Dupilumab: a potential new treatment for severe asthma

In The Lancet, a phase 2b dose-ranging study of dupilumab, a human anti-interleukin-4 receptor α antibody that inhibits the downstream effects of the type 2 mucosal immunity cytokines, interleukin 4 and interleukin 13, is reported. 1 Wenzel S Castro M Corren J et al. Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial. Lancet. 2016; (published online April 26.)http://dx.doi.org/10.1016/S0140-6736(16)30307-5 Google Scholar Over 24 weeks, dupilumab was efficacious as an add-on therapy to medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist in patients with uncontrolled persistent asthma, with improvement in baseline forced expiratory volume in 1 s (FEV1), which was the primary endpoint, as well as a reduction in annualised exacerbation rates and improvements in quality of life and asthma control all being more evident when injections were given every 2 weeks compared with every 4 weeks. The changes observed in the whole group were clinically relevant, with a least-squares mean difference in FEV1 of 17·75% (SE 1·84) and a risk reduction of severe exacerbations of 70·5% (95% CI 45·4–84·1) in those receiving 300 mg dupilumab every 2 weeks, the highest dose used, compared with placebo (6·06% [SE 1·89]). Adverse events were similar in the placebo and treated groups, with a higher rate of injection-site reactions with dupilumab. Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trialDupilumab increased lung function and reduced severe exacerbations in patients with uncontrolled persistent asthma irrespective of baseline eosinophil count and had a favourable safety profile, and hence in addition to inhaled corticosteroids plus long-acting β2-agonist therapy could improve the lives of patients with uncontrolled persistent asthma compared with standard therapy alone. Full-Text PDF