MedicalResearch.com Interview with:
Mario Castro, M.D., M.P.H.
Alan A. and Edith L. Wolff Professor of Pulmonary and Critical Care Medicine,
Professor of Medicine, Pediatrics, and Radiology
Washington University School of Medicine
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: This is a confirmatory phase 3 pivotal study that assessed the efficacy and safety of dupilumab in a population of uncontrolled moderate to severe asthmatics.
This was the largest phase 3 placebo controlled trial conducted in this population evaluating a biologic. It enrolled patients without any minimum requirement for any type of biomarker such as blood eosinophils. It clearly confirmed the efficacy of dupilumab in reducing severe asthma exacerbations, improving lung function, asthma control and quality of life in the overall population. It also showed that patients with evidence of type 2 inflammation (increased blood eosinophils or exhaled NO) had a greater magnitude of effect.
MedicalResearch.com: What should readers take away from your report?
Response: This study clearly demonstrates that dupilumab represents a great therapeutic option for a broad asthma population that remains uncontrolled despite the use of medium to high dose ICS in combination with up to 2 controllers. It not only reduces the risk for exacerbations but it has a rapid, sustained and clinically meaningful effect on lung function with a magnitude not seen with other available therapies.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: We should continue studying different severe asthma phenotypes to better differentiate responders from non-responders. Future research is needed to confirm the long-term effects of dupilumab in preventing loss of asthma of control and providing disease modification by reducing airway remodeling, as suggested by the results of this study.
MedicalResearch.com: Is there anything else you would like to add?
Response: This study confirms that mechanism of action of dupilumab is unique and plays a critical role in controlling type 2 inflammation commonly seen in these patients. Dupilumab has also demonstrated beneficial effects in controlling symptoms of other co-morbidities, such as atopic dermatitis, allergic rhinitis and nasal polyposis, where type 2 inflammation is also key feature.
Sanofi-Regeneron provided funding to my University for conduct of this study. Otherwise I have no stock or funding in this company or drug.
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