RT Journal Article
SR Electronic
T1 A phase II placebo-controlled study of tralokinumab in moderate-to-severe asthma
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 330
OP 338
DO 10.1183/09031936.00223411
VO 41
IS 2
A1 Edward Piper
A1 Christopher Brightling
A1 Robert Niven
A1 Chad Oh
A1 Raffaella Faggioni
A1 Kwai Poon
A1 Dewei She
A1 Chris Kell
A1 Richard D. May
A1 Gregory P. Geba
A1 Nestor A. Molfino
YR 2013
UL http://erj.ersjournals.com/content/41/2/330.abstract
AB Pre-clinical data demonstrate a pivotal role for interleukin (IL)-13 in the development and maintenance of asthma. This study assessed the effects of tralokinumab, an investigational human IL-13-neutralising immunoglobulin G4 monoclonal antibody, in adults with moderate-to-severe uncontrolled asthma despite controller therapies.194 subjects were randomised to receive tralokinumab (150, 300 or 600 mg) or placebo subcutaneously every 2 weeks. Primary end-point was change from baseline in mean Asthma Control Questionnaire score (ACQ-6; ACQ mean of six individual item scores) at week 13 comparing placebo and combined tralokinumab dose groups. Secondary end-points included pre-bronchodilator lung function, rescue β2-agonist use and safety. Numerical end-points are reported as mean±sd.At week 13, change from baseline in ACQ-6 was -0.76±1.04 for tralokinumab versus -0.61±0.90 for placebo (p=0.375). Increases from baseline in forced expiratory volume in 1 s (FEV1) were 0.21±0.38 L versus 0.06±0.48 L (p=0.072), with a dose-response observed across the tralokinumab doses tested. β2-agonist use (puffs per day) was decreased for tralokinumab -0.68±1.45 versus placebo -0.10±1.49 (p=0.020). The increase in FEV1 following tralokinumab treatment remained evident 12 weeks after the final dose. Safety profile was acceptable with no serious adverse events related to tralokinumab.No improvement in ACQ-6 was observed, although tralokinumab treatment was associated with improved lung function.