[en] Rationale: Although clinical trials have documented the oral corticosteroid (OCS)-sparing effect of biologics in patients with severe asthma, little is known about whether this translates to a reduction of new-onset OCS-related adverse outcomes. Objective: To compare the risk of developing new-onset OCS-related adverse outcomes between biologic initiators and noninitiators. Methods: This was a longitudinal cohort study using pooled data from the International Severe Asthma Registry (ISAR; 16 countries) and the Optimum Patient Care Research database (OPCRD; United Kingdom). For biologic initiators, the index date was the date of biologic initiation. For noninitiators, it was the date of enrollment (for ISAR) or a random medical appointment date (for OPCRD). Inverse probability of treatment weighting was used to improve comparability between groups, and weighted Cox proportional hazard models were used to estimate the hazard ratios (HRs) of developing OCS-related adverse outcomes for up to 5 years from the index date. Measurements and Main Results: A total of 42,908 patients were included. Overall, 27.3% and 4.7% of biologic initiators and noninitiators were long-term OCS users (daily intake ⩾90 consecutive days in year before the index date), with a mean prednisolone-equivalent daily dose of 10.2 mg and 6.2 mg, respectively. Compared with noninitiators, biologic initiators had decreased rate of developing any OCS-related adverse outcome (HR [95% confidence interval (CI)]: 0.82 [0.72-0.93]; P = 0.002), primarily driven by reduced rate of developing diabetes (0.62 [0.45-0.87]; P = 0.006), major cardiovascular events (0.65 [0.44-0.97]; P = 0.034), and anxiety and/or depression (0.68 [0.55-0.85]; P = 0.001). There were no significant differences in the rates of new-onset cataract (HR, 0.77 [95% CI, 0.47-1.25]), sleep apnea (HR, 0.82 [95% CI, 0.78-1.41]), or other OCS-related adverse outcomes assessed (e.g., osteoporosis). The results were consistent across both datasets. Conclusions: Our findings highlight the role for biologics in preventing new-onset OCS-related adverse outcomes in patients with severe asthma.
Disciplines :
Cardiovascular & respiratory systems
Author, co-author :
Sadatsafavi, Mohsen; Respiratory Evaluation Sciences Program, Faculty of Pharmaceutical Sciences.
Tran, Trung N; BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, Maryland.
Scelo, Ghislaine; Observational and Pragmatic Research Institute, Singapore, Singapore. ; Optimum Patient Care Global, Cambridge, United Kingdom.
Tsai, Ming-Ju; Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Medical University Hospital, and. ; Department of Internal Medicine, School of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.
Busby, John; Centre for Public Health, School of Medicine, Dentistry, and Biomedical Sciences, and.
Heaney, Liam G; Wellcome-Wolfson Institute for Experimental Medicine, Queen's University Belfast, Belfast, United Kingdom.
Jenkins, Christine; Head Respiratory Group, The George Institute, Barangaroo, New South Wales, Australia. ; University of New South Wales, Sydney, New South Wales, Australia.
Hoyte, Flavia; Division of Allergy and Clinical Immunology, and.
Canonica, Giorgio Walter; Personalized Medicine, Asthma, and Allergy, IRCCS Humanitas Research Hospital, Rozzano (MI), Italy. ; Department of Biomedical Sciences, Humanitas University, Milan, Italy.
Katial, Rohit; Division of Allergy and Clinical Immunology, and.
Heffler, Enrico; Personalized Medicine, Asthma, and Allergy, IRCCS Humanitas Research Hospital, Rozzano (MI), Italy. ; Department of Biomedical Sciences, Humanitas University, Milan, Italy.
Wang, Eileen; Division of Allergy and Clinical Immunology, and. ; Division of Allergy and Clinical Immunology, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado.
Puggioni, Francesca; Personalized Medicine, Asthma, and Allergy, IRCCS Humanitas Research Hospital, Rozzano (MI), Italy.
Wechsler, Michael E; National Jewish Health Cohen Family Asthma Institute, Department of Medicine, National Jewish Health, Denver, Colorado.
Ardusso, Ledit R F; Pulmonology, Allergy, and Immunology Department, Rosario School of Medicine, National University of Rosario, Rosario, Santa Fe, Argentina.
Máspero, Jorge; Clinical Research for Allergy and Respiratory Medicine, CIDEA Foundation, Buenos Aires, Argentina. ; University Career of Specialists in Allergy and Clinical Immunology at the Buenos Aires University School of Medicine, Buenos Aires, Argentina.
Sivori, Martin; Neumonology Center of School of Medicine, University of Buenos Aires, Hospital "Dr. J. M. Ramos Mejia", Buenos Aires, Argentina.
Emmas, Cathy; BioPharmaceuticals Medical, AstraZeneca, Cambridge, United Kingdom.
Menzies-Gow, Andrew N; BioPharmaceuticals Medical, AstraZeneca, Cambridge, United Kingdom. ; Lung Division, Royal Brompton and Harefield Hospital, London, United Kingdom.
Bosnic-Anticevich, Sinthia Z; AstraZeneca Pty. Ltd., Medical Affairs, Biopharmaceuticals Unit, Sydney, New South Wales, Australia. ; Macquarie Medical School, Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, New South Wales, Australia. ; Woolcock Institute of Medical Research, Sydney, New South Wales, Australia.
Cochrane, Belinda; Department of Respiratory and Sleep Medicine, Campbelltown Hospital, Campbelltown, New South Wales, Australia. ; School of Medicine, Western Sydney University, Sydney, New South Wales, Australia.
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Middleton, Peter G ; Westmead Hospital, Sydney, New South Wales, Australia.
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Chapman, Kenneth R; University of Toronto, Toronto, Ontario, Canada.
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Couillard, Simon; Faculté de Médecine et des Sciences de la Santé, Université de Sherbrooke, Sherbrooke, Québec, Canada.
Dorscheid, Delbert R; Center for Heart Lung Innovation, The University of British Columbia, Vancouver, British Columbia, Canada.
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Mitchell, Patrick D; School of Medicine, Trinity College Dublin, Dublin, Ireland.
Iwanaga, Takashi; Sleep Medicine Centre, Kindai University Hospital, Osakasayama, Japan.
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Chaves Loureiro, Cláudia ; Unidade de Pneumologia, Hospitais da Universidade de Coimbra, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal. ; Centre of Pneumology, Faculty of Medicine, University of Coimbra, Coimbra, Portugal.
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Chen, Wenjia; Saw Swee Hock School of Public Health, National University of Singapore, Singapore, Singapore.
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