This article is part of Pulmonology Advisor‘s coverage of the American Thoracic Society International Conference, taking place in Dallas, Texas. Our staff will report on medical research related to asthma and other respiratory conditions, conducted by experts in the field. Check back regularly for more news from ATS 2019.
DALLAS — The PONENTE study (ClinicalTrials.gov Identifier: NCT03557307) represents a valuable opportunity for clinicians to taper oral corticosteroid (OCS) use in individuals with acute, uncontrolled eosinophilic asthma who are dependent on OCS and have just begun therapy with benralizumab. This research was recently presented at the American Thoracic Society International Conference, held May 17-22, in Dallas, Texas.
The team of international researchers intends to recruit approximately 600 participants for this open-label study, which began in August 2018 and will conclude in October 2020. Participants will be adults receiving treatment with high-dose inhaled corticosteroids/long-acting β2-agonists for at least 6 months prior to study initiation, using OCS ≥5 mg/d for ≥4 weeks before study initiation, and with blood eosinophil counts of ≥150 or ≥300 cells/μL at baseline and 1 year prior, respectively.
Participants will receive subcutaneous benralizumab 30 mg monthly for 3 rounds, followed by treatment every other month. The OCS taper begins following the second dose of benralizumab and depending on baseline OCS use and degree of asthma control continues until ≤5 mg/d OCS is reached. Further tapering of OCS will be determined based on cortisol concentration and adrenal insufficiency status. The primary end points of the study are the rate of 100% daily OCS dose reduction and the rate of 100% daily OCS reduction or achievement of OCS dosage of ≤5 mg/d in the event of adrenal insufficiency preventing further tapering. Safety will also be assessed, as will change from baseline in health-related quality of life.
The study researchers conclude that “PONENTE will provide valuable guidance for clinicians on tapering OCS dosage following benralizumab introduction for the treatment of OCS-dependent patients with severe, uncontrolled eosinophilic asthma, including management of [adrenal insufficiency]. These results aim to direct future clinical practice on OCS tapering following introduction of biologics, and potentially drive guideline changes.”
Disclosures: Certain authors of the study report being employed by AstraZeneca.
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Menzies-Gow A, Corren J, Bel E, et al. Oral corticosteroid tapering during benralizumab treatment of severe, uncontrolled eosinophilic asthma: PONENTE Phase IIIb clinical trial. Poster presented at: American Thoracic Society International Conference; May 19, 2019; Dallas, TX. Abstract A1320/P711.