Nucala significantly reduces exacerbations in first global prospective real-world study of a biologic in severe eosinophilic asthma
Issued: London, UK
GlaxoSmithKline plc (GSK) today 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. Results show a significant reduction in exacerbations and oral corticosteroid (OCS) use in patients after one year of treatment with Nucala when taken in a routine care setting, compared to the prior 12 months.
Christopher Corsico, Senior Vice President Development, GSK, 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.?
REALITI-A is a two year, global, prospective, single-arm, observational study of patients with severe eosinophilic asthma newly prescribed Nucala and is being conducted in a routine care setting. The interim analysis of 368 patients presented at the 2019 European Respiratory Society (ERS) International Congress showed that, compared to the prior 12 months, after a year of treatment there was a:
- 69% reduction in the annual rate of clinically significant exacerbations (RR 0.31; 95% CI 0.27, 0.35), the primary endpoint of the study.
- 77% reduction in the annual rate of exacerbations requiring hospitalisation/emergency room visits (RR 0.23; 95% CI 0.18, 0.30).
- Reduction in median OCS dose (n=159) from 10 mg/day to 5mg/day, with 34% of patients (49/143) able to stop OCS completely.