Comparative effectiveness of anti-IL5 and anti-IgE biologic classes in patients with severe asthma eligible for both.
ISAR
biologics
exacerbation
oral corticosteroids
real life
Journal
Allergy
ISSN: 1398-9995
Titre abrégé: Allergy
Pays: Denmark
ID NLM: 7804028
Informations de publication
Date de publication:
07 2023
07 2023
Historique:
revised:
13
12
2022
received:
12
10
2022
accepted:
22
12
2022
medline:
3
7
2023
pubmed:
18
3
2023
entrez:
17
3
2023
Statut:
ppublish
Résumé
Patients with severe asthma may present with characteristics representing overlapping phenotypes, making them eligible for more than one class of biologic. Our aim was to describe the profile of adult patients with severe asthma eligible for both anti-IgE and anti-IL5/5R and to compare the effectiveness of both classes of treatment in real life. This was a prospective cohort study that included adult patients with severe asthma from 22 countries enrolled into the International Severe Asthma registry (ISAR) who were eligible for both anti-IgE and anti-IL5/5R. The effectiveness of anti-IgE and anti-IL5/5R was compared in a 1:1 matched cohort. Exacerbation rate was the primary effectiveness endpoint. Secondary endpoints included long-term-oral corticosteroid (LTOCS) use, asthma-related emergency room (ER) attendance, and hospital admissions. In the matched analysis (n = 350/group), the mean annualized exacerbation rate decreased by 47.1% in the anti-IL5/5R group and 38.7% in the anti-IgE group. Patients treated with anti-IL5/5R were less likely to experience a future exacerbation (adjusted IRR 0.76; 95% CI 0.64, 0.89; p < 0.001) and experienced a greater reduction in mean LTOCS dose than those treated with anti-IgE (37.44% vs. 20.55% reduction; p = 0.023). There was some evidence to suggest that patients treated with anti-IL5/5R experienced fewer asthma-related hospitalizations (IRR 0.64; 95% CI 0.38, 1.08), but not ER visits (IRR 0.94, 95% CI 0.61, 1.43). In real life, both anti-IgE and anti-IL5/5R improve asthma outcomes in patients eligible for both biologic classes; however, anti-IL5/5R was superior in terms of reducing asthma exacerbations and LTOCS use.
Sections du résumé
BACKGROUND
Patients with severe asthma may present with characteristics representing overlapping phenotypes, making them eligible for more than one class of biologic. Our aim was to describe the profile of adult patients with severe asthma eligible for both anti-IgE and anti-IL5/5R and to compare the effectiveness of both classes of treatment in real life.
METHODS
This was a prospective cohort study that included adult patients with severe asthma from 22 countries enrolled into the International Severe Asthma registry (ISAR) who were eligible for both anti-IgE and anti-IL5/5R. The effectiveness of anti-IgE and anti-IL5/5R was compared in a 1:1 matched cohort. Exacerbation rate was the primary effectiveness endpoint. Secondary endpoints included long-term-oral corticosteroid (LTOCS) use, asthma-related emergency room (ER) attendance, and hospital admissions.
RESULTS
In the matched analysis (n = 350/group), the mean annualized exacerbation rate decreased by 47.1% in the anti-IL5/5R group and 38.7% in the anti-IgE group. Patients treated with anti-IL5/5R were less likely to experience a future exacerbation (adjusted IRR 0.76; 95% CI 0.64, 0.89; p < 0.001) and experienced a greater reduction in mean LTOCS dose than those treated with anti-IgE (37.44% vs. 20.55% reduction; p = 0.023). There was some evidence to suggest that patients treated with anti-IL5/5R experienced fewer asthma-related hospitalizations (IRR 0.64; 95% CI 0.38, 1.08), but not ER visits (IRR 0.94, 95% CI 0.61, 1.43).
CONCLUSIONS
In real life, both anti-IgE and anti-IL5/5R improve asthma outcomes in patients eligible for both biologic classes; however, anti-IL5/5R was superior in terms of reducing asthma exacerbations and LTOCS use.
Substances chimiques
Adrenal Cortex Hormones
0
Anti-Asthmatic Agents
0
anti-IgE antibodies
0
Antibodies, Monoclonal, Humanized
0
Biological Products
0
Immunosuppressive Agents
0
Types de publication
Comparative Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1934-1948Subventions
Organisme : AstraZeneca
Organisme : Optimum Patient Care Global
Informations de copyright
© 2023 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.
Références
Pavord ID, Beasley R, Agusti A, et al. After asthma: redefining airways diseases. Lancet. 2018;391:350-400.
McGregor MC, Krings JG, Nair P, Castro M. Role of biologics in asthma. Am J Respir Crit Care Med. 2019;199:433-445.
Kuruvilla ME, Lee FE-H, Lee GB. Understanding asthma phenotypes, endotypes, and mechanisms of disease. Clin Rev Allergy Immunol. 2019;56:219-233.
Bateman ED, Hurd SS, Barnes PJ, et al. Global strategy for asthma management and prevention: GINA executive summary. Eur Respir J. 2008;31:143-178.
GINA. Difficult-to-treat and severe asthma in adolescent and adult patients. Diagnosis and management. A GINA Pocket Guide for Health Professionals. 2018 https://ginasthma.org/wp-content/uploads/2019/04/GINA-Severe-asthma-Pocket-Guide-v2.0-wms-1.pdf
Molfino NA, Gossage D, Kolbeck R, Parker JM, Geba GP. Molecular and clinical rationale for therapeutic targeting of interleukin-5 and its receptor. Clin Exp Allergy. 2012;42:712-737.
FitzGerald JM, Bleecker ER, Nair P, et al. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016;388:2128-2141.
Bleecker ER, FitzGerald JM, Chanez P, et al. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β (2)-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388:2115-2127.
Castro M, Mathur S, Hargreave F, et al. Reslizumab for poorly controlled, eosinophilic asthma: a randomized, placebo-controlled study. Am J Respir Crit Care Med. 2011;184:1125-1132.
Castro M, Zangrilli J, Wechsler ME, et al. Reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: results from two multicentre, parallel, double-blind, randomised, placebo-controlled, phase 3 trials. Lancet Respir Med. 2015;3:355-366.
Pavord ID, Korn S, Howarth P, et al. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012;380:651-659.
Ortega HG, Yancey SW, Mayer B, et al. Severe eosinophilic asthma treated with mepolizumab stratified by baseline eosinophil thresholds: a secondary analysis of the DREAM and MENSA studies. Lancet Respir Med. 2016;4:549-556.
Heaney LG, Perez de Llano L, Al-Ahmad M, et al. Eosinophilic and non-eosinophilic asthma: an expert consensus framework to characterize phenotypes in a global real-life severe asthma cohort. Chest. 2021;160:814-830.
Corren J. Inhibition of interleukin-5 for the treatment of eosinophilic diseases. Discov Med. 2012;13:305-312.
Global Initiative for Asthma. Global Strategy for Asthma Managment and Prevention. 2020 https://ginasthma.org/wp-content/uploads/2020/04/GINA-2020-full-report_-final-_wms.pdf
Kuruvilla M, Ariue B, Oppenheimer JJ, Singh U, Bernstein JA. Clinical use of biologics for asthma treatment by allergy specialists: a questionnaire survey. Ann Allergy Asthma Immunol. 2020;125:433-439. doi:10.1016/j.anai.2020.06.041
Porsbjerg CM, Menzies-Gow AN, Tran TN, et al. Global variability in administrative approval prescription criteria for biologic therapy in severe asthma. J Allergy Clin Immunol Pract. 2022;10:1202-1216.
Albers FC, Müllerová H, Gunsoy NB, et al. Biologic treatment eligibility for real-world patients with severe asthma: the IDEAL study. J Asthma. 2018;55:152-160.
Cockle SM, Stynes G, Gunsoy NB, et al. Comparative effectiveness of mepolizumab and omalizumab in severe asthma: an indirect treatment comparison. Respir Med. 2017;123:140-148.
Chapman KR, Albers FC, Chipps B, et al. The clinical benefit of mepolizumab replacing omalizumab in uncontrolled severe eosinophilic asthma. Allergy. 2019;74:1716-1726.
ISAR Study Group. International severe asthma registry (ISAR): Mission statement. Chest. 2020;157:805-814.
FitzGerald JM, Tran TN, Alacqua M, et al. International severe asthma registry (ISAR): protocol for a global registry. BMC Med Res Methodol. 2020;20:212.
Bulathsinhala L, Eleangovan N, Heaney LG, et al. Development of the international severe asthma registry (ISAR): a modified Delphi study. J Allergy Clin Immunol Pract. 2019;7:578-588.e2.
Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. 2018 https://goldcopd.org/wp-content/uploads/2017/11/GOLD-2018-v6.0-FINAL-revised-20-Nov_WMS.pdf
Ivanova JI, Bergman R, Birnbaum HG, Colice GL, Silverman RA, McLaurin K. Effect of asthma exacerbations on health care costs among asthmatic patients with moderate and severe persistent asthma. J Allergy Clin Immunol. 2012;129:1229-1235.
Price DB, Trudo F, Voorham J, et al. Adverse outcomes from initiation of systemic corticosteroids for asthma: long-term observational study. J Asthma Allergy. 2018;11:193-204.
Fong WCG, Azim A, Knight D, et al. Real-world omalizumab and mepolizumab treated difficult asthma phenotypes and their clinical outcomes. Clin Exp Allergy. 2021;51:1019-1032.
Jackson DJ, Busby J, Pfeffer PE, et al. Characterisation of patients with severe asthma in the UK severe asthma registry in the biologic era. Thorax. 2021;76:220-227.
Agache I, Akdis C, Akdis M, et al. EAACI biologicals guidelines: recommendations for severe asthma. Allergy. 2021;76:14-44. https://www.eaaci.org/resources-list/resources/4704-eaeaaci-biologicals-guidelines-%E2%80%93-recommendations-for-severe-asthma.html
Brown T, Jones T, Gove K, et al. Randomised controlled trials in severe asthma: selection by phenotype or stereotype. Eur Respir J. 2018;52:1801444.
Kavanagh JE, Hearn AP, Dhariwal J, et al. Real-world effectiveness of Benralizumab in severe eosinophilic asthma. Chest. 2021;159:496-506.
Domingo Ribas C, Carrillo Díaz T, Blanco Aparicio M, Martínez Moragón E, Banas Conejero D, Sánchez Herrero MG. REal worlD effectiveness and safety of mepolizumab in a multicentric Spanish cohort of asthma patients stratified by eosinophils: the REDES study. Drugs. 2021;81:1763-1774.
Wechsler ME, Peters SP, Hill TD, et al. Clinical outcomes and health-care resource use associated with Reslizumab treatment in adults with severe eosinophilic asthma in real-world practice. Chest. 2021;159:1734-1746.
Papaioannou AI, Mplizou M, Porpodis K, et al. Long-term efficacy and safety of omalizumab in patients with allergic asthma: a real-life study. Allergy Asthma Proc. 2021;42:235-242.
Chung Y, Katial R, Mu F, et al. Real-world effectiveness of benralizumab: results from the ZEPHYR 1 study. Ann Allergy Asthma Immunol. 2022;128:669-676.
Chen W, Sadatsafavi M, Chong Boon Wong N, et al. Impact of initiating biologics in patients on long-term OCS or frequent rescue steroids (GLITTER). American Thoracic Society. 2022;205:A2365.
Viswanathan RK, Busse WW. How to compare the efficacy of biologic agents in asthma. Ann Allergy Asthma Immunol. 2020;125:137-149.
Praetorius K, Henriksen DP, Schmid JM, et al. Indirect comparison of efficacy of dupilumab versus mepolizumab and omalizumab for severe type 2 asthma. ERJ Open Res. 2021;7:7. doi:10.1183/23120541.00306-2021
Kotisalmi E, Hakulinen A, Mäkelä M, Toppila-Salmi S, Kauppi P. A comparison of biologicals in the treatment of adults with severe asthma - real-life experiences. Asthma Res Pract. 2020;6:2.
AlShareef S, McDonald CF, Lee J. Clinical and lung function outcomes after anti-IgE or anti-IL5 therapy in severe asthma. J Asthma Allergy. 2022;15:209-217.
Charles D, Shanley J, Temple S-N, Rattu A, Khaleva E, Roberts G. Real-world efficacy of treatment with benralizumab, dupilumab, mepolizumab and reslizumab for severe asthma: a systematic review and meta-analysis. Clin Exp Allergy. 2022;52:616-627.
Menzies-Gow A, Gurnell M, Heaney LG, et al. Oral corticosteroid elimination via a personalised reduction algorithm in adults with severe, eosinophilic asthma treated with benralizumab (PONENTE): a multicentre, open-label, single-arm study. Lancet Respir Med. 2021;10:47-58. doi:10.1016/S2213-2600(21)00352-0
Menzies-Gow AN, McBrien C, Unni B, et al. Real world biologic use and switch patterns in severe asthma: data from the international severe asthma registry and the US CHRONICLE study. J Asthma Allergy. 2022;15:63-78.
Study of magnitude and precision of response to omalizumab and mepolizumab in adult severe asthma (PREDICTUMAB). https://clinicaltrials.gov/ct2/show/NCT03476109?term=NCT03476109&draw=2&rank=1