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.
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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.
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By GlobalDataGSK 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.”
