Does Tralokinumab Improve Uncontrolled Asthma Outcomes?
Tralokinumab, an anti-interleukin-13 human monoclonal antibody, did not significantly affect eosinophilic inflammation in bronchial submucosa, blood, or sputum compared with placebo, according to the results of a recent study.
In order to examine the role of interleukin 13 in airway inflammation in asthma, as well as the effects of tralokinumab on airway eosinophilic infiltration, blood and sputum eosinophil concentrations, and eosinophil activation, researchers conducted a double-blind, randomized, placebo-controlled phase 2 trial at 15 centers across the UK, Denmark, and Canada.
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The study included 79 participants aged 18 to 75 years with inadequately controlled moderate-to-severe asthma for 12 months or more, which required treatment with inhaled corticosteroids at a stable dose.
They were randomly assigned (1:1) to either tralokinumab 300 mg or placebo, both of which were administered subcutaneously every 2 weeks.
The primary outcome was the change in bronchial biopsy eosinophil count from baseline to week 12. Secondary outcomes included change in blood and sputum eosinophil counts.
Overall, tralokinumab was not associated with a significant change in bronchial eosinophil count, blood eosinophil count, or sputum eosinophil count, compared with placebo. However, FENO concentrations and total blood IgE concentrations were significantly reduced in patients receiving tralokinumab.
“These results suggest interleukin 13 is not crucial for eosinophilic airway inflammation control in moderate-to-severe asthma,” the researchers concluded.
Russell RJ, Chanchi L, FitzGerald JM, et al. Effect of tralokinumab, an interleukin-13 neutralising monoclonal antibody, on eosinophilic airway inflammation in uncontrolled moderate-to-severe asthma (MESOS): a multicentre, double-blind, randomised, placebo-controlled phase 2 trial. Lancet Respiratory Medicine. 2018;6(7):499-510.