Dupilumab sustains lung function improvements in patients with moderate-to-severe asthma - 13/03/24
, Mario Castro b, Jonathan Corren c, Ian D. Pavord d, Yuji Tohda e, Arman Altincatal f, Nami Pandit-Abid g, Elizabeth Laws g, Bolanle Akinlade h, Leda P. Mannent i, Rebecca Gall h, Juby A. Jacob-Nara g, Yamo Deniz h, Paul J. Rowe g, David J. Lederer h, Megan Hardin fAbstract |
Background |
TRAVERSE (NCT02134028), a phase 3 open-label extension study, assessed dupilumab safety and efficacy in patients with asthma aged ≥12 years who completed a previous dupilumab asthma study. This analysis evaluated changes in multiple lung function parameters in patients with moderate-to-severe asthma with elevated type 2 biomarkers (baseline eosinophils ≥150 cells·μL−1 or fractional exhaled nitric oxide ≥25 ppb) who completed QUEST (parent study) and 2 years of dupilumab treatment in TRAVERSE.
Methods |
Endpoints analyzed included: pre-bronchodilator forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), forced expiratory flow (FEF25-75 %), and pre- and post-bronchodilator FEV1/FVC at parent study baseline (PSBL) at Weeks 0, 2, 48, and 96 in TRAVERSE, as well as pre- and post-bronchodilator FEV1 slopes in QUEST and TRAVERSE. Statistical analyses were descriptive.
Results |
Dupilumab improved pre-bronchodilator FEV1, FVC, and FEF25–75 % in QUEST; these improvements were sustained in TRAVERSE. In QUEST patients who received placebo, dupilumab initiation in TRAVERSE resulted in rapid lung function improvements. Mean (standard deviation) changes from PSBL at TRAVERSE Weeks 48 and 96 in pre-bronchodilator FEV1 were 0.52 (0.59) and 0.45 (0.49) L in the dupilumab/dupilumab group and 0.47 (0.42) and 0.44 L (0.45) in the placebo/dupilumab group, respectively. Similar trends were observed for FVC and FEF25–75 %. Dupilumab also improved FEV1 slopes in QUEST and TRAVERSE.
Conclusion |
Dupilumab demonstrated sustained improvements across multiple spirometric lung function measurements for up to 3 years; patients who received placebo in QUEST experienced rapid lung function improvement upon initiation of dupilumab in TRAVERSE.
Le texte complet de cet article est disponible en PDF.Highlights |
• | This analysis included patients ≥12 years old with moderate-to-severe type 2 asthma. |
• | Dupilumab sustained improvements in several spirometric measures for up to 3 years. |
• | Pre-bronchodilator FVC, similarly to FEV1, improved in the long term. |
• | FEV1 slope results suggest that dupilumab may prevent lung function loss over time. |
• | Dupilumab may impact long-term small/large airway function and airflow obstruction. |
Keywords : Dupilumab, Moderate-to-severe asthma, Lung function, Type 2 inflammation
Plan
Vol 224
Article 107535- avril 2024 Retour au numéro
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