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

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 analysis assesses the impact of OCS dose at baseline (≤10 or >10 mg·day) on long-term outcomes of dupilumab treatment.

METHODS

Annualised severe asthma exacerbation rates, forced expiratory volume in 1 s (FEV), 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 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 at PSBL) and 0.221-0.366 (OCS >10 mg·day at PSBL)). Improvements in pre-bronchodilator FEV, asthma control and quality of life observed in VENTURE dupilumab patients were sustained throughout TRAVERSE. Patients on placebo during VENTURE showed rapid improvements in FEV 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 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.