Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Clinical and Translational Allergy
Published in: Clinical and Translational Allergy 1/2020

01-12-2020 | Omalizumab | Research

Effectiveness of omalizumab in patients with severe allergic asthma with and without chronic rhinosinusitis with nasal polyps: a PROXIMA study post hoc analysis

Authors: Enrico Heffler, Fabiana Saccheri, Marta Bartezaghi, Giorgio Walter Canonica

Published in: Clinical and Translational Allergy | Issue 1/2020

Login to get access

Abstract

Background

A significant proportion of patients with severe asthma may also suffer from nasal polyposis, which is commonly defined as chronic rhinosinusitis with nasal polyps (CRSwNP), the presence of which may adversely affect asthma treatment outcomes. The biologic agent omalizumab is effective as add-on therapy in patients with severe allergic asthma. The aim of this post hoc analysis of the PROXIMA study was to compare the efficacy of omalizumab between patients with severe allergic asthma, with and without comorbid CRSwNP.

Methods

PROXIMA was a prospective observational 2-part study conducted in Italy in adult patients with severe allergic asthma, where, in the second part, patients eligible for add-on omalizumab initiated treatment for 12 months. Patient baseline data such as comorbidities and history of exacerbations were collected. Outcomes were asthma control (Asthma Control Questionnaire [ACQ]), lung function (forced expiratory volume in 1 s [FEV1]) and exacerbation rate. The post hoc analysis compared these outcomes between the cohort with comorbid CRSwNP and the cohort without CRSwNP.

Results

Of 123 patients included in this analysis, 17 (13.8%) were in the CRSwNP cohort. There was no significant difference between cohorts in baseline clinical characteristics or in change from baseline at 12 months in ACQ values,  % of predicted FEV1 or annual asthma exacerbation rate, although results were numerically in favor of the CRSwNP cohort versus the non-CRSwNP cohort. The proportion of patients who achieved an improvement in all three outcomes was numerically greater in the CRSwNP cohort (35.7% vs 23.0%).

Conclusions

In an observational real-world setting, add-on omalizumab for severe allergic asthma was effective in improving asthma control, lung function and in reducing exacerbations, including in those patients with CRSwNP.
Appendix
Available only for authorised users
Literature
1.
2.
Kuruvilla ME, Lee FE, Lee GB. Understanding asthma phenotypes, endotypes, and mechanisms of disease. Clin Rev Allergy Immunol. 2019;56:219–33.PubMedPubMedCentral
3.
Chung KF, Wenzel SE, Brozek JL, Bush A, Castro M, Sterk PJ, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014;43:343–73.PubMed
4.
Corren J. New Targeted Therapies for Uncontrolled Asthma. J Allergy Clin Immunol Pract. 2019;7:1394–403.PubMed
5.
Canonica GW, Ferrando M, Baiardini I, Puggioni F, Racca F, Passalacqua G, et al. Asthma: personalized and precision medicine. Curr Opin Allergy Clin Immunol. 2018;18:51–8.PubMed
6.
Incorvaia C, Mauro M, Makri E, Leo G, Ridolo E. Two decades with omalizumab: what we still have to learn. Biologics. 2018;12:135–42.PubMedPubMedCentral
7.
Belliveau PP. Omalizumab: a monoclonal anti-IgE antibody. Med Gen Med. 2005;7:27.
8.
Alhossan A, Lee CS, MacDonald K, Abraham I. “Real-life” Effectiveness Studies of Omalizumab in Adult Patients with Severe Allergic Asthma: meta-analysis. J Allergy Clin Immunol Pract. 2017;5(1362–70):e2.
9.
Canonica GW, Rottoli P, Bucca C, Zappa MC, Michetti G, Macciocchi B, et al. Improvement of patient-reported outcomes in severe allergic asthma by omalizumab treatment: the real life observational PROXIMA study. World Allergy Organ J. 2018;11:33.PubMedPubMedCentral
10.
Walker S, Monteil M, Phelan K, Lasserson TJ, Walters EH. Anti-IgE for chronic asthma in adults and children. Cochrane Database Syst Rev. 2006:CD003559.
11.
Bousquet J, Cabrera P, Berkman N, Buhl R, Holgate S, Wenzel S, et al. The effect of treatment with omalizumab, an anti-IgE antibody, on asthma exacerbations and emergency medical visits in patients with severe persistent asthma. Allergy. 2005;60:302–8.PubMed
12.
Busse WW, Massanari M, Kianifard F, Geba GP. Effect of omalizumab on the need for rescue systemic corticosteroid treatment in patients with moderate-to-severe persistent IgE-mediated allergic asthma: a pooled analysis. Curr Med Res Opin. 2007;23:2379–86.PubMed
13.
Busse WW, Morgan WJ, Gergen PJ, Mitchell HE, Gern JE, Liu AH, et al. Randomized trial of omalizumab (anti-IgE) for asthma in inner-city children. N Engl J Med. 2011;364:1005–15.PubMedPubMedCentral
14.
Martinez-Moragon E, Climent M, Chiner E, Fernandez-Aracil C, Sanchez-Toril F, Lluch-Tortajada I. Effectiveness and pharmacoeconomic analysis of the treatment of severe asthma with omalizumab in clinical practice. Farm Hosp. 2019;43:101–9.PubMed
15.
Brussino L, Solidoro P, Rolla G. Is it severe asthma or asthma with severe comorbidities? J Asthma Allergy. 2017;10:303–5.PubMedPubMedCentral
16.
Novelli F, Bacci E, Latorre M, Seccia V, Bartoli ML, Cianchetti S, et al. Comorbidities are associated with different features of severe asthma. Clin Mol Allergy. 2018;16:25.PubMedPubMedCentral
17.
Porsbjerg C, Menzies-Gow A. Co-morbidities in severe asthma: clinical impact and management. Respirology. 2017;22:651–61.PubMed
18.
Fokkens WJ, Lund VJ, Hopkins C, Hellings PW, Kern R, Reitsma S, et al. European Position Paper on Rhinosinusitis and Nasal Polyps. Rhinology. 2020;58(S29):1–464.PubMed
19.
Heffler E, Blasi F, Latorre M, Menzella F, Paggiaro P, Pelaia G, et al. The severe asthma network in Italy: findings and perspectives. J Allergy Clin Immunol Pract. 2019;7:1462–8.PubMed
20.
Maio S, Baldacci S, Bresciani M, Simoni M, Latorre M, Murgia N, et al. RItA: the Italian severe/uncontrolled asthma registry. Allergy. 2018;73:683–95.PubMed
21.
Shaw DE, Sousa AR, Fowler SJ, Fleming LJ, Roberts G, Corfield J, et al. Clinical and inflammatory characteristics of the European U-BIOPRED adult severe asthma cohort. Eur Respir J. 2015;46:1308–21.PubMed
22.
Heffler E, Malvezzi L, Boita M, Brussino L, De Virgilio A, Ferrando M, et al. Immunological mechanisms underlying chronic rhinosinusitis with nasal polyps. Expert Rev Clin Immunol. 2018;14:731–7.PubMed
23.
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;7:1418–29.PubMed
24.
Wang M, Zhang N, Zheng M, Li Y, Meng L, Ruan Y, et al. Cross-talk between TH2 and TH17 pathways in patients with chronic rhinosinusitis with nasal polyps. J Allergy Clin Immunol. 2019;144:1254–64.PubMed
25.
Khalaf K, Paoletti G, Puggioni F, Racca F, De Luca F, Giorgis V, et al. Asthma from immune pathogenesis to precision medicine. Semin Immunol. 2019;46:101294.PubMed
26.
Kowalski ML, Agache I, Bavbek S, Bakirtas A, Blanca M, Bochenek G, et al. Diagnosis and management of NSAID-Exacerbated Respiratory Disease (N-ERD)-a EAACI position paper. Allergy. 2019;74:28–39.PubMed
27.
Bochenek G, Stachura T, Szafraniec K, Plutecka H, Sanak M, Nizankowska-Mogilnicka E, et al. Diagnostic Accuracy of Urinary LTE4 measurement to predict aspirin-exacerbated respiratory disease in patients with asthma. J Allergy Clin Immunol Pract. 2018;6:528–35.PubMed
28.
Heffler E, Pizzimenti S, Badiu I, Guida G, Ricciardolo FL, Bucca C, et al. Nasal nitric oxide is a marker of poor asthma control. J Breath Res. 2013;7:026009.PubMed
29.
Ceylan E, Gencer M, San I. Nasal polyps and the severity of asthma. Respirology. 2007;12:272–6.PubMed
30.
Westerhof GA, Coumou H, de Nijs SB, Weersink EJ, Bel EH. Clinical predictors of remission and persistence of adult-onset asthma. J Allergy Clin Immunol. 2018;141(104–9):e3.
31.
Guida G, Rolla G, Badiu I, Marsico P, Pizzimenti S, Bommarito L, et al. Determinants of exhaled nitric oxide in chronic rhinosinusitis. Chest. 2010;137:658–64.PubMed
32.
Maniscalco M, Calabrese C, D’Amato M, Guida P, Molino A, Aliani M, et al. Association between exhaled nitric oxide and nasal polyposis in severe asthma. Respir Med. 2019;152:20–4.PubMed
33.
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(1449–56):e4.
34.
Wu D, Li L, Zhang M, Wang J, Wei Y. Two inflammatory phenotypes of nasal polyps and comorbid asthma. Ann Allergy Asthma Immunol. 2017;118:318–25.PubMed
35.
Canonica GW, Bartezaghi M, Marino R, Rigoni L. Prevalence of perennial severe allergic asthma in Italy and effectiveness of omalizumab in its management: PROXIMA—an observational, 2 phase, patient reported outcomes study. Clin Mol Allergy. 2015;13:10.PubMedPubMedCentral
36.
ISPE. Guidelines for good pharmacoepidemiology practices (GPP). Pharmacoepidemiol Drug Saf. 2008;17:200–8.
37.
38.
von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP, et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol. 2008;61:344–9.
39.
Juniper EF, O’Byrne PM, Guyatt GH, Ferrie PJ, King DR. Development and validation of a questionnaire to measure asthma control. Eur Respir J. 1999;14:902–7.PubMed
40.
Tiotiu A, Oster JP, Roux P, Nguyen Thi PL, Peiffer G, Bonniaud P, et al. Omalizumab’s effectiveness in severe allergic asthma and nasal polyps: a real-life study. J Investig Allergol Clin Immunol. 2019;30(1):49–57.PubMed
41.
Clavenna MJ, Turner JH, Samuelson M, Tanner SB, Duncavage J, Chandra RK. Differential effect of omalizumab on pulmonary function in patients with allergic asthma with and without chronic rhinosinusitis. Allergy Asthma Proc. 2016;37:23–6.PubMed
42.
Solidoro P, Patrucco F, de Blasio F, Brussino L, Bellocchia M, Dassetto D, et al. Predictors of reversible airway obstruction with omalizumab in severe asthma: a real-life study. Ther Adv Respir Dis. 2019;13:1753466619841274.PubMedPubMedCentral
43.
Pellegrino R, Viegi G, Brusasco V, Crapo RO, Burgos F, Casaburi R, et al. Interpretative strategies for lung function tests. Eur Respir J. 2005;26:948–68.PubMed
44.
Axelsson M, Ekerljung L, Lundback B. The Significance of Asthma Follow-Up Consultations for Adherence to Asthma Medication, Asthma Medication Beliefs, and Asthma Control. Nurs Res Pract. 2015;2015:139070.PubMedPubMedCentral
45.
Pelaia C, Calabrese C, Barbuto S, Busceti MT, Preiano M, Gallelli L, et al. Omalizumab lowers asthma exacerbations, oral corticosteroid intake and blood eosinophils: results of a 5-YEAR single-centre observational study. Pulm Pharmacol Ther. 2019;54:25–30.PubMed
46.
Tepper RS, Wise RS, Covar R, Irvin CG, Kercsmar CM, Kraft M, et al. Asthma outcomes: pulmonary physiology. J Allergy Clin Immunol. 2012;129:S65–87.PubMedPubMedCentral
47.
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(110–6):e1.
48.
ClinicalTrials.gov. A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps (POLYP 1) [NCT03280550].https://​clinicaltrials.​gov. Accessed 14 Nov 2019.
49.
ClinicalTrials.gov. A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitus With Nasal Polyps (POLYP 2) [NCT03280537].https://​clinicaltrials.​gov. Accessed 11 Nov 2019.
50.
Gevaert P. Omalizumab efficacy and safety in nasal polyposis: results from two parallel, double-blind, placebo-controlled trials. American College of Allergy, Asthma and Immunology Annual Scientific Meeting, Nov 7–11; Houston (TX): 2019.
51.
Rivero A, Liang J. Anti-IgE and Anti-IL5 biologic therapy in the treatment of nasal polyposis: a systematic review and meta-analysis. Ann Otol Rhinol Laryngol. 2017;126:739–47.PubMed
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(12):2312–9.PubMedPubMedCentral
53.
Agusti A, Bel E, Thomas M, Vogelmeier C, Brusselle G, Holgate S, et al. Treatable traits: toward precision medicine of chronic airway diseases. Eur Respir J. 2016;47:410–9.PubMed
54.
Heffler E, Malvezzi L, Pirola F, Zieba N, Paoletti G, Mercante G, et al. Treatable traits in chronic rhinosinusitis with nasal polyps. Curr Opin Allergy Clin Immunol. 2019;19:373–8.PubMed
Metadata
Title
Effectiveness of omalizumab in patients with severe allergic asthma with and without chronic rhinosinusitis with nasal polyps: a PROXIMA study post hoc analysis
Authors
Enrico Heffler
Fabiana Saccheri
Marta Bartezaghi
Giorgio Walter Canonica
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Clinical and Translational Allergy / Issue 1/2020
Electronic ISSN: 2045-7022
DOI
https://doi.org/10.1186/s13601-020-00330-1

Other articles of this Issue 1/2020

Clinical and Translational Allergy 1/2020 Go to the issue

Letter to the Editor

IgE-binding to vicilin-like antimicrobial peptides is associated with systemic reactions to macadamia nut

Research

Chemokines during anaphylaxis: the importance of CCL2 and CCL2-dependent chemotactic activity for basophils

Research

The disease burden in patients with respiratory allergies induced by house dust mites: a year-long observational survey in three European countries

Letter to the Editor

Modified protocol of omalizumab treatment to prevent carboplatin-induced drug hypersensitivity reactions: a case study

Review

New approach to intermittent and mild asthma therapy: evolution or revolution in the GINA guidelines?

Research

A novel ELISA method to determine human MrgX2 in chronic urticaria