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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 300 mg every 2 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 1 s (FEV 1 ) 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 ≥300 cells·μL −1  or baseline exhaled nitric oxide fraction ≥25 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 FEV 1  (least squares (LS) mean difference  versus  placebo: ≥1 exacerbations, 0.15–0.25 L; ≥2 exacerbations, 0.12–0.32 L; ≥3 exacerbations, 0.09–0.38 L; majority p&lt;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&lt;0.05) were observed, irrespective of prior exacerbation history, across all subgroups.    Conclusions  Dupilumab significantly reduced severe exacerbations and improved FEV 1  and asthma control in patients with elevated type 2 biomarkers irrespective of exacerbation history and baseline ICS dose.

Effect of exacerbation history on clinical response to dupilumab in moderate-to-severe uncontrolled asthma