Patients with normal adrenal function are largely able to eliminate the use of oral corticosteroids or achieve a daily dose of 5 mg or less, according to research presented at the American Thoracic Society (ATS) 2021 International Conference, held virtually from May 14 to 19, 2021.
Currently, limited data are available to guide clinicians in reducing oral corticosteroid dependence in patients with adrenal insufficiency. To address this, researchers analyzed data from patients participating in the multicenter, open-label, phase 3B PONENTE trial (ClinicalTrials.gov Identifier: NCT03557307) to determine the ability of benralizumab to either eliminate or reduce daily oral corticosteroid dose based on adrenal function status.
A cohort of 530 patients completed the initial hypothalamic-pituitary-adrenal axis integrity assessment, conducted when patients reached a daily oral corticosteroid dose of 5 mg for 4 weeks. At this first testing point, 40% of patients had normal corticosteroid levels, 33% had partial adrenal insufficiency, and 27% had complete adrenal insufficiency.
More than one-third of patients with either partial or complete adrenal insufficiency recovered adrenal function between 2 and 3 months later (36.2% from partial to normal levels and 31.9% from complete to partial or normal levels). More than 90% of patients with normal adrenal function or patients who improved from partial adrenal insufficiency to normal levels, and more than 60% of patients who improved from complete to partial adrenal insufficiency or to normal levels, were able to eliminate use of oral corticosteroids.
“Most patients with normal adrenal function eliminated [oral corticosteroids] or achieved a daily [oral corticosteroid] dosage of ≤5 mg,” the researchers concluded, “and a substantial percentage of patients with initially impaired adrenal function were able to reduce or eliminate [oral corticosteroids] with careful management.”
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Gurnell M, Menzies-Gow A, Heaney L, et al. Adrenal insufficiency is not a barrier to OCS elimination in the PONENTE Study. Presented at: the American Thoracic Society (ATS) 2021 International Conference; May 14-19, 2021. Abstract 1472.