Dupilumab reduces OCS use and improves lung function in patients with severe OCS-dependent asthma

Mark Gurnell; Christian  Domingo; Klaus F Rabe; Andrew Menzies-Gow; David Price; Guy  Brusselle; Michael E Wechsler; Changming  Xia; Nami  Pandit-Abid; Rebecca Gall; Juby A.  Jacob-Nara; Paul J.  Rowe; Yamo  Deniz; Shahid  Siddiqui

Dupilumab reduces OCS use and improves lung function in patients with severe OCS-dependent asthma

Mark Gurnell, Christian Domingo, Klaus F Rabe, Andrew Menzies-Gow, David Price, Guy Brusselle, Michael E Wechsler, Changming Xia, Nami Pandit-Abid, Rebecca Gall, Juby A. Jacob-Nara, Paul J. Rowe, Yamo Deniz, Shahid Siddiqui

Research output: Contribution to conference › Abstract › peer-review

Abstract

Background Dupilumab (DPL), a fully human anti-IL-4Rα mAb, blocks interleukin-4/13, key and central drivers of type 2 inflammation. TRAVERSE (NCT02134028), a single-arm, open-label extension study, evaluated the long-term safety and efficacy of DPL 300mg q2w for up to 96 weeks in patients
(pts) from VENTURE. Aim To assess DPL efficacy in TRAVERSE pts with severe OCS-dependent asthma by OCS dose at parent study baseline (PSBL; VENTURE).
Methods Pts from TRAVERSE were analyzed as DPL/DPL or placebo (PBO)/DPL group and stratified by OCS dose (≤10/>10mg/day at PSBL). % reduction in OCS dose and change in pre-BD FEV1 from PSBL at TRAVERSE Weeks (Wks) 0/96; % of pts achieving 0, <5, or <10mg/day OCS; AER during VENTURE and TRAVERSE were assessed.
Results 187 pts from TRAVERSE were analyzed. The daily-dose % reductions observed in VENTURE continued during TRAVERSE in DPL/DPL pts (Wk96: ≤10mg/day: −89%, >10mg/day: −83%) and PBO/DPL pts (Wk96: ≤10mg/day: −70%, >10mg/day: −76%). The % pts achieving 0, <5, or <10mg/day
OCS continued to improve throughout TRAVERSE regardless of OCS dose at PSBL. Also, AER was lower in TRAVERSE (range: 0.284–0.599) vs VENTURE (0.463–1.587), and pre-BD FEV1 continued to improve in all subgroups (Table).
2
Conclusion OCS dose reductions were sustained, and improvements in AER and lung function continued during TRAVERSE.

Original language	English
Publication status	E-pub ahead of print - 30 Nov 2022
Event	European Respiratory Society (ERS) International Congress. - FIRA Barcelona Gran Via Congress Centre, Barcelona, Spain Duration: 4 Sept 2022 → 6 Sept 2022 https://www.ersnet.org/congress-and-events/congress/

Conference

Conference	European Respiratory Society (ERS) International Congress.
Abbreviated title	ERS International Congress 2022
Country/Territory	Spain
City	Barcelona
Period	4/09/22 → 6/09/22
Internet address	https://www.ersnet.org/congress-and-events/congress/

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Gurnell_etal_ERS2022_Dupilumab_Reduces_OCS_AAMAccepted author manuscript, 160 KBLicence: Unspecified

Cite this

Gurnell, M., Domingo, C., Rabe, K. F., Menzies-Gow, A., Price, D., Brusselle, G., Wechsler, M. E., Xia, C., Pandit-Abid, N., Gall, R., Jacob-Nara, J. A., Rowe, P. J., Deniz, Y., & Siddiqui, S. (2022). Dupilumab reduces OCS use and improves lung function in patients with severe OCS-dependent asthma. Abstract from European Respiratory Society (ERS) International Congress., Barcelona, Spain.

Gurnell, M, Domingo, C, Rabe, KF, Menzies-Gow, A, Price, D, Brusselle, G, Wechsler, ME, Xia, C, Pandit-Abid, N, Gall, R, Jacob-Nara, JA, Rowe, PJ, Deniz, Y & Siddiqui, S 2022, 'Dupilumab reduces OCS use and improves lung function in patients with severe OCS-dependent asthma', European Respiratory Society (ERS) International Congress., Barcelona, Spain, 4/09/22 - 6/09/22.

@conference{ab934c96cda8410793e524ceedb73f4c,

title = "Dupilumab reduces OCS use and improves lung function in patients with severe OCS-dependent asthma",

abstract = "Background Dupilumab (DPL), a fully human anti-IL-4Rα mAb, blocks interleukin-4/13, key and central drivers of type 2 inflammation. TRAVERSE (NCT02134028), a single-arm, open-label extension study, evaluated the long-term safety and efficacy of DPL 300mg q2w for up to 96 weeks in patients(pts) from VENTURE. Aim To assess DPL efficacy in TRAVERSE pts with severe OCS-dependent asthma by OCS dose at parent study baseline (PSBL; VENTURE).Methods Pts from TRAVERSE were analyzed as DPL/DPL or placebo (PBO)/DPL group and stratified by OCS dose (≤10/>10mg/day at PSBL). % reduction in OCS dose and change in pre-BD FEV1 from PSBL at TRAVERSE Weeks (Wks) 0/96; % of pts achieving 0, <5, or <10mg/day OCS; AER during VENTURE and TRAVERSE were assessed.Results 187 pts from TRAVERSE were analyzed. The daily-dose % reductions observed in VENTURE continued during TRAVERSE in DPL/DPL pts (Wk96: ≤10mg/day: −89%, >10mg/day: −83%) and PBO/DPL pts (Wk96: ≤10mg/day: −70%, >10mg/day: −76%). The % pts achieving 0, <5, or <10mg/dayOCS continued to improve throughout TRAVERSE regardless of OCS dose at PSBL. Also, AER was lower in TRAVERSE (range: 0.284–0.599) vs VENTURE (0.463–1.587), and pre-BD FEV1 continued to improve in all subgroups (Table).2Conclusion OCS dose reductions were sustained, and improvements in AER and lung function continued during TRAVERSE.",

author = "Mark Gurnell and Christian Domingo and Rabe, {Klaus F} and Andrew Menzies-Gow and David Price and Guy Brusselle and Wechsler, {Michael E} and Changming Xia and Nami Pandit-Abid and Rebecca Gall and Jacob-Nara, {Juby A.} and Rowe, {Paul J.} and Yamo Deniz and Shahid Siddiqui",

year = "2022",

month = nov,

day = "30",

language = "English",

note = "European Respiratory Society (ERS) International Congress., ERS International Congress 2022 ; Conference date: 04-09-2022 Through 06-09-2022",

url = "https://www.ersnet.org/congress-and-events/congress/",

}

TY - CONF

T1 - Dupilumab reduces OCS use and improves lung function in patients with severe OCS-dependent asthma

AU - Gurnell, Mark

AU - Domingo, Christian

AU - Rabe, Klaus F

AU - Menzies-Gow, Andrew

AU - Price, David

AU - Brusselle, Guy

AU - Wechsler, Michael E

AU - Xia, Changming

AU - Pandit-Abid, Nami

AU - Gall, Rebecca

AU - Jacob-Nara, Juby A.

AU - Rowe, Paul J.

AU - Deniz, Yamo

AU - Siddiqui, Shahid

PY - 2022/11/30

Y1 - 2022/11/30

N2 - Background Dupilumab (DPL), a fully human anti-IL-4Rα mAb, blocks interleukin-4/13, key and central drivers of type 2 inflammation. TRAVERSE (NCT02134028), a single-arm, open-label extension study, evaluated the long-term safety and efficacy of DPL 300mg q2w for up to 96 weeks in patients(pts) from VENTURE. Aim To assess DPL efficacy in TRAVERSE pts with severe OCS-dependent asthma by OCS dose at parent study baseline (PSBL; VENTURE).Methods Pts from TRAVERSE were analyzed as DPL/DPL or placebo (PBO)/DPL group and stratified by OCS dose (≤10/>10mg/day at PSBL). % reduction in OCS dose and change in pre-BD FEV1 from PSBL at TRAVERSE Weeks (Wks) 0/96; % of pts achieving 0, <5, or <10mg/day OCS; AER during VENTURE and TRAVERSE were assessed.Results 187 pts from TRAVERSE were analyzed. The daily-dose % reductions observed in VENTURE continued during TRAVERSE in DPL/DPL pts (Wk96: ≤10mg/day: −89%, >10mg/day: −83%) and PBO/DPL pts (Wk96: ≤10mg/day: −70%, >10mg/day: −76%). The % pts achieving 0, <5, or <10mg/dayOCS continued to improve throughout TRAVERSE regardless of OCS dose at PSBL. Also, AER was lower in TRAVERSE (range: 0.284–0.599) vs VENTURE (0.463–1.587), and pre-BD FEV1 continued to improve in all subgroups (Table).2Conclusion OCS dose reductions were sustained, and improvements in AER and lung function continued during TRAVERSE.

AB - Background Dupilumab (DPL), a fully human anti-IL-4Rα mAb, blocks interleukin-4/13, key and central drivers of type 2 inflammation. TRAVERSE (NCT02134028), a single-arm, open-label extension study, evaluated the long-term safety and efficacy of DPL 300mg q2w for up to 96 weeks in patients(pts) from VENTURE. Aim To assess DPL efficacy in TRAVERSE pts with severe OCS-dependent asthma by OCS dose at parent study baseline (PSBL; VENTURE).Methods Pts from TRAVERSE were analyzed as DPL/DPL or placebo (PBO)/DPL group and stratified by OCS dose (≤10/>10mg/day at PSBL). % reduction in OCS dose and change in pre-BD FEV1 from PSBL at TRAVERSE Weeks (Wks) 0/96; % of pts achieving 0, <5, or <10mg/day OCS; AER during VENTURE and TRAVERSE were assessed.Results 187 pts from TRAVERSE were analyzed. The daily-dose % reductions observed in VENTURE continued during TRAVERSE in DPL/DPL pts (Wk96: ≤10mg/day: −89%, >10mg/day: −83%) and PBO/DPL pts (Wk96: ≤10mg/day: −70%, >10mg/day: −76%). The % pts achieving 0, <5, or <10mg/dayOCS continued to improve throughout TRAVERSE regardless of OCS dose at PSBL. Also, AER was lower in TRAVERSE (range: 0.284–0.599) vs VENTURE (0.463–1.587), and pre-BD FEV1 continued to improve in all subgroups (Table).2Conclusion OCS dose reductions were sustained, and improvements in AER and lung function continued during TRAVERSE.

M3 - Abstract

T2 - European Respiratory Society (ERS) International Congress.

Y2 - 4 September 2022 through 6 September 2022

ER -