S78 Dupilumab reduces risk of severe exacerbations and improves FEV1 regardless of baseline disease severity in patients with uncontrolled, moderate-to-severe asthma: data from the phase 3 LIBERTY ASTHMA QUEST study
THORAX(2018)
摘要
Introduction and objectives Dupilumab, a fully human anti-interleukin (IL)−4α monoclonal antibody that inhibits IL-4 and IL-13, key drivers of Type 2 inflammation, is approved for treatment of adults with inadequately controlled moderate-to-severe atopic dermatitis. In a double-blind, placebo-controlled phase 3 study (NCT02414854), patients with asthma aged ≥12 years, without a minimum baseline eosinophil requirement and uncontrolled with medium-to-high-dose inhaled corticosteroids (ICS) plus up to two additional controllers, received add-on dupilumab 200 mg or 300 mg or matched placebo every 2 weeks (q2w) for 52 weeks. In the overall intent-to-treat population, both dupilumab doses significantly reduced annualized severe exacerbation rates during the 52 week treatment period, improved pre-bronchodilator forced expiratory volume in 1 s (FEV 1 ), improved quality of life measures, and were generally well tolerated. This pre-specified analysis assessed the efficacy of dupilumab by disease severity determined by baseline ICS dose (high/medium). Methods Annualized severe exacerbation rates during the 52 week treatment period and change from baseline in pre-bronchodilator FEV 1 at Week 12 were analyzed by baseline ICS dose (high/medium) subgroup. These parameters were further analyzed by subgroups defined by baseline levels of eosinophils (≥300 cells/µL) and fractional exhaled nitric oxide levels (FeNO;≥25 ppb). Results Both dupilumab q2w doses significantly reduced annualized severe exacerbation rates over the 52–week treatment period (p 1 at Week 12 (p 1 appeared similar between high- and medium-dose ICS subgroups with increased efficacy in subgroups with baseline eosinophil levels of ≥300 cells/µL (both p Conclusions Add-on dupilumab significantly reduced the rate of severe exacerbations, and improved FEV 1 in patients with moderate or severe asthma (as assessed by medium or high ICS dose at baseline). Dupilumab demonstrated increased efficacy in patients with higher levels of Type 2 inflammation, as defined by elevated baseline eosinophil counts and FeNO levels. Dupilumab was generally well tolerated. Please refer to page A265 for declarations of interest related to this abstract.
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