Yıl: 2023 Cilt: 71 Sayı: 1 Sayfa Aralığı: 24 - 33 Metin Dili: İngilizce DOI: 10.5578/tt.20239904 İndeks Tarihi: 30-05-2023

Can omalizumab be an alternative treatment for non-atopic severe asthma? A real-life experience with omalizumab

Öz:
Introduction: Omalizumab, a humanized monoclonal anti-IgE antibody, has largely demonstrated its efficacy in severe allergic asthma. There are limited data about the effectiveness of omalizumab in patients with non-atopic severe persistent asthma. In this study, we aimed to determine the effect of omalizu- mab in patients with non-atopic severe asthma and compare the data obtai- ned with those in patients with allergic severe asthma. Materials and Methods: This study was an observational, retrospective, terti- ary single-center study that assessed and compared the clinical outcome of adult patients with severe asthma (165 atopic and 41 non-atopic) who have been on omalizumab for one year or longer between January 2008 and January 2020. Effectiveness was assessed by considering symptom scores (GINA symptom control score), daily systemic corticosteroids (SCS) dosage, blood eosinophil counts, pulmonary function, and number of severe exacer- bations and hospitalizations within the last one year. Results: Omalizumab exhibited significant improvement in the clinical status of non-atopic asthma patients as measured by GINA symptom score [decrea- sed from 3.77 ± 0.63 to 1.36 ± 1.27 (p< 0.001)], the number of emergency room visits for asthma [decreased from 11.25 ± 14.69 to 0.25 ± 0.55 (p< 0.001)], and the number of hospitalizations [decreased from 1.17 ± 2.87 to 0.14 ± 0.36 (p= 0.036)]. These results were not significantly different from those obtained in allergic asthma patients. FEV1 improved significantly from 2.08 ± 0.86 to 2.14 ± 0.84 (p= 0.041) and oral corticosteroid doses decrea- sed significantly from 1.67 ± 7.49 to 0.46 ± 2.74 (p= 0.015) in the only atopic group. Conclusion: Omalizumab, which is a proven and effective treatment option for allergic asthma, may also be an efficacious alternative option in non-atopic severe asthma.
Anahtar Kelime:

Omalizumab atopik olmayan ağır astımda alternatif bir tedavi olabilir mi? Omalizumab ile gerçek yaşam deneyimi

Öz:
Giriş: Humanize monoklonal bir anti-IgE antikoru olan omalizumab, ağır alerjik astımda etkinliğini büyük ölçüde göstermiştir. Non atopik ağır astımı olan hastalarda omalizumabın etkinliğiyle ilgili sınırlı veri vardır. Bu çalışmada non atopik ağır astımda omalizuma- bın etkisini belirlemeyi ve alerjik astımlı olgularla karşılaştırmayı amaçladık. Materyal ve Metod: Bu retrospektif gözlemsel çalışmada üçüncü basamak tedavi merkezinde Ocak 2008 ile Ocak 2020 arasında bir yıl veya daha uzun süredir omalizumab kullanan ağır astımlı (165 alerjik ve 41 atopik olmayan) erişkin hastaların klinik sonuçları değerlendirildi. Etkinlik; GINA semptom skoru, günlük sistemik kortikosteroid (SK) dozu, kan eozinofil sayıları, akciğer fonksiyonu ve son bir yıldaki ciddi alevlenmeler ve hastaneye yatış sayısıyla değerlendirildi. Bulgular: Omalizumab ile non-atopik astım hastalarında GINA semptom skoru 3,77 ± 0,63’ten 1,36 ± 1,27’ye (p< 0,001), astım için acil servis ziyaret sayısı 11,25 ± 14,69’dan 0,25 ± 0,55’e (p< 0,001), yıllık hastaneye yatış sayısı 1,17 ± 2,87’den 0,14 ± 0,36’ya (p= 0,036) gerilemiştir. Bu sonuçlar alerjik astımlı hastalar ile benzerdi, iki grup arası fark istatistiksel olarak anlamlı değildi. Alerjik astımlı grupta farklı olarak FEV1 2,08 ± 0,86 lt’den 2,14 ± 0,84 lt’ye yükseldi (p= 0,041) ve oral kortikosteroid dozları anlamlı olarak 1,67 ± 7,49 mg’dan 0,46 ± 2,74 mg’a geriledi (p= 0,015). Sonuç: Alerjik astımda kanıtlanmış ve etkin bir tedavi seçeneği olan omalizumab, non-atopik ağır astımda da etkili bir alternatif ola- bilir.
Anahtar Kelime:

Belge Türü: Makale Makale Türü: Araştırma Makalesi Erişim Türü: Erişime Açık
  • 1. GBD Chronic Respiratory Disease Collaborators. Global, regional, and national deaths, prevalence, disability-ad- justed life years, and years lived with disability for chronic obstructive pulmonary disease and asthma, 1990-2015: A systematic analysis for the Global Burden of Disease Study 2015. Lancet Respir Med 2017; 5(9): 691-706.
  • 2. Boulet LP, Boulay MÈ. Asthma-related comorbidities. Expert Rev Respir Med 2011; 5(3): 377-93. https://doi. org/10.1586/ers.11.34
  • 3. Global Initiative for Asthma (GINA). Diagnosis and man- agement of difficult-to-treat & severe asthma. Available from: https://ginasthma.org/ severeasthma/ (Accessed date: 21.06.2021).
  • 4. Nieves A, Magnan A, Boniface S, Proudhon H, Lanteaume A, Romanet S, et al. Phenotypes of asthma revisited upon the presence of atopy. Respir Med 2005; 99(3): 347-54. https://doi.org/10.1016/j.rmed.2004.08.004
  • 5. Romanet-Manent S, Charpin D, Magnan A, Lanteaume A, Vervloet D; EGEA Cooperative Group. Allergic vs nonallergic asthma: What makes the difference? Allergy 2002; 57(7): 607-13. https://doi.org/10.1034/j.1398-9995.2002.23504.x
  • 6. Humbert M, Durham SR, Ying S, Kimmitt P, Barkans J, Assoufi B, et al. IL-4 and IL-5 mRNA and protein in bron- chial biopsies frompatients with atopic and nonatopic asthma: Evidence against “intrinsic” asthma being a dis- tinct immunopathologic entity. Am J Respir Crit Care Med 1996; 154(5): 1497-504. https://doi.org/10.1164/ajrc- cm.154.5.8912771
  • 7. Garcia G, Magnan A, Chiron R, Contin-Bordes C, Berger P, Taillé C, et al. A proof-of-concept, randomized, controlled trial of omalizumab in patients with severe, difficult-to control, nonatopic asthma. Chest 2013; 144: 411-9. https://doi.org/10.1378/chest.12-1961
  • 8. Sözener ZÇ, Aydın Ö, Mısırlıgil Z, Mungan D, Demirel YS, Çelik GE, et al. Omalizumab in non-allergic asthma: A report of 13 cases. J Asthma 2018; 55(7): 756-63. https:// doi.org/10.1080/02770903.2017.1362427
  • 9. Campo P, Soto Campos G, Moreira A, Quirce S, Padilla- Galo A, Martínez-Moragón E, et al. Real-life study in non-atopic severe asthma patients achieving disease con- trol by omalizumab treatment. Allergy 2021; 76(6): 1868- 72. https://doi.org/10.1111/all.14668
  • 10. Niven RM, Saralaya D, Chaudhuri R, Masoli M, Clifton I, Mansur AH, et al. Impact of omalizumab on treatment of severe allergic asthma in UK clinical practice: A UK mul- ticentre observational study (the APEX II study). BMJ Open 2016; 6: e011857. https://doi.org/10.1136/bmjop- en-2016-011857
  • 11. de Llano LP, Vennera Mdel C, Álvarez FJ, Medina JF, Borderías L, Pellicer C, et al. Effects of omalizumab in non-atopic asthma: Results from a Spanish multicenter registry. J Asthma 2013; 50(3): 296-301. https://doi.org/1 0.3109/02770903.2012.757780
  • 12. Manga V, Humbert M, Djukanovic R, Greenberg S, Omachi TA, Trzaskoma B, et al. Blood eosinophils and serum IgE predict response to omalizumab in patients with severe allergic asthma: INNOVATE trial post-hoc analysis. JACI 2016; 137(2): AB16. https://doi. org/10.1016/j.jaci.2015.12.051
  • 13. Humbert M, Taillé C, Mala L, Le Gros V, Just J, Molimard M, et al. Omalizumab effectiveness in patients with severe allergic asthma according to blood eosinophil count: The STELLAIR study. Eur Respir J 2018; 51(5): 1702523. https://doi.org/10.1183/13993003.02523-2017
  • 14. Massanari M, Holgate ST, Busse WW, Jimenez P, Kianifard F, Zeldin R. Effect of omalizumab on peripheral blood eosinophilia in allergic asthma. Respir Med 2010; 104(2): 188-96. https://doi.org/10.1016/j.rmed.2009.09.011
  • 15. Türk M, Bahçecioğlu SN, Tutar N, Oymak FS, Gülmez İ, Yılmaz İ. Omalizumab treatment for atopic severe per- sistant asthma: A single-center, long-term, real-life experi- ence with 38 patients. Turk Thorac J 2018; 19(4): 187-92.
  • 16. Storms W, Bowdish MS, Farrar JR. Omalizumab and asth- ma control in patients with moderate-to-severe allergic asthma: A 6-year pragmatic data review. Allergy Asthma Proc 2012; 33: 172-7. https://doi.org/10.2500/ aap.2012.33.3527
  • 17. Bhutani M, Yang WH, Hébert J, de Takacsy F, Stril JL. The real world effect of omalizumab add on therapy for patients with moderate to severe allergic asthma: The ASTERIX observational study. PLoS One 2017; 12(8): e0183869. https://doi.org/10.1371/journal.pone.0183869
  • 18. Pilon D, Kavati A, Ortiz B, Paknis B, Vegesna A, Schiffman B, et al. Asthma control, lung function, symptoms, and corticosteroid sparing after omalizumab initiation in patients with allergic asthma. Allergy Asthma Proc 2018; 39(2): 127-35.https://doi.org/10.2500/aap.2018.39.4111
  • 19. Chen HC, Huang CD, Chang E, Kuo HP. Efficacy of omal- izumab (Xolair®) in patients with moderate to severe pre- dominately chronic oral steroid dependent asthma in Taiwan: A retrospective, population-based database cohort study. BMC Pulm Med 2016; 16: 3. https://doi. org/10.1186/s12890-015-0156-2
  • 20. Lommatzsch M, Korn S, Buhl R, Virchow JC. Against all odds: Anti-IgE for intrinsic asthma? Thorax 2013; 69(1): 94-6. https://doi.org/10.1136/thoraxjnl-2013-203738
  • 21. Pillai P, Chan YC, Wu SY, Ohm-Laursen L, Thomas C, Durham SR, et al. Omalizumab reduces bronchial muco- sal IgE and improves lung function in non-atopic asthma. Eur Respir J 2016; 48(6): 1593-601. https://doi. org/10.1183/13993003.01501-2015
  • 22. Barbee R, Lebowitz M, Thompson H, Burrows B. Immediate skin-test reactivity in a general population sample. Ann Intern Med 1976; 84: 129-33. https://doi. org/10.7326/0003-4819-84-2-129
  • 23. Tschopp JM, Sistek D, Schindler C, Leuenberger P, Perruchoud AP, Wüthrich B, et al. Current allergic asthma and rhinitis: Diagnostic efficiency of three commonly used atopic markers (IgE, skin prick tests, and Phadiatop). Results from 8329 randomized adults from the Sapaldia Study. Swiss study on air pollution and lung diseases in adults. Allergy 1998; 53: 608-13. https://doi. org/10.1111/j.1398-9995.1998.tb03937.x
APA Ediger D, Günaydın F, Erbay M, Pekbak G (2023). Can omalizumab be an alternative treatment for non-atopic severe asthma? A real-life experience with omalizumab. , 24 - 33. 10.5578/tt.20239904
Chicago Ediger Dane,Günaydın Fatma Esra,Erbay Müge,Pekbak Gülseren Can omalizumab be an alternative treatment for non-atopic severe asthma? A real-life experience with omalizumab. (2023): 24 - 33. 10.5578/tt.20239904
MLA Ediger Dane,Günaydın Fatma Esra,Erbay Müge,Pekbak Gülseren Can omalizumab be an alternative treatment for non-atopic severe asthma? A real-life experience with omalizumab. , 2023, ss.24 - 33. 10.5578/tt.20239904
AMA Ediger D,Günaydın F,Erbay M,Pekbak G Can omalizumab be an alternative treatment for non-atopic severe asthma? A real-life experience with omalizumab. . 2023; 24 - 33. 10.5578/tt.20239904
Vancouver Ediger D,Günaydın F,Erbay M,Pekbak G Can omalizumab be an alternative treatment for non-atopic severe asthma? A real-life experience with omalizumab. . 2023; 24 - 33. 10.5578/tt.20239904
IEEE Ediger D,Günaydın F,Erbay M,Pekbak G "Can omalizumab be an alternative treatment for non-atopic severe asthma? A real-life experience with omalizumab." , ss.24 - 33, 2023. 10.5578/tt.20239904
ISNAD Ediger, Dane vd. "Can omalizumab be an alternative treatment for non-atopic severe asthma? A real-life experience with omalizumab". (2023), 24-33. https://doi.org/10.5578/tt.20239904
APA Ediger D, Günaydın F, Erbay M, Pekbak G (2023). Can omalizumab be an alternative treatment for non-atopic severe asthma? A real-life experience with omalizumab. Tüberküloz ve Toraks, 71(1), 24 - 33. 10.5578/tt.20239904
Chicago Ediger Dane,Günaydın Fatma Esra,Erbay Müge,Pekbak Gülseren Can omalizumab be an alternative treatment for non-atopic severe asthma? A real-life experience with omalizumab. Tüberküloz ve Toraks 71, no.1 (2023): 24 - 33. 10.5578/tt.20239904
MLA Ediger Dane,Günaydın Fatma Esra,Erbay Müge,Pekbak Gülseren Can omalizumab be an alternative treatment for non-atopic severe asthma? A real-life experience with omalizumab. Tüberküloz ve Toraks, vol.71, no.1, 2023, ss.24 - 33. 10.5578/tt.20239904
AMA Ediger D,Günaydın F,Erbay M,Pekbak G Can omalizumab be an alternative treatment for non-atopic severe asthma? A real-life experience with omalizumab. Tüberküloz ve Toraks. 2023; 71(1): 24 - 33. 10.5578/tt.20239904
Vancouver Ediger D,Günaydın F,Erbay M,Pekbak G Can omalizumab be an alternative treatment for non-atopic severe asthma? A real-life experience with omalizumab. Tüberküloz ve Toraks. 2023; 71(1): 24 - 33. 10.5578/tt.20239904
IEEE Ediger D,Günaydın F,Erbay M,Pekbak G "Can omalizumab be an alternative treatment for non-atopic severe asthma? A real-life experience with omalizumab." Tüberküloz ve Toraks, 71, ss.24 - 33, 2023. 10.5578/tt.20239904
ISNAD Ediger, Dane vd. "Can omalizumab be an alternative treatment for non-atopic severe asthma? A real-life experience with omalizumab". Tüberküloz ve Toraks 71/1 (2023), 24-33. https://doi.org/10.5578/tt.20239904