GlaxoSmithKline has released long-term data showing that its biologic Nucala significantly decreased exacerbations in patients with severe, eosinophilic asthma as well as improvement in disease control.
According to results of the COLUMBA trial, which GSK says is the longest study of an anti-IL5 biologic treatment in severe eosinophilic asthma to be reported, one third of patients treated with Nucala (mepolizumab) experienced no exacerbations at all, despite entering the study with an average of almost two exacerbations (1.74) per year.
The data, which relate to patients on Nucala therapy for an average of 3.5 years and a maximum of 4.5 years, show an overall 61 percent decrease in exacerbation rate, and an 8 percent reduction in blood eosinophils (which cause inflammation in certain people with severe asthma), by week 4, sustained until the end of the study.
“These new data give us evidence that Nucala, a targeted biologic treatment, provides an enduring benefit to patients with severe eosinophilic asthma,” said Dave Allen, head of Respiratory Therapy Area R&D, GSK.
“People with severe eosinophilic asthma for whom control has not been possible with inhaled or oral therapy have always sought options to improve control. We know this may be achieved with biologic therapy and are excited to see the long-term effectiveness of the anti-IL-5 therapy, Nucala, balanced with a long-term safety profile,” added Sumita Khatri, associate professor of Medicine at Cleveland Clinic, Ohio and principal investigator in the COLUMBA study.
Interleukin-5 (IL-5) is the main promoter of eosinophil growth, activation and survival, and Nucala is the first and only approved biologic therapy that targets IL-5 and stops it from binding to its receptor, thereby interrupting the inflammation pathway.
The treatment was first approved in the EU back in December 2015, as add-on therapy in adult patients with severe refractory eosinophilic asthma.