GlaxoSmithKline and Innoviva (formerly Theravance, Inc.) have announced data from the Salford Lung Study (SLS) showing that COPD patients using the Relvar Ellipta 100/25 mcg fluticasone furuoate/vilanterol DPI had an 8.41% lower rate of moderate or severe exacerbations compared to patients receiving LAMAs, LABAs, and/or ICS as monotherapy or in combination. Relvar Ellipta is marketed as Breo Ellipta in the US and in Canada.
The incidence of serious adverse events was 29% for patients using Relvar Ellipta compared to 27% for usual care and the rate of pneumonia was 7% for Relvar Ellipta vs. 6% for usual care.
The SLS randomized over 2,800 COPD patients to get Relvar Ellipta or to continue with their usual care. Patients using a LAMA in addition to their usual care who were randomized to the Relvar group continued to use the LAMA with Relvar. All of the patients, whose mean age was 67, had experienced at least one exacerbation in the previous 3 years. Patients were followed for 12 months via electronic medical records.
GSK President, Pharmaceuticals R&D, Patrick Vallance, commented, “In this genuinely ground-breaking study we have worked closely with the local NHS clinical community to study patients in their everyday setting. To ensure the results from Salford were as robust as possible, we made a long-term financial investment in the study, including supporting local infrastructure and training. Innovation often means you have to ask challenging questions to make significant advances, and I believe this is what we have achieved in these positive results announced today.”
Innoviva President and CEO Michael W. Aguiar added, “We are very pleased that Relvar Ellipta achieved superiority compared to usual care in SLS, a world-first effectiveness study in COPD. These data provide a significant body of evidence in everyday clinical practice and add to the data generated from other randomized controlled studies. These data are unique in the world of evidence generation in COPD. We look forward to disclosing further data and analyses, which we believe will be of significant value to both physicians and patients.”
Results from another Salford Lung Study in asthma patients are expected in 2017.
Read the GSK and Innoviva press release.
