GlaxoSmithKline Presents New Data for Nucala (mepolizumab) from REALITI-A Interim Analysis
Posted on October 1, 2019
GlaxoSmithKline plc (GSK) 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.
Study investigator, Professor Tim Harrison, University of Nottingham and Nottingham University Hospitals NHS Trust, UK added: “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. I look forward to seeing the full results.”
Safety data from the study were consistent with results from previous clinical trials. 14% (53/368) of patients had on-treatment adverse events, with the most common being headache (23/368), nausea (5/368), fatigue (4/368), influenza like illness (4/368), back pain (3/368) and myalgia (3/368) and <1% (2/368) had on-treatment serious adverse events. There were no deaths.
REALITI-A is expected to complete in 2021 and full results will be published and presented at future scientific meetings in due course.
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