Long term study of Nucala shows reduced exacerbations in eosinophilic asthma.- GlaxoSmithKline.

GlaxoSmithKline presented new data from the longest study of Nucala (mepolizumab) treatment in severe eosinophilic asthma to be reported. The study showed consistent reductions in exacerbations and improvements in asthma control, with a safety profile similar to previous clinical studies, in severe eosinophilic asthma patients treated with mepolizumab over the long-term study period. One third of patients in the study treated with mepolizumab experienced no exacerbations, despite entering the study with an average of almost two exacerbations (1.74) per year.

The open-label COLUMBA study is a long-term safety and efficacy study of mepolizumab in patients with severe eosinophilic asthma. The study reports data from patients who were on mepolizumab treatment for an average of 3.5 years and a maximum of 4.5 years. Results showed a 61% decrease in exacerbation rate (from 1.74 events/year at enrolment to 0.68 events/year during the treatment period; 95% confidence interval 0.60, 0.78). There were consistent exacerbation rates per year over the study period (year one, 0.71, year two, 0.82, year three, 0.71) as well as improvement in asthma control (improved (ACQ5) by -0.47) from first assessment (Week 12) and maintained for over four years (until Week 228). There was a 78% reduction in blood eosinophils (white blood cells that cause inflammation in certain people with severe asthma), by week 4, sustained until the end of the study.

Finally safety and immunogenicity profiles of long-term Nucala treatment observed in the COLUMBA study similar to that seen in prior severe asthma studies. Data were presented at the American Thoracic Society (ATS) conference.