The Impact of Stepwise Withdrawal of ICS on FEV1, mMRC, and SQRQ in Severe to Very Severe COPD Patients Treated With LAMA+LABA: The WISDOM Study.

SESSION TITLE: COPD TreatmentSESSION TYPE: Original Investigation SlidePRESENTED ON: Sunday, October 26, 2014 at 01:30 PM - 03:00 PMPURPOSE: The WISDOM study demonstrated ICS may be successfully withdrawn in patients receiving LAMA+LABA without significantly increasing COPD exacerbation risk (Chest 2014). We report change in FEV1 and symptoms.METHODS: All patients in the 12-month, double-blind, parallel-group, active-controlled WISDOM study (NCT00975195) received triple therapy (tiotropium 18 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 (dose reduction every 6 weeks). Secondary end points included trough FEV1, mMRC, and SGRQ.RESULTS: 2485 patients were treated (2049 male), with a mean age of 63.8 years and mean FEV1 of 0.98 L (34.2%) at baseline. Adjusted mean decrease from baseline in trough FEV1 was 50 mL with complete ICS withdrawal versus 11 mL with ICS at Week 18 (p<0.0001), with similar results at Week 52 (59 mL versus 16 mL, respectively; p=0.0014). Difference in change from baseline in mMRC was non-significant for ICS withdrawal compared to ICS at Week 18 (0.029; p=0.3588) and Week 52 (0.064; p=0.0632). Change from baseline in SGRQ total score was 0.55 with ICS withdrawal and -0.42 with ICS at Week 27 (p=0.0845), and 1.15 and -0.07, respectively, at Week 52 (p=0.0467).CONCLUSIONS: Although exacerbation risk was comparable between ICS withdrawal versus continued ICS therapy in patients with GOLD 3-4 COPD receiving LAMA+LABA, there was a modest but statistically significantly greater decrease in FEV1 with complete ICS withdrawal, no observable effect on mMRC, and a small but significant effect seen in SGRQ.CLINICAL IMPLICATIONS: Complete withdrawal of ICS was associated with a small but statistically significantly greater decrease from baseline in lung function and variably significant differences in mMRC grade and total SGRQ score compared to continued ICS treatment. Funding: Boehringer Ingelheim. Editorial assistance: Complete HealthVizion.

DISCLOSURE: Helgo Magnussen: Consultant fee, speaker bureau, advisory committee, etc.: Almirall, Boehringer Ingelheim, Chiesi, Berlin-Chemi, 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 - Fees for Lecturing, Consultant fee, speaker bureau, advisory committee, etc.: Novartis - Speaker - Fees for Lecturing, Consultant fee, speaker bureau, advisory committee, etc.: TEVA -Chair - Fees for participating, Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim - 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: I am 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 the study design and conduct of trials sponsered by BI, Novartis, ALK-Abello and Vectura, Consultant fee, speaker bureau, advisory committee, etc.: Has spoken at meetings sponsered by BI, 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): BI & takeda, University grant monies: UK NIHR The following authors have nothing to disclose: Marc Decramer, Pascal Chanez, Emiel WoutersNo Product/Research Disclosure Information.