Mepolizumab and Oral Corticosteroid Stewardship: Data from the Australian Mepolizumab Registry

Dennis Thomas; Erin S Harvey; Vanessa M McDonald; Sean Stevens; John W Upham; Constance H Katelaris; Vicky Kritikos; Andrew Gillman; John Harrington; Mark Hew; Philip Bardin; Matthew Peters; Paul N Reynolds; David Langton; Melissa Baraket; Jeffrey J Bowden; Simon Bowler; Jimmy Chien; Li Ping Chung; Claude S Farah; Christopher Grainge; Christine Jenkins; Gregory P Katsoulotos; Joy Lee; Naghmeh Radhakrishna; Helen K Reddel; Janet Rimmer; Pathmanathan Sivakumaran; Peter A B Wark; Peter G Gibson

doi:10.1016/j.jaip.2021.01.028

Mepolizumab and Oral Corticosteroid Stewardship: Data from the Australian Mepolizumab Registry

J Allergy Clin Immunol Pract. 2021 Jul;9(7):2715-2724.e5. doi: 10.1016/j.jaip.2021.01.028. Epub 2021 Feb 3.

Authors

Dennis Thomas¹, Erin S Harvey², Vanessa M McDonald², Sean Stevens¹, John W Upham³, Constance H Katelaris⁴, Vicky Kritikos⁵, Andrew Gillman⁶, John Harrington⁷, Mark Hew⁸, Philip Bardin⁹, Matthew Peters¹⁰, Paul N Reynolds¹¹, David Langton¹², Melissa Baraket¹³, Jeffrey J Bowden¹⁴, Simon Bowler¹⁵, Jimmy Chien¹⁶, Li Ping Chung¹⁷, Claude S Farah¹⁸, Christopher Grainge⁷, Christine Jenkins¹⁸, Gregory P Katsoulotos¹⁹, Joy Lee²⁰, Naghmeh Radhakrishna²¹, Helen K Reddel²², Janet Rimmer²³, Pathmanathan Sivakumaran²⁴, Peter A B Wark², Peter G Gibson²⁵

Affiliations

¹ Priority Research Centre for Healthy Lungs, Faculty of Health, University of Newcastle, Newcastle, Australia.
² Priority Research Centre for Healthy Lungs, Faculty of Health, University of Newcastle, Newcastle, Australia; Department of Respiratory and Sleep Medicine, John Hunter Hospital, Newcastle, Australia.
³ Department of Respiratory Medicine, Princess Alexandra Hospital, Brisbane, Australia; Faculty of Medicine, the University of Queensland, Brisbane, Australia.
⁴ School of Medicine, Western Sydney University, Campbelltown, Australia; Immunology and Allergy Unit, Campbelltown Hospital, Campbelltown, Australia.
⁵ Department of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Camperdown, Australia.
⁶ Allergy, Asthma and Clinical Immunology Clinic, Alfred Health, Melbourne, Australia.
⁷ Department of Respiratory and Sleep Medicine, John Hunter Hospital, Newcastle, Australia.
⁸ Allergy, Asthma and Clinical Immunology Clinic, Alfred Health, Melbourne, Australia; School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
⁹ Lung Sleep Allergy & Immunology, Monash University and Medical Centre and Hudson Institute, Clayton, Melbourne, Australia.
¹⁰ Department of Thoracic Medicine, Concord Hospital, Concord, Australia.
¹¹ Lung Research Unit, Department of Thoracic Medicine, Royal Adelaide Hospital, University of Adelaide, Adelaide, Australia.
¹² Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, Australia; Department of Thoracic Medicine, Frankston Hospital, Frankston, Australia.
¹³ South Western Sydney Clinical School, University of New South Wales, Sydney, Australia; Department of Respiratory Medicine, Ingham Institute for Applied Medical Research, Sydney, Australia.
¹⁴ Respiratory and Sleep Services, Flinders Medical Centre and Flinders University, Bedford Park, Australia.
¹⁵ Department of Respiratory Medicine, Mater Hospital, Brisbane, Australia.
¹⁶ Department of Respiratory and Sleep Medicine, Westmead Hospital, Westmead, Australia; School of Medicine, the University of Sydney, Sydney, Australia.
¹⁷ Department of Respiratory Medicine, Fiona Stanley Hospital, Murdoch, Australia.
¹⁸ Department of Thoracic Medicine, Concord Hospital, Concord, Australia; Concord Clinical School, University of Sydney, Concord, Australia.
¹⁹ St George Specialist Centre, Kogarah, Australia; St George and Sutherland Clinical School, University of New South Wales, Sydney, Australia; Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia.
²⁰ Department of Respiratory Medicine Austin Health, Melbourne, Victoria, Australia.
²¹ Respiratory Department, St Vincent's Hospital, Melbourne, Australia.
²² Department of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Camperdown, Australia; Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia.
²³ Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Department of Thoracic Medicine, St Vincent's Clinic, Darlinghurst, Australia.
²⁴ Department of Respiratory Medicine, Gold Coast University Hospital, Gold Coast, Australia.
²⁵ Priority Research Centre for Healthy Lungs, Faculty of Health, University of Newcastle, Newcastle, Australia; Department of Respiratory and Sleep Medicine, John Hunter Hospital, Newcastle, Australia. Electronic address: peter.gibson@newcastle.edu.au.

PMID: 33545399
DOI: 10.1016/j.jaip.2021.01.028

Abstract

Background: Oral corticosteroids (OCS) carry serious health risks. Innovative treatment options are required to reduce excessive exposure and promote OCS stewardship.

Objectives: This study evaluated the trajectories of OCS exposure (prednisolone-equivalent) in patients with severe eosinophilic asthma before and after starting mepolizumab and the predictors of becoming OCS free after 6 months of mepolizumab therapy.

Methods: This real-world observational study included 309 patients from the Australian Mepolizumab Registry who were followed up for 1 year (n = 225).

Results: Patients had a median age of 60 (interquartile range: 50, 68) years, and 58% were female. At baseline, 48% used maintenance OCS, 96% had ≥1 OCS burst, and 68% had received ≥1 g of OCS in the previous year. After commencing mepolizumab, only 55% of those initially on maintenance OCS remained on this treatment by 12 months. Maintenance OCS dose reduced from median 10 (5.0, 12.5) mg/day at baseline to 2 (0, 7.0) mg/day at 12 months (P < .001). Likewise, proportions of patients receiving OCS bursts in the previous year reduced from 96% at baseline to 50% at 12 months (P < .001). Overall, 137 (48%) patients required OCS (maintenance/burst) after 6 months' mepolizumab therapy. Becoming OCS free was predicted by a lower body mass index (odds ratio: 0.925; 95% confidence interval: 0.872-0.981), late-onset asthma (1.027; 1.006-1.048), a lower Asthma Control Test score (1.111; 0.011-1.220), and not receiving maintenance OCS therapy at baseline (0.095; 0.040-0.227).

Conclusion: Mepolizumab led to a significant and sustained reduction in OCS dependence in patients with severe eosinophilic asthma. This study supports the OCS-sparing effect of mepolizumab and highlights the pivotal role of mepolizumab in OCS stewardship initiatives.

Keywords: Mepolizumab; OCS stewardship; Observational study; Oral corticosteroid; Severe eosinophilic asthma.

Publication types

Observational Study
Research Support, Non-U.S. Gov't

MeSH terms

Adrenal Cortex Hormones / therapeutic use
Aged
Anti-Asthmatic Agents* / therapeutic use
Antibodies, Monoclonal, Humanized
Australia / epidemiology
Female
Humans
Male
Middle Aged
Registries

Substances

Adrenal Cortex Hormones
Anti-Asthmatic Agents
Antibodies, Monoclonal, Humanized
mepolizumab