RT Journal Article
SR Electronic
T1 Tralokinumab did not demonstrate oral corticosteroid-sparing effects in severe asthma
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 1800948
DO 10.1183/13993003.00948-2018
VO 53
IS 2
A1 William W. Busse
A1 Guy G. Brusselle
A1 Stephanie Korn
A1 Piotr Kuna
A1 Antoine Magnan
A1 David Cohen
A1 Karin Bowen
A1 Teresa Piechowiak
A1 Millie M. Wang
A1 Gene Colice
YR 2019
UL http://erj.ersjournals.com/content/53/2/1800948.abstract
AB Long-term oral corticosteroid (OCS) use in patients with severe asthma is associated with significant adverse effects.This 40-week, randomised, double-blind trial evaluated the OCS-sparing potential of tralokinumab in patients with severe, uncontrolled asthma requiring maintenance OCS treatment plus inhaled corticosteroids/long-acting β2-agonists. Overall, 140 patients were randomised to tralokinumab 300 mg or placebo (n=70 in each group) administered subcutaneously every 2 weeks. The primary end-point was percentage change from baseline in average OCS dose at week 40, while maintaining asthma control. Secondary end-points included proportion of patients with a prescribed maintenance OCS dose of ≤5 mg, those with a ≥50% reduction in prescribed maintenance OCS dose and asthma exacerbation rate. Safety was also assessed.At week 40, the percentage reduction from baseline in the final daily average OCS dose was not significantly different between tralokinumab and placebo (37.62% versus 29.85%; p=0.271). There were no significant between-treatment differences for any secondary end-point. Overall, reporting of adverse events and serious adverse events were similar for the tralokinumab and placebo groups. Although a greater proportion of tralokinumab-treated patients reported upper respiratory tract infections (35.7% versus 14.3%), there were no reported cases of pneumonia.Overall, tralokinumab did not demonstrate an OCS-sparing effect in patients with severe asthma.Tralokinumab did not demonstrate significant OCS-sparing benefits versus placebo in severe asthma http://ow.ly/kzCt30mC43j