GlaxoSmithKline has presented new data showing that its asthma drug Nucala “significantly improves” quality of life and lung function in patients with a severe, eosinophilic form of the condition.
The Phase IIIb MUSCA study successfully met all its primary and secondary endpoints, showing that when the first-in-class biologic was added to standard of care, patients experienced clinically and statistically significant improvements in their health-related quality of life and lung function compared to those treated with placebo and standard of care.
According to findings from the study, presented at the American Academy of Allergy, Asthma & Immunology Annual Meeting, after 24 weeks the Nucala (mepolizumab) treated group reported a 7.7 unit improvement from baseline on the George’s Respiratory Questionnaire (SGRQ) score (primary endpoint), a measure of quality of life, compared to placebo.
Lung function (first secondary endpoint) as measured by pre-bronchodilator FEV1, increased by 120mL more than in placebo patients, while asthma control, measured by the Asthma Control Questionnaire-5 (ACQ-5) (additional secondary endpoint), was also significantly improved, the drug giant said.
Exploratory endpoints were the annual rate of exacerbations (asthma attacks), which was reduced by 58 percent, and the number of exacerbations requiring emergency room visits or hospitalisation, which was reduced by 68 percent for people treated with Nucala versus placebo.
The data “underscore the importance of Nucala as a treatment option for patients with severe asthma with an eosinophilic phenotype,” noted Dr Frank Albers, Medical Affairs Lead for Nucala, GSK. “These are patients who have very limited treatment options to control their asthma. For them shortness of breath, wheezing, coughing and the risk of an asthma attack is an ever present occurrence and one that can have a severe impact their life on a daily basis.”
It is estimated that 5 - 10 percent of all asthma patients have severe asthma. In a sub-set of these patients (around 100,000), the over-production of eosinophils (a type of white blood cell) is known to cause inflammation in the lungs that can affect the airways, making breathing difficult and increasing the frequency of asthma attacks.
Nucala is the first biologic therapy that targets interleukin-5 (IL-5) - the main promotor of eosinophil growth, activation and survival - in severe asthma and stops it from binding to its receptor, thereby interrupting the inflammation pathway.
The drug was approved in Europe in December 2015, and was given a final green light for NHS use by the National Institute for Health and Care Excellence in January this year.