Biologic therapy benralizumab (Fasenra) is associated with possible elimination or maximal reduction of oral corticosteroid (OCS) use in dependent patients with asthma, in new phase 3b data.
The findings from the PONENTE Trial, presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2021 Virtual Sessions this weekend, evidence the AstraZeneca biologic’s benefit for reducing maintenance therapy needs in patients with severe asthma, regardless of baseline parameters including eosinophil counts.
Presented by study author Andrew Menzies-Gow, BSc, MBBS, PhD, deputy medical director at the Royal Brompton & Harefield Hospitals in the UK, the PONENTE data showed benralizumab’s influence on OCS dose reduction among 598 participants to receive at least 1 dose of the monoclonal antibody.
Mean patient age was 53.3 years old, with a majority being female (64%) and White (80.6%). A majority of patients were taking ≥5 mg OCS daily (67.7%) at baseline; 84.4% had suffered an exacerbation in the prior 12 months. Eosinophil levels at baseline varied from <150 (20.8%), ≥150 to <300 (43.7%), to ≥300 cells/mcL (35.5%).
Investigators administered benralizumab throughout the induction and OCS-reduction phases of the trial, by 30 mg subcutaneous injection every 4 weeks for 3 dosages, then every 8 weeks thereafter.
At study’s end, 62.2% (95% CI, 58.18–66.11) of patients had eliminated OCS use.Another 80.6% (95% CI, 77.20–83.70) eliminated use or reduced the daily dosage to ≤5 mg if instances of adrenal insufficiency prevented further reduction.
Another 91.3% (95% CI, 88.75–93.44) of patients achieved a daily ≤5 mg OCS dosage, regardless of the cause for stopping the reduction.
In an interview with HCPLive during AAAAI 2021, Menzies-Gow discussed his team’s findings and their indication for benralizumab’s benefit for lessened OCS dependency in severe asthma.
“If you looked across the globe, depending on where you are, somewhere between 20% and 50% of severe asthmatics are stuck on OCS, so this is a big clinical problem,” he explained.
The study, “Elimination of Oral Corticosteroids (OCS) with Benralizumab Treatment in OCS-Dependent Asthmatics Using a Rapid, Personalized Algorithm: The PONENTE Trial,” was presented at AAAAI 2021.