Effect of exacerbation history on clinical response to dupilumab in moderate-to-severe uncontrolled asthma.
Eur Respir J
; 58(4)2021 10.
Article
en En
| MEDLINE
| ID: mdl-34266940
ABSTRACT
BACKGROUND:
The phase 3 LIBERTY ASTHMA QUEST study (ClinicalTrials.gov NCT02414854) in patients with uncontrolled, moderate-to-severe asthma has demonstrated the efficacy and safety of dupilumab 200 and 300â mg every 2â weeks versus placebo. This post hoc analysis assessed the effect of dupilumab on efficacy outcomes and asthma control across a range of historical exacerbation rates in patients with type 2-high asthma.METHODS:
Annualised severe exacerbation rates over the 52-week treatment period, pre-bronchodilator forced expiratory volume in 1â s (FEV1) at weeks 12 and 52, and the five-item Asthma Control Questionnaire (ACQ-5) score at weeks 24 and 52 were assessed in patients with ≥1, ≥2 or ≥3 exacerbations in the previous year. Subgroups were stratified by baseline blood eosinophils ≥150 or ≥300â cells·µL-1 or baseline exhaled nitric oxide fraction ≥25â ppb and baseline inhaled corticosteroid (ICS) dose.RESULTS:
Across all type 2-high subgroups, dupilumab versus placebo significantly reduced severe exacerbations by 54-90%, with greater improvements in patients with more exacerbations prior to study initiation. Similarly, improvements in FEV1 (least squares (LS) mean difference versus placebo ≥1 exacerbations, 0.15-0.25â L; ≥2 exacerbations, 0.12-0.32â L; ≥3 exacerbations, 0.09-0.38â L; majority p<0.05) and ACQ-5 score (LS mean difference range ≥1 exacerbations, -0.30 to -0.57; ≥2 exacerbations, -0.29 to -0.56; ≥3 exacerbations, -0.43 to -0.61; all p<0.05) were observed, irrespective of prior exacerbation history, across all subgroups.CONCLUSIONS:
Dupilumab significantly reduced severe exacerbations and improved FEV1 and asthma control in patients with elevated type 2 biomarkers irrespective of exacerbation history and baseline ICS dose.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Asma
/
Antiasmáticos
Tipo de estudio:
Clinical_trials
Límite:
Humans
Idioma:
En
Revista:
Eur Respir J
Año:
2021
Tipo del documento:
Article
País de afiliación:
Estados Unidos