The Efficacy of Omalizumab in Patients with Chronic Rhinosinusitis with Nasal Polyps and Comorbid Severe Allergic Asthma
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Abstract
Chronic rhinosinusitis whit nasal polyps (CRSwNP) is the most common comorbid disease accompanying asthma. Omalizumab is a recombinant anti-immunoglobulin (Ig) E antibody, and studies suggest that omalizumab may also affect CRSwNP regardless of asthma. We aimed to assess the effect of omalizumab treatment on CRSwNP accompanying severe allergic asthma (SAA) patients.
Clinical data including spirometry measurements, serum/nasal secretion biomarker levels were collected. NP scores and CRS scores (Lund-Mancay [LM] scores) were also recorded before omalizumab treatment, as well as at the 4th and 12th months of omalizumab treatment.
Twenty-one patients with both CRSwNP and SAA who underwent omalizumab therapy were assessed. There was a significant difference among forced expiratory volume (FEV1), ACT scores, NP scores, LM scores, serum IgE, and blood eosinophil levels of the patients before omalizumab therapy at the 4th and 12th months of omalizumab treatment. A significant negative correlation was observed between ∆FEV1 and ∆NP scores (r=−0.485), between ∆ACT and ∆NP scores (r=−0.469), and ∆ACT and ∆LM scores (r=−0.436). When we grouped the patients who benefited from 1 year of omalizumab therapy and those who did not in terms of NP, there was no difference between the two groups related to local eosinophil and local IgE levels in the nasal polyp biopsy.
Omalizumab treatment is effective for asthma and CRSwNP in patients with CRSwNP accompanied by SAA. Improvement in asthma is associated with improvement in CRSwNP. The efficacy of omalizumab on NP in patients with CRSwNP accompanied by SAA is independent of local IgE and eosinophil counts.
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2. Gevaert P, Calus L, Van Zele T, Blomme K, De Ruyck N, Bauters W, et al. Omalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma. J Allergy Clin Immunol. 2013;131(1):110-6 e1.
3. Wu D, Mueller SK, Nocera AL, Finn K, Libermann TA, Bleier BS. Axonal Guidance Signaling Pathway Is Suppressed in Human Nasal Polyps. Am J Rhinol Allergy. 2018;32(4):208-16.
4. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2020 (GINA, 2020).
5. Agache I, Beltran J, Akdis C, Akdis M, Canelo-Aybar C, Canonica GW, 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.
6. Lin DC, Chandra RK, Tan BK, Zirkle W, Conley DB, Grammer LC, et al. Association between severity of asthma and degree of chronic rhinosinusitis. Am J Rhinol Allergy. 2011;25(4):205-8.
7. Humbert M, Bousquet J, Bachert C, Palomares O, Pfister P, Kottakis I, et al. IgE-Mediated Multimorbidities in Allergic Asthma and the Potential for Omalizumab Therapy. J Allergy Clin Immunol Pract. 2019;7(5):1418-29.
8. Castillo Vizuete JA, Sastre J, Del Cuvillo Bernal A, Picado C, Martinez Moragon E, Ignacio Garcia JM, et al. Asthma, rhinitis, and nasal polyp multimorbidities. Arch Bronconeumol (Engl Ed). 2019;55(3):146-55.
9. Banoub RG, Phillips KM, Hoehle LP, Caradonna DS, Gray ST, Sedaghat AR. Relationship between chronic rhinosinusitis exacerbation frequency and asthma control. Laryngoscope. 2018;128(5):1033-8.
10. Bachert C, Zhang L, Gevaert P. Current and future treatment options for adult chronic rhinosinusitis: Focus on nasal polyposis. J Allergy Clin Immunol. 2015;136(6):1431-40.
11. Takeda K, Sakakibara S, Yamashita K, Motooka D, Nakamura S, El Hussien MA, et al. Allergic conversion of protective mucosal immunity against nasal bacteria in patients with chronic rhinosinusitis with nasal polyposis. J Allergy Clin Immunol. 2019;143(3):1163-75 e15.
12. Zheng M, Wang M, Li Y, Wang XD, Zhang L. [Expression of immunological and inflammatory biomarkers in chronic rhinosinusitis with nasal polyps and its predictive value for recurrence]. Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2019;54(3):174-80.
13. McGregor MC, Krings JG, Nair P, Castro M. Role of Biologics in Asthma. Am J Respir Crit Care Med. 2019;199(4):433-45.
14. 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.
15. Kariyawasam HH, James LK. Chronic Rhinosinusitis with Nasal Polyps: Targeting IgE with Anti-IgE Omalizumab Therapy. Drug Des Devel Ther. 2020;14:5483-94.
16. Tiotiu A, Oster JP, Roux PR, Nguyen Thi PL, Peiffer G, Bonniaud P, et al. Effectiveness of Omalizumab in Severe Allergic Asthma and Nasal Polyposis: A Real-Life Study. J Investig Allergol Clin Immunol. 2020;30(1):49-57.
17. Heffler E, Saccheri F, Bartezaghi M, Canonica GW. Effectiveness of omalizumab in patients with severe allergic asthma with and without chronic rhinosinusitis with nasal polyps: a PROXIMA study post hoc analysis. Clin Transl Allergy. 2020;10:25.
18. 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.
19. Heinzerling L, Mari A, Bergmann KC, Bresciani M, Burbach G, Darsow U, et al. The skin prick test - European standards. Clin Transl Allergy. 2013;3(1):3.
20. Ren L, Zhang N, Zhang L, Bachert C. Biologics for the treatment of chronic rhinosinusitis with nasal polyps - state of the art. World Allergy Organ J. 2019;12(8):100050.
21. Ruiz-Hornillos J, Rodriguez Jimenez B, Feliu Vila A, Moreno Fernandez A, Hernandez Garcia MJ, Dominguez-Ortega J, et al. Omalizumab as a Therapeutic Option for Nasal Polyposis in Moderate-to-Severe Persistent Allergic Asthma: Evidence From a Prospective Study in a Real-World Setting. J Investig Allergol Clin Immunol. 2020;30(6):470-2.
22. Ahmadiafshar A, Farjd HR, Moezzi F, Mousavinasab N. Nasal polyposis in patients with asthma and allergic rhinitis. J Laryngol Otol. 2012;126(8):780-3.
23. Laidlaw TM, Buchheit KM. Biologics in chronic rhinosinusitis with nasal polyposis. Ann Allergy Asthma Immunol. 2020;124(4):326-32.
24. Bilodeau L, Boulay ME, Prince P, Boisvert P, Boulet LP. Comparative clinical and airway inflammatory features of asthmatics with or without polyps. Rhinology. 2010;48(4):420-5.
25. Busse WW, Humbert M, Haselkorn T, Ortiz B, Trzaskoma BL, Stephenson P, et al. Effect of omalizumab on lung function and eosinophil levels in adolescents with moderate-to-severe allergic asthma. Ann Allergy Asthma Immunol. 2020;124(2):190-6.
26. Djukanovic R, Wilson SJ, Kraft M, Jarjour NN, Steel M, Chung KF, et al. Effects of treatment with anti-immunoglobulin E antibody omalizumab on airway inflammation in allergic asthma. Am J Respir Crit Care Med. 2004;170(6):583-93.
27. Pinto JM, Mehta N, DiTineo M, Wang J, Baroody FM, Naclerio RM. A randomized, double-blind, placebo-controlled trial of anti-IgE for chronic rhinosinusitis. Rhinology. 2010;48(3):318-24.
28. Wu D, Bleier BS, Li L, Zhan X, Zhang L, Lv Q, et al. Clinical Phenotypes of Nasal Polyps and Comorbid Asthma Based on Cluster Analysis of Disease History. J Allergy Clin Immunol Pract. 2018;6(4):1297-305 e1.
29. Wang M, Bu X, Luan G, Lin L, Wang Y, Jin J, et al. Distinct type 2-high inflammation associated molecular signatures of chronic rhinosinusitis with nasal polyps with comorbid asthma. Clin Transl Allergy. 2020;10:26.
30. Bachert C, Zhang N, Holtappels G, De Lobel L, van Cauwenberge P, Liu S, et al. Presence of IL-5 protein and IgE antibodies to staphylococcal enterotoxins in nasal polyps is associated with comorbid asthma. J Allergy Clin Immunol. 2010;126(5):962-8, 8 e1-6.
2. Gevaert P, Calus L, Van Zele T, Blomme K, De Ruyck N, Bauters W, et al. Omalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma. J Allergy Clin Immunol. 2013;131(1):110-6 e1.
3. Wu D, Mueller SK, Nocera AL, Finn K, Libermann TA, Bleier BS. Axonal Guidance Signaling Pathway Is Suppressed in Human Nasal Polyps. Am J Rhinol Allergy. 2018;32(4):208-16.
4. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2020 (GINA, 2020).
5. Agache I, Beltran J, Akdis C, Akdis M, Canelo-Aybar C, Canonica GW, 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.
6. Lin DC, Chandra RK, Tan BK, Zirkle W, Conley DB, Grammer LC, et al. Association between severity of asthma and degree of chronic rhinosinusitis. Am J Rhinol Allergy. 2011;25(4):205-8.
7. Humbert M, Bousquet J, Bachert C, Palomares O, Pfister P, Kottakis I, et al. IgE-Mediated Multimorbidities in Allergic Asthma and the Potential for Omalizumab Therapy. J Allergy Clin Immunol Pract. 2019;7(5):1418-29.
8. Castillo Vizuete JA, Sastre J, Del Cuvillo Bernal A, Picado C, Martinez Moragon E, Ignacio Garcia JM, et al. Asthma, rhinitis, and nasal polyp multimorbidities. Arch Bronconeumol (Engl Ed). 2019;55(3):146-55.
9. Banoub RG, Phillips KM, Hoehle LP, Caradonna DS, Gray ST, Sedaghat AR. Relationship between chronic rhinosinusitis exacerbation frequency and asthma control. Laryngoscope. 2018;128(5):1033-8.
10. Bachert C, Zhang L, Gevaert P. Current and future treatment options for adult chronic rhinosinusitis: Focus on nasal polyposis. J Allergy Clin Immunol. 2015;136(6):1431-40.
11. Takeda K, Sakakibara S, Yamashita K, Motooka D, Nakamura S, El Hussien MA, et al. Allergic conversion of protective mucosal immunity against nasal bacteria in patients with chronic rhinosinusitis with nasal polyposis. J Allergy Clin Immunol. 2019;143(3):1163-75 e15.
12. Zheng M, Wang M, Li Y, Wang XD, Zhang L. [Expression of immunological and inflammatory biomarkers in chronic rhinosinusitis with nasal polyps and its predictive value for recurrence]. Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2019;54(3):174-80.
13. McGregor MC, Krings JG, Nair P, Castro M. Role of Biologics in Asthma. Am J Respir Crit Care Med. 2019;199(4):433-45.
14. 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.
15. Kariyawasam HH, James LK. Chronic Rhinosinusitis with Nasal Polyps: Targeting IgE with Anti-IgE Omalizumab Therapy. Drug Des Devel Ther. 2020;14:5483-94.
16. Tiotiu A, Oster JP, Roux PR, Nguyen Thi PL, Peiffer G, Bonniaud P, et al. Effectiveness of Omalizumab in Severe Allergic Asthma and Nasal Polyposis: A Real-Life Study. J Investig Allergol Clin Immunol. 2020;30(1):49-57.
17. Heffler E, Saccheri F, Bartezaghi M, Canonica GW. Effectiveness of omalizumab in patients with severe allergic asthma with and without chronic rhinosinusitis with nasal polyps: a PROXIMA study post hoc analysis. Clin Transl Allergy. 2020;10:25.
18. 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.
19. Heinzerling L, Mari A, Bergmann KC, Bresciani M, Burbach G, Darsow U, et al. The skin prick test - European standards. Clin Transl Allergy. 2013;3(1):3.
20. Ren L, Zhang N, Zhang L, Bachert C. Biologics for the treatment of chronic rhinosinusitis with nasal polyps - state of the art. World Allergy Organ J. 2019;12(8):100050.
21. Ruiz-Hornillos J, Rodriguez Jimenez B, Feliu Vila A, Moreno Fernandez A, Hernandez Garcia MJ, Dominguez-Ortega J, et al. Omalizumab as a Therapeutic Option for Nasal Polyposis in Moderate-to-Severe Persistent Allergic Asthma: Evidence From a Prospective Study in a Real-World Setting. J Investig Allergol Clin Immunol. 2020;30(6):470-2.
22. Ahmadiafshar A, Farjd HR, Moezzi F, Mousavinasab N. Nasal polyposis in patients with asthma and allergic rhinitis. J Laryngol Otol. 2012;126(8):780-3.
23. Laidlaw TM, Buchheit KM. Biologics in chronic rhinosinusitis with nasal polyposis. Ann Allergy Asthma Immunol. 2020;124(4):326-32.
24. Bilodeau L, Boulay ME, Prince P, Boisvert P, Boulet LP. Comparative clinical and airway inflammatory features of asthmatics with or without polyps. Rhinology. 2010;48(4):420-5.
25. Busse WW, Humbert M, Haselkorn T, Ortiz B, Trzaskoma BL, Stephenson P, et al. Effect of omalizumab on lung function and eosinophil levels in adolescents with moderate-to-severe allergic asthma. Ann Allergy Asthma Immunol. 2020;124(2):190-6.
26. Djukanovic R, Wilson SJ, Kraft M, Jarjour NN, Steel M, Chung KF, et al. Effects of treatment with anti-immunoglobulin E antibody omalizumab on airway inflammation in allergic asthma. Am J Respir Crit Care Med. 2004;170(6):583-93.
27. Pinto JM, Mehta N, DiTineo M, Wang J, Baroody FM, Naclerio RM. A randomized, double-blind, placebo-controlled trial of anti-IgE for chronic rhinosinusitis. Rhinology. 2010;48(3):318-24.
28. Wu D, Bleier BS, Li L, Zhan X, Zhang L, Lv Q, et al. Clinical Phenotypes of Nasal Polyps and Comorbid Asthma Based on Cluster Analysis of Disease History. J Allergy Clin Immunol Pract. 2018;6(4):1297-305 e1.
29. Wang M, Bu X, Luan G, Lin L, Wang Y, Jin J, et al. Distinct type 2-high inflammation associated molecular signatures of chronic rhinosinusitis with nasal polyps with comorbid asthma. Clin Transl Allergy. 2020;10:26.
30. Bachert C, Zhang N, Holtappels G, De Lobel L, van Cauwenberge P, Liu S, et al. Presence of IL-5 protein and IgE antibodies to staphylococcal enterotoxins in nasal polyps is associated with comorbid asthma. J Allergy Clin Immunol. 2010;126(5):962-8, 8 e1-6.
| Files | ||
| Issue | Vol 23 No 3 (2024) | |
| Section | Original Article(s) | |
| DOI | https://doi.org/10.18502/ijaai.v23i3.15635 | |
| Keywords | ||
| Allergy Asthma Nasal polyps Omalizumab Sinusitis chronic | ||
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How to Cite
1.
Atayik E, Aytekin G, Aydin İsa, Omeroglu E. The Efficacy of Omalizumab in Patients with Chronic Rhinosinusitis with Nasal Polyps and Comorbid Severe Allergic Asthma. Iran J Allergy Asthma Immunol. 2024;23(3):245-256.
