The role of omalizumab in the treatment of chronic rhinosinusitis with nasal polyposis

References

• Bhattacharyya N. Incremental health care utilization and expenditures for chronic rhinosinusitis in the United States. Ann Otol Rhinol Laryngol. 2011 Jul;120(7):423–427. PubMed PMID: 21859049; eng.
   PubMed Web of Science ®Google Scholar
• Chaaban MR, Walsh EM, Woodworth BA. Epidemiology and differential diagnosis of nasal polyps. Am J Rhinol Allergy. 2013 Nov-Dec;27(6):473–478. PubMed PMID: 24274222; PubMed Central PMCID: PMCPMC3899526. eng.
   PubMed Web of Science ®Google Scholar
• Fokkens WJ, Lund VJ, Mullol J, et al. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology. 2012 Mar;50(1):1–12. PubMed PMID: 22469599; eng.
   PubMed Web of Science ®Google Scholar
• Stevens WW, Schleimer RP, Kern RC. Chronic Rhinosinusitis with Nasal Polyps. The Journal of Allergy and Clinical Immunology in Practice. 2016 Jul-Aug;4(4):565–572. PubMed PMID: 27393770; PubMed Central PMCID: PMCPMC4939220. eng.
   PubMed Web of Science ®Google Scholar
• Han JK, Bosso JV, Cho SH, et al.Multidisciplinary consensus on a stepwise treatment algorithm for management of chronic rhinosinusitis with nasal polyps [https://doi.org/10.1002/alr.22851]. Int Forum Allergy Rhinol. 2021; n/a(n/a) 2021 May 31. DOI:https://doi.org/10.1002/alr.22851.
   Google Scholar
• Gevaert P, Calus L, Van Zele T, et al. Omalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma. J Allergy Clin Immunol. 2013;131(1):110–116.e1.
   PubMed Web of Science ®Google Scholar
• DeConde AS, Mace JC, Levy JM, et al. Prevalence of polyp recurrence after endoscopic sinus surgery for chronic rhinosinusitis with nasal polyposis. Laryngoscope. 2017 Mar;127(3):550–555. PubMed PMID: 27859303; PubMed Central PMCID: PMCPMC5321782. eng.
   PubMed Web of Science ®Google Scholar
• Bhattacharyya N, Villeneuve S, Joish VN, et al. Cost burden and resource utilization in patients with chronic rhinosinusitis and nasal polyps. Laryngoscope. 2019 Sep;129(9):1969–1975. PubMed PMID: 30720213; PubMed Central PMCID: PMCPMC6767455. eng.
   PubMed Web of Science ®Google Scholar
• Shinee T, Sutikno B, Abdullah B. The use of biologics in children with allergic rhinitis and chronic rhinosinusitis: current updates. Pediatric Investigation. 2019;3(3):165–172.
   Google Scholar
• Hull BP, Chandra RK. Refractory Chronic Rhinosinusitis with Nasal Polyposis. Otolaryngol Clin North Am. 2017 Feb;50(1):61–81. PubMed PMID: 27888916; eng.
   PubMed Web of Science ®Google Scholar
• Han JK. Subclassification of chronic rhinosinusitis. Laryngoscope. 2013 Mar;123(Suppl 2):S15–27. PubMed PMID: 23371324; eng.
   PubMed Web of Science ®Google Scholar
• Staudacher AG, Peters AT, Kato A, et al. Use of endotypes, phenotypes, and inflammatory markers to guide treatment decisions in chronic rhinosinusitis. Ann Allergy Asthma Immunol. 2020 Apr;124(4):318–325. PubMed PMID: 32007571; PubMed Central PMCID: PMCPMC7192133. eng.
   PubMed Web of Science ®Google Scholar
• Olcott CM, Han JK, Cunningham TD, et al. Interleukin-9 and interleukin-17C in chronic rhinosinusitis. Int Forum Allergy Rhinol. 2016 Aug 6;8:841–847. https://doi.org/10.1002/alr.21745. PubMed PMID: 26989880; eng.
   Google Scholar
• Tomassen P, Vandeplas G, Van Zele T, et al. Inflammatory endotypes of chronic rhinosinusitis based on cluster analysis of biomarkers. J Allergy Clin Immunol. 2016 May;137(5):1449–1456.e4. PubMed PMID: 26949058; eng.
   PubMed Web of Science ®Google Scholar
• Bachert C, Zhang N, Holtappels G, 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 Nov;126(5):962–8, 968.e1-6. PubMed PMID: 20810157; eng.
   Web of Science ®Google Scholar
• Bachert C, Han JK, Desrosiers M, et al. Efficacy and safety of dupilumab in patients with severe chronic rhinosinusitis with nasal polyps (LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52): results from two multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 3 trials. Lancet. 2019;394(10209):1638–1650.
   PubMed Web of Science ®Google Scholar
• Kim J, Naclerio R. Therapeutic Potential of Dupilumab in the Treatment of Chronic Rhinosinusitis with Nasal Polyps: evidence to Date. Ther Clin Risk Manag. 2020;16:31–37. PubMed PMID: 32158216; eng.
   PubMed Web of Science ®Google Scholar
• Nasta MS, Chatzinakis VA, Georgalas CC. Updates on current evidence for biologics in chronic rhinosinusitis. PubMed PMID: 00020840-202002000-00006 Curr Opin Otolaryngol Head Neck Surg. 2020;281:18–24.
   PubMed Web of Science ®Google Scholar
• Boyle JV, Lam K, Han JK. Dupilumab in the treatment of chronic rhinosinusitis with nasal polyposis. Immunotherapy. 20202020/02/01;12(2):111–121.
   PubMed Web of Science ®Google Scholar
• Gevaert P, Van Bruaene N, Cattaert T, et al. Mepolizumab, a humanized anti-IL-5 mAb, as a treatment option for severe nasal polyposis. J Allergy Clin Immunol. 2011 Nov;128(5). 989-95.e1-8. doi: https://doi.org/10.1016/j.jaci.2011.07.056. PubMed PMID: 21958585; eng.
   Web of Science ®Google Scholar
• Han JK, Bachert C, Fokkens W, et al. Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2021 Apr 16 PubMed PMID: 33872587; eng. DOI:https://doi.org/10.1016/s2213-2600(21)00097-7.
   Google Scholar
• Gevaert P, Lang-Loidolt D, Lackner A, et al. Nasal IL-5 levels determine the response to anti-IL-5 treatment in patients with nasal polyps. J Allergy Clin Immunol. 2006 Nov;118(5):1133–1141. PubMed PMID: 17088140; eng.
   PubMed Web of Science ®Google Scholar
• Lam K, Kern RC, Luong A. Is there a future for biologics in the management of chronic rhinosinusitis? Int Forum Allergy Rhinol. 2016 Sep;6(9):935–942. PubMed PMID: 27103607; PubMed Central PMCID: PMCPMC5012929. eng.
   PubMed Web of Science ®Google Scholar
• Bachert C, Akdis CA. Phenotypes and Emerging Endotypes of Chronic Rhinosinusitis. The Journal of Allergy and Clinical Immunology in Practice. 2016 Jul-Aug;4(4):621–628. PubMed PMID: 27393777; eng.
   PubMed Web of Science ®Google Scholar
• Baroody FM, Suh SH, Naclerio RM. Total IgE serum levels correlate with sinus mucosal thickness on computerized tomography scans. J Allergy Clin Immunol. 1997 Oct;100(4):563–568. PubMed PMID: 9338553; eng.
   PubMed Web of Science ®Google Scholar
• Bachert C, Zhang N, Patou J, et al. Role of staphylococcal superantigens in upper airway disease. Curr Opin Allergy Clin Immunol. 2008 Feb 8;1:34–38. DOI:https://doi.org/10.1097/ACI.0b013e3282f4178f. PubMed PMID: 18188015; eng.
   Google Scholar
• Godse K, Mehta A, Patil S, et al. Omalizumab-A Review. Indian J Dermatol. 2015 Jul-Aug;60(4):381–384. PubMed PMID: 26288408; PubMed Central PMCID: PMCPMC4533538. eng.
   PubMed Web of Science ®Google Scholar
• Genentech USA and Novartis Pharmaceuticals. XOLAIR (omalizumab) injection, for subcutaneous use: US prescribing information. 2020. US Food and Drug Administration Website
   Google Scholar
• Matera MG, Calzetta L, Rogliani P, et al. Monoclonal antibodies for severe asthma: pharmacokinetic profiles. Respir Med. 2019 Jul;153:3–13. PubMed PMID: 31136930; eng.
   PubMed Web of Science ®Google Scholar
• Chang TW. The pharmacological basis of anti-IgE therapy. Nat Biotechnol. 2000 Feb;18(2):157–162. PubMed PMID: 10657120; eng.
   PubMed Web of Science ®Google Scholar
• Hook WA, Zinsser FU, Berenstein EH, et al. Monoclonal antibodies defining epitopes on human IgE. Mol Immunol. 1991 Jun;28(6):631–639. PubMed PMID: 1713647; eng.
   PubMed Web of Science ®Google Scholar
• Belliveau PP. Omalizumab: a monoclonal anti-IgE antibody. MedGenMed: Medscape general medicine. 2005 Jan 27;7(1):27. PubMed PMID: 16369332; PubMed Central PMCID: PMCPMC1681435. eng.
   PubMedGoogle Scholar
• Malveaux FJ, Conroy MC, Adkinson NF Jr., et al. IgE receptors on human basophils. Relationship to serum IgE concentration. J Clin Invest. 1978 Jul;62(1):176–181. PubMed PMID: 659631; PubMed Central PMCID: PMCPMC371751. eng.
   PubMed Web of Science ®Google Scholar
• MacGlashan DW Jr., Bochner BS, Adelman DC, 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 Feb 1;158(3):1438–1445. PubMed PMID: 9013989; eng.
   PubMed Web of Science ®Google Scholar
• Saban R, Haak-Frendscho M, Zine M, et al. Human FcERI-IgG and humanized anti-IgE monoclonal antibody MaE11 block passive sensitization of human and rhesus monkey lung. J Allergy Clin Immunol. 1994 Nov;94(5):836–843. PubMed PMID: 7525678; eng.
   PubMed Web of Science ®Google Scholar
• Sahota J, Bidder T, Livingston R, et al. Chronic rhinosinusitis and omalizumab: eosinophils not IgE predict treatment response in real-life. Rhinology Online. 2018;10/01(1):147–153.
   Google Scholar
• Sreeparvathi A, Kalyanikuttyamma LK, Kumar M, et al. Significance of Blood Eosinophil Count in Patients with Chronic Rhinosinusitis with Nasal Polyposis. J Clin Diagn Res. 2017;11(2):MC08–MC11. PubMed PMID: 28384896; eng.
   PubMed Web of Science ®Google Scholar
• Aslan F, Altun E, Paksoy S, et al. Could Eosinophilia predict clinical severity in nasal polyps? Multidiscip Respir Med. 2017;12(1):21. PubMed PMID: 28835819; PubMed Central PMCID: PMCPMC5563888. eng.
   PubMed Web of Science ®Google Scholar
• Takaku Y, Soma T, Nishihara F, et al. Omalizumab attenuates airway inflammation and interleukin-5 production by mononuclear cells in patients with severe allergic asthma. Int Arch Allergy Immunol. 2013;161(Suppl 2):107–117. PubMed PMID: 23711861; eng.
   PubMed Web of Science ®Google Scholar
• Wright JD, Chu H-M, Huang C-H, et al. Structural and Physical Basis for Anti-IgE Therapy. Sci Rep. 2015;5(1):11581. PubMed PMID: 26113483; eng.
   PubMed Web of Science ®Google Scholar
• Pinto JM, Mehta N, DiTineo M, et al. A randomized, double-blind, placebo-controlled trial of anti-IgE for chronic rhinosinusitis. Rhinology. 2010 Sep;48(3):318–324. PubMed PMID: 21038023; eng.
   PubMed Web of Science ®Google Scholar
• Gevaert P, Omachi TA, Corren J, et al. Efficacy and safety of omalizumab in nasal polyposis: 2 randomized phase 3 trials. J Allergy Clin Immunol. 2020;146(3):595–605.
   PubMed Web of Science ®Google Scholar
• Corren J, Casale TB, Lanier B, et al. Safety and tolerability of omalizumab. Clinical and experimental allergy. journal of the British Society for Allergy and Clinical Immunology. 2009 Jun;39(6):788–797. doi: https://doi.org/10.1111/j.1365-2222.2009.03214.x PubMed PMID: 19302249; eng
   Web of Science ®Google Scholar
• Lai T, Wang S, Xu Z, et al. Long-term efficacy and safety of omalizumab in patients with persistent uncontrolled allergic asthma: a systematic review and meta-analysis. Sci Rep. 2015 Feb 3;5(1):8191. PubMed PMID: 25645133; PubMed Central PMCID: PMCPMC4314644. eng.
   PubMed Web of Science ®Google Scholar
• Gevaert P, Saenz R, Corren J, et al. D202 CONTINUED SAFETY/EFFICACY OF OMALIZUMAB IN CHRONIC RHINOSINUSITIS WITH NASAL POLYPS: AN OPEN-LABEL EXTENSION STUDY. Ann Allergy Asthma Immunol. 2020;125(5):S15.
   Web of Science ®Google Scholar
• Fokkens WJ, Lund V, Bachert C, et al. EUFOREA consensus on biologics for CRSwNP with or without asthma. Allergy. 2019;74(12):2312–2319.
   PubMed Web of Science ®Google Scholar
• Wu AC, Paltiel AD, Kuntz KM, et al. Cost-effectiveness of omalizumab in adults with severe asthma: results from the Asthma Policy Model. J Allergy Clin Immunol. 2007 Nov;120(5):1146–1152. PubMed PMID: 17904628; PubMed Central PMCID: PMCPMC3476046. eng.
   PubMed Web of Science ®Google Scholar
• Morishima T, Ikai H, Imanaka Y. Cost-Effectiveness Analysis of Omalizumab for the Treatment of Severe Asthma in Japan and the Value of Responder Prediction Methods Based on a Multinational Trial. Value Health Reg Issues. 2013;2(1):29–36.
   PubMedGoogle Scholar
• Sullivan PW, Li Q, Bilir SP, et al. Cost-effectiveness of omalizumab for the treatment of moderate-to-severe uncontrolled allergic asthma in the United States. Curr Med Res Opin. 2020 Jan;36(1):23–32. PubMed PMID: 31491337; eng.
   PubMed Web of Science ®Google Scholar
• Suzuki C, Lopes Da Silva N, Kumar P, et al. Cost-effectiveness of omalizumab add-on to standard-of-care therapy in patients with uncontrolled severe allergic asthma in a Brazilian healthcare setting. J Med Econ. 2017 Aug;20(8):832–839. PubMed PMID: 28532191; eng.
   PubMed Web of Science ®Google Scholar
• Canonica GW, Colombo GL, Rogliani P, et al. Omalizumab for Severe Allergic Asthma Treatment in Italy: a Cost-Effectiveness Analysis from PROXIMA Study. Risk Manag Healthc Policy. 2020;13:43–53. PubMed PMID: 32158289; PubMed Central PMCID: PMCPMC6986414. eng.
   PubMed Web of Science ®Google Scholar
• Codispoti CD, Mahdavinia M. A call for cost-effectiveness analysis for biologic therapies in chronic rhinosinusitis with nasal polyps. Ann Allergy Asthma Immunol. 2019 Sep;123(3):232–239. PubMed PMID: 31295554; eng.
   PubMed Web of Science ®Google Scholar
• Brown WC, Senior B, Critical A. Look at the Efficacy and Costs of Biologic Therapy for Chronic Rhinosinusitis with Nasal Polyposis. Curr Allergy Asthma Rep. 2020 Apr 22;20(6):16. PubMed PMID: 32323067; eng.
   PubMed Web of Science ®Google Scholar