GSK reveals "significant improvement" in Nucala severe asthma tests

GlaxoSmithKline has reported encouraging data on the effect of its Nucala drug on severe asthma sufferers.

GSK presented results at the American Academy of Allergy, Asthma & Immunology (AAAAI) late on Monday that showed patients with severe asthma experienced a "significant improvement" when treated with Nucala, the brand name for a subcutaneous injection of its mepolizumab drug, compared to placebo.

Results of the post-hoc study, taken from a meta-analysis of data from two studies of 1,192 patients, also showed that patients with higher levels of eosinophils, a type of blood cell that plays a role in causing the lung inflammation that can lead to asthma attacks, enjoyed the greatest improvement from receiving mepolizumab.

This using eosinophils as a biomarker, GSK was able to identify those asthma patients whose disease is severe and driven by the over-expression of eosinophils and are therefore likely to respond to treatment from the drug.

Or, as more exactly, when patients were stratified according to their baseline eosinophil levels, the greatest improvement occurred in patients with higher baseline levels.

"Whereas overall there was a 47% reduction in exacerbations compared to placebo, the actual reduction ranged from 52% in patients with baseline eosinophil levels of 150 cells/µL to 70% for patients with baseline levels of 500 cells/µL or higher," the FTSE 100 drugmaker said.

Steve Yancey, GSK's leader of the mepolizumab development programme, added: "This post-hoc analysis confirms the predictive nature of the relationship between baseline blood eosinophil counts and efficacy outcomes in patients treated with mepolizumab.”

In the US Nucala is licensed as an add-on maintenance treatment for patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.

In the EU Nucala is licensed as an add-on treatment for severe refractory eosinophilic asthma in adult patients.