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- W3206421422 abstract "TOPIC: Obstructive Lung Diseases TYPE: Original Investigations PURPOSE: Chronic oral corticosteroid (OCS) treatment improves asthma control but is associated with severe side effects. Dupilumab (DPL), a fully human monoclonal antibody, blocks the shared receptor component for interleukin-4/-13, key and central drivers of type 2 inflammation in multiple diseases. In the phase 3 VENTURE study (NCT02528214), add-on DPL 300 mg every two weeks (q2w) vs placebo (PBO) significantly reduced daily OCS dose and severe asthma exacerbation rate, improving pre-bronchodilator FEV1 in patients with OCS-dependent, severe asthma. TRAVERSE (NCT02134028), a single-arm, open-label, extension study, evaluated long-term safety, tolerability, and efficacy of add-on DPL in patients who had completed a DPL study. Overall, 2,182 (96%) patients completed TRAVERSE to Week (Wk) 48 and 1,240 (54%) to Wk 96, with a cumulative study duration of 3,507 patient-years. This post hoc analysis assessed long-term improvements in lung function in patients with OCS-dependent asthma from VENTURE who enrolled in TRAVERSE. METHODS: Mean change from baseline (BL) of the VENTURE study in lung function was assessed at Wk 0, 2, and 48 in patients treated with DPL or PBO for 24 Wks in VENTURE who then enrolled in TRAVERSE and received DPL 300 mg q2w for up to 96 Wks. Treatment duration was amended from 96 to 48 Wks for some patients. RESULTS: Mean reductions in OCS dose from parent study BL (PSBL) at Wk 0 (end of VENTURE/start of TRAVERSE) were 74.2% and 45.8% in the DPL-DPL (n=90) and PBO-DPL (n=97) groups. In DPL-DPL–treated patients, FEV1 improvements in VENTURE were sustained in TRAVERSE (PSBL [SD]: 1.53 [0.50] L; mean change [SD] from PSBL: 0.29 [0.46], 0.28 [0.48], and 0.33 [0.53] L at Wk 0, 2, and 48). Improvements persisted for FEF25–75% (PSBL [SD]: 0.87 [0.49] L/s; mean change [SD] from PSBL: 0.23 [0.49], 0.23 [0.57], and 0.29 [0.66] L/s at Wk 0, 2, and 48) and FVC (PSBL [SD]: 2.59 [0.73] L; mean change [SD] from PSBL: 0.34 [0.58], 0.32 [0.48], and 0.38 [0.56]L at Wk 0, 2, and 48). In PBO-DPL–treated patients starting DPL at Wk 0, rapid improvement in lung function occurred by Wk 2 and continued through Wk 48 in FEV1 (PSBL [SD]: 1.62 [0.62] L; mean change [SD] from PSBL: −0.01 [0.50], 0.25 [0.49], and 0.31 [0.50] L at Wk 0, 2, and 48), FEF25-75% (PSBL [SD]: 0.93 [0.57] L/s; mean change [SD] from PSBL: 0.04 [0.52], 0.26 [0.56], and 0.34 [0.56] L/s at Wk 0, 2, and 48), and forced vital capacity (FVC) (PSBL [SD]: 2.74 [0.80] L; mean change [SD] from PSBL: −0.04 [0.52], 0.23 [0.50], and 0.29 [0.56] L at Wk 0, 2, and 48). There were minimal changes in the FEV1/FVC ratio, consistent with balanced improvement in FEV1 and FVC. CONCLUSIONS: Dupilumab demonstrated sustained lung function improvements in the DPL-DPL–treated group, and rapid, sustained improvements in the PBO-DPL group. CLINICAL IMPLICATIONS: Dupilumab shows long-term lung function improvements in OCS-dependent severe asthma patients who enrolled in TRAVERSE. DISCLOSURES: Employee relationship with Regeneron Pharmaceuticals Please note: Since 01/04/2016 Added 04/30/2021 by Nikhil Amin, source=Web Response, value=Salary Author relationship with Elsevier Please note: $1-$1000 by Mario Castro, source=Web Response, value=Royalty Removed 04/30/2021 by Mario Castro, source=Web Response Principal Investigator relationship with Novartis Please note: $20001 - $100000 by Mario Castro, source=Web Response, value=Grant/Research Support Removed 04/30/2021 by Mario Castro, source=Web Response Consultant relationship with Novartis Please note: $5001 - $20000 by Mario Castro, source=Web Response, value=Consulting fee Removed 04/30/2021 by Mario Castro, source=Web Response Principal Investigator relationship with AstraZeneca Please note: $20001 - $100000 by Mario Castro, source=Web Response, value=Grant/Research Support Removed 04/30/2021 by Mario Castro, source=Web Response Speaker/Speaker's Bureau relationship with AstraZeneca Please note: $5001 - $20000 by Mario Castro, source=Web Response, value=Honoraria Removed 04/30/2021 by Mario Castro, source=Web Response Principal Investigator relationship with ALA Please note: $20001 - $100000 by Mario Castro, source=Web Response, value=Grant/Research Support Removed 04/30/2021 by Mario Castro, source=Web Response Principal Investigator relationship with Sanofi-Aventis Please note: $20001 - $100000 by Mario Castro, source=Web Response, value=Grant/Research Support Removed 04/30/2021 by Mario Castro, source=Web Response Consultant relationship with Sanofi-Aventis Please note: $5001 - $20000 by Mario Castro, source=Web Response, value=Consulting fee Removed 04/30/2021 by Mario Castro, source=Web Response Speaker/Speaker's Bureau relationship with Sanofi-Aventis Please note: $5001 - $20000 by Mario Castro, source=Web Response, value=Honoraria Removed 04/30/2021 by Mario Castro, source=Web Response Speaker/Speaker's Bureau relationship with Regeneron Please note: $5001 - $20000 by Mario Castro, source=Web Response, value=Honoraria Removed 04/30/2021 by Mario Castro, source=Web Response Advisory Committee Member relationship with PCORI Please note: $5001 - $20000 Added 04/30/2021 by Mario Castro, source=Web Response, value=Honoraria Removed 04/30/2021 by Mario Castro, source=Web Response Consultant relationship with Teva Please note: $5001 - $20000 by Mario Castro, source=Web Response, value=Consulting fee Removed 04/30/2021 by Mario Castro, source=Web Response Principal Investigator relationship with GSK Please note: $20001 - $100000 by Mario Castro, source=Web Response, value=Grant/Research Support Removed 04/30/2021 by Mario Castro, source=Web Response Speaker/Speaker's Bureau relationship with GSK Please note: $5001 - $20000 by Mario Castro, source=Web Response, value=Honoraria Removed 04/30/2021 by Mario Castro, source=Web Response Speaker/Speaker's Bureau relationship with Genentech Please note: $5001 - $20000 by Mario Castro, source=Web Response, value=Honoraria Removed 04/30/2021 by Mario Castro, source=Web Response Consultant relationship with Genentech Please note: $5001 - $20000 by Mario Castro, source=Web Response, value=Consulting fee Removed 04/30/2021 by Mario Castro, source=Web Response Principal Investigator relationship with Shionogi Please note: $20001 - $100000 by Mario Castro, source=Web Response, value=Grant/Research Support Removed 04/30/2021 by Mario Castro, source=Web Response Principal Investigator relationship with NIH Please note: >$100000 by Mario Castro, source=Web Response, value=Grant/Research Support Removed 04/30/2021 by Mario Castro, source=Web Response Principal Investigator relationship with PCORI Please note: >$100000 by Mario Castro, source=Web Response, value=Grant/Research Support Removed 04/30/2021 by Mario Castro, source=Web Response Principal Investigator relationship with PCORI Please note: Ongoing Added 04/30/2021 by Mario Castro, source=Web Response, value=Study Funding Principal Investigator relationship with AstraZeneca Please note: Ongoing Added 04/30/2021 by Mario Castro, source=Web Response, value=Study Funding Speaker/Speaker's Bureau relationship with AstraZeneca Please note: Ongoing Added 04/30/2021 by Mario Castro, source=Web Response, value=Honoraria Principal Investigator relationship with Novartis Please note: Ongoing Added 04/30/2021 by Mario Castro, source=Web Response, value=Study Funding Consultant relationship with Novartis Please note: Ongoing Added 04/30/2021 by Mario Castro, source=Web Response, value=Consulting fee Principal Investigator relationship with GSK Please note: Ongoing Added 04/30/2021 by Mario Castro, source=Web Response, value=Study Funding Speaker/Speaker's Bureau relationship with GSK Please note: Ongoing Added 04/30/2021 by Mario Castro, source=Web Response, value=Honoraria Principal Investigator relationship with Sanofi-Aventis Please note: Ongoing Added 04/30/2021 by Mario Castro, source=Web Response, value=Study Funding Speaker/Speaker's Bureau relationship with Sanofi-Aventis Please note: Ongoing Added 04/30/2021 by Mario Castro, source=Web Response, value=Honoraria Consultant relationship with Sanofi-Aventis Please note: Ongoing Added 04/30/2021 by Mario Castro, source=Web Response, value=Consulting fee Consultant relationship with Ongoing Please note: Ongoing Added 04/30/2021 by Mario Castro, source=Web Response, value=Consulting fee Speaker/Speaker's Bureau relationship with Teva Please note: Ongoing Added 04/30/2021 by Mario Castro, source=Web Response, value=Honoraria Speaker/Speaker's Bureau relationship with Genentech Please note: Ongoing Added 04/30/2021 by Mario Castro, source=Web Response, value=Honoraria Consultant relationship with Genentech Please note: Ongoing Added 04/30/2021 by Mario Castro, source=Web Response, value=Consulting fee Speaker/Speaker's Bureau relationship with Regeneron Please note: Ongoing Added 04/30/2021 by Mario Castro, source=Web Response, value=Honoraria Author relationship with Elsevier Please note: Ongoing Added 04/30/2021 by Mario Castro, source=Web Response, value=Royalty Principal Investigator relationship with Shionogi Please note: Ongoing Added 04/30/2021 by Mario Castro, source=Web Response, value=Study Funding Advisory Committee Member relationship with AstraZeneca Please note: $1001 - $5000 by Jonathan Corren, source=Web Response, value=Honoraria Speaker/Speaker's relationship with AstraZeneca Please note: $5001 - $20000 by Jonathan Corren, source=Web Response, value=Honoraria Speaker/Speaker's Bureau relationship with Genetech Please note: $5001 - $20000 by Jonathan Corren, source=Web Response, value=Honoraria Research funds relationship with Genetech Please note: $5001 - $20000 by Jonathan Corren, source=Web Response, value=Grant/Research Support Research funds relationship with AstraZeneca Please note: $5001 - $20000 by Jonathan Corren, source=Web Response, value=Grant/Research Support Board Member relationship with Novartis Please note: $1001 - $5000 by Jonathan Corren, source=Web Response, value=Honoraria Research funds relationship with Novartis Please note: $5001 - $20000 by Jonathan Corren, source=Web Response, value=Grant/Research Support Speaker/Speaker's Bureau relationship with Regeneron/Sanofi Please note: $5001 - $20000 by Jonathan Corren, source=Web Response, value=Honoraria Board Member relationship with Regeneron/Sanofi Please note: $1001 - 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$20000 by David Lederer, source=Web Response, value=Consulting fee Removed 04/30/2021 by David Lederer, source=Web Response Employee relationship with Regeneron Please note: July 2019 to current Added 04/30/2021 by David Lederer, source=Web Response, value=Salary Stock/Stock options relationship with Regeneron Please note: July 2019 to current Added 04/30/2021 by David Lederer, source=Web Response, value=Stock/Stock options Employee relationship with Sanofi Please note: 2000-2021 Added 04/30/2021 by Leda Mannent, source=Web Response, value=Salary Employee relationship with Sanofi Please note: 09/02/2014 Added 05/04/2021 by Xuezhou Mao, source=Web Response, value=Salary Employee relationship with Regeneron Pharmaceuticals Inc. 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- W3206421422 title "EFFECT OF DUPILUMAB ON LUNG FUNCTION PARAMETERS IN ORAL CORTICOSTEROID-DEPENDENT PATIENTS WITH ASTHMA ENROLLED IN LIBERTY ASTHMA TRAVERSE" @default.
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