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Allergy and Airway |

Exacerbation Risk Is Not Worse When ICS Are Withdrawn in a Stepwise Manner in Severe to Very Severe COPD Patients Receiving LAMA+LABA: The WISDOM Study FREE TO VIEW

Helgo Magnussen; Bernd Disse; Roberto Rodriguez-Roisin; Anne Kirsten; Henrik Watz; Kay Tetzlaff; Lesley Towse; Helen Finnigan; Ronald Dahl; Marc Decramer; Pascal Chanez; Emiel Wouters; Peter Calverley
Author and Funding Information

Biometry and Data Management Department, Boehringer Ingelheim (UK), Berkshire, United Kingdom


Chest. 2014;146(4_MeetingAbstracts):63A. doi:10.1378/chest.1994339
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Abstract

SESSION TITLE: COPD Exacerbation Risk

SESSION TYPE: Original Investigation Slide

PRESENTED ON: Wednesday, October 29, 2014 at 02:45 PM - 04:15 PM

PURPOSE: GOLD strategy recommends treating patients with recurrent exacerbations of chronic obstructive pulmonary disease (COPD) with inhaled corticosteroids (ICS). The Withdrawal of Inhaled Steroids during Optimized bronchodilator Management (WISDOM) study was designed to evaluate the effects of stepwise withdrawal of ICS in patients with GOLD grade 3-4 COPD and a history of exacerbation who are treated with long-acting muscarinic antagonists + long-acting β-agonists (LAMA+LABA).

METHODS: All patients in the 12-month, double-blind, parallel-group, active-controlled study (NCT00975195) received triple therapy (tiotropium18 µg QD, salmeterol 50 µg BID, and fluticasone 500 µg BID) for a 6-week run-in period. Following this, baseline assessments were made and patients randomized 1:1 to continue triple therapy or stepwise withdrawal of ICS over 12 weeks, with dose reduction every 6 weeks. We report time to first moderate to severe on-treatment exacerbation (primary end point; non-inferiority margin pre-defined as a hazard ratio of <1.2), along with results for the following subgroups: geographic region, age, sex, smoking status, baseline body mass index, and previous COPD therapy.

RESULTS: 2485 patients were treated (2049 male), with a mean age of 63.8 years and mean forced expiratory volume in 1 second of 0.98 L (34.2%) at baseline. The risk of experiencing an on-treatment COPD exacerbation with ICS withdrawal was non-inferior to continued ICS therapy (hazard ratio 1.058; 95% CI 0.941, 1.189). Similar results were seen in a sensitivity analysis that included post-treatment exacerbations (hazard ratio 1.061; 95% CI 0.945, 1.192), and in all pre-defined sub-groups analyzed. No significant safety signals were identified.

CONCLUSIONS: The risk of moderate to severe exacerbation after stepwise ICS withdrawal was comparable to continued ICS treatment in patients with GOLD grade 3-4 COPD receiving LAMA+LABA.

CLINICAL IMPLICATIONS: ICS may be successfully withdrawn in patients receiving LAMA+LABA without significantly increasing the risk of COPD exacerbation. Funding: Boehringer Ingelheim. Editorial assistance: Complete HealthVizion.

DISCLOSURE: Helgo Magnussen: Consultant fee, speaker bureau, advisory committee, etc.: Almirall, Boehringer Ingelheim, Chiesi, Berlin-Chemie, Novartis, Other: I am an employee of PRI. PRI recieved payments for the conduct of this study Bernd Disse: Employee: Boehringer Ingelheim Roberto Rodriguez-Roisin: Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim - Speaker - Fee for lecturing, Consultant fee, speaker bureau, advisory committee, etc.: Novartis - Speaker - Fee for lecturing, Consultant fee, speaker bureau, advisory committee, etc.: TEVA - Chair - Fee for participating, Consultant fee, speaker bureau, advisory committee, etc.: BI - Consultant - Fee for advisory board, Consultant fee, speaker bureau, advisory committee, etc.: PEARL - Consultant - Fee for advisory board, Consultant fee, speaker bureau, advisory committee, etc.: TEVA - Consultant - Fee for advisory board Anne Kirsten: Other: I am an employee of PRI. PRI recieved payment for the conduct of this study Henrik Watz: Consultant fee, speaker bureau, advisory committee, etc.: Almirall, Boehringer Ingelheim, Novartis, Astra Zeneca, GSK, Berlin-Chemie, Chiesi, Other: Iam an employee of PRI. PRI recieved payment for the conduct of this study Kay Tetzlaff: Employee: Boehringer Ingelheim Lesley Towse: Employee: Boehringer Ingelheim Helen Finnigan: Employee: Boehringer Ingelheim Ronald Dahl: Consultant fee, speaker bureau, advisory committee, etc.: Advised on study design and conduct of trails sponsored by Boehringer Ingelheim, Novartis, ALK-Abello and Vectura, Consultant fee, speaker bureau, advisory committee, etc.: Spoken at meetings sponsored by Boehringer Ingelheim, Novartis, ALK-Abello and Vectura Peter Calverley: Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim, GSK, Novartis, AZ, Takeda, Grant monies (from industry related sources): Boehringer Ingelheim & Takeda, University grant monies: UK NIHR The following authors have nothing to disclose: Marc Decramer, Pascal Chanez, Emiel Wouters

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