Severe Asthma Research - May 2016
Christina E Ciaccio, MD, MSc
Assistant Professor of Pediatrics
University of Chicago Medicine
Comer Children’s Hospital
Chicago, Illinois, United States
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.
Treatment options for those with severe, uncontrolled asthma despite treatment by inhaled corticosteroids and long acting beta agonists (LABA) remain incomplete. This phase 2b clinical trial assed the efficacy and safety of dupilumab in those with uncontrolled asthma on inhaled corticosteroids and a LABA. This multicenter trial was undertaken at 174 study sites in 16 countries. Participants were >18, diagnosed with asthma for >12 months, and had at least one systemic corticosteroid burst in the past year. Patients received dupilumab subcutaneous 200mg every 4 weeks, 300mg every 4 weeks, 200mg every 2 weeks, 300mg every 2 weeks, or placebo. Between June 2013 and June 2014, 1532 patients were screened and 776 randomized. Baseline characteristics were similar among groups. Every dose except 200mg every 4 weeks showed a significant improvement in FEV1 in those with baseline eosinophil count > 300 eos/uL (primary endpoint). A significant improvement in FEV1 was also seen in those with eosinophil counts < 300 eos/uL when dupilumab was dosed every 2 weeks (secondary endpoint). The rate of severe asthma exacerbations was also significantly reduced in this group as was time to first severe exacerbation. Finally, in the overall population, quality of life was improved when dupilumab was given every 2 weeks and FeNO levels decreased. Adverse events were similar in the dupilumab groups compared to placebo except for injection site reaction rates. The results of this study were promising that treatment with dupilumab might benefit patients with uncontrolled asthma despite traditional therapy.
Wenzel S, Castro M, Corren J, Maspero J, Wang L 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. The Lancet 2016; published online ahead of print, April 26. (doi:10.1016/S0140-6736(16)30307-5)