Skip to main content
Log in

Real-Life Effectiveness of Benralizumab, Mepolizumab and Omalizumab in Severe Allergic Asthma Associated with Nasal Polyps

  • Published:
Clinical Reviews in Allergy & Immunology Aims and scope Submit manuscript

Abstract

Biological therapies are available for the treatment of the severe allergic asthma (SAA) with blood eosinophil count ≥ 0.3 × 109/L. Several of them also showed benefits on nasal polyps (NP), one of the most frequent comorbidities of the severe asthma, but comparative studies on their effectiveness in the association SAA-NP are currently lacking. The aim of this study is to compare the effectiveness of benralizumab, mepolizumab and omalizumab in patients with SAA-NP in real-life settings. A retrospective, observational, multicenter real-life study was realized including patients with SAA-NP treated by benralizumab, mepolizumab or omalizumab for 6 months. We analysed the nasal and respiratory symptoms, the number of asthma attacks and salbutamol use/week, acute sinusitis and severe exacerbation rates, the asthma control score, the lung function parameters, the NP endoscopic score, the sinus imaging and the blood eosinophil count 6 months before and after treatment. Seventy-two patients with SAA-NP were included: 16 treated by benralizumab, 21 by mepolizumab and 35 by omalizumab. After 6 months of treatment, almost all studied parameters were improved (except sinus imaging) with a greater effect of omalizumab on the nasal pruritus (p = 0.001) and more benefits of benralizumab on exacerbations rate, asthma attacks per week and lung function (all p < 0.05). Benralizumab and mepolizumab were more effective to improve the NP endoscopic score and the blood eosinophil count (both p < 0.001). All three biological therapies showed effectiveness by improving asthma and nasal outcomes in patients with SAA-NP. Several differences have been found that should be confirmed by larger comparative studies.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

Abbreviations

ICS:

Inhaled corticosteroids

LABA:

Long-acting β2 receptors agonists

CS:

Systemic corticosteroids

IgE:

Immunoglobulin E

BEC:

Blood eosinophil count

IL-5:

Interleukin 5

IL-5R:

Interleukin 5 receptor

IL-4:

Interleukin 4

NP:

Nasal polyps

SAA:

Severe allergic asthma

ENT:

Ear Nose Throat

SABA:

Short-acting β2 receptors agonists

ACT:

Asthma Control Test

FEV1:

Forced expiratory volume in one second

FVC:

Forced vital capacity

T0:

At baseline

T6:

After 6 months of treatment

CT:

Computed tomography

OR:

Odds ratios

GINA:

Global Initiative for Asthma

References

  1. GINA Difficult-to-treat & severe asthma in adolescent and adult patients. Diagnosis and management; 2021. Available from: https://ginasthma.org/wp-content/uploads/2021/08/SA-Pocket-guide-v3.0-SCREEN-WMS.pdf. [cited 2021 Nov 16]

  2. Humbert M, Bousquet J, Bachert C, Palomares O, Pfister P, Kottakis I et al (2019) IgE-mediated multimorbidities in allergic asthma and the potential for omalizumab therapy. J Allergy Clin Immunol Pract 7:1418–1429

    Article  PubMed  Google Scholar 

  3. Shaw DE, Sousa AR, Fowler SJ, Fleming LJ, Roberts G, Corfield J et al (2015) Clinical and inflammatory characteristics of the European U-BIOPRED adult severe asthma cohort. Eur Respir J 46:1308–1321

    Article  CAS  PubMed  Google Scholar 

  4. Pretolani M, Soussan D, Poirier I, Thabut G, Aubier M, COBRA Study Group et al (2017) Clinical and biological characteristics of the French COBRA cohort of adult subjects with asthma. Eur Respir J 50:1700019. https://doi.org/10.1183/13993003.00019-2017

  5. Wang E, Wechsler ME, Tran TN, Heaney LG, Jones RC, Menzies-Gow AN et al (2020) Characterization of severe asthma worldwide: data from the international severe asthma registry. Chest 157:790–804

    Article  CAS  PubMed  Google Scholar 

  6. Fokkens WJ, Lund VJ, Hopkins C, Hellings PW, Kern R, Reitsma S et al (2020) European position paper on rhinosinusitis and nasal polyps 2020. Rhinology 58(Suppl S29):1–464

  7. Bilodeau L, Boulay M-E, Prince P, Boisvert P, Boulet L-P (2010) Comparative clinical and airway inflammatory features of asthmatics with or without polyps. Rhinology 48:420–425

    Article  PubMed  Google Scholar 

  8. Bhattacharyya N, Villeneuve S, Joish VN, Amand C, Mannent L, Amin N et al (2019) Cost burden and resource utilization in patients with chronic rhinosinusitis and nasal polyps. Laryngoscope 129:1969–1975

    Article  PubMed  PubMed Central  Google Scholar 

  9. Bagnasco D, Brussino L, Bonavia M, Calzolari E, Caminati M, Caruso C et al (2020) Efficacy of Benralizumab in severe asthma in real life and focus on nasal polyposis. Respir Med 171:106080. https://doi.org/10.1016/j.rmed.2020.106080

    Article  PubMed  Google Scholar 

  10. Blakey JD, Price DB, Pizzichini E, Popov TA, Dimitrov BD, Postma DS et al (2017) Identifying risk of future asthma attacks using UK medical record data: a respiratory effectiveness group initiative. J Allergy Clin Immunol Pract 5:1015–1024

    Article  PubMed  Google Scholar 

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

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  12. Bachert C, Han JK, Desrosiers M, Hellings PW, Amin N, Lee SE et al (2019) 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 394:1638–1650

    Article  CAS  PubMed  Google Scholar 

  13. Gevaert P, Omachi TA, Corren J, Mullol J, Han J, Lee SE et al (2020) Efficacy and safety of omalizumab in nasal polyposis: 2 randomized phase 3 trials. J Allergy Clin Immunol 146:595–605

    Article  CAS  PubMed  Google Scholar 

  14. Han JK, Bachert C, Fokkens W, Desrosiers M, Wagenmann M, Lee SE et al (2021) Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med 9:1141–1153

    Article  CAS  PubMed  Google Scholar 

  15. Heinzerling L, Mari A, Bergmann K-C, Bresciani M, Burbach G, Darsow U et al (2013) The skin prick test - European standards. Clin Transl Allergy 3:3. https://doi.org/10.1186/2045-7022-3-3

    Article  PubMed  PubMed Central  Google Scholar 

  16. Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A et al (2005) Standardisation of spirometry. Eur Respir J 26:319–338

    Article  CAS  PubMed  Google Scholar 

  17. GINA Main Report 2021.Available from: https://ginasthma.org/wp-content/uploads/2021/05/GINA-Main-Report-2021-V2-WMS.pdf. [cited 2021 Nov 21]

  18. Gevaert P, Calus L, Van Zele T, Blomme K, De Ruyck N, Bauters W et al (2013) Omalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma. J Allergy Clin Immunol 131:110-116.e1

    Article  CAS  PubMed  Google Scholar 

  19. Abraham I, Alhossan A, Lee CS, Kutbi H, MacDonald K (2016) ‘Real-life’ effectiveness studies of omalizumab in adult patients with severe allergic asthma: systematic review. Allergy 71:593–610

    Article  CAS  PubMed  Google Scholar 

  20. Alhossan A, Lee CS, MacDonald K, Abraham I (2017) ‘Real-life’ effectiveness studies of omalizumab in adult patients with severe allergic asthma: meta-analysis. J Allergy Clin Immunol Pract 5:1362-1370.e2

    Article  PubMed  Google Scholar 

  21. Damask C, Chen M, Holweg CTJ, Yoo B, Millette LA, Franzese C (2022) Defining the efficacy of omalizumab in nasal polyposis: a POLYP 1 and POLYP 2 subgroup analysis. Am J Rhinol Allergy 36:135–141

    Article  PubMed  Google Scholar 

  22. Novartis. Xolair (omalizumab) label. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103976s5238lbl.pdf#page=36. [cited 2021 Dec 21]

  23. Agache I, Song Y, Alonso-Coello P, Vogel Y, Rocha C, Solà I et al (2021) Efficacy and safety of treatment with biologicals for severe chronic rhinosinusitis with nasal polyps: A systematic review for the EAACI guidelines. Allergy 76:2337–2353

    Article  CAS  PubMed  Google Scholar 

  24. Tsabouri S, Ntritsos G, Koskeridis F, Evangelou E, Olsson P, Kostikas K (2021) Omalizumab for the treatment of allergic rhinitis: a systematic review and meta-analysis. Rhinology 59:501–510

    CAS  PubMed  Google Scholar 

  25. Bidder T, Sahota J, Rennie C, Lund VJ, Robinson DS, Kariyawasam HH (2018) Omalizumab treats chronic rhinosinusitis with nasal polyps and asthma together-a real life study. Rhinology 56:42–45

    Article  CAS  PubMed  Google Scholar 

  26. Heffler E, Saccheri F, Bartezaghi M, Canonica GW (2020) 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 10:25. https://doi.org/10.1186/s13601-020-00330-1

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  27. Ruiz-Hornillos J, Rodríguez Jiménez B, Feliu Vila A, Moreno Fernández A, Hernández García MJ, Domínguez-Ortega J et al (2020) 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 30:470–472

    Article  CAS  PubMed  Google Scholar 

  28. Tiotiu A, Oster JP, Roux PR, Nguyen Thi PL, Peiffer G, Bonniaud P et al (2020) Effectiveness of omalizumab in severe allergic asthma and nasal polyposis: a real-life study. J Investig Allergol Clin Immunol 30:49–57

    Article  CAS  PubMed  Google Scholar 

  29. GlaxoSmithKline LLC. Nucala (mepolizumab) label. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761122s006,125526s018lbl.pdf. [cited 2021 Dec 26]

  30. Ortega HG, Liu MC, Pavord ID, Brusselle GG, FitzGerald JM, Chetta A et al (2014) Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med 371:1198–1207

    Article  PubMed  Google Scholar 

  31. Khatri S, Moore W, Gibson PG, Leigh R, Bourdin A, Maspero J et al (2019) Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma. J Allergy Clin Immunol 143:1742-1751.e7

    Article  CAS  PubMed  Google Scholar 

  32. Howarth P, Chupp G, Nelsen LM, Bradford ES, Bratton DJ, Smith SG et al (2020) Severe eosinophilic asthma with nasal polyposis: a phenotype for improved sinonasal and asthma outcomes with mepolizumab therapy. J Allergy Clin Immunol 145:1713–1715

    Article  CAS  PubMed  Google Scholar 

  33. AstraZeneca. Fasenra (benralizumab) label. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761070s005lbl.pdf. [cited 2021 Dec 28]

  34. Harrison TW, Chanez P, Menzella F, Canonica GW, Louis R, Cosio BG et al (2021) Onset of effect and impact on health-related quality of life, exacerbation rate, lung function, and nasal polyposis symptoms for patients with severe eosinophilic asthma treated with benralizumab (ANDHI): a randomised, controlled, phase 3b trial. Lancet Respir Med 9:260–274

    Article  CAS  PubMed  Google Scholar 

  35. Bachert C, Han JK, Desrosiers MY, Gevaert P, Heffler E, Hopkins C et al (2021) Efficacy and safety of benralizumab in chronic rhinosinusitis with nasal polyps: a randomized, placebo-controlled trial. J Allergy Clin Immunol S0091–6749(21):01459–01467. https://doi.org/10.1016/j.jaci.2021.08.030

    Article  CAS  Google Scholar 

  36. Canonica GW, Harrison TW, Chanez P, Menzella F, Louis R, Cosio BG et al (2022) Benralizumab improves symptoms of patients with severe, eosinophilic asthma with a diagnosis of nasal polyposis. Allergy 77:150–161

    Article  CAS  PubMed  Google Scholar 

  37. Lombardo N, Pelaia C, Ciriolo M, Della Corte M, Piazzetta G, Lobello N et al (2020) Real-life effects of benralizumab on allergic chronic rhinosinusitis and nasal polyposis associated with severe asthma. Int J Immunopathol Pharmacol 34:2058738420950851. https://doi.org/10.1177/2058738420950851

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  38. Wenzel SE (2021) Severe adult asthmas: integrating clinical features, biology, and therapeutics to improve outcomes. Am J Respir Crit Care Med 203:809–821

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  39. Taillé C, Chanez P, Devouassoux G, Didier A, Pison C, Garcia G et al (2020) Mepolizumab in a population with severe eosinophilic asthma and corticosteroid dependence: results from a French early access programme. Eur Respir J 55:1902345. https://doi.org/10.1183/13993003.02345-2019

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  40. Kavanagh JE, Hearn AP, Dhariwal J, d’Ancona G, Douiri A, Roxas C et al (2021) Real-world effectiveness of benralizumab in severe eosinophilic asthma. Chest 159:496–506

    Article  CAS  PubMed  Google Scholar 

  41. Humbert M, Boulet LP, Niven RM, Panahloo Z, Blogg M, Ayre G (2009) Omalizumab therapy: patients who achieve greatest benefit for their asthma experience greatest benefit for rhinitis. Allergy 64:81–84

    Article  CAS  PubMed  Google Scholar 

  42. Samitas K, Carter A, Kariyawasam HH, Xanthou G (2018) Upper and lower airway remodelling mechanisms in asthma, allergic rhinitis and chronic rhinosinusitis: the one airway concept revisited. Allergy 73:993–1002

    Article  CAS  PubMed  Google Scholar 

  43. Tiotiu A, Novakova P, Baiardini I, Bikov A, Chong-Neto H, de-Sousa JC et al (2021) Manifesto on united airways diseases (UAD): an Interasma (global asthma association - GAA) document. J Asthma 1–16. https://doi.org/10.1080/02770903.2021.1879130

  44. Bandi F, Gallo S, Preti A, Mozzanica F, Visca D, Marelli M et al (2020) Effects of biological therapies on chronic rhinosinusitis in severe asthmatic patients. Acta Otorhinolaryngol Ital 40:435–443

    Article  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Angelica Tiotiu.

Ethics declarations

Conflict of Interest

Iulia Ioan, Rodrigo Romero-Fernandez, Thi-cam-tu Hoang and Diana Carolina Ochoa-Gutierrez have no conflicts of interest. Angelica Tiotiu reports speaker and consulting fees from ALK, AstraZeneca, GSK, Novartis and Sanofi outside the submitted work. Paula Méndez-Brea Paula reports personal fees from ALK, Allergy Therapeutics, Chiesi, GSK and Stallergenes outside the submitted work. Jean Philippe Oster reports speaker and consulting fees from AstraZeneca, GSK, Novartis and Sanofi outside the submitted work. Pauline Roux reports speaker and consulting fees from AstraZeneca, Chiesi, GSK and Novartis outside the submitted work. Philippe Bonniaud reports speaker and consulting fees from AstraZeneca, Chiesi, GSK, Novartis and Sanofi outside the submitted work. Frederic de Blay reports speaker and consulting fees from ALK, AstraZeneca, Chiesi, GSK, Novartis and Sanofi outside the submitted work. Francisco-Javier Gonzalez-Barcala has received speaker fees, consulting fees or research grants from ALK, AstraZeneca, Bial, Boehringer-Ingelheim, Chiesi, Gebro Pharma, GSK, Laboratorios Esteve, Menarini, Mundipharma, Novartis, Rovi, Roxall, Sanofi, Stallergenes and Teva.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Supplementary Information

Below is the link to the electronic supplementary material.

Supplementary file1 (DOCX 32 kb)

Supplementary file2 (DOCX 30 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Tiotiu, A., Mendez-Brea, P., Ioan, I. et al. Real-Life Effectiveness of Benralizumab, Mepolizumab and Omalizumab in Severe Allergic Asthma Associated with Nasal Polyps. Clinic Rev Allerg Immunol 64, 179–192 (2023). https://doi.org/10.1007/s12016-022-08938-w

Download citation

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s12016-022-08938-w

Keywords

Navigation