Fasenra eliminated oral corticosteroid use in a majority of OCS-dependent patients with asthma in PONENTE phase IIIb trial.- AstraZeneca.

High-level results from the PONENTE Phase IIIb open-label trial showed Fasenra (benralizumab) from AstraZeneca, eliminated the use of maintenance oral corticosteroids (OCS) in OCS-dependent asthma patients with a broad range of blood eosinophil counts. Severe asthma is an often debilitating condition affecting approximately 34 million people worldwide. More than one-third of these patients currently use chronic or intermittent OCS on top of other therapies to control their symptoms and exacerbations. However, frequent or chronic OCS use can lead to serious adverse effects. 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. PONENTE included nearly 600 patients in Europe, North America, South America, and Taiwan. 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. The PONENTE trial also has a longer maintenance phase of approximately 24–32 weeks, which shows more durable OCS reduction and asthma control than was shown in ZONDA and all other published trials for biologic medicines. 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.