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Obstructive Lung Diseases |

Subgroup Analyses of Lung-Function Change From the WISDOM Study FREE TO VIEW

Henrik Watz; Helgo Magnussen; Roberto Rodriguez-Roisin; Emiel Wouters; Bernd Disse; Kay Tetzlaff; Helen Finnigan; Peter Calverley
Author and Funding Information

Pulmonary Research Institute at Lung Clinic Grosshansdorf, Airway Research Center North, Member of the German Center for Lung Research, Grosshansdorf, Germany; Servei de Pneumologia (ICT), Hospital Clínic-IDIBAPS-CIBERES, Universitat de Barcelona, Barcelona, Spain; Department of Respiratory Medicine, Maastricht University Medical Centre (MUMC+), Maastricht, Netherlands; Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany; Biometry and Data Management Department, Boehringer Ingelheim (UK), Berkshire, United Kingdom; Institute of Ageing and Chronic Disease, University Hospital Aintree, Liverpool, United Kingdom


Chest. 2015;148(4_MeetingAbstracts):755A. doi:10.1378/chest.2277533
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Abstract

SESSION TITLE: Outcomes in COPD

SESSION TYPE: Original Investigation Slide

PRESENTED ON: Tuesday, October 27, 2015 at 02:45 PM - 04:15 PM

PURPOSE: WISDOM showed that in patients with severe to very severe chronic obstructive pulmonary disease (COPD) and exacerbation history receiving long-acting muscarinic antagonist with long-acting β2-agonist, stepwise withdrawal of inhaled corticosteroids (ICS) was not inferior to continued ICS for risk of first moderate or severe COPD exacerbation, but there was a greater decrease in lung function following complete ICS withdrawal. To evaluate factors associated with this, further subgroup analyses were performed.

METHODS: Patients were randomized to triple therapy or ICS withdrawal over 12 weeks (wks). A post hoc subgroup analysis of change from baseline in in-clinic trough forced expiratory volume in 1 s (FEV1) at wks 6, 12, 18, and 52 was performed using restricted maximum likelihood repeated measures models. Also, multiple linear regression using backward elimination was performed for change from baseline in in-clinic trough FEV1 at wk 52 to identify potential subgroups associated with a reduction in lung function over 1 year.

RESULTS: Consistent with the overall population, post hoc subgroup analysis of on-treatment trough FEV1 did not indicate notable differences between treatments (continued ICS vs ICS withdrawal) during ICS withdrawal at wks 6 and 12 for any subgroups. At wk 18 (6 wks after complete withdrawal) and wk 52, the overall adjusted mean difference between treatment groups was significant, favoring ICS for in-clinic trough FEV1. This was also generally reflected in the subgroups. Multivariate analyses at wk 52 identified 3 subgroups as significantly associated with trough FEV1 changes independent of treatment group. These were geographic region (greater decreases in trough FEV1 for Asian region vs non-Asian [p=0.003]), Global initiative for chronic Obstructive Lung Disease (GOLD) at screening (greater decreases for GOLD 4 [p=0.003] vs GOLD 3), and sex (p=0.004). Only sex was associated with treatment effect, with men showing a greater decrease in trough FEV1 after ICS withdrawal vs continued ICS (p=0.001). No differences were observed for women between treatment groups (p=0.876).

CONCLUSIONS: Men demonstrated a greater decrease in lung function following ICS withdrawal. Female gender was associated with lung-function changes irrespective of treatment.

CLINICAL IMPLICATIONS: Adequately powered prospective clinical studies will need to confirm these findings. Funding: Boehringer Ingelheim. Editorial assistance: Complete HealthVizion.

DISCLOSURE: Henrik Watz: Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim, Consultant fee, speaker bureau, advisory committee, etc.: AstraZeneca, Consultant fee, speaker bureau, advisory committee, etc.: GlaxoSmithKline, Consultant fee, speaker bureau, advisory committee, etc.: Novartis , Consultant fee, speaker bureau, advisory committee, etc.: BerlinChemie Roberto Rodriguez-Roisin: Grant monies (from industry related sources): Almirall, Consultant fee, speaker bureau, advisory committee, etc.: lectured for Boehringer Ingelheim, Chiesi, Ferrer, Menarini, Novartis, Pfizer, Takeda and TEVA; consulted with AstraZeneca, Boehringer Ingelheim, Foster, Merck, Sharp & Dome, Mylan, Novartis, Pearl Therapeutics, Pfizer, Takeda, and TEVA Bernd Disse: Employee: Boehringer Ingelheim Pharma GmbH&Co KG, Ingelheim, Germany Kay Tetzlaff: Employee: Boehringer-Ingelheim Helen Finnigan: Employee: Boehringer Ingelheim Helgo Magnussen: Consultant fee, speaker bureau, advisory committee, etc.: Aerocrine, Almirall, AstraZeneca, Boehringer Ingelheim, Consultant fee, speaker bureau, advisory committee, etc.: Berlin Chemie, Novartis, Chiesi, Other: Almirall, AstraZeneca, Boehringer Ingelheim, Other: GSK, Novartis, Chiesi, Takeda, AB2BIO, Bayer Peter Calverley: Consultant fee, speaker bureau, advisory committee, etc.: GSK: Scientific committee of TORCH, ECLIPSE and SUMMIT studies, Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim: Scientific Committee of TIOSPIR and DYGINITO studies, Consultant fee, speaker bureau, advisory committee, etc.: Nycomed: Scientific committee of the REACT trial, Consultant fee, speaker bureau, advisory committee, etc.: Department of Health Respiratory Programme Board, Consultant fee, speaker bureau, advisory committee, etc.: Novartis: Advice on new product development, Fiduciary position (of any organization, association, society, etc, other than ACCP: Forest: FDA submission, University grant monies: Money paid to University of Liverpool for lectures including service on speakers bureaus for Novartis and Pfizer, Consultant fee, speaker bureau, advisory committee, etc.: Payment for lectures including service on speakers bureaus: GSK, Astrazeneca, Takeda Nycomed, Other: Boehringer Ingelheim: Accommodation costs at ATS meetings The following authors have nothing to disclose: Emiel Wouters

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