Long-term efficacy of dupilumab in severe asthma by baseline oral corticosteroid dose

Christian Domingo; Klaus F Rabe; David Price; Guy Brusselle; Michael E Wechsler; Changming Xia; Nami Pandit-Abid; Rebecca Gall; Paul J Rowe; Yamo Deniz; Juby A Jacob-Nara; Amr Radwan

doi:10.1183/23120541.00056-2023

Long-term efficacy of dupilumab in severe asthma by baseline oral corticosteroid dose

ERJ Open Res. 2023 Nov 13;9(6):00056-2023. doi: 10.1183/23120541.00056-2023. eCollection 2023 Nov.

Authors

Christian Domingo¹, Klaus F Rabe^{2

3}, David Price^{4

5}, Guy Brusselle⁶, Michael E Wechsler⁷, Changming Xia⁸, Nami Pandit-Abid⁸, Rebecca Gall⁷, Paul J Rowe⁸, Yamo Deniz⁷, Juby A Jacob-Nara⁸, Amr Radwan⁷

Affiliations

¹ Pulmonary Service, Corporació Sanitària Parc Taulí, Sabadell, Universitat Autònoma de Barcelona (UAB), Barcelona, Spain.
² Christian-Albrechts University (member of the DZL), ARCN, Kiel, Germany.
³ Observational and Pragmatic Research Institute, Midview City, Singapore.
⁴ Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.
⁵ Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium.
⁶ Department of Medicine, National Jewish Health, Denver, CO, USA.
⁷ Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
⁸ Sanofi, Bridgewater, NJ, USA.

Abstract

Background: Dupilumab has been shown to improve clinical outcomes long term while reducing oral corticosteroid (OCS) dose in patients with severe OCS-dependent asthma. This post hoc analysis assesses the impact of OCS dose at baseline (≤10 or >10 mg·day^-1) on long-term outcomes of dupilumab treatment.

Methods: Annualised severe asthma exacerbation rates, forced expiratory volume in 1 s (FEV₁), measures of asthma control and quality of life, and OCS dose were evaluated in patients from the phase 3 VENTURE trial with severe OCS-dependent asthma, further categorised by OCS dose ≤10 or >10 mg·day^-1 at parent study baseline (PSBL), who enrolled in TRAVERSE.

Results: Dupilumab reduced the annualised exacerbation rate in VENTURE, and it remained low throughout TRAVERSE (0.202-0.265 (OCS ≤10 mg·day^-1 at PSBL) and 0.221-0.366 (OCS >10 mg·day^-1 at PSBL)). Improvements in pre-bronchodilator FEV₁, asthma control and quality of life observed in VENTURE dupilumab patients were sustained throughout TRAVERSE. Patients on placebo during VENTURE showed rapid improvements in FEV₁ upon initiating dupilumab in TRAVERSE, which were sustained to the end of TRAVERSE. Reductions in OCS dose observed in VENTURE were maintained throughout TRAVERSE, with more than two-thirds of patients achieving reductions in OCS doses to ≤5 mg·day^-1 by TRAVERSE week 48.

Conclusions: Improvements in clinical outcomes and reductions in OCS dose with dupilumab observed in VENTURE were maintained throughout TRAVERSE, regardless of baseline disease severity. Patients who switched from placebo in VENTURE to dupilumab in TRAVERSE had improved clinical outcomes and reductions in OCS dose comparable to those given dupilumab in VENTURE.