologicals in severe asthma. Allergy 2020; 75(5): 1023-42. https://doi. org/10.1111/all.14221
- 39. Kavanagh JE, Hearn AP, Dhariwal J, d'Ancona G, Douiri A, Roxas C, et al. Real-world effectiveness of benralizumab in severe eosinophilic asthma. Chest 2021; 159(2): 496-506. https://doi.org/10.1016/j.chest.2020.08.2083
- 40. Li J, Wang F, Lin C, Du J, Xiao B, Du C, et al. The efficacy and safety of reslizumab for inadequately controlled asth- ma with elevated blood eosinophil counts: A systematic review and meta-analysis. J Asthma 2017; 54(3): 300-7. https://doi.org/10.1080/02770903.2016.1212371
- 41. Namazy J, Cabana MD, Scheuerle AE, Thorp JM Jr, Chen H, Carrigan G, et al. The Xolair Pregnancy Registry (EXPECT): The safety of omalizumab use during pregnan- cy. J Allergy Clin Immunol 2015; 135(2): 407-12. https:// doi.org/10.1016/j.jaci.2014.08.025
- 42. Namazy J, Cabana MD, Scheuerle AE, Thorp JM Jr, Chen H, Carrigan G, et al. Pregnancy outcomes in the omali- zumab pregnancy registry and a disease-matched com- parator cohort. J Allergy Clin Immunol 2020; 145(2): 528-36. https://doi.org/10.1016/j.jaci.2019.05.019
- 43. Vennera Mdel C, Valero A, Uría E, Forné C, Picado C. Cost- effectiveness analysis of omalizumab for the treatment of severe persistent asthma in real clinical practice in Spain. Clin Drug Investig 2016; 36(7): 567-78. https://doi. org/10.1007/s40261-016-0402-2
- 44. Arrobas A, Barbosa MP, Rabiais S, Vandewalle B. Cost- effectiveness of omalizumab in real world uncontrolled allergic asthma patients. Pulmonology 2021; 27(2): 124- 33. https://doi.org/10.1016/j.pulmoe.2020.03.001
- 45. McQueen RB, Sheehan DN, Whittington MD, van Boven JFM, Campbell JD. Cost-effectiveness of biological asthma treatments: A systematic review and recommendations for future economic evaluations. Pharmacoeconomics 2018; 36(8): 957-71. https://doi.org/10.1007/s40273-018- 0658-x
- 46. Andersson M, Janson C, Kristensen T, Szende A, Golam S. Cost effectiveness of benralizumab for severe, uncon- trolled oral corticosteroid-dependent asthma in Sweden. J Med Econ 2020; 23(8): 877-84. https://doi.org/10.1080/ 13696998.2020.1760285
- 47. Antonio Buendía J, Patiño DG. Cost-utility analysis of dup- ilumab add on therapy versus standard therapy in adoles- cents and adults for severe asthma in Colombia. Expert Rev Pharmacoeconom Outcomes Res 2022; 22(4): 575- 80. https://doi.org/10.1080/14737167.2022.2011217
- 48. Lam J, Hay JW, Salcedo J, Kenyon NJ. A cost-effectiveness analysis of reslizumab in the treatment of poorly con- trolled eosinophilic asthma. J Asthma 2019; 56(8): 872- 81. https://doi.org/10.1080/02770903.2018.1500584
- 49. Hanania NA, Wenzel S, Rosén K, Hsieh HJ, Mosesova S, Choy DF, et al. Exploring the effects of omalizumab in allergic asthma: an analysis of biomarkers in the EXTRA study. Am J Respir Crit Care Med 2013; 187(8): 804-11. https://doi.org/10.1164/rccm.201208-1414OC
- 50. Bousquet J, Rabe K, Humbert M, Chung KF, Berger W, Fox H, et al. Predicting and evaluating response to omalizum- ab in patients with severe allergic asthma. Respir Med 2007; 101(7): 1483-92. https://doi.org/10.1016/j. rmed.2007.01.011
- 51. Casale TB, Luskin AT, Busse W, Zeiger RS, Trzaskoma B, Yang M, et al. Omalizumab effectiveness by biomarker status in patients with asthma: Evidence from PROSPERO, a prospective real-world study. J Allergy Clin Immunol Pract 2019; 7(1): 156-64. https://doi.org/10.1016/j. jaip.2018.04.043
- 52. Humbert M, Taillé C, Mala L, Le Gros V, Just J, Molimard M; STELLAIR investigators. Omalizumab effectiveness in patients with severe allergic asthma according to blood eosinophil count: The STELLAIR study. Eur Respir J 2018; 51(5). https://doi.org/10.1183/13993003.02523-2017
- 53. Gevaert P, Omachi TA, Corren J, Mullol J, Han J, Lee SE, et al. Efficacy and safety of omalizumab in nasal polyposis: 2 randomized phase 3 trials. J Allergy Clin Immunol 2020; 146(3): 595-605. https://doi.org/10.1016/j. jaci.2020.05.032
- 54. McGregor MC, Krings JG, Nair P, Castro M. Role of biolog- ics in asthma. Am J Respir Crit Care Med 2019; 199(4): 433-45. https://doi.org/10.1164/rccm.201810-1944CI
- 55. Bleecker ER, Wechsler ME, FitzGerald JM, Menzies-Gow A, Wu Y, Hirsch I, et al. Baseline patient factors impact on the clinical efficacy of benralizumab for severe asthma. Eur Respir J 2018; 52(4). https://doi. org/10.1183/13993003.00936-2018
- 56. Mukherjee M, Nair P. Blood or sputum eosinophils to guide asthma therapy?, Lancet Respir Med 2015; 3(11): 824-5. https://doi.org/10.1016/S2213-2600(15)00419-1
- 57. Smith SG, Chen R, Kjarsgaard M, Huang C, Oliveria JP, O'Byrne PM, et al. Increased numbers of activated group 2 innate lymphoid cells in the airways of patients with severe asthma and persistent airway eosinophilia. J Allergy Clin Immunol 2016; 137(1): 75-86. https://doi. org/10.1016/j.jaci.2015.05.037
- 58. Katz LE, Gleich GJ, Hartley BF, Yancey SW, Ortega HG. Blood eosinophil count is a useful biomarker to identify patients with severe eosinophilic asthma. Ann Am Thorac Soc 2014; 11(4): 531-6. https://doi.org/10.1513/ AnnalsATS.201310-354OC
- 59. Nair P. Predictors of response to anti IL 5 biologics. Respirology 2020; 25(11): 1123-5. https://doi. org/10.1111/resp.13926
- 60. Mukherjee M, Aleman Paramo F, Kjarsgaard M, Salter B, Nair G, LaVigne N, et al. Weight-adjusted intravenous reslizumab in severe asthma with inadequate response to fixed-dose subcutaneous mepolizumab. Am J Respir Crit Care Med 2018; 197(1): 38-46. https://doi.org/10.1164/ rccm.201707-1323OC
- 61. Mukherjee M, Forero DF, Tran S, Boulay ME, Bertrand M, Bhalla A, et al. Suboptimal treatment response to anti-IL-5 monoclonal antibodies in severe eosinophilic asthmatics with airway autoimmune phenomena. Eur Respir J 2020; 56(4). https://doi.org/10.1183/13993003.00117-2020
- 62. Prazma CM, Albers F, Mallett S, Llanos-Ackert, JP, Yancey SW. Mepolizumab improves patient outcomes and reduc- es exacerbations in severe asthma patients with comorbid upper airways disease. J Allergy Clin Immunol 2019; 143(2): AB94. https://doi.org/10.1016/j.jaci.2018.12.286
- 63. Hopkins C, Bachert C, Fokkens W, Desrosiers M, Wagenmann M, Lee S, et al. Late breaking abstract-add-on mepolizumab for chronic rhinosinusitis with nasal polyps: SYNAPSE study. Eur Respiratory Soc 2020. https://doi. org/10.1183/13993003.congress-2020.4616
- 64. Baba S, Kagoya R, Kondo K, Suzukawa M, Ohta K, Yamasoba T. T-cell phenotypes in chronic rhinosinusitis with nasal polyps in Japanese patients. Allergy Asthma Clin Immunol 2015; 11(1): 1-11. https://doi.org/10.1186/ s13223-015-0100-2
- 65. Roufosse F. Targeting the interleukin-5 pathway for treat- ment of eosinophilic conditions other than asthma. Front Med 2018; 5: 49. https://doi.org/10.3389/ fmed.2018.00049
- 66. Ryu G, Kim DW. Th2 inflammatory responses in the devel- opment of nasal polyps and chronic rhinosinusitis. Curr Opin Allergy Clin Immunol 2020; 20(1): 1-8. https://doi. org/10.1097/ACI.0000000000000588
- 67. Pelaia C, Vatrella A, Busceti MT, Gallelli L, Terracciano R, Savino R, et al. Severe eosinophilic asthma: From the pathogenic role of interleukin-5 to the therapeutic action of mepolizumab. Drug Des Devel Ther 2017; 11: 3137. https://doi.org/10.2147/DDDT.S150656
- 68. Ortega HG, Yancey SW, Mayer B, Gunsoy NB, Keene ON, Bleecker ER, et al. Severe eosinophilic asthma treated with mepolizumab stratified by baseline eosinophil thresholds: A secondary analysis of the DREAM and MENSA studies. Lancet Respir Med 2016; 4(7): 549-56. https://doi. org/10.1016/S2213-2600(16)30031-5
- 69. Chapman KR, Albers FC, Chipps B, Muñoz X, Devouassoux G, Bergna M, et al. The clinical benefit of mepolizumab replacing omalizumab in uncontrolled severe eosinophilic asthma. Allergy 2019; 74(9): 1716-26. https://doi. org/10.1111/all.13850
- 70. Eger K, Kroes JA, Ten Brinke A, Bel EH, Long-term therapy response to anti-IL-5 biologics in severe asthma-a real-life evaluation. J Allergy Clin Immunol Pract 2021; 9(3): 1194-200. https://doi.org/10.1016/j.jaip.2020.10.010
- 71. Wenzel SE. Severe adult asthmas: Integrating clinical fea- tures, biology, and therapeutics to improve outcomes. Am J Respir Crit Care M 2021; 203(7): 809-21. https://doi. org/10.1164/rccm.202009-3631CI
- 72. Bagnasco D, Milanese M, Rolla G, Lombardi C, Bucca C, Heffler E, et al. The North-Western Italian experience with anti IL-5 therapy amd comparison with regulatory trials. World Allergy Organization J 2018; 11(1): 1-5. https:// doi.org/10.1186/s40413-018-0210-7
- 73. Llanos JP, Bell CF, Packnett E, Thiel E, Irwin DE, Hahn B, et al. Real-world characteristics and disease burden of patients with asthma prior to treatment initiation with mepolizumab or omalizumab: A retrospective cohort database study. J Asthma Allergy 2019; 12: 43. https:// doi.org/10.2147/JAA.S189676
- 74. Castro M, Corren J, Pavord ID, Maspero J, Wenzel S, Rabe KF, et al. Dupilumab efficacy and safety in moderate-to-se- vere uncontrolled asthma. N Engl J Med 2018; 378(26): 2486-96. https://doi.org/10.1056/NEJMoa1804092
- 75. Beck LA, Thaçi D, Hamilton JD, Graham NM, Bieber T, Rocklin R, et al. Dupilumab treatment in adults with mod- erate-to-severe atopic dermatitis. N Engl J Med 2014; 371(2): 130-9. https://doi.org/10.1056/NEJMoa1314768
- 76. Parulekar AD, Diamant Z, Hanania NA. Role of biologics targeting type 2 airway inflammation in asthma: What have we learned so far? Curr Opin Pulm Med 2017; 23(1): 3-11. https://doi.or g/10.1097/ MCP.0000000000000343
- 77. Parnes JR, Molfino NA, Colice G, Martin U, Corren J, Menzies-Gow A. Targeting TSLP in Asthma. J Asthma Allergy 2022; 15: 749. https://doi.org/10.2147/JAA. S275039
- 78. Menzies-Gow A, Corren J, Bourdin A, Chupp G, Israel E, Wechsler ME, et al. Tezepelumab in adults and adoles- cents with severe, uncontrolled asthma. N Engl J Med 2021; 384(19): 1800-9. https://doi.org/10.1056/ NEJMoa2034975
- 79. Corren J, Parnes JR, Wang L, Mo M, Roseti SL, Griffiths JM, et al. Tezepelumab in adults with uncontrolled asthma. N Engl J Med 2017; 377(10): 936-46. https://doi. org/10.1056/NEJMoa1704064
- 80. Emson C, Corren J, Sałapa K, Hellqvist Å, Parnes JR, Colice G. Efficacy of tezepelumab in patients with severe, uncon- trolled asthma with and without nasal polyposis: A post hoc analysis of the phase 2b PATHWAY study. J Asthma Allergy 2021; 14: 91. https://doi.org/10.2147/JAA. S288260
- 81. Wechsler ME, Menzies-Gow A, Brightling CE, Kuna P, Korn S, Welte T, et al. Evaluation of the oral corticosteroid-spar- ing effect of tezepelumab in adults with oral corticoste- roid-dependent asthma (SOURCE): A randomised, place- bo-controlled, phase 3 study. Lancet Respir Med 2022. https://doi.org/10.1164/ajrccm-conference.2021.203.1_ MeetingAbstracts.A1197
- 82. Menzies-Gow A, Colice G, Griffiths JM, Almqvist G, Ponnarambil S, Kaur P, et al. NAVIGATOR: A phase 3 mul- ticentre, 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): 1-12. https://doi.org/10.1186/s12931-020-01526-6
- 83. Kucharczyk A, Więsik-Szewczyk E, Poznańska A, Jahnz- Różyk K. Clinical determinants of successful omalizumab therapy in severe allergic asthma patients: 4-year-long, real-life observation. J Asthma Allergy 2020; 13: 659. https://doi.org/10.2147/JAA.S282203
- 84. Kupryś-Lipińska I, Majak P, Molinska J, Kuna P. Effectiveness of the Polish program for the treatment of severe allergic asthma with omalizumab: A single-center experience. BMC Pulm Med 2016; 16(1): 1-9. https://doi. org/10.1186/s12890-016-0224-2
- 85. Bousquet J, Humbert M, Gibson PG, Kostikas K, Jaumont X, Pfister P, et al. Real-world effectiveness of omalizumab in severe allergic asthma: A meta-analysis of observational studies. J Allergy Clin Immunol Pract 2021; 9(7): 2702-14. https://doi.org/10.1016/j.jaip.2021.01.011
- 86. Abbas F, Georas S, Cai X, Khurana S. Asthma biologics: Real-world effectiveness, impact of switching biologics, and predictors of response. Ann Allergy Asthma Immunol 2021; 127(6): 655-60. https://doi.org/10.1016/j. anai.2021.08.416
- 87. Kavanagh JE, d'Ancona G, Elstad M, Green L, Fernandes M, Thomson L, et al. Real-world effectiveness and the characteristics of a "super-responder" to mepolizumab in severe eosinophilic asthma. Chest 2020; 158(2): 491-500. https://doi.org/10.1016/j.chest.2020.03.042
- 88. Fong WCG, Azim A, Knight D, Mistry H, Freeman A, Felongco M, et al. Real world omalizumab and mepoli- zumab treated difficult asthma phenotypes and their clinical outcomes. Clin Exp Allergy 2021; 51(8): 1019-32. https://doi.org/10.1111/cea.13882
- 89. Harvey ES, Langton D, Katelaris C, Stevens S, Farah CS, Gillman A, et al. Mepolizumab effectiveness and identifi- cation of super-responders in severe asthma. Eur Respir J 2020; 55(5). https://doi.org/10.1183/13993003.02420- 2019
- 90. Rabe KF, Nair P, Brusselle G, Maspero JF, Castro M, Sher L, et al. Efficacy and safety of dupilumab in glucocorti- coid-dependent severe asthma. N Engl J Med 2018; 378(26): 2475-85. https://doi.org/10.1056/ NEJMoa1804093
- 91. Numata T, Araya J, Miyagawa H, Okuda K, Takekoshi D, Hashimoto M, et al. Real-world effectiveness of dupilum- ab for patients with severe asthma: A retrospective study. Jf Asthma Allergy 2022; 15: 395. https://doi.org/10.2147/ JAA.S357548
- 92. Dupin C, Belhadi D, Guilleminault L, Gamez AS, Berger P, De Blay F, 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): 789-98. https://doi.org/10.1111/cea.13614
- 93. Yılmaz İ, Çetin GP, Arslan B. Anti-IL5/IL5R switching between biologics in patients with severe eosinophilic asthma. J Allergy Clin Immunol Pract 2022; 10(7): 1935-6. https://doi.org/10.1016/j.jaip.2022.04.017
- 94. Ledford D, Busse W, Trzaskoma B, Omachi TA, Rosén K, Chipps BE, et al. A randomized multicenter study evaluat- ing Xolair persistence of response after long-term therapy. J Allergy Clin Immunol 2017; 140(1): 162-9. https://doi. org/10.1016/j.jaci.2016.08.054
- 95. Haldar P, Brightling CE, Singapuri A, Hargadon B, Gupta S, Monteiro W, et al. Outcomes after cessation of mepoli- zumab therapy in severe eosinophilic asthma: A 12-month follow-up analysis. J Allergy Clin Immunol 2014; 133(3): 921-3. https://doi.org/10.1016/j.jaci.2013.11.026
- 96. Moore WC, Kornmann O, Humbert M, Poirier C, Bel EH, Kaneko N, et al. Stopping versus continuing long-term mepolizumab treatment in severe eosinophilic asthma (COMET study). Eur Respir J 2022; 59(1). https://doi. org/10.1183/13993003.00396-2021
- 97. Molimard M, Mala L, Bourdeix I, Le Gros V. Observational study in severe asthmatic patients after discontinuation of omalizumab for good asthma control. Respir Med 2014. 108(4): 571-6. https://doi.org/10.1016/j. rmed.2014.02.003
- 98. Nopp A, Johansson SG, Adédoyin J, Ankerst J, Palmqvist M, Oman H. After 6 years with Xolair; A 3 year withdraw- al follow up. Allergy 2010; 65(1): 56-60. https://doi. org/10.1111/j.1398-9995.2009.02144.x
- 99. Arslan B, Paçacı Çetin G, Türk M, Gülmez İ, Yılmaz İ. Discontinuing omalizumab treatment in super-responder patients with allergic severe asthma: Can the baseline total IgE level be used as a biological marker to decide discontinuing omalizumab treatment? Int Arch Allergy Immunol 2022: 1-7. https://doi.org/10.1159/000525723
- 100. Upham JW, Le Lievre C, Jackson DJ, Masoli M, Wechsler ME, Price DB; Delphi Panel. Defining a severe asthma super-responder: Findings from a Delphi process. J Allergy Clin Immunol Pract 2021; 9(11): 3997-4004. https://doi. org/10.1016/j.jaip.2021.06.041
- 101. Vennera MDC, Sabadell C, Picado C; Spanish Omalizumab Registry. Duration of the efficacy of omalizumab after treatment discontinuation in 'real life'severe asthma. Thorax 2018; 73(8): 782-4. https://doi.org/10.1136/tho- raxjnl-2017-210017
- 102. Jeffery MM, Inselman JW, Maddux JT, Lam RW, Shah ND, Rank MA. Asthma patients who stop asthma biologics have a similar risk of asthma exacerbations as those who continue asthma biologics. J Allergy Clin Immunol Pract 2021; 9(7): 2742-50. https://doi.org/10.1016/j. jaip.2021.02.031
- 103. Zervas E, Samitas K, Papaioannou AI, Bakakos P, Loukides S, Gaga M. An algorithmic approach for the treatment of severe uncontrolled asthma. ERJ Open Res 2018; 4(1). https://doi.org/10.1183/23120541.00125-2017
- 104. Tran TN, Zeiger RS, Peters SP, Colice G, Newbold P, Goldman M, et al. Overlap of atopic, eosinophilic, and TH2-high asthma phenotypes in a general population with current asthma. Ann Allergy Asthma Immunol 2016; 116(1): 37-42. https://doi.org/10.1016/j. anai.2015.10.027
- 105. Kroes JA, Zielhuis SW, van Roon EN, Ten Brinke A. Prediction of response to biological treatment with mono- clonal antibodies in severe asthma. Biochem Pharmacol 2020; 179: 113978. https://doi.org/10.1016/j. bcp.2020.113978
- 106. Chaigne B, Watier H, Monoclonal antibodies in excess: A simple way to avoid immunogenicity in patients? J Allergy Clin Immunol 2015; 136(3): 814-6. https://doi. org/10.1016/j.jaci.2015.03.013
- 107. Cormier M, Chaboillez S, Lemiere C, Secondary loss of response to mepolizumab in severe eosinophilic asthma. J Allergy Clin Immunol Pract 2020; 8(2): 736-8. https://doi. org/10.1016/j.jaip.2019.08.005
- 108. Nanzer AM, Chowdhury A, Raheem A, Roxas C, Fernandes M, Thomson L, et al. Prevalence and recovery of adrenal insufficiency in steroid-dependent asthma patients receiv- ing biologic therapy. Eur Respir J 2020; 56(1). https://doi. org/10.1183/13993003.02273-2019
- 109. Rowan NR, Naclerio RM. Persistence of sinonasal disease despite mepolizumab. J Allergy Clin Immunol Pract 2020; 8(5): 1550-5. https://doi.org/10.1016/j.jaip.2020.01.049
- 110. Kaur R, Chupp G. Phenotypes and endotypes of adult asthma: moving toward precision medicine. J Allergy Clin Immunol 2019; 144(1): 1-12. https://doi.org/10.1016/j. jaci.2019.05.031
- 111. Fahy JV. Type 2 inflammation in asthma-present in most, absent in many. Nat Rev Immunol 2015; 15(1): 57-65. https://doi.org/10.1038/nri3786
- 112. Bachert C, Gevaert P, Hellings P. Biotherapeutics in chron- ic rhinosinusitis with and without nasal polyps. J Allergy Clin Immunol Pract 2017; 5(6): 1512-6. https://doi. org/10.1016/j.jaip.2017.04.024
- 113. Shrimanker R, Pavord ID, Yancey S, Heaney LG, Green RH, Bradding P, et al. Exacerbations of severe asthma in patients treated with mepolizumab. Eur Respir J. 2018; 52(6). https://doi.org/10.1183/13993003.01127-2018
- 114. Choy DF, Hart KM, Borthwick LA, Shikotra A, Nagarkar DR, Siddiqui S, et al. TH2 and TH17 inflammatory path- ways are reciprocally regulated in asthma. Sci Transl Med 2015; 7(301): 301ra129-301ra129. https://doi. org/10.1126/scitranslmed.aab3142
- 115. Kuo CS, Pavlidis S, Loza M, Baribaud F, Rowe A, Pandis I, et al. T-helper cell type 2 (Th2) and non-Th2 molecular phenotypes of asthma using sputum transcriptomics in U-BIOPRED. Eur Respir J 2017; 49(2). https://doi. org/10.1183/13993003.02135-2016
- 116. Chua JC, Douglass JA, Gillman A, O'Hehir RE, Meeusen EN. Galectin-10, a potential biomarker of eosinophilic airway inflammation. PLoS One 2012; 7(8): e42549. https://doi.org/10.1371/journal.pone.0042549
- 117. Caruso M, Morjaria J, Emma R, Amaradio MD, Polosa R. Biologic agents for severe asthma patients: Clinical per- spectives and implications. Inten Emerg Med 2018. 13(2): 155-76. https://doi.org/10.1007/s11739-017-1773-y
- 118. Pelaia C, Calabrese C, Vatrella A, Busceti MT, Garofalo E, Lombardo N, et al. Benralizumab: From the basic mecha- nism of action to the potential use in the biological thera- py of severe eosinophilic asthma. BioMed Res Int 2018; 2018. https://doi.org/10.1155/2018/4839230
- 119. Persson EK, Verstraete K, Heyndrickx I, Gevaert E, Aegerter H, Percier JM, et al. Protein crystallization promotes type 2 immunity and is reversible by antibody treatment. Science 2019; 364(6442): eaaw4295. https://doi. org/10.1126/science.aaw4295
- 120. Matsuno O, Minamoto S. Eosinophils depletion therapy for severe asthma management following favorable response to mepolizumab. Respir Med Case Rep 2019; 28: 100899. https://doi.org/10.1016/j.rmcr.2019.100899
- 121. Numata T, Miyagawa H, Nishioka S, Okuda K, Utsumi H, Hashimoto M, et al. Efficacy of benralizumab for patients with severe eosinophilic asthma: A retrospective, real-life study. BMC Pulm Med 2020; 20(1): 1-10. https://doi. org/10.1186/s12890-020-01248-x
- 122. Imai A, Takizawa T, Sato K, Inoue T, Nishida Y, Yagi H, et al. Switching biologics led to good control in severe child- hood asthma: A case report. Arerugi 2019; 68(7): 869- 73.
- 123. Lombardi C, Menzella F, Passalacqua G. Long-term respon- siveness to mepolizumab after failure of omalizumab and bronchial thermoplasty: Two triple-switch case reports. Resp Med Case Rep 2020; 29: 100967. https://doi. org/10.1016/j.rmcr.2019.100967
- 124. Minami D, Kayatani H, Sato K, Fujiwara K, Shibayama T. Effectiveness of benralizumab for allergic and eosinophilic predominant asthma following negative initial results with omalizumab. Respirol Case Rep 2019; 7(1): e00388. https://doi.org/10.1002/rcr2.388
- 125. Kurosawa M, Sutoh E. Severe uncontrolled eosinophilic asthma, which responded to benralizumab after failure to respond to mepolizumab. Ann Allergy Asthma Immunol 2019; 122(4): 431-3. https://doi.org/10.1016/j. anai.2018.12.014
- 126. Pérez de Llano LA, Cosío BG, Domingo C, Urrutia I, Bobolea I, Valero A, et al. Efficacy and safety of reslizumab in patients with severe asthma with inadequate response to omalizumab: A multicenter, open-label pilot study. J Allergy Clin Immunol Pract 2019; 7(7): 2277-83. https:// doi.org/10.1016/j.jaip.2019.01.017
- 127. Mümmler C, Munker D, Barnikel M, Veit T, Kayser MZ, Welte T, et al. Dupilumab improves asthma control and lung function in patients with insufficient outcome during previous antibody therapy. J Allergy Clin Immunol Pract 2021; 9(3): 1177-85. https://doi.org/10.1016/j. jaip.2020.09.014
- 128. Papaioannou AI, Fouka E, Papakosta D, Papiris S, Loukides S. Switching between biologics in severe asthma patients. When the first choice is not proven to be the best. Clin Exp Allergy 2021; 51(2): 221-2. https://doi.org/10.1111/ cea.13809
| APA | Yilmaz I, ÇETİN g, arslan b, ŞEKER S, Bozkurt Yılmaz H, AKTAŞ E, köylüce s, ACAR E (2023). Biological therapy management from the initial selection of biologics to switching between biologics in severe asthma. , 75 - 93. 10.5578/tt.20239910 |
| Chicago | Yilmaz Insu,ÇETİN gülden,arslan bahar,ŞEKER SERHAT,Bozkurt Yılmaz Hatice Eylül,AKTAŞ ELİF,köylüce serpil,ACAR ELİF Biological therapy management from the initial selection of biologics to switching between biologics in severe asthma. (2023): 75 - 93. 10.5578/tt.20239910 |
| MLA | Yilmaz Insu,ÇETİN gülden,arslan bahar,ŞEKER SERHAT,Bozkurt Yılmaz Hatice Eylül,AKTAŞ ELİF,köylüce serpil,ACAR ELİF Biological therapy management from the initial selection of biologics to switching between biologics in severe asthma. , 2023, ss.75 - 93. 10.5578/tt.20239910 |
| AMA | Yilmaz I,ÇETİN g,arslan b,ŞEKER S,Bozkurt Yılmaz H,AKTAŞ E,köylüce s,ACAR E Biological therapy management from the initial selection of biologics to switching between biologics in severe asthma. . 2023; 75 - 93. 10.5578/tt.20239910 |
| Vancouver | Yilmaz I,ÇETİN g,arslan b,ŞEKER S,Bozkurt Yılmaz H,AKTAŞ E,köylüce s,ACAR E Biological therapy management from the initial selection of biologics to switching between biologics in severe asthma. . 2023; 75 - 93. 10.5578/tt.20239910 |
| IEEE | Yilmaz I,ÇETİN g,arslan b,ŞEKER S,Bozkurt Yılmaz H,AKTAŞ E,köylüce s,ACAR E "Biological therapy management from the initial selection of biologics to switching between biologics in severe asthma." , ss.75 - 93, 2023. 10.5578/tt.20239910 |
| ISNAD | Yilmaz, Insu vd. "Biological therapy management from the initial selection of biologics to switching between biologics in severe asthma". (2023), 75-93. https://doi.org/10.5578/tt.20239910 |
| APA | Yilmaz I, ÇETİN g, arslan b, ŞEKER S, Bozkurt Yılmaz H, AKTAŞ E, köylüce s, ACAR E (2023). Biological therapy management from the initial selection of biologics to switching between biologics in severe asthma. Tüberküloz ve Toraks, 71(1), 75 - 93. 10.5578/tt.20239910 |
| Chicago | Yilmaz Insu,ÇETİN gülden,arslan bahar,ŞEKER SERHAT,Bozkurt Yılmaz Hatice Eylül,AKTAŞ ELİF,köylüce serpil,ACAR ELİF Biological therapy management from the initial selection of biologics to switching between biologics in severe asthma. Tüberküloz ve Toraks 71, no.1 (2023): 75 - 93. 10.5578/tt.20239910 |
| MLA | Yilmaz Insu,ÇETİN gülden,arslan bahar,ŞEKER SERHAT,Bozkurt Yılmaz Hatice Eylül,AKTAŞ ELİF,köylüce serpil,ACAR ELİF Biological therapy management from the initial selection of biologics to switching between biologics in severe asthma. Tüberküloz ve Toraks, vol.71, no.1, 2023, ss.75 - 93. 10.5578/tt.20239910 |
| AMA | Yilmaz I,ÇETİN g,arslan b,ŞEKER S,Bozkurt Yılmaz H,AKTAŞ E,köylüce s,ACAR E Biological therapy management from the initial selection of biologics to switching between biologics in severe asthma. Tüberküloz ve Toraks. 2023; 71(1): 75 - 93. 10.5578/tt.20239910 |
| Vancouver | Yilmaz I,ÇETİN g,arslan b,ŞEKER S,Bozkurt Yılmaz H,AKTAŞ E,köylüce s,ACAR E Biological therapy management from the initial selection of biologics to switching between biologics in severe asthma. Tüberküloz ve Toraks. 2023; 71(1): 75 - 93. 10.5578/tt.20239910 |
| IEEE | Yilmaz I,ÇETİN g,arslan b,ŞEKER S,Bozkurt Yılmaz H,AKTAŞ E,köylüce s,ACAR E "Biological therapy management from the initial selection of biologics to switching between biologics in severe asthma." Tüberküloz ve Toraks, 71, ss.75 - 93, 2023. 10.5578/tt.20239910 |
| ISNAD | Yilmaz, Insu vd. "Biological therapy management from the initial selection of biologics to switching between biologics in severe asthma". Tüberküloz ve Toraks 71/1 (2023), 75-93. https://doi.org/10.5578/tt.20239910 |
