Two Studies Evaluate Monoclonal Antibody Tralokinumab For Asthma

MedicalResearch.com Interview with:

Reynold A. Panettieri, Jr., M.D. Professor of Medicine, Robert Wood Johnson Medical School Vice Chancellor, Clinical & Translational Science Director, Rutgers Institute for Translational Medicine & Science Emeritus Professor of Medicine, University of Pennsylvania Child Health Institute of New Jersey Rutgers, The State University of New Jersey New Brunswick, NJ  08901

Dr. Panettieri

Reynold A. Panettieri, Jr., M.D.
Professor of Medicine, Robert Wood Johnson Medical School
Vice Chancellor, Clinical & Translational Science
Director, Rutgers Institute for Translational Medicine & Science
Emeritus Professor of Medicine, University of Pennsylvania
Child Health Institute of New Jersey
Rutgers, The State University of New Jersey
New Brunswick, NJ  08901

MedicalResearch.com: What is the background for this study?

Response: Severe asthma is characterized by Type 2 inflammation manifested by increases in IL-13, IL-4 and Il-5 levels in the airways that promotes airway hyperresponsiveness and in part irreversible airway obstruction.  These clinical manifestations profoundly increase asthma morbidity and mortality.

To address an unmet therapeutic need, Tralokinumab was developed as a monoclonal antibody targeting soluble IL-13 with the goal of improving lung function and patient reported outcomes while decreasing annual exacerbation rates.  Stratus 1 and 2 represent two identical randomized, double-blind, placebo-controlled, phase 3 clinical trials in severe asthma.  These international trials enrolled approximately 2000 subjects with severe asthma and examined whether Tralokinumab decreased annualized exacerbation rates (AER) as compared with placebo (primary outcome).

MedicalResearch.com: What are the main findings?

Response: Although pulmonary function increased in subjects receiving Tralokinumab as compared to placebo, only Stratus 1 but not 2 met the primary outcome of decreasing the annualized exacerbation rates.

Patient reported outcomes numerically improved in response to Tralokinumab as compared with placebo. 

MedicalResearch.com: What should readers take away from your report?

Response: These studies align with those performed with another anti-IL13 antibody, lebrikizumab, in which targeting IL-13 alone inconsistently decreases annualized exacerbation rates in asthma.  Curiously, both antibodies did improve lung function in subjects with severe asthma.

Other approaches targeting the IL4alpha receptor that binds both IL13 and IL4 appears to be more effective in decreasing AER. Clinical challenges exist in identifying the ideal medication for asthma patients that manifest a predominant IL13/IL4 airway inflammatory signature.

MedicalResearch.com: What recommendations do you have for future research as a result of this work?

Response: Future studies need to focus on biomarkers that predict response to monoclonal antibodies in severe asthma such that the right medication for the right patient can be chosen at the right time.

Disclosures:  This study was sponsored by AstraZeneca Inc.  I receive remuneration for consultation and research support from AstraZeneca, Sanofi-Regeneron, Novartis and NIH.

Citations

Tralokinumab for severe, uncontrolled asthma (STRATOS 1 and STRATOS 2): two randomised, double-blind, placebo-controlled, phase 3 clinical trials
Panettieri, Reynold A et al.
The Lancet Respiratory Medicine , Volume 6 , Issue 7 , 511 – 525

 

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