Peanut allergy treatments: What’s next for the field?Ticker(s): AIMT, DBVT
Name: Dr Erwin Gelfand - MD
Institution: National Jewish Health
- Pediatric allergist and immunologist and Professor of Pediatrics at National Jewish Health in Denver.
- Follows hundreds of patients with peanut allergy at his center; has researched and published on peanut allergy, and is very familiar with the competing interests of Aimmune (AR-101) and Viaskin patch.
- Clinical interests include the diagnosis and treatment of immune deficiency and autoimmune disorders and severe atopic diseases; has received numerous grants from the National Institutes of Health, the Environmental Protection Agency and several foundations, and has published more than 750 papers in peer-reviewed journals.
Question from the STAT Reporting Team to Come!
Given the emerging evidence potentially linking microbiome and food allergy (preventative and therapeutic), is it known if any patients take probiotics in the pivotal studies for AIMT and DBVT (controlled or not) and if the usage of probiotics had any impact on safety or efficacy? And could there be a rationale to take OTC probiotics to improve safety/efficacy profile for either of the products, especially AR101?Added By: homer
The AR101 protocol call for 5 updoses on the first day, with a minimum 30 minutes separating each dose, and if a patient has an AE, at least 60 minutes separating the doses. This seems to roughly equate to 5 hours of clinic time to treat a patient. How would a practice with limited room manage this? Community waiting room or occupy a single room? Will this create a bottleneck to treat patients?Added By: trip
As a follow up, as reported by AIMT in NEJM publication on the PALISADE study, 50% of patients experience an AE on the initiation of therapy. 22% of these children experience abdominal pain on the first day of therapy. How would you characterize these AE's in light of the fact that 20% of AR101 patients withdraw from their studies? How would this translate to real world practice?Added By: trip
Please ask Dr. Gelfand his thoughts on the "homebrew" practitioners using off the shelf peanut flour and various protocols. These practices also charge $4-$5k.
There are approximately 400 "homebrew allergists".
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