GSK announce positive results for chronic obstructive pulmonary disease treatment

pharmafile | September 5, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing GlaxoSmithKline, Innoviva, Revlar Ellipta, chronic obstructive pulmonary disease 

GlaxoSmithKline and its partner Innoviva have announced that its Relvar Ellipta achieved positive results in its COPD Salford lung study to evaluate its efficacy and safety in the treatment of patients with chronic obstructive pulmonary disease (COPD).

The results of the study have been published in the New England Journal of Medicine (NEJM) and are were presented at the European Respiratory Society International Congress in London.

Patients treated with 100/25mcg (fluticasone furoate ‘FF’/vilanterol ‘VI’ or ‘FF/VI’) of the drug saw a reduction of 8.4% (p=0.025; 95% CI 1.1 to 15.2) in the rate of moderate or severe exacerbations compared with patients receiving ‘usual care’, the majority (88%) of whom were taking an inhaled corticosteroid-containing regimen. Similarly, a reduction in exacerbations with FF/VI was seen in patients on an ICS/long-acting beta2-agonist (LABA) at baseline (8.0%; 95% CI 0.11 to 15.4, p=0.047).

For the intent to treat (ITT) population there were no differences observed between FF/VI and usual care on secondary outcomes measured including the time to first moderate or severe exacerbation and rate of severe exacerbations, the rate of secondary care healthcare contacts and COPD related primary care contacts. There were more primary care contacts overall on FF/VI (12.3% increase, 95% CI 5.4 to19.6). The COPD Assessment Test (CAT), which measures the impact of disease on health status, demonstrated 45% of patients receiving FF/VI improved their CAT score by two or more, a clinically relevant improvement, compared to 36% in the usual care group (odds ratio 1.51, 95% CI, 1.28 to 1.77).

Neil Barnes, global medical head, Respiratory Franchise at GSK said: “In the SLS study we included a broad spectrum of patients who had minimal interventions to see if this would allow us to observe a difference between treatments.  The results from SLS provide robust evidence that will enable the healthcare community to begin to understand how the choice of COPD treatment can significantly influence patient outcomes.   We are continuing to analyse the data from the study as we know there is so much more we will learn and we look forward to sharing our findings in future publications. I want to thank all of the patients who participated and the partners who collaborated with GSK to make this unique study possible.”

Innoviva’s president and CEO Michael W. Aguiar added: “The data being presented at ERS and published in NEJM confirm the effectiveness of Relvar Ellipta compared with not only usual care, but also with those patients who were taking a different medicine in the same ICS/LABA class. These are important data to share with physicians, from a unique study carried out in conditions closely reflecting everyday clinical practice.”

A second Salford Lung Study is currently being conducted in patients with asthma, with results expected in 2017.

Matt Fellows

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