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
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).