ATS 2021 will feature presentations of original research from accepted abstracts. Mini Symposia and Thematic Poster Sessions are abstract based sessions.
Please use the form below to browse scientific abstracts and case reports accepted for ATS 2021. Abstracts presented at the ATS 2021 will be published in the Online Abstract Issue of the American Journal of Respiratory and Critical Care Medicine, Volume 203, May 3, 2021.
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Adrenal Insufficiency Is Not a Barrier to OCS Elimination in the PONENTE Study
Session Title
TP10 - TP010 CLINICAL AND POPULATION-LEVEL STUDIES OF ASTHMA
Abstract
A1472 - Adrenal Insufficiency Is Not a Barrier to OCS Elimination in the PONENTE Study
Author Block: M. Gurnell1, A. Menzies-Gow2, L. Heaney3, J. Corren4, E. Bel5, J. Maspero6, T. Harrison7, D. Jackson8, D. Price9, N. L. Lugogo10, J. L. Kreindler11, A. Burden12, A. De Giorgio-Miller13, K. Padilla14, U. J. Martin15, E. Garcia Gil16; 1Wellcome-MRC Institute of Metabolic Science, Cambridge Biomedical Campus, Cambridge, United Kingdom, 2Royal Brompton & Harefield NHS Foundation Trust, London, United Kingdom, 3Centre for Experimental Medicine, Queen's University Belfast, Belfast, United Kingdom, 4David Geffen School of Medicine at UCLA and Allergy Medical Clinic Inc., Los Angeles, CA, United States, 5Pulmnology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands, 6Fundación CIDEA, Buenos Aires, Argentina, 7Respiratory Medicine, Nottingham Respiratory NIHR BRC, University of Nottingham; AstraZeneca, Nottingham, United Kingdom, 8Guy's Severe Asthma Center, Guy’s & St. Thomas’ NHS Trust; Asthma UK Centre, School of Immunology & Microbial Sciences, King's College London, London, United Kingdom, 9Observational and Pragmatic Research Institute; Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Singapore, Singapore, 10University of Michigan Medical Center, Ann Arbor, MI, United States, 11Global Medical Respiratory, BioPharmaceuticals Medical, AstraZeneca, Wilmington, DE, United States, 12BioPharmaceuticals R&D, Late Respiratory & Immunology, Biometrics, AstraZeneca, Cambridge, United Kingdom, 13Medical & Scientific Affairs, BioPharmaceuticals Medical, AstraZeneca, Luton, United Kingdom, 14Late Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Durham, NC, United States, 15Late Stage Development, Respiratory and Immunology Therapeutic Area, AstraZeneca, Gaithersburg, MD, United States, 16Global Medical Respiratory, BioPharmaceuticals Medical, AstraZeneca, Barcelona, Spain.
Rationale: Oral corticosteroid (OCS) dependence is prevalent in severe asthma and causes adverse effects, including adrenal insufficiency (AI). Benralizumab may reduce or eliminate the need for long-term OCS for adults with severe asthma. AI may be perceived as a barrier to OCS reduction, and limited data are available to guide the extent to which OCS can be tapered in the presence of AI. Methods: An analysis of patients in the multicenter, open-label phase IIIb PONENTE trial was conducted to demonstrate benralizumab’s ability to eliminate or reduce the daily OCS dosage according to adrenal function status. Hypothalamic-pituitary-adrenal (HPA) axis integrity was evaluated after patients reached a daily OCS dosage of 5 mg for 4 weeks. A morning cortisol level was obtained to determine if patients had normal adrenal function (>350 nmol/L) or complete AI (<100 nmol/L). Patients with indeterminate results (100-350 nmol/L) underwent an ACTH stimulation test. According to this result, patients were classified as having normal cortisol levels (>450 nmol/L), complete AI (<250 nmol/L), or partial AI (250-450 nmol/L). Adrenal status determined whether the OCS down-titration was continued (and the rate of OCS down-titration) or suspended (due to complete AI), and was re-evaluated 2-3 months later to guide further reductions; patients with a finding of complete AI at the second test were not allowed any further dosage reductions. Endpoints included OCS elimination and achieving a daily OCS dosage ≤5 mg. Results: A total of 530 of 598 eligible patients completed the initial HPA axis assessment. At first testing, 40% of patients had normal cortisol levels, 33% had partial AI, and 27% had complete AI. Overall, more than one-third of patients with initial complete or partial AI recovered their adrenal function 2 to 3 months later (36.2% from partial AI to normal levels and 31.9% from complete AI to partial AI or normal levels). More than 90% of patients with normal adrenal function or who improved from partial AI to normal levels and more than 60% of patients who improved from complete AI to partial AI or normal levels eliminated OCS use. Nearly all patients eliminated OCS or achieved a dosage ≤5 mg, regardless of initial AI status (Table). Conclusions: Most patients with normal adrenal function eliminated OCS or achieved a daily OCS dosage ≤5 mg, and a substantial percentage of patients with initially impaired adrenal function were able to reduce or eliminate OCS with careful management.
Author Block: M. Gurnell1, A. Menzies-Gow2, L. Heaney3, J. Corren4, E. Bel5, J. Maspero6, T. Harrison7, D. Jackson8, D. Price9, N. L. Lugogo10, J. L. Kreindler11, A. Burden12, A. De Giorgio-Miller13, K. Padilla14, U. J. Martin15, E. Garcia Gil16; 1Wellcome-MRC Institute of Metabolic Science, Cambridge Biomedical Campus, Cambridge, United Kingdom, 2Royal Brompton & Harefield NHS Foundation Trust, London, United Kingdom, 3Centre for Experimental Medicine, Queen's University Belfast, Belfast, United Kingdom, 4David Geffen School of Medicine at UCLA and Allergy Medical Clinic Inc., Los Angeles, CA, United States, 5Pulmnology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands, 6Fundación CIDEA, Buenos Aires, Argentina, 7Respiratory Medicine, Nottingham Respiratory NIHR BRC, University of Nottingham; AstraZeneca, Nottingham, United Kingdom, 8Guy's Severe Asthma Center, Guy’s & St. Thomas’ NHS Trust; Asthma UK Centre, School of Immunology & Microbial Sciences, King's College London, London, United Kingdom, 9Observational and Pragmatic Research Institute; Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Singapore, Singapore, 10University of Michigan Medical Center, Ann Arbor, MI, United States, 11Global Medical Respiratory, BioPharmaceuticals Medical, AstraZeneca, Wilmington, DE, United States, 12BioPharmaceuticals R&D, Late Respiratory & Immunology, Biometrics, AstraZeneca, Cambridge, United Kingdom, 13Medical & Scientific Affairs, BioPharmaceuticals Medical, AstraZeneca, Luton, United Kingdom, 14Late Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Durham, NC, United States, 15Late Stage Development, Respiratory and Immunology Therapeutic Area, AstraZeneca, Gaithersburg, MD, United States, 16Global Medical Respiratory, BioPharmaceuticals Medical, AstraZeneca, Barcelona, Spain.
Rationale: Oral corticosteroid (OCS) dependence is prevalent in severe asthma and causes adverse effects, including adrenal insufficiency (AI). Benralizumab may reduce or eliminate the need for long-term OCS for adults with severe asthma. AI may be perceived as a barrier to OCS reduction, and limited data are available to guide the extent to which OCS can be tapered in the presence of AI. Methods: An analysis of patients in the multicenter, open-label phase IIIb PONENTE trial was conducted to demonstrate benralizumab’s ability to eliminate or reduce the daily OCS dosage according to adrenal function status. Hypothalamic-pituitary-adrenal (HPA) axis integrity was evaluated after patients reached a daily OCS dosage of 5 mg for 4 weeks. A morning cortisol level was obtained to determine if patients had normal adrenal function (>350 nmol/L) or complete AI (<100 nmol/L). Patients with indeterminate results (100-350 nmol/L) underwent an ACTH stimulation test. According to this result, patients were classified as having normal cortisol levels (>450 nmol/L), complete AI (<250 nmol/L), or partial AI (250-450 nmol/L). Adrenal status determined whether the OCS down-titration was continued (and the rate of OCS down-titration) or suspended (due to complete AI), and was re-evaluated 2-3 months later to guide further reductions; patients with a finding of complete AI at the second test were not allowed any further dosage reductions. Endpoints included OCS elimination and achieving a daily OCS dosage ≤5 mg. Results: A total of 530 of 598 eligible patients completed the initial HPA axis assessment. At first testing, 40% of patients had normal cortisol levels, 33% had partial AI, and 27% had complete AI. Overall, more than one-third of patients with initial complete or partial AI recovered their adrenal function 2 to 3 months later (36.2% from partial AI to normal levels and 31.9% from complete AI to partial AI or normal levels). More than 90% of patients with normal adrenal function or who improved from partial AI to normal levels and more than 60% of patients who improved from complete AI to partial AI or normal levels eliminated OCS use. Nearly all patients eliminated OCS or achieved a dosage ≤5 mg, regardless of initial AI status (Table). Conclusions: Most patients with normal adrenal function eliminated OCS or achieved a daily OCS dosage ≤5 mg, and a substantial percentage of patients with initially impaired adrenal function were able to reduce or eliminate OCS with careful management.
