One-third of patients treated with mepolizumab experienced no exacerbations, GSK reported – down from an average of two exacerbations each year at the start of the study.
The 347-patient Columba trial gave participants 100-mg of mepolizumab in a subcutaneous injection every four weeks, on top of the standard of care for an average of 3.5 years.
Mepolizumab, also known as Nucala, is a biologic therapy that has won approval in the EU, U.S. and Japan for an array of eosinophilic conditions, like eosinophilic granulomatosis with polyangiitis. In the U.S., Nucala is licensed as an add-on maintenance therapy for patients with severe asthma and for those with an eosinophilic phenotype.
Severe eosinophilic asthma is characterized by inflammation due to high levels of eosinophils in the bloodstream. Overproduction of these white blood cells can create inflammation in organs and tissues, including the lungs. Inflammation in the lungs makes it hard to breathe, boosting the frequency of exacerbations and asthma attacks, according to GSK.
It’s not exactly clear how Nucala works, the company added, but it is thought that the biologic therapy stops the IL-5 cytokine from binding to its receptor on eosinophil cells, lowering eosinophil levels.
In the Columba trial, researchers observed a 61% decrease in exacerbation rate for patients treated with Nucala. In the treatment group, patients went from having 1.74 events per year, on average, to 0.68 events per year. The scientists added that the exacerbation rates were consistent each year throughout the study period.
After four weeks, the GSK team observed a 78% reduction in blood eosinophils. That drop was sustained until the end of the study, according to the company.
The product’s long-term safety profile was similar to results reported in earlier studies, GSK added.
“These new data give us evidence that Nucala, a targeted biologic treatment, provides an enduring benefit to patients with severe eosinophilic asthma,” Dave Allen, head of GSK’s respiratory therapy area R&D unit, said in prepared remarks.
“People with severe eosinophilic asthma for whom control has not been possible with inhaled or oral therapy have always sought options to improve control,” Sumita Khatri, principal investigator and associate professor of medicine at the Cleveland Clinic, added. “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.”