ACAAI 2018 Perspectives - Episode 1
The very positive findings for what could become the first US Food and Drug Administration (FDA)-approved peanut allergy drug are historical for their success, but not for their practice.
In an interview with MD Magazine®, Simon Murray, MD, an internist from Princeton, NJ, discussed the findings of the PALISADES phase 3 trial assessing investigative oral therapy AR101 for the preventive desensitization of peanut allergies in patients. The trial results, which were initially presented at the 2018 American College of Allergy, Asthma & Immunology (ACAAI) annual meeting in Seattle, WA, come in short time before the anticipated FDA new drug application submission by company Aimmune Therapeutics.
If it were approved for peanut allergy care, it will mark a major breakthrough in allergy-related treatment. But, Murray noted, it's not the first drug to address desensitization.
MD Mag: What were the biggest takeaways from the phase 3 PALISADES trial results for AR101?
Murray: It's a really exciting study, because it may answer—in part, at least—a problem that is rather common in our society and is troublesome to a large majority of children. In fact, peanut allergy, which is what this drug addresses, affects about 1 in 50 young children between the ages of 4 and 17, which turns out to be about 1.5 million people in the United States alone.
But it is increasing at a quick rate in this country, as well as other industrial countries. Not only peanut allergy, but allergies in general.
What are your thoughts on it being efficacious solely in the pediatric population?
Yeah, that was interesting. It did not seem to have any clinically significant benefit in children older than 18 they were included in the study. This particular study involved 550 individuals who had been pre-selected because they were sensitive to small amount of peanut allergen.
About two-thirds of the group were under 17 I believe, and the rest were over 17, up to the age of about 50. But no benefit was seen in that older population. Yeah, allergy is a very complicated subject, but the attempt to desensitize people to allergies has been going on for a 100 years and historically, allergists have used subcutaneous preparations of small doses of allergens and increasing them on a regular basis over long periods of time to build tolerance to those allergens. And more recently, scientists have used oral mechanisms to try to treat food allergies, particularly subcutaneous preparations and oral preparations, with mixed results.
So in general, there haven't been great oral desensitization trials yet ,and this particular trial was a more favorable trial than many other trials using oral desensitization. But other forms of these sensitization are well-known and have been used for many, many years.