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

Author:

Domingo ChristianORCID,Rabe Klaus F.,Price DavidORCID,Brusselle GuyORCID,Wechsler Michael E.,Xia Changming,Pandit-Abid Nami,Gall Rebecca,Rowe Paul J.,Deniz Yamo,Jacob-Nara Juby A.,Radwan Amr

Abstract

BackgroundDupilumab has been shown to improve clinical outcomes long term while reducing oral corticosteroid (OCS) dose in patients with severe OCS-dependent asthma. Thispost hocanalysis assesses the impact of OCS dose at baseline (≤10 or >10 mg·day−1) on long-term outcomes of dupilumab treatment.MethodsAnnualised 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−1at parent study baseline (PSBL), who enrolled in TRAVERSE.ResultsDupilumab reduced the annualised exacerbation rate in VENTURE, and it remained low throughout TRAVERSE (0.202–0.265 (OCS ≤10 mg·day−1at PSBL) and 0.221–0.366 (OCS >10 mg·day−1at 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 FEV1upon 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−1by TRAVERSE week 48.ConclusionsImprovements 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.

Funder

Regeneron Pharmaceuticals

Sanofi

Publisher

European Respiratory Society (ERS)

Subject

Pulmonary and Respiratory Medicine

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5. Precise and in situ genetic humanization of 6 Mb of mouse immunoglobulin genes

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