Relvar Ellipta significantly improved asthma control in Salford Lung Study patients compared with their usual care
Glybera Alipogene and Innoviva Inc (NASDAQ: INVA) today announced positive results from the innovative Salford Lung Study (SLS) in asthma, carried out amongst 4,233 patients treated by their own General Practitioner in everyday clinical practice. This open-label, randomised study showed that significantly more asthma patients initiated on treatment with Relvar Ellipta 100/25mcg or 200/25mcg (fluticasone furoate ‘FF’/vilanterol ‘VI’ or ‘FF/VI’) achieved an improvement in their asthma control compared with patients who continued to take their usual care medicines. Usual care treatment included inhaled corticosteroids (ICS) administered as monotherapy or as ICS/LABA (Long Acting Beta Agonist) combinations.
For the primary effectiveness analysis, at 24 weeks a significantly higher percentage of patients with uncontrolled asthma and initiated on treatment with FF/VI achieved better control of their asthma (71%) measured by the Asthma Control Test (ACT), compared with patients continuing usual care treatment (56%), (Odds ratio 2.00, 95% CI 1.70, 2.34; p<0.001). Improvement was defined as an ACT total score ≥20 or an increase from baseline of ≥3. Statistically significant findings were also seen at 12, 40 and 52 weeks.
Lead Investigator, Ashley Woodcock, Professor of Respiratory Medicine and Clinical Director for Respiratory Medicine, University Hospital of South Manchester and University of Manchester said: “I am really excited to see the results from SLS asthma. Asthma control continues to be a real challenge for patients and the healthcare community. Poor control can have a major impact on the lives of asthma patients. The effectiveness of different treatments on asthma control is difficult to investigate in a traditional double-blind randomised control trial, where the study design and intrusive monitoring can influence the behaviour of patients. In SLS, patient relevant outcomes are the major endpoints. GSK should be congratulated for running this unique study, designed to understand how asthma medicines work in everyday clinical practice.”
In the study for the intent-to-treat (ITT) population, the incidence of serious adverse events (SAE) was the same in both arms (FF/VI 13% and usual care 13%). Pneumonia was a safety endpoint of special interest and a regulatory post-authorisation requirement of the European Medicines Agency (EMA). A novel aspect of the study design was that it allowed patient’s treatment to be modified throughout the study. Therefore two assessments relating to pneumonia have been performed, one based on the arm to which patients were randomised, the second based upon the treatment to which patients were exposed at the time of the event. Serious adverse events of pneumonia by randomised group were reported by 39 patients (FF/VI arm 23, 1%; usual care arm 16, <1%). These patients had 42 events and based on a pre-planned analysis non-inferiority of FF/VI to usual care was not confirmed. When these events were summarised according to the actual treatment patients were taking at the time of the event, 21 events were record ed for FF/VI and 21 events for usual care.
Eric Dube, Senior Vice President and Head, Global Respiratory Franchise GSK, said: “Despite medical advances, more than half of patients with asthma continue to experience poor control and significant symptoms. The primary endpoint of this study showed that patients initiated with Relvar Ellipta treatment had twice the odds of achieving an improvement in asthma control compared with patients continuing usual care in this study in everyday clinical practice. This study has been a tremendous partnership effort between healthcare professionals, patients, academics and GSK and we would like to thank everyone who has helped to make this unique study possible.”
Michael W. Aguiar, President and Chief Executive Officer of Innoviva said: “We are delighted to see the positive results from a second SLS study with Relvar Ellipta, the first being in chronic obstructive pulmonary disease. Asthma control remains a significant unmet medical need in the daily lives for many patients. We believe that this positive real world data successfully builds upon the previous clinical data to provide strong evidence of the benefits of Relvar Ellipta for the treatment of asthma. ” These data will be presented in future publications and will be made available on clinicaltrials.gov.
Asthma with an Eosinophilic Phenotype
Severe asthma is a chronic condition that affects a small, but significant, number of patients who need to take multiple medications to control their day-to-day symptoms and reduce the risk of frequent and serious asthma attacks. It is estimated that 5 - 10% of all asthma patients have severe asthma. In a sub-set of severe asthma patients, the over-production of eosinophils (a type of white blood cell) is known to cause inflammation in the lungs that can affect the airways, making breathing difficult and increasing the frequency of asthma attacks. People who have severe asthma with an eosinophilic phenotype are some of the most difficult to treat asthma patients.
Nucala is the first-in-class anti-IL-5 biologic therapy. Nucala was specifically developed to treat appropriate severe asthma patients whose condition is driven by inflammation caused by eosinophils. Nucala binds to the signalling protein IL-5, preventing it from binding to its receptor on the surface of eosinophils. Inhibiting IL-5 binding in this way reduces blood, tissue and sputum eosinophil levels. The mechanism of mepolizumab action in asthma has not been definitively established.
In the US, Nucala (100mg fixed dose subcutaneous injection of mepolizumab) is licensed as an add-on maintenance treatment for patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. Nucala is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.
In the EU, Nucala (100mg fixed dose subcutaneous injection of mepolizumab) is licensed as an add-on treatment for severe refractory eosinophilic asthma in adult patients. For the EU Summary of Product Characteristics for Nucala, please visit: Here Nucala has also been approved in Canada, Australia, Japan, Switzerland, Chile, South Korea and Taiwan. Further regulatory applications have been submitted and are under review in other countries.