GlaxoSmithKline (GSK) has reported positive results from its study of Nucala (mepolizumab) in patients with severe eosinophilic asthma.
Results were presented at 2019 European Respiratory Society (ERS) International Congress.
Mepolizumab is a monoclonal antibody designed to prevent IL-5 from binding to its receptor on eosinophils’ surface and lower blood eosinophils without depletion.
REAL world effectiveness of mepolizumab In paTIent care – Asthma (REALITI-A) is a two-year, global, prospective, single-arm, observational cohort study.
The trial evaluated the drug in 368 severe eosinophilic asthma patients, and included the administration of mepolizumab in a routine care setting.
Mepolizumab was found to reduce exacerbations and oral corticosteroid (OCS) use in patients after one-year of treatment.
GSK Development senior vice-president Christopher Corsico said: “Exacerbations can be devastating for people living with severe eosinophilic asthma.
“The interim results from REALITI-A continue to demonstrate Nucala effectively reduces exacerbations, this time in a routine care setting. We look forward to sharing the full results from this study after it completes in 2021.”
The trial met the primary endpoint of the study with a 69% reduction in the annual rate of clinically significant exacerbations.
It also met the secondary endpoint of a 77% reduction in the annual rate of exacerbations requiring hospitalisation or emergency room visits.
A significant reduction was also observed in median OCS dose from 10mg/day to 5mg/day, with 34% of patients able to stop OCS completely.
Study investigator professor Tim Harrison said: “Real-world studies like REALITI-A enhance our understanding of the beneficial effects medicines can make over and above data from randomised controlled trials. REALITI-A included a wider range of patients with severe asthma, studied in a setting that more closely resembles their everyday lives.
“Severe eosinophilic asthma can have a devastating impact on patients’ quality of life, so to see the interim analysis show patients benefitting from treatment with mepolizumab after a year is encouraging and mirrors my personal experience with using mepolizumab.”