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

Affiliation

Thomas D(1), Harvey ES(2), McDonald VM(2), Stevens S(1), Upham JW(3), Katelaris CH(4), Kritikos V(5), Gillman A(6), Harrington J(7), Hew M(8), Bardin P(9), Peters M(10), Reynolds PN(11), Langton D(12), Baraket M(13), Bowden JJ(14), Bowler S(15), Chien J(16), Chung LP(17), Farah CS(18), Grainge C(7), Jenkins C(18), Katsoulotos GP(19), Lee J(20), Radhakrishna N(21), Reddel HK(22), Rimmer J(23), Sivakumaran P(24), Wark PAB(2), Gibson PG(25).
Author information:
(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: [Email]

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.