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GSK’s ECLIPSE study shows association between improving health status and reduced morbidity and mortality in patients with COPD

Issued: London, UK

The latest findings from the landmark GSK-sponsored ECLIPSE (Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints) study, published in this month’s issue of Thorax, demonstrate that improving or keeping stable health status in patients with obstructive pulmonary disease (COPD) significantly reduces the likelihood of having an exacerbation of COPD, hospital admission and dying.1

The primary objectives of COPD treatment are to enable patients to effectively manage their disease, improve their health status (measured by the St George’s Respiratory Questionnaire (SGRQ)) and slow the rate of decline from this chronic and progressive disease. However, the extent to which clinically relevant changes in health status may affect morbidity and mortality is not well understood. This analysis of the ECLIPSE study, which included 1,832 subjects with at least 12 months of follow-up, showed that COPD patients with improved or stable health status over a period of just one-year, compared with those who deteriorated, had fewer hospital admissions for COPD (p=0.004 for improved and p=0.023 for stable SGRQ), a lower likelihood of having a moderate/severe exacerbation of COPD (p<0.001 for improved and p=0.016 for stable SGRQ) or dying (p=0.027 for improved and p=0.019 stable SGRQ). These findings support the recommendation by the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) committee to include the improvement of health status as an objective measure of COPD management.1

Commenting on the results, John W. Walsh Co-founder and President of the COPD Foundation said: “These data are particularly compelling as we know that approximately half of all patients with COPD experience exacerbations which have a significant impact on their disease and wellbeing, as well as their overall disease burden. These findings demonstrate the importance of closely monitoring health status and we would encourage all individuals with COPD to work with their physicians to understand how simple tools, such as the COPD Assessment Test, can help them manage their condition more effectively.”

Professor Emiel F.M Wouters, Pulmonologist at the Maastricht UMC+, Professor of Respiratory Medicine at Maastricht University and Director of the CIRO Centre of Expertise in Horn said: “These data suggest that over a period as short as one-year, actively managing or improving a patient’s health status may positively impact their morbidity and mortality, which is a significant finding given this is a long-term progressive disease. We hope that these findings will help encourage healthcare professionals to closely monitor their COPD patients’ health status so that those with a decline can be identified early on and appropriate management steps taken to try and prevent further consequences. These additional actions could ultimately improve patient outcomes.”

Study Design

Of the 2,138 patients with COPD participating in the three-year observational ECLIPSE study, 1,832 (85.7%) patients with complete health status (SGRQ score) and outcomes data and at least 12 months of follow-up were included. Change in health status (=4 units in SGRQ score, equal to minimum clinically important difference) was associated with outcomes occurring during the remainder of the study follow-up (up to 3 years). Outcome measures included survival time to death and first event of moderate/severe exacerbation and hospitalizations for COPD. The SGRQ-C is a disease-specific health status questionnaire reflecting a broad variety of health impacts in patients with chronic respiratory diseases. The questionnaire has three domain scores (symptoms, activity and impact) and a Total score, ranging from 0 (optimal) to 100 points (worst).1

Additional information and updates about the ECLIPSE study are available from the ECLIPSE website www.eclipse-copd.com.

About COPD

COPD is a disease of the lungs that includes chronic bronchitis, emphysema or both. COPD is characterised by obstruction to airflow that interferes with normal breathing. COPD is thought to affect around 210 million people worldwide.2

Long-term exposure to lung irritants that damage the lungs and the airways are usually the cause of COPD. Cigarette smoke, breathing in second hand smoke, air pollution, chemical fumes or dust from the environment or workplace can all contribute to COPD. Most people who have COPD are at least 40 years old when symptoms begin.3

GSK has a long-standing commitment to researching COPD in line with our goal to better understand the condition and improve outcomes for patient.

Notes to Editors

About ECLIPSE
The ECLIPSE (Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints) study is a multicentre, longitudinal, prospective three-year observational study to identify novel endpoints in COPD. The study is led by a Steering Committee and a Scientific Committee of international COPD experts and GSK staff. Full details of committee members can be found at www.eclipse-copd.com

ECLIPSE has four specific aims: definition of clinically relevant COPD subtypes; identification of parameters that predict disease progression in these subtypes; examination of biomarkers that correlate with COPD subtypes and may predict disease progression and identification of novel genetic factors and/or biomarkers that both correlate with clinically relevant COPD subtypes and predict disease progression. Since publication of the initial results in 2010 ECLIPSE has resulted in several scientific publications and has led to significant advances in the way COPD is understood.

References

1. Wilke S et al. One-year change in health status and subsequent outcomes in COPD. Thorax. 2015 May;70(5):420-5. doi: 10.1136/thoraxjnl-2014-205697. Epub 2015 Mar 17. Last accessed April 2015.
2. World Health Organization. Chronic Respiratory Diseases. Last accessed April 2015. Available at: http://www.who.int/gard/publications/chronic_respiratory_diseases.pdf
3. National Heart Lung and Blood Institute. Who is at risk for COPD? Last accessed April 2015. Available at: https://www.nhlbi.nih.gov/health/health-topics/topics/copd/atrisk.html

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Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2014.