Abstract
Introduction: Dupilumab, a fully human IL-4R-α monoclonal antibody, inhibits IL-4 and IL-13, key drivers of Type 2-mediated inflammation.
Aim: To evaluate the efficacy and safety of dupilumab dose regimens for uncontrolled asthma.
Methods: Multinational, double-blind, pivotal phase 2b study (NCT01854047). Adults with uncontrolled asthma despite medium-to-high dose ICS/LABA were randomized to add on therapy with dupilumab 200 or 300 mg every 2 weeks (q2w) or every 4 weeks (q4w), or placebo (PBO), for 24 weeks. The primary endpoint was change from baseline to Week 12 in FEV1 (L) in pts with high eosinophil (Eos) count (HEos; ≥300/µL). Secondary endpoints included change from baseline in FEV1 (%), annualized severe exacerbation rate, and safety. Data were reported for HEos, low Eos (LEos; <300/µL), and overall groups.
Results: Of 776 randomized pts, 325 (42%) had HEos. Dupilumab q2w regimens showed significant improvements in FEV1 at Week 12, and reduced annualized severe exacerbation rates in HEos, LEos and overall groups vs PBO. The q4w regimens were less efficacious vs q2w regimens. The most common adverse event was injection-site reaction (13–26% vs 13% PBO).
Conclusions: Dupilumab q2w plus ICS/LABA therapy improves FEV1 and reduces severe exacerbations in pts with uncontrolled asthma, irrespective of Eos count (≥300/µL or <300/µL).
- Copyright ©ERS 2015