AstraZeneca’s monoclonal antibody (mAb) significantly eliminated oral corticosteroid (OCS) use in OCS-dependent asthma patients with a broad range of blood eosinophils counts.
In the PONENTE trial, 62% of patients achieved complete elimination of daily OCS use, the primary endpoint of the study. On the secondary 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.
In addition, both primary endpoints were sustained for at least four weeks while also maintaining asthma control.
The PONENTE trial expands on OCS-sparing data previously observed in the ZONDA phase III trial by using a faster steroid tapering schedule in patients who did not experience adrenal insufficiency to reduce OCS from higher doses.
Around 13.5 million people worldwide with severe asthma currently rely on oral corticosteroids to control exacerbations and prevent hospitalisations,” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D at AZ.
“However, over-reliance on oral corticosteroids can also cause significant health risks for patients, as well as additional strain on health systems. These data further support Fasenra’s clinical profile in eliminating oral corticosteroid use across a broader population of severe asthma patients,” he added.
Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan and other countries. It is also approved for self-administration in the US, EU and other countries.