Efficacy and safety of monoclonal antibody therapy for chronic rhinosinusitis with nasal polyposis

1. Hastan D, Fokkens WJ, Bachert C, Newson RB, Bislimovska J, Bockelbrink A, et al. Chronic rhinosinusitis in Europe – an underestimated disease. A GA-2LEN study. Allergy. 2011;66:1216-23. DOI: 10.1111/j.1398-9995.2011.02646.x. Open DOISearch in Google Scholar

2. Fokkens WJ, Lund VJ, Hopkins C, Hellings PW, Kern R, Reitsma S, et al. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology. 2020;58(Suppl S29):1-464. DOI: 10.4193/Rhin20.600. Open DOISearch in Google Scholar

3. Schiller JS, Lucas JW, Peregoy JA. Summary health statistics for u.s. Adults: national health interview survey, 2011. Vital Health Stat 10. 2012;(256):1-218. Search in Google Scholar

4. Him JH, Cho C, Lee EJ, Suh YS, Choi BI, Kim KS. Prevalence and risk factors of chronic rhinosinusitis in South Korea according to diagnostic criteria. Rhinology. 2016;54(4):239-35. DOI: 10.4193/Rhino15.157. Open DOISearch in Google Scholar

5. Shi JB, Fu QL, Zhang H, Cheng L, Wang YJ, Zhu DD, et al. Allergy. 2015;70(5):533-9. DOI: 10.1111/all.12577. Open DOISearch in Google Scholar

6. Kim C, Han J, Wu T, Bachert C, Fokkens W, Hellings P, et al. Role of biologics in chronic rhinosinusitis with nasal polyposis: state of the art review. Otolaryngol Head Neck Surg. 2021;164(1):57-66. DOI: 10.1177/0194599820939964. Open DOISearch in Google Scholar

7. Patel GB, Peters AT. The role of biologics in chronic rhinosinusitis with nasal polyps. Ear Nose Throat J. 2021;100(1):44-7. DOI: 10.1177/0145561320964653. Open DOISearch in Google Scholar

8. Ren L, Zhang N, Zhang L, Bachert C. Biologics for the treatment of chronic rhinosinusitis with nasal polyps – state of art. World Allergy Organ J. 2019;12(8):1000050. DOI: 10.1016/j.waojou.2019.100050. Open DOISearch in Google Scholar

9. Lange B, Holst R, Thilsing T, Baelum J, Kjeldsen A. Quality of life and associated factors in persons with chronic rhinosinusitis in the general population: a prospective questionnaire and clinical cross-sectional study. Clin Otolaryngol. 2013;38(6):474-80. DOI: 10.1111/coa.12189. Open DOISearch in Google Scholar

10. Benjamin MR, Stevens WW, Li N, Bose S, Grammar L, Kern RC, et al. Clinical characteristics of patients with chronic rhinosinusitis without nasal polyps in an academic setting. J Allergy Clin Immunol Pract. 2019;7(3):1010-16. DOI: 10.1016/j.jaip.2018.10.014. Open DOISearch in Google Scholar

11. Tsetsos N, Goudakos JK, Daskalakis D, Konstantinidis I, Markou K. Monocloncal antibodies for the treatment of chronic rhinosinusitis with nasal polyposis: a systematic review. Rhinology. 2018:56:11-21. DOI: 10.4193/Rhino17.156. Open DOISearch in Google Scholar

12. Bhattacharyya N, Orlandi RR, Grebner J, Martinson M. Cost burden of chronic rhinosinusitis: a claims-based study. Otolaryngol Head Neck Surg. 2011;144(3):440-5. DOI: 10.1177/0194599810391852. Open DOISearch in Google Scholar

13. Loftus CA, Soler ZM, Koochakzadeh S, Desiato VM, Yoo F, Nguyen SA, et al. Revision surgery rates in chronic rhinosinusitis with nasal polyps: meta-analysis of risk factors. Int Forum Allergy Rhinol. 2020;10(2):199-207. DOI: 10.1002/alr.22487. Open DOISearch in Google Scholar

14. DeConde AS, Mace JC, Levy JM, Rudmik L, Alt JA, Smith T. Prevalence of polyp recurrence after endoscopic sinus surgery for chronic rhinosinusitis with nasal polyposis. Laryngoscope. 2017;127(3):550-5. DOI: 10.1002/lary.26391. Open DOISearch in Google Scholar

15. Caminati M, Le Pham D, Bagnasco D, Canonica GW. Type 2 immunity in asthma. World Allergy Organ J. 2018;11(1):13. DOI: 10.1186/s40413-018-0192-5. Open DOISearch in Google Scholar

16. Hulse KE, Stevens WW, Tan BK, Schleimer RP. Pathogenesis of nasal polyposis. Clin Exp Allergy. 2015;45(2):328-46. DOI: 10.1111/cea.12473. Open DOISearch in Google Scholar

17. Bachert C, Zhang N, Hellings PW, Bousquet J. Endotype-driven care pathways in patients with chronic rhinosinusitis. J allergy Clin Immunol. 2018;141:1543-51. Search in Google Scholar

18. Schwarts JS, Tajudeen BA, Cohen NA. Medical management of chronic rhino-sinusitis – a review of traditional and novel medical therapies. Expert Opin Investig Drug. 2017;26:1123-30. Search in Google Scholar

19. Presta LG, Lahr SJ, Shields RL, Porter JP, Gorman CM, Fendly BM, et al. Humanization of an antibody directed against IgE. J Immunol. 1993;151-2623-32. Search in Google Scholar

20. MacGlashan DW Jr, Bochner BS, Adelman DC, Jardieu PM, Togias A, McKenzie-White J, et al. Down-regulation of Fc(epsilon)RI expression on human basophils during in vivo treatment of atopic patients with anti-IgE antibody. J Immunol. 1997;158:1438-45. Search in Google Scholar

21. Genentech Announces FDA Approval of Xolair (omalizumab) for Adults with Nasal Polyps [News Release] December 1, 2020; San Francisco, CA. Accessed December 1, 2020. https://www.gene.com/media/press-releases/14887/2020-12-01/genentech-announces-fda-approval-of-xola. Search in Google Scholar

22. European Medicines Agency. Xolair. Omalizumab. [Internet]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/xolair. Accessed July 21, 2022. Search in Google Scholar

23. Van Zele T, Holappels G, Gevaert P, Bachert C. Differences in initial immuno-profiles between recurrent and nonrecurrent chronic rhinosinusitis with nasal polyps. Am J Rhinol Allergy. 2014;28:192-8. Search in Google Scholar

24. Gevaert P, Bachert C, Holtappels G, Novo CP, Van der Heyden J, Fransen L, et al. Enhanced soluble interleukin-5 receptor alpha expression in nasal polyposis. Allergy. 2003;58:371-9. Search in Google Scholar

25. GSK announces FDA approval for Nucala (mepolizumab) for use in adults with chronic rhinosinusitis with nasal polyps. [Internet]. GlaxoSmithKline; July 29, 2021. Available from: https://www.gsk.com/en-gb/media/press-releases/gsk-announces-fda-approval-for-nucala-mepolizumab-for-use-in-adults-with-chronic-rhinosinusitis-with-nasal-polyps/. Accessed 21 July 2022. Search in Google Scholar

26. European Medicines Agency. Nucala. Mepolizumab. [Internet]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/nucala. Accessed 24 July 2022. Search in Google Scholar

27. Steinke JW, Crouse CD, Bradley D, Hise K, Lynch K, Kountakis SE, et al. Characterization of interleukin-4-stimulated nasal polyp fibroblasts. Am J Respir Cell Mol Biol. 2004;30(2):212-9. DOI: 10.1165/rcmb.2003-0071OC. Open DOISearch in Google Scholar

28. Pinto JM, Mehta N, DeTineo M, Wang J, Baroody FM, Naclerio RM. A randomized, double-blind, placebo-controlled trial of anti-IgE for chronic rhino-sinusitis. Rhinology. 2010;48:318-324. DOI: 10.4193/Rhino09.144. Open DOISearch in Google Scholar

29. 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. DOI: 10.1016/j.jaci.2012.07.047. Open DOISearch in Google Scholar

30. Bachert C, Mannent L, Naclerio RM, Mullol J, Ferguson BJ, Gevaert P, et al. Effect of subcutaneous dupilumab on nasal polyp burden in patients with chronic sinusitis and nasal polyposis: A randomized clinical trial. JAMA. 2016;315(5):469-79. DOI: 10.1001/jama.2015.19330. Open DOISearch in Google Scholar

31. Jonstam K, Swanson BN, Mannent LP, Cardell LO, Tian N, Wang Y, et al. Dupilumab reduces local type 2 pro-inflammatory biomarkers in chronic rhino-sinusitis with nasal polyposis. Allergy. 2019;74:743-52. DOI: 10.1111/all.13685. Open DOISearch in Google Scholar

32. Bachert C, Hellings PW, Mullol J, Nacleiro RM, Chao J, Amin N, et al. Dupilumab improves patient-reported outcomes in patients with chronic rhinosinusitis with nasal polyps and comorbid asthma. J Allergy Clin Immunol Pract. 2019;7(7):2447-49.e2. Search in Google Scholar

33. Fujieda S, Matsune S, Takeno S, Asako M, Takeuchi M, Fujita H, et al. The effect of dupilumab on intractable chronic rhinosinusitis with nasal polyps in Japan. Laryngoscope. 2021;131:E1770-77. Search in Google Scholar

34. Gevaert P, Lang-Loidolt D, Lackner A, Stammberger H, Staudinger H, Van Zele T. Nasal IL-5 levels determine the response to anti-IL-5 treatment in patients with nasal polyps. J Allergy Clin Immunol. 2006;118(5):1133-41. DOI: 10.1016/j.jaci.2006.05.031. Open DOISearch in Google Scholar

35. Bachert C, Sousa AR, Lund AJ, Scadding GK, Gevaert P, Nasser S, et al. reduced need for surgery in severe nasal polyposis with mepolizumab: Randomized trial. J Allergy Clin Immunol. 2017;140(4):1024-31. DOI: 10.1016/j.jaci.2017.05.044. Open DOISearch in Google Scholar

36. Gevaert P, Van Bruaene N, Cattaert T, Van Steen K, Van Zele T, Acke F, et al. Mepolizumab, a humanized anti-IL-5 mAB, as a treatment option for severe nasal polyposis. J Allergy Clin Immunol. 2011;128(5):989-65. DOI: 10.1016/j.jaci.2011.07.056. Open DOISearch in Google Scholar

37. Controlled clinical study of dupilumab in patients with nasal polyps (SINUS-52). ClinicalTrials.gov Identifier: NCT02898454. [Internet]. Available from: https://clinicaltrials.gov/ct2/show/results/NCT02898454. Search in Google Scholar

38. A controlled clinical study of dupilumab in patients with bilateral nasal polyps (SINUS-24). ClinicalTrials.gov Identifier: NCT02912468. [Internet]. Available from: https://clinicaltrials.gov/ct2/show/NCT02912468. Search in Google Scholar

39. A clinical trial of omalizumab in participants with chronic rhinosinusitis with nasal polyps (POLYP 1). ClinicalTrials.gov Identifier: NCT03280550. [Internet]. Available from: https://clinicaltrials.gov/ct2/show/NCT03280550. Search in Google Scholar

40. A clinical trial of omalizumab in pariticipants with chronic rhinosinusitis with nasal polyps (POLYP 2). ClinicalTrials.gov Identifier: NCT03280537. [Internet]. Available from: https://clinicaltrials.gov/ct2/show/NCT03280537. Search in Google Scholar

41. Effect of mepolizumab in severe bilateral nasal polyps. ClinicalTrials.gov Identifier: NCT03085797. [Internet]. Available from: https://clinicaltrials.gov/ct2/show/NCT03085797. Search in Google Scholar

42. Efficacy and safety study of benralizumab for patients with severe nasal polyposis (OSTRO). ClinicalTrial.gov Identifier: NCT03401229. [Internet]. Available from: https://clinicaltrials.gov/ct2/show/NCT03401229. Search in Google Scholar

43. Nasal polyps: Inflammatory & molecular phenotyping of responders to benralizumab (NAPPREB). ClinicalTrials.gov Identifier: NCT04185012. [Internet]. Available from: https://clinicaltrials.gov/ct2/show/NCT04185012. Search in Google Scholar

44. Lund VJ, Mackay IS. Staging in rhinosinusitis. Rhinology. 1993;31(4):183-4. Search in Google Scholar

45. Chuang CC, Guillemin I, Bachert C, Lee SE, Hellings PW, Fokkens WJ, et al. Dupilumab in CRSwNP: responder analysis using clinically meaningful efficacy outcome thresholds. Laryngoscope. 2022;132:259-64. DOI: 10.1002/lary.29911. Open DOISearch in Google Scholar

46. Bachert C, Zinreich SJ, Hellings PW, Mullol J, Hamilos DL, Gavaert P, et al. Dupilumab reduces opacification across all sinuses and related symptoms in patients with CRSwNP. Rhinology. 2020;58(1):10-7. DOI: 10.4193/Rhin18.282. Open DOISearch in Google Scholar

47. Bachert C, Han JK, Desrosiers MY, Gevaert P, Heffler E, Hopkins C, et al. Efficacy and safety of benralizumab in chronic rhinosinusitis with nasal polyps: A randomized, placebo-controlled trial. J Allergy Clin Immunol. 2022;149:1309-17. Search in Google Scholar

48. Chong LY, Piromchai P, Sharp S, Snidvongs K, Webster KE, Philpott C, et al. Biologics for chronic rhinosinusitis. Cochrane Database of Systematic Reviews. 2021;3. Search in Google Scholar

49. Doty RL, Shaman P, Kimmelman CP, Dann MS. University of Pennsylvania Smell Identification Test: a rapid quantitative olfactory function test for the clinic. Laryngoscope. 1984;94(2 Pt 1):176-8. DOI: 10.1288/00005537-198402000-00004. Open DOISearch in Google Scholar

50. Tomassen P, Vandeplas G, Van Zele T, Cardell LO, Arebro J, Olze H, et al. Inflammatory endotypes of chronic rhinosinusitis based on cluster analysis of biomarkers. J Allergy Clin Immunol. 2016;137(5):1449-56.e4. DOI: 10.1016/j.jaci.2015.12.1324. Open DOISearch in Google Scholar

51. Camelo A, Rosignoli G, Ohne Y, Stewart RA, Overed-Sayer C, Sleeman MA, et al. IL-33, IL-25, and TSLP induce a distinct phenotypic and activation profile in human type 2 innate lymphoid cells. Blood Adv. 2017;1(10):577-89. DOI: 10.1182/bloodadvances.2016002352. Open DOISearch in Google Scholar

52. Fokkens WJ, Lund V, Bachert C, Mullol J, Bjermer L, Bousquet J, et al. EUFOREA consensus on biologics for CRSwNP with or without asthma. Allergy. 2019;74(2):2312-9. DOI: 10.1111/all.13875. Open DOISearch in Google Scholar

53. Scangas GA, Wu AW, Ting JY, Metson R, Walgama E, Shrime MG, et al. Cost utility analysis of dupilumab versus endoscopic sinus surgery for chronic rhinosinusitis with nasal polyps. Laryngoscope. 2021;131(1):E26-33. DOI: 10.1002/lary.28648. Open DOISearch in Google Scholar

54. Smith KA, Orlandi RR, Rudmik L. Cost of adult rhinosinusitis: A systematic review. Laryngoscope. 2015;125(7):1547-56. DOI: 10.1002/lary.25180. Open DOISearch in Google Scholar

55. Andreson WC 3rd, Szefler SJ. Cost-effectiveness and comparative effectiveness of biologic therapy for asthma: To biologic or nor to biologic? Ann Allergy Asthma Immunol. 2019;122(4):367-72. DOI: 10.1016/j.anai.2019.01.018. Open DOISearch in Google Scholar

56. Lam K, Kern RC, Luong A. Is there a future for biologics in the management of chronic rhinosinusitis? Int Forum Allergy Rhinol. 2016;6(9):935-42. DOI: 10.1002/alr.21780. Open DOISearch in Google Scholar

57. Wang WW, Lu DM, Zheng M, Zhang JG, Zhang B. TSLP regulates eotaxin-1 production by nasal epithelial cells from patients with eosinophilic CRSwNP. Rhinology. 2018;56(4):370-7. DOI: 10.4193/Rhin17.045. Open DOISearch in Google Scholar

58. Kim DK, Jin HR, Eun KM, Mo JH, Cho SH, Oh S, et al. The role of interleukin-33 in chronic rhinosinusitis. Thorax. 2017;72(7):635-45. Search in Google Scholar

59. Luo X, Li C, Wang Y, Yang G, Xu Y, Li G, et al. Interleukin-33 promotes Th2/Th17 response in eosinophilic and non-eosinophilic nasal polyps. ORL J Otorhinolaryngol Relat Spec. 2020;82(1):34-9. Search in Google Scholar

60. Nagarkar DR, Poposki JA, Tan BK, Comeau MR, Peters AT, Hulse KE, et al. Thymic stromal lymphopoietin activity is increased in nasal polyps of patients with chronic rhinosinusitis. J Allergy Clin Immunol. 2013;132(3):593-600. DOI: 10.1016/j.jaci.2013.04.005. Open DOISearch in Google Scholar