August 21, 2015
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Tralokinumab does not significantly reduce asthma exacerbations

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Tralokinumab did not significantly reduce asthma exacerbation rates in patients with severe uncontrolled asthma, according to study results.

However, patients receiving tralokinumab every 2 weeks experienced improvement in forced expiratory volume in 1 second, according to the researchers.

Christopher E. Brightling, MD, a senior research fellow and clinical professor in respiratory medicine at University of Leicester in the U.K., and colleagues conducted a randomized placebo controlled, double blind, parallel-group, multicenter phase 2b study at 98 sites across North America, South America, Europe and Asia to analyze the efficacy and safety of two doses of tralokinumab in patients with severe uncontrolled asthma.

The analysis included 452 adults aged 18 to 75 years with severe uncontrolled asthma. Researchers randomly assigned patients to receive either 300 mg of tralokinumab every 2 weeks for 50 weeks (n = 150), every 2 weeks for 12 weeks and then every 4 weeks until week 48 (n = 151) or placebo (n = 151) for 1 year.

Patients receiving tralokinumab every 2 weeks (0.91 per year), every 4 weeks (0.97 per year) and placebo (0.9 per year) all had similar unadjusted annual asthma exacerbation rates.

Prebronchodilator forced expiratory volume in 1 second increased compared with placebo in patients receiving tralokinumab every 2 weeks (change from baseline = 7.3%; P = .003) but not every 4 weeks (1.8%; P = .448).

Limitations did exist within the study, according to researchers.

“The sample size of some prespecified and post-hoc subgroups was insufficient to detect significant differences in efficacy outcomes,” the researchers wrote.

More research is needed to better determine the safety and efficacy of tralokinumab.

“Phase 3 studies investigating the efficacy and safety of tralokinumab in patients with uncontrolled severe asthma are underway,” the researchers wrote. – by Ryan McDonald 

Disclosure: Brightling reports receiving a grant from MedImmune. Please see the full study for a list of all other researchers’ relevant financial disclosures.