Nucala significantly reduces exacerbations in first global prospective real-world study of a biologic in severe eosinophilic asthma.- GSK

GlaxoSmithKline plc 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.

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.>

About real-world studies : Evidence demonstrating the efficacy and safety of medicines to support their regulatory approval is typically generated through randomised controlled trials (RCTs) which are considered the �gold standard� of evidence-based medicine because of the highly rigorous controlled and scientific way in which they are conducted. Real world data are data on patient health or healthcare delivery collected outside of a conventional RCT setting that reflect the everyday patient experience. Real world evidence is evidence derived from these data through the application of scientific research methods. Real world studies are not a replacement for RCTs, as they may not be able to account for certain biases or confounding factors the way an RCT can, however they can complement RCTs, providing information on a medicine�s effectiveness and safety in a routine care setting.

About REALITI-A : The REALITI-A (REAL world effectiveness of mepolizumab In paTIent care � Asthma) is a two year, global, prospective, single-arm, observational cohort study enrolling patients with severe eosinophilic asthma and newly prescribed mepolizumab 100mg subcutaneously at physician�s discretion (i.e. with no pre-defined eligibility criteria). This is the first prospective global real-world study investigating a biologic in severe eosinophilic asthma and aims to recruit 850 patients across seven countries. Data are being collected at routine healthcare visits; one-year pre-exposure data are collected retrospectively at enrolment. The primary endpoint is the rate of clinically significant exacerbations (defined as exacerbations requiring oral corticosteroid use and/or emergency room visit/hospitalisation). Exacerbations requiring emergency room visit/hospitalisation and maintenance oral corticosteroid use are key secondary endpoints. The interim analysis presented at ERS includes patients with one-year post-exposure data. The study is expected to complete in 2021.