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
A1 Busse, William W.
A1 Brusselle, Guy G.
A1 Korn, Stephanie
A1 Kuna, Piotr
A1 Magnan, Antoine
A1 Cohen, David
A1 Bowen, Karin
A1 Piechowiak, Teresa
A1 Wang, Millie M.
A1 Colice, Gene
YR 2018
UL http://erj.ersjournals.com/content/early/2018/11/01/13993003.00948-2018.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 each) administered subcutaneously every 2 weeks. The primary endpoint was percent change from baseline in average OCS dose at Week 40, while maintaining asthma control. Secondary endpoints 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 percent 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 endpoint. Overall, reporting of adverse events (AEs) and serious AEs 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.FootnotesThis manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.Conflict of interest: Dr. Busse reports personal fees from AstraZeneca, during the conduct of the study; personal fees from 3M, personal fees from Boehringer Ingelheim, personal fees from Boston Scientific, personal fees from GlaxoSmithKline, personal fees from Novartis, personal fees from Sanofi-Regeneron, personal fees from Teva, personal fees from Genentech, personal fees from Elsevier, personal fees from Medscape, personal fees from ICON Clinical Research Limited, outside the submitted work.Conflict of interest: Dr. Brusselle reports personal fees from AstraZeneca, Boehringer-Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Pfizer, Sanofi/Regeneron, Teva, UCB, and Zambon, during the period of the conduct of the study.Conflict of interest: Dr. Korn reports personal fees from Almirall, personal fees from AstraZeneca, personal fees from Boehringer Ingelheim, personal fees from Chiesi, grants and personal fees from GlaxoSmithKline, grants and personal fees from Novartis, personal fees from Teva, personal fees from Roche, during the conduct of the study.Conflict of interest: Dr. Magnan reports personal fees and non-financial support from Novartis, personal fees from Boehringer Ingelheim, personal fees and non-financial support from AstraZeneca, personal fees from Stallergènes, personal fees from ALK, personal fees from MundiPharma, personal fees from Teva, personal fees from Menarini, personal fees from Meda Pharma, during the conduct of the study.Conflict of interest: Dr. Cohen is an employee of AstraZeneca.Conflict of interest: Mrs. Bowen is an employee of AstraZeneca, and own shares in AstraZeneca.Conflict of interest: T. Piechowiak is an employee of AstraZeneca and owns stock options in AstraZeneca.Conflict of interest: M. Wang is an employee of AstraZeneca and owns shares in AstraZeneca.Conflict of interest: Gene Colice is an employee of AstraZeneca and owns shares and stock options in AstraZeneca.Conflict of interest: Dr. Kuna reports personal fees from Adamed, personal fees from Allergopharma, personal fees from ALK, personal fees from AstraZeneca, personal fees from Bayer Celon Pharma, personal fees from Chiesi, personal fees from FAES, personal fees from HAL Allergy, personal fees from Lekam, personal fees from Polpharma, personal fees from Pfizer, personal fees from Sandoz, personal fees from Teva , during the conduct of the study; personal fees from Berlin Chemie, personal fees from Boehringer Ingelheim, personal fees from Novartis, outside the submitted work.