GlaxoSmithKline has presented new data for Nucala (mepolizumab) from an interim analysis of REALITI-A, the first prospective global real-world study of a biologic treatment in patients with severe eosinophilic asthma.
The results showed a significant reduction in exacerbations and oral corticosteroid (OCS) use in patients after one year of treatment with the drug when taken in a routine care setting, compared to the prior 12 months.
The two year, global, prospective, single-arm, observational study demonstrated a 69% reduction in the annual rate of clinically significant exacerbations - the primary endpoint of the study.
It also showed a 77% reduction in the annual rate of exacerbations requiring hospitalisation or emergency room visits and a reduction in median OCS dose from 10 mg/day to 5mg/day, with 34% of patients able to stop OCS completely.
“Exacerbations can be devastating for people living with severe eosinophilic asthma”, explained Christopher Corsico, senior vice president of development at GSK.
He continued, “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.”
Safety data from the study were also consistent with results from previous clinical trials.
The company says that REALITI-A is expected to complete in 2021 and full results will be published and presented at future scientific meetings in due course.
Severe asthma is defined as asthma which requires treatment with high dose inhaled corticosteroids (ICS) plus a second controller (and/or systemic corticosteroids) to prevent it from becoming “uncontrolled”.