01 Dec PONENTE Study: Severe Asthma Patients Receiving Fasenra (Benralizumab) Able To Reduce or Discontinue Oral Steroids
MedicalResearch.com Interview with:
Frank Trudo, MD MBA
Vice President, US Medical, Respiratory & Immunology
MedicalResearch.com: What is the background for this study?
Response: PONENTE is a multicenter, open-label, single-arm, Phase IIIb trial to evaluate the efficacy and safety of reducing daily oral corticosteroids (OCS) use after initiation of 30 mg dose of FASENRA (benralizumab) administered subcutaneously in adult patients with severe eosinophilic asthma on high-dose inhaled corticosteroids plus long-acting beta2-agonist and long-term use of OCS therapy with or without additional asthma controller(s). The trial expands on OCS-sparing data previously seen in the ZONDA Phase III trial by using a faster steroid tapering schedule in patients who did not experience adrenal insufficiency to reduce OCS use from higher doses.
Compared to published trials of other biologics, PONENTE has a personalized OCS tapering schedule that allows for more rapid OCS tapering from higher OCS doses, followed by an assessment of the adrenal function as part of decision-making to manage the risk of adrenal insufficiency. PONENTE also has a longer maintenance phase (approximately 24-32 weeks), allowing assessment of the durability of OCS reduction.
FASENRA is a monoclonal antibody that binds directly to IL-5 receptor alpha on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of eosinophils via apoptosis (programmed cell death).
MedicalResearch.com: How is it administered?
Response: FASENRA is injected under your skin (subcutaneously) one time every 4 weeks for the first 3 doses, and then every 8 weeks. In 2019, FASENRA was approved in the US for self-administration in a single dose prefilled autoinjector, the FASENRA pen.
MedicalResearch.com: What are the main findings?
Response: This study found that FASENRA eliminated the use of maintenance oral corticosteroids in OCS-dependent severe asthma patients with a broad range of blood eosinophil counts. On the first primary endpoint, 62% of patients achieved complete elimination of daily OCS use. On the second primary endpoint, 81% of patients achieved complete elimination or were able to reduce their daily OCS dose to 5mg or less when further reduction was not possible due to adrenal insufficiency. Both primary endpoints were sustained for at least four weeks while maintaining asthma control.
MedicalResearch.com: What should readers take away from your report?
Response: More than one-third of severe asthma patients currently use chronic or intermittent oral corticosteroids on top of other therapies to control their symptoms and exacerbations, however frequent or chronic OCS use can lead to serious adverse effects. These data can help to inform treatment decisions regarding reduction or elimination of chronic OCS in patients with severe asthma.
MedicalResearch.com: Is there anything else you would like to add?
Response: The safety profile and tolerability of FASENRA in PONENTE were consistent with the known profile of the medicine. The trial results will be presented at a forthcoming medical meeting.
Clinicaltrials.gov. Study to Evaluate Efficacy and Safety of Benralizumab in Reducing Oral Corticosteroid Use in Adult Patients With Severe Asthma (PONENTE). Available at: https://clinicaltrials.gov/ct2/show/NCT03557307
Menzies-Gow A, Corren J, Bel EH, Maspero J, Heaney LG, Gurnell M, Wessman P, Martin UJ, Siddiqui S, Garcia Gil E. Corticosteroid tapering with benralizumab treatment for eosinophilic asthma: PONENTE Trial. ERJ Open Res. 2019 Sep 25;5(3):00009-2019. doi: 10.1183/23120541.00009-2019. PMID: 31579676; PMCID: PMC6759576.
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