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DOI: 10.1055/s-0039-3403258
Dupilumab Effect on Lung Function in Patients with Uncontrolled, Moderate-to-Severe Asthma with an Allergic Phenotype
Publikationsverlauf
Publikationsdatum:
28. Februar 2020 (online)
Background: Dupilumab, a fully human VelocImmune®-derived monoclonal antibody, blocks the shared receptor component for interleukin (IL)-4/IL-13, key drivers of type 2 inflammation in multiple diseases. In the phase 3 LIBERTY ASTHMA QUEST study (NCT02414854), add-on dupilumab every 2 weeks (q2w) versus placebo reduced severe exacerbations and improved pre-bronchodilator (BD) forced expiratory flow in 1 s (FEV1) in patients with uncontrolled, moderate-to-severe asthma. Treatment effects were greater in patients with elevated baseline type 2 biomarkers, which includes the overlapping phenotypes allergic asthma and eosinophilic asthma. This post hoc analysis assessed the effect of dupilumab on lung function parameters in uncontrolled, moderate-to-severe asthma patients with an allergic phenotype.
Methods: Change from baseline at Weeks 12 and 52 in pre- and post-BD FEV1 and pre-BD forced vital capacity (FVC), forced expiratory flow 25 – 75% (FEF25 – 75), and FEV1/FVC ratio were assessed in patients with an allergic asthma phenotype (serum total IgE ≥ 30 IU/mL and ≥ 1 perennial aeroallergen-specific IgE value ≥ 0.35 kU/L at baseline).
Results: Dupilumab 200/300 mg q2w vs. placebo improved lung function parameters at Week 12, with significant changes from baseline in pre-BD FEV1 (least squares mean difference vs. placebo: 0.13/0.16 L; P = 0.0006/< 0.0001), post-BD FEV1 (0.13/0.11 L; P < 0.0001/= 0.0008), FEF25 – 75 (0.14/0.22 L/s; P = 0.0028/< 0.0001), and FVC (0.15/0.11 L; P = 0.0002/0.0059). The FEV1/FVC ratio improved by 0.56/2.78% (P = 0.3513/< 0.0001); however, this was not significant for dupilumab 200 mg. Sustained or better improvements in lung function parameters were observed at Week 52 (all P < 0.05). In the overall population, the most frequent adverse event in the dupilumab groups vs. placebo was injection-site reaction (15%/18% vs. 5%/10%).
Conclusion: Dupilumab improved lung function parameters in uncontrolled, moderate-to-severe asthma patients with an allergic phenotype.
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