GSK presents post-hoc analysis of Anoro Ellipta data assessing markers of COPD deterioration compared to tiotropium or placebo using a novel composite endpoint

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The FINANCIAL — GlaxoSmithKline plc (GSK) and Theravance, Inc. on September 27 announced data presented by GSK at the European Respiratory Society (ERS) International Congress (poster PA1001), from an exploratory post-hoc analysis of phase III data, which showed that patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) who received Anoro Ellipta (UMEC/VI 62.5/25mcg) had a reduced risk of experiencing a clinically important deterioration compared to tiotropium 18mcg or placebo over a 12-week treatment period.

This post-hoc analysis used a novel, composite endpoint, defined as a clinically important deterioration, to assess the effect of treatment on a number of factors that are each believed to represent a worsening of a patient’s COPD. The analysis examined the time to a first clinically important deterioration which was determined by the occurrence of any of the following events: A decrease in lung function of ≥100 ml from baseline as measured by trough FEV1; a deterioration in health-related quality of life defined as ≥4 unit increase from baseline in St George’s Respiratory Questionnaire (SGRQ) total score; or the occurrence of an on-treatment moderate-to-severe COPD exacerbation, according to GlaxoSmithKline.

The results of the analysis showed that the risk of experiencing a clinically important deterioration was significantly lower for patients on UMEC/VI 62.5/25mcg once daily compared to tiotropium 18mcg once daily (hazard ratio: 0.62; 95% confidence interval [CI]: 0.54, 0.71; p<0.001) or placebo (hazard ratio: 0.37; 95% CI: 0.30, 0.45; p<0.001) in an intention to treat population, based on analysis of time to first deterioration.

Eric Dube, Senior Vice President and Head, Global Respiratory Franchise at GSK said: “Most studies are designed to show whether COPD medicines improve outcomes however, there are currently limited data to assess whether they also prevent a worsening, or deterioration, in a patient’s condition which is a key part of the management of COPD. Helping physicians understand the relevance of our medicines as they make decisions in the treatment of COPD is important therefore we performed this post-hoc analysis to explore the potential impact of Anoro on disease deterioration. This is a new area of research and we will be conducting prospective studies to further evaluate these findings in the future.”

Michael W. Aguiar, President and Chief Executive Officer of Theravance, Inc: said: “We already have a substantial amount of evidence which demonstrates the efficacy and safety of Anoro across a number of individual endpoints. However, this is a novel concept which evaluates time to a first clinically important deterioration, and may in the future help our understanding of the factors which drive clinical stability in COPD, once more evidence accumulates on this concept.”

 

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