Abstract
Severe asthma is a high-burden disease. Real-world data on mepolizumab in patients with severe eosinophilic asthma is needed to assess whether the data from randomised controlled trials are applicable in a broader population.
The Australian Mepolizumab Registry (AMR) was established with an aim to assess the use, effectiveness and safety of mepolizumab for severe eosinophilic asthma in Australia.
Patients (n=309) with severe eosinophilic asthma (median age 60 years, 58% female) commenced mepolizumab. They had poor symptom control (median Asthma Control Questionnaire (ACQ)-5 score of 3.4), frequent exacerbations (median three courses of oral corticosteroids (OCS) in the previous 12 months), and 47% required daily OCS. Median baseline peripheral blood eosinophil level was 590 cells·µL−1. Comorbidities were common: allergic rhinitis 63%, gastro-oesophageal reflux disease 52%, obesity 46%, nasal polyps 34%.
Mepolizumab treatment reduced exacerbations requiring OCS compared with the previous year (annualised rate ratio 0.34 (95% CI 0.29–0.41); p<0.001) and hospitalisations (rate ratio 0.46 (95% CI 0.33–0.63); p<0.001). Treatment improved symptom control (median ACQ-5 reduced by 2.0 at 6 months), quality of life and lung function. Higher blood eosinophil levels (p=0.003) and later age of asthma onset (p=0.028) predicted a better ACQ-5 response to mepolizumab, whilst being male (p=0.031) or having body mass index ≥30 (p=0.043) predicted a lesser response. Super-responders (upper 25% of ACQ-5 responders, n=61, 24%) had a higher T2 disease burden and fewer comorbidities at baseline.
Mepolizumab therapy effectively reduces the significant and long-standing disease burden faced by patients with severe eosinophilic asthma in a real-world setting.
Abstract
In clinical practice, mepolizumab reduces the burden of severe eosinophilic asthma by reducing severe exacerbations and improving asthma control, quality of life and lung function. Super-responders have a T2 phenotype and few comorbidities. http://bit.ly/2UIio4x
Footnotes
This article has supplementary material available from erj.ersjournals.com
Author contributions: All authors were involved in data interpretation and critical review of the manuscript. P.G. Gibson, E.S. Harvey, D. Langton, C. Katelaris, C.S. Farah, A. Gillman, J. Harrington, M. Hew, V. Kritikos, N. Radhakrishna, P. Bardin, M. Peters, P.N. Reynolds and J.W. Upham contributed to development of study concept and design. S. Stevens performed data analysis. E.S. Harvey, P.G. Gibson, D. Langton, C. Katelaris, C.S. Farah, A. Gillman, J. Harrington, M. Hew, V. Kritikos and N. Radhakrishna drafted the manuscript.
Conflict of interest: E.S. Harvey reports grants from GlaxoSmithKline that were paid to her employer, during the conduct of the study.
Conflict of interest: D. Langton has received fees from GlaxoSmithKline for participation in severe asthma advisory boards.
Conflict of interest: C. Katelaris reports grants from GlaxoSmithKline, during the conduct of the study; grants and personal fees for advisory board work and lectures from Sanofi, Novartis and CSL, personal fees from Seqirus and Takeda, outside the submitted work.
Conflict of interest: S. Stevens has nothing to disclose.
Conflict of interest: C.S. Farah reports personal fees from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline and Sanofi Genzyme, outside the submitted work.
Conflict of interest: A. Gillman reports personal fees for advisory board work and education from GlaxoSmithKline, outside the submitted work.
Conflict of interest: J. Harrington reports personal fees for education and advisory board work from AstraZeneca and GlaxoSmithKline, personal fees for education from Novartis, outside the submitted work.
Conflict of interest: M. Hew reports grants and personal fees from AstraZeneca, GlaxoSmithKline and Novartis, personal fees from Sanofi, Teva and Seqirus, outside the submitted work; all paid to his institutional employer Alfred Health.
Conflict of interest: V. Kritikos has nothing to disclose.
Conflict of interest: N. Radhakrishna reports grants from Sanofi, outside the submitted work.
Conflict of interest: P. Bardin reports per patient trial participation fees from Monash Lung and Sleep, during the conduct of the study; personal fees for advisory board work from Philip Bardin, outside the submitted work.
Conflict of interest: M. Peters reports personal fees for advisory board work from Sanofi Genzyme, Novartis Pharmaceuticals and AstraZeneca, outside the submitted work.
Conflict of interest: P.N. Reynolds reports grants from GlaxoSmithKline and AstraZeneca, during the conduct of the study.
Conflict of interest: J.W. Upham reports grants and personal fees from AstraZeneca and GlaxoSmithKline, personal fees from Novartis and Boehringer Ingelheim, outside the submitted work.
Conflict of interest: M. Baraket has nothing to disclose.
Conflict of interest: S. Bowler reports personal fees for advisory board work from GlaxoSmithKline, outside the submitted work.
Conflict of interest: J. Bowden reports personal fees for advisory board work from GlaxoSmithKline, AstraZeneca and Novartis, outside the submitted work.
Conflict of interest: J. Chien reports personal fees from GlaxoSmithKline, outside the submitted work.
Conflict of interest: L.P. Chung has nothing to disclose.
Conflict of interest: C. Grainge reports personal fees from Boehringer Ingelheim, Roche Pharmaceuticals and GlaxoSmithKline, outside the submitted work.
Conflict of interest: C. Jenkins reports personal fees for advisory board work, conducting meetings and developing educational content, and non-financial support from AstraZeneca, personal fees for advisory board work from Boehringer Ingleheim, grants and personal fees for advisory board work from GlaxoSmithKline, personal fees for advisory board work, facilitating symposia and developing educational content from Novartis, outside the submitted work.
Conflict of interest: G.P. Katsoulotos has nothing to disclose.
Conflict of interest: J. Lee reports personal fees for lectures from Boehringer Ingelheim and AstraZeneca, personal fees for consultancy from GlaxoSmithKline, outside the submitted work.
Conflict of interest: V.M. McDonald reports grants and personal fees from GlaxoSmithKline, AstraZeneca and Menarini, outside the submitted work.
Conflict of interest: H.K. Reddel reports grants from GlaxoSmithKline, during the conduct of the study; grants and personal fees for data monitoring committee work, advisory board work, providing independent medical education and consultancy from AstraZeneca, grants, personal fees for data monitoring committee work, advisory board work, providing independent medical education and consultancy and non-financial support (study medication) from GlaxoSmithKline, personal fees for data monitoring committee work from Merck, grants and personal fees for data monitoring committee work, advisory board work and providing independent medical education from Novartis, personal fees for providing independent medical education from Teva and Mundipharma, personal fees for advisory board work and providing independent medical education from Boehringer Ingelheim, personal fees for advisory board work from Sanofi Genzyme, outside the submitted work.
Conflict of interest: J. Rimmer has nothing to disclose.
Conflict of interest: P.A.B. Wark has nothing to disclose.
Conflict of interest: P.G. Gibson reports grants from GlaxoSmithKline, during the conduct of the study; personal fees for lectures from AstraZeneca, GlaxoSmithKline and Novartis, grants from AstraZeneca and GlaxoSmithKline, outside the submitted work.
Support statement: The Australian Mepolizumab Registry is an investigator-initiated and managed study funded through the GlaxoSmithKline Investigator-Sponsored Studies program. Funding information for this article has been deposited with the Crossref Funder Registry.
- Received December 17, 2019.
- Accepted February 7, 2020.
- Copyright ©ERS 2020
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