Abstract
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.
Abstract
Tralokinumab did not demonstrate significant OCS-sparing benefits versus placebo in severe asthma http://ow.ly/kzCt30mC43j
Footnotes
This article has supplementary material available from erj.ersjournals.com
This study is registered at clinicaltrials.gov with identifier NCT02281357. Data underlying the findings described in this manuscript may be obtained in accordance with AstraZeneca's data sharing policy described at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Conflict of interest: W.W. Busse reports personal fees for consultancy from AstraZeneca, during the conduct of the study; personal fees for consultancy from 3M, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Sanofi-Regeneron and Teva, personal fees for data and safety monitoring board work from Boston Scientific and Genentech, personal fees (royalties) from Elsevier, personal fees for educational videos from Medscape, personal fees for joint oversight committee work from ICON Clinical Research Limited, and personal fees from Pfizer, Roche, AstraZeneca and Circassia, and grants from NIH-NIAID and NIH-NHLBI, outside the submitted work.
Conflict of interest: G.G. Brusselle reports honoraria for advisory boards and/or lectures from AstraZeneca, Boehringer-Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Pfizer, Sanofi/Regeneron, Teva, UCB and Zambon, during the conduct of the study.
Conflict of interest: S. Korn reports consulting and lecture fees from Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Teva and Roche, and grants and personal fees from GlaxoSmithKline and Novartis, during the conduct of the study.
Conflict of interest: P. Kuna reports personal fees from Adamed, Allergopharma, ALK, AstraZeneca, Bayer Celon Pharma, Chiesi, FAES, HAL Allergy, Lekam, Polpharma, Pfizer, Sandoz and Teva, during the conduct of the study; and personal fees from Berlin Chemie, Boehringer Ingelheim and Novartis, outside the submitted work.
Conflict of interest: A. Magnan reports personal fees and non-financial support from GlaxoSmithKline, Novartis, Boehringer Ingelheim, AstraZeneca, Stallerg nes, ALK, MundiPharma, Teva, Menarini and Meda Pharma, during the the past 5 years.
Conflict of interest: D. Cohen is an employee of AstraZeneca.
Conflict of interest: K. Bowen is an employee of and own shares in AstraZeneca.
Conflict of interest: T. Piechowiak is an employee of and owns stock options in AstraZeneca.
Conflict of interest: M.M. Wang is an employee of and owns shares in AstraZeneca.
Conflict of interest: G. Colice is an employee of and owns shares and stock options in AstraZeneca.
Support statement: This study was sponsored by AstraZeneca. Funding information for this article has been deposited with the Crossref Funder Registry.
- Received May 21, 2018.
- Accepted October 30, 2018.
- Copyright ©ERS 2019
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