Please use this identifier to cite or link to this item: http://hdl.handle.net/2381/45180
Title: Blood eosinophils: a biomarker of COPD exacerbation reduction with inhaled corticosteroids.
Authors: Siddiqui, SH
Pavord, ID
Barnes, NC
Guasconi, A
Lettis, S
Pascoe, S
Petruzzelli, S
First Published: 6-Nov-2018
Publisher: Dove Medical Press
Citation: International Journal of Chronic Obstructive Pulmonary Disease, 2018, 13, pp. 3669-3676
Abstract: Background: Growing evidence suggests that blood eosinophil count is associated with patient responsiveness to inhaled corticosteroids (ICS). We performed post hoc predictive modeling on data from the FORWARD study and two replicate studies by Dransfield, to evaluate the relationships between baseline eosinophil count and the effect of ICS on exacerbations and lung function in patients with COPD. Methods: The studies assessed ICS/long-acting β2 agonist (LABA) combinations vs LABA alone. Using data from each study, we modeled COPD exacerbation rates, predose FEV1, and St George's Respiratory Questionnaire score ([FORWARD only]) over a continuous range of eosinophils (0-1,000 eosinophils/µL in FORWARD, 0-993 eosinophils/µL in Dransfield). Results: In all studies, ICS/LABA reduced exacerbations versus LABA alone across all eosinophil levels, with progressively greater reductions at increasing baseline blood eosinophil counts. In FORWARD, annual exacerbation rates ranged from 0.78 to 0.83 per year between 0 and 1,000 eosinophils/µL in the ICS/LABA arm, and from 0.81 to 1.54 per year in the LABA-only arm. In the Dransfield studies, exacerbation rates ranged from 0.54 to 1.02 per year in the ICS/LABA arm between 0 and 993 eosinophils/µL, and from 0.56 to 1.75 per year in the LABA-only arm. Change in FEV1 was not associated with eosinophil count in ICS-treated patients in FORWARD, whereas an increased treatment benefit in terms of FEV1 was observed at higher eosinophil levels in the Dransfield studies. ICS/LABA led to greater improvements in St George's Respiratory Questionnaire total scores compared to LABA alone in patients in FORWARD with ≥67 eosinophils/µL. Conclusion: Higher blood eosinophil count in patients with COPD is associated with an increased beneficial effect from ICS in terms of exacerbation reduction. Further prospective data are required to assess the role of blood eosinophils as a biomarker for therapeutic recommendations.
DOI Link: 10.2147/COPD.S179425
eISSN: 1178-2005
Links: https://www.dovepress.com/blood-eosinophils-a-biomarker-of-copd-exacerbation-reduction-with-inha-peer-reviewed-article-COPD
http://hdl.handle.net/2381/45180
Version: Publisher Version
Status: Peer-reviewed
Type: Journal Article
Rights: Copyright © the authors, 2018. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-commercial License (https://creativecommons.org/licenses/by-nc/3.0/), which permits unrestricted use, distribution, and reproduction in any medium non-commercially, provided the original author and source are credited.
Description: The manuscript reports results from an analysis of three studies: “FORWARD” NCT00929851 (Chiesi) and replicate Dransfield studies NCT01009463/NCT01017952 (GSK). For GSK clinical trials, within 6 months of publishing the results of the primary endpoints of the study, anonymized individual participant data plus the annotated case report form, protocol, reporting and analysis plan, data set specifications, raw dataset, analysis-ready dataset, and clinical study report are available for research proposals approved by an independent review committee. Proposals should be submitted to www. clinicalstudydatarequest.com. A data access agreement will be required. From January 1, 2019, Chiesi commits to sharing the anonymized, patient-level data, study-level data, the clinical protocol, and the full clinical study report of the FORWARD study (NCT00929851) with qualified scientific and medical researchers, conducting legitimate research. Chiesi provides access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Fundamental conditions for providing the requested clinical trial data are that qualified researchers agree to sign a Data Sharing Agreement, to use the data only for noncommercial purposes and to seek publication of their research results. Other information on Chiesi’s data sharing commitment, access and research request’s approval process will be available from January 1, 2019, in the Clinical Trial Transparency section of this webpage page: http:// www.chiesi.com/en/research-and-development/.
Appears in Collections:Published Articles, Dept. of Infection, Immunity and Inflammation

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