Top

Published in:

30-08-2023 | Omalizumab

Omalizumab Treatment in Uncontrolled Asthma and CRSwNP Patients, with Previous Endoscopic Sinus Surgery, to Improve Quality of Life and Endoscopic Outcomes: a Two-Year Real-Life Study

Authors: Juan Maza-Solano, Amparo Callejon-Leblic, Daniel Martin-Jimenez, Ramon Moreno-Luna, Jaime Gonzalez-Garcia, Alfonso Cuvillo, Serafin Sanchez-Gomez

Published in: Current Allergy and Asthma Reports | Issue 10/2023

Abstract

Purpose of Review

Despite molecular underlying advances, limited and divergent data on monoclonal antibodies (mAb) therapy in chronic rhinosinusitis with nasal polyps (CRSwNP) make further analysis necessary. The objective of this study is to evaluate the effect of omalizumab as an adjunct to endoscopic sinus surgery (ESS) on the treatment of CRSwNP under real-life conditions.

Recent Findings

Since the introduction of omalizumab, as the first biologic agent for the treatment of diseases such as severe allergic asthma, different studies have demonstrated an effect of omalizumab on CRSwNP, with significant improvements in sinonasal symptoms and endoscopic scores. The high efficacy derived from mAb therapy and the need for ESS prior to mAb recommended by guidelines, has led to compare both therapeutic alternatives, finding discrepancies in their effect on quality of life (QoL) and complementary tests outcomes.

Summary

Patients with moderate-to-severe asthma with clinical criteria for omalizumab indication, and coexistent CRSwNP disease, were selected for a non-randomized interventional retrospective study into four treatment subgroups. Measures were analyzed and compared between groups and over time at the baseline, 16 weeks and 1 and 2 years after treatment. Omalizumab treatment in patients with previous ESS exhibited an earlier and more pronounced improvement in QoL, symptoms scale and endoscopic findings (nasal polyp score and the bilateral modified Lund-Kennedy) as early from week 16, which improvement persisted for 2 years. A greater mean improvement of 33.4 ± 6.5 (95% CI: 20.3–46.4; p < 0.001) points in sinonasal outcome test 22 (SNOT-22) was associated with ESS at week 16, against omalizumab effect (17.8 ± 7.6 [95% CI: 2.6–33.0]; p = 0.023). At year 2, an improvement in SNOT-22 of 62.6 ± 8.9 (95% CI: 48.4–84.1; p < 0.001) points was exclusively associated with omalizumab. Clinical evidence of the effect of omalizumab added to ESS treatment is provided in this study in the short- and long-term.

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. https://doi.org/10.4193/rhin20.600.

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. https://doi.org/10.2500/ajra.2011.25.3613.CrossRefPubMed

Sanchez-Collado I, Mora T, Munoz-Cano R, Ribo P, Mullol J, Valero A. Prevalence of chronic rhinosinusitis with nasal polyps in Catalonia (Spain): a retrospective, large-scale population-based study. Rhinology. 2022;60(5):384–96. https://doi.org/10.4193/rhin21.364.CrossRefPubMed

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):1449-1456.e4. https://doi.org/10.1016/j.jaci.2015.12.1324.CrossRefPubMed

Bachert C, Marple B, Hosemann W, Cavaliere C, Wen W, Zhang N. Endotypes of chronic rhinosinusitis with nasal polyps: pathology and possible therapeutic implications. J Allergy Clin Immunol Pract. 2020;8(5):1514–9. https://doi.org/10.1016/j.jaip.2020.03.007.CrossRefPubMed

Cardell LO, Stjärne P, Jonstam K, Bachert C. Endotypes of chronic rhinosinusitis: Impact on management. J Allergy Clin Immunol. 2020;145(3):752–6. https://doi.org/10.1016/j.jaci.2020.01.019.CrossRefPubMed

Rudmik L, Hopkins C, Peters A, Smith TL, Schlosser RJ, Soler ZM. Patient-reported outcome measures for adult chronic rhinosinusitis: a systematic review and quality assessment. J Allergy Clin Immunol. 2015;136(6):1532-1540.e2. https://doi.org/10.1016/j.jaci.2015.10.012.CrossRefPubMed

C Morse J, Miller C, Senior B. Management of chronic rhinosinusitis with nasal polyposis in the era of biologics. J Asthma Allergy. 2021;14:873–82. https://doi.org/10.2147/jaa.s258438.

Chen FH, Deng J, Hong HY, Xu R, Guo JB, Hou WJ, et al. Extensive versus functional endoscopic sinus surgery for chronic rhinosinusitis with nasal polyps and asthma: A 1-year study. Am J Rhinol Allergy. 2016;30(2):143–8. https://doi.org/10.2500/ajra.2016.30.4271.CrossRefPubMed

10.

Alsharif S, Jonstam K, van Zele T, Gevaert P, Holtappels G, Bachert C. Endoscopic sinus surgery for type-2 CRS wNP: an endotype-based retrospective study. Laryngoscope. 2019;129(6):1286–92. https://doi.org/10.1002/lary.27815.CrossRefPubMed

11.

Moreno-Luna R, Martin-Jimenez DI, Callejon-Leblic MA, Gonzalez-Garcia J, Maza-Solano JM, Porras-Gonzalez C, et al. Usefulness of bilateral mucoplasty plus reboot surgery in severe type-2 chronic rhinosinusitis with nasal polyps. Rhinology. 2022;60(5):368–76. https://doi.org/10.4193/rhin22.131.CrossRefPubMed

12.

•• Bachert C, Maurer M, Palomares O, Busse WW. What is the contribution of IgE to nasal polyposis? J Allergy Clin Immunol. 2021;147(6):1997–2008. https://doi.org/10.1016/j.jaci.2021.03.016. Outcomes of this review reinforce the role of IgE as a central mediator of type 2 eosinophil-dominated inflammation in nasal polyposis, which may be inferred from the efficacy of omalizumab.

13.

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. https://doi.org/10.1016/j.waojou.2019.100050.

14.

Zhang N, Holtappels G, Gevaert P, Patou J, Dhaliwal B, Gould H, et al. Mucosal tissue polyclonal IgE is functional in response to allergen and SEB. Allergy. 2011;66(1):141–8. https://doi.org/10.1111/j.1398-9995.2010.02448.x.CrossRefPubMed

15.

Kartush AG, Schumacher JK, Shah R, Patadia MO. Biologic agents for the treatment of chronic rhinosinusitis with nasal polyps. Am J Rhinol Allergy. 2019;33(2):203–11. https://doi.org/10.1177/1945892418814768.CrossRefPubMed

16.

Bachert C, Zhang N, Cavaliere C, Weiping W, Gevaert E, Krysko O. Biologics for chronic rhinosinusitis with nasal polyps. J Allergy Clin Immunol. 2020;145(3):725–39. https://doi.org/10.1016/j.jaci.2020.01.020.CrossRefPubMed

17.

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. https://doi.org/10.4193/rhino09.144.CrossRefPubMed

18.

Wu Q, Yuan L, Qiu H, Wang X, Huang X, Zheng R, et al. Efficacy and safety of omalizumab in chronic rhinosinusitis with nasal polyps: a systematic review and meta-analysis of randomised controlled trials. BMJ Open. 2021;11(9):e047344. https://doi.org/10.1136/bmjopen-2020-047344.

19.

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.CrossRefPubMed

20.

Bajpai S, Marino MJ, Rank MA, Donaldson AM, O’Brien EK, Lal D. Benefits of biologic therapy administered for asthma on co-existent chronic rhinosinusitis: a real-world study. Int Forum Allergy Rhinol. 2021;11(8):1152–61. https://doi.org/10.1002/alr.22774.CrossRefPubMed

21.

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):110-116.e1. https://doi.org/10.1016/j.jaci.2012.07.047.CrossRefPubMed

22.

Fokkens WJ, Viskens AS, Backer V, Conti D, De Corso E, Gevaert P, et al. EPOS/EUFOREA update on indication and evaluation of biologics in chronic rhinosinusitis with nasal polyps 2023. Rhinology. 2023;61(3):194–202. https://doi.org/10.4193/rhin22.489.CrossRefPubMed

23.

Orlandi RR, Kingdom TT, Smith TL, Bleier B, DeConde A, Luong AU, et al. International consensus statement on allergy and rhinology: rhinosinusitis 2021. Int Forum Allergy Rhinol. 2021;11(3):213–739. https://doi.org/10.1002/alr.22741.CrossRefPubMed

24.

Alobid I, Colás C, Castillo JA, Arismendi E, Del Cuvillo A, Gómez-Outes A, et al. Spanish consensus on the management of chronic rhinosinusitis with nasal polyps (POLIposis NAsal / POLINA 2.0). J Investig Allergol Clin Immunol. 2023;0. Online ahead of print. https://doi.org/10.18176/jiaci.0910.

25.

Bachert C, Sousa AR, Lund VJ, 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):1024-1031.e14. https://doi.org/10.1016/j.jaci.2017.05.044.CrossRefPubMed

26.

Hopkins C, Wagenmann M, Bachert C, Desrosiers M, Han JK, Hellings PW, et al. Efficacy of dupilumab in patients with a history of prior sinus surgery for chronic rhinosinusitis with nasal polyps. Int Forum Allergy Rhinol. 2021;11(7):1087–101. https://doi.org/10.1002/alr.22780.CrossRefPubMedPubMedCentral

27.

Miglani A, Soler ZM, Smith TL, Mace JC, Schlosser RJ. A comparative analysis of endoscopic sinus surgery versus biologics for treatment of chronic rhinosinusitis with nasal polyposis. Int Forum Allergy Rhinol. 2023;13(2):116–28. https://doi.org/10.1002/alr.23059.CrossRefPubMed

28.

Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, et al. European position paper on rhinosinusitis and nasal polyps 2012. Rhinol Suppl. 2012;23:3 p preceding table of contents, 1–298.

29.

Global Initiative for Asthma - GINA. In: Global Initiative for Asthma. 2022. https://ginasthma.org/. Accessed 5 April 2023.

30.

Rudmik L, Soler ZM, Hopkins C, Schlosser RJ, Peters A, White AA, et al. Defining appropriateness criteria for endoscopic sinus surgery during management of uncomplicated adult chronic rhinosinusitis: a RAND/UCLA appropriateness study. Rhinology. 2016;54(2):117–28. https://doi.org/10.4193/rhino16.023.CrossRefPubMed

31.

Toma S, Hopkins C. Stratification of SNOT-22 scores into mild, moderate or severe and relationship with other subjective instruments. Rhinology. 2016;54(2):129–33. https://doi.org/10.4193/rhino15.072.CrossRefPubMed

32.

Doulaptsi M, Prokopakis E, Seys S, Pugin B, Steelant B, Hellings P. Visual analogue scale for sino-nasal symptoms severity correlates with sino-nasal outcome test 22: paving the way for a simple outcome tool of CRS burden. Clin Transl Allergy. 2018;8:32. https://doi.org/10.1186/s13601-018-0219-6.CrossRefPubMedPubMedCentral

33.

Meltzer EO, Hamilos DL, Hadley JA, Lanza DC, Marple BF, Nicklas RA, et al. Rhinosinusitis: developing guidance for clinical trials. J Allergy Clin Immunol. 2006;118(5 Suppl):S17-61. https://doi.org/10.1016/j.jaci.2006.09.005.CrossRefPubMed

34.

Psaltis AJ, Li G, Vaezeafshar R, Cho KS, Hwang PH. Modification of the Lund-Kennedy endoscopic scoring system improves its reliability and correlation with patient-reported outcome measures. Laryngoscope. 2014;124(10):2216–23. https://doi.org/10.1002/lary.24654.CrossRefPubMed

35.

Hopkins C, Browne JP, Slack R, Lund V, Brown P. The Lund-Mackay staging system for chronic rhinosinusitis: how is it used and what does it predict? Otolaryngol-Head Neck Surg Off J Am Acad Otolaryngol-Head Neck Surg. 2007;137(4):555–61. https://doi.org/10.1016/j.otohns.2007.02.004.CrossRef

36.

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. https://doi.org/10.18176/jiaci.0391.

37.

• Damask C, Chen M, Holweg CTJ, Yoo B, Millette LA, Franzese C. Defining the efficacy of omalizumab in nasal polyposis: a POLYP 1 and POLYP 2 subgroup analysis. Am J Rhinol Allergy. 2022;36(1):135–41. https://doi.org/10.1177/19458924211030486. Findings suggest broad efficacy of omalizumab across clinical and patient-reported outcomes in patients with CRSwNP, independent of the underlying patient features analyzed.

38.

Han JK, Yoo B, Saenz R, Braid J, Millette LA, Lee SE. Omalizumab and quality of life in nasal polyps: a post hoc analysis. Int Forum Allergy Rhinol. 2022;12(9):1188–90. https://doi.org/10.1002/alr.22963.

39.

Huang Y, Zhang N, Xu Z, Zhang L, Bachert C. The development of the mucosal concept in chronic rhinosinusitis and its clinical implications. J Allergy Clin Immunol Pract. 2022;10(3):707–15. https://doi.org/10.1016/j.jaip.2021.10.054.CrossRefPubMed

40.

Jonstam K, Alsharif S, Bogaert S, Suchonos N, Holtappels G, Jae-Hyun Park J, et al. Extent of inflammation in severe nasal polyposis and effect of sinus surgery on inflammation. Allergy. 2021;76(3):933–6. https://doi.org/10.1111/all.14550.CrossRefPubMed

41.

López-Enríquez S, Porras-González C, Moreno-Luna R, Ebert CS, Alba G, Santa-María C, et al. Tissue-specific activated regulatory lymphocytes immunophenotype in chronic rhinosinusitis with nasal polyps. Arch Bronconeumol. 2023;59(5):337–40. https://doi.org/10.1016/j.arbres.2022.12.013.CrossRefPubMed

42.

Kobayashi Y, Kanda A, Bui DV, Yun Y, Nguyen LM, Chu HH, et al. Omalizumab restores response to corticosteroids in patients with eosinophilic chronic rhinosinusitis and severe asthma. Biomedicines. 2021;9(7):787. https://doi.org/10.3390/biomedicines9070787.CrossRefPubMedPubMedCentral

43.

•• Armengot-Carceller M, Gómez-Gómez MJ, García-Navalón C, Doménech-Campos E, Muñoz-Fernández N, Miguel AGL de, et al. Effects of omalizumab treatment in patients with recalcitrant nasal polyposis and mild asthma: a multicenter retrospective study. Am J Rhinol Allergy. 2021;35(4):516–24. https://doi.org/10.1177/1945892420972326. This real-life study demonstrated the efficacy of Omalizumab in patients with recalcitrant CRSwNP and mild asthma, even when AERD was present, decreasing polyp size and improvement quality of life.

44.

Bidder T, Sahota J, Rennie C, Lund VJ, Robinson DS, Kariyawasam HH. Omalizumab treats chronic rhinosinusitis with nasal polyps and asthma together-a real life study. Rhinology. 2018;56(1):42–5. https://doi.org/10.4193/rhino17.139.CrossRefPubMed

45.

Vennera M del C, Picado C, Mullol J, Alobid I, Bernal-Sprekelsen M. Efficacy of omalizumab in the treatment of nasal polyps. Thorax. 2011;66(9):824–5. https://doi.org/10.1136/thx.2010.152835.

46.

Tokunaga T, Sakashita M, Haruna T, Asaka D, Takeno S, Ikeda H, et al. Novel scoring system and algorithm for classifying chronic rhinosinusitis: the JESREC study. Allergy. 2015;70(8):995–1003. https://doi.org/10.1111/all.12644.CrossRefPubMed

47.

DeConde AS, Mace JC, Levy JM, Rudmik L, Alt JA, Smith TL. Prevalence of polyp recurrence after endoscopic sinus surgery for chronic rhinosinusitis with nasal polyposis. Laryngoscope. 2017;127(3):550–5. https://doi.org/10.1002/lary.26391.CrossRefPubMed

48.

Mümmler C, Dünzelmann K, Kneidinger N, Barnikel M, Munker D, Gröger M, et al. Real-life effectiveness of biological therapies on symptoms in severe asthma with comorbid CRSwNP. Clin Transl Allergy. 2021;11(5):e12049. https://doi.org/10.1002/clt2.12049.

49.

Penn R, Mikula S. The role of anti-IgE immunoglobulin therapy in nasal polyposis: a pilot study. Am J Rhinol. 2007;21(4):428–32.CrossRefPubMed

50.

Cai S, Xu S, Lou H, Zhang L. Comparison of different biologics for treating chronic rhinosinusitis with nasal polyps: a network analysis. J Allergy Clin Immunol Pract. 2022;10(7):1876-1886.e7. https://doi.org/10.1016/j.jaip.2022.02.034.CrossRefPubMed

51.

Roland LT, Smith TL, Schlosser RJ, Soler ZM, Peters AT, Laidlaw TM, et al. Guidance for contemporary use of biologics in management of chronic rhinosinusitis with nasal polyps: discussion from a National Institutes of Health–sponsored workshop. Int Forum Allergy Rhinol. 2020;10(9):1037–42. https://doi.org/10.1002/alr.22633.CrossRefPubMed

Title: Omalizumab Treatment in Uncontrolled Asthma and CRSwNP Patients, with Previous Endoscopic Sinus Surgery, to Improve Quality of Life and Endoscopic Outcomes: a Two-Year Real-Life Study
Authors: Juan Maza-Solano
Amparo Callejon-Leblic
Daniel Martin-Jimenez
Ramon Moreno-Luna
Jaime Gonzalez-Garcia
Alfonso Cuvillo
Serafin Sanchez-Gomez
Publication date: 30-08-2023
Publisher: Springer US
Keywords: Omalizumab
Bronchial Asthma
Sinus Surgery
Published in: Current Allergy and Asthma Reports / Issue 10/2023
Print ISSN: 1529-7322
Electronic ISSN: 1534-6315
DOI: https://doi.org/10.1007/s11882-023-01106-w

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Omalizumab Treatment in Uncontrolled Asthma and CRSwNP Patients, with Previous Endoscopic Sinus Surgery, to Improve Quality of Life and Endoscopic Outcomes: a Two-Year Real-Life Study

Abstract

Purpose of Review

Recent Findings

Summary

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Purpose of Review

Recent Findings

Summary

Please log in to get access to this content

Other articles of this Issue 10/2023

Occupational Rhinitis: An Update

The Role of IgA in the Manifestation and Prevention of Allergic Immune Responses

Environmental risk factors in schools and childhood asthma

Allergen Stability in Food Allergy: A Clinician’s Perspective

Management of Mechanical Nasal Obstruction Isolated or Associated to Upper Airway Inflammatory Diseases in Real Life: Use of both Subjective and Objective Criteria