NEW PALESTINE, Ind. — Reiland Applegate and his family are ecstatic about the progress they've witnessed with his severe peanut allergy. Applegate was selected to participate in an oral immunotherapy clinical trial three years ago.
"When we started, his numbers were off the charts," Amy Applegate, Reiland's mom, said. "He was a class 6 and there are 6 classes. His was mainly ingestion."
In order to get into the study, the patient had to do an "entrance challenge."
"They start dosing you with the peanut powder, and as soon as they start finding any symptoms of a reaction, that's where they stop and you earn your spot in the study," Applegate explained.
Applegate was diagnosed with a peanut allergy when he was 2-years-old. Applegate said a severe allergy like this impacts your whole life.
"Overwhelming anxiety, you worry about everything," Applegate said. "If they're at school, did somebody else bring peanuts? And, is Reiland going to touch the same pencil as they did."
Applegate said she even worried about things like her son enduring bullying or having a hard time making friends.
"You really worry about their emotional well-being of them being included and not feeling so left out," Applegate said.
Reiland is in a three-year PALISADE (peanut allergen desensitization clinical trial) by Aimmune Therapeutics, Inc. Palforzia is the name of oral immunotherapy he takes each day. The goal is to reduce the number, and severity, of allergic reactions, including anaphylaxis, which could happen after a person is accidentally exposed to peanuts. Those in the study are between 4 and 17-years-old, and have a confirmed diagnosis of peanut allergy.
"When we first started, we had a little bit of trouble, discomfort and such," Applegate explained. "Sometimes he has a little bit of acid reflux. But other than that, it's been more than we could have ever expected."
The Applegate Family joined others from around the country to speak before the Food and Drug Administration's Allergenic Products Advisory Committee on Friday. The committee voted 7-2 the efficacy data and 8-1 the the safety data, along with additional safeguards, are adequate to support the use Palforzia. Until now, the only treatments for severe peanut allergies are avoidance and Epinephrine.
Essentially, those in the clinical trial are given doses of peanut protein, increased every two to four weeks, in order to build up tolerance. The hope is that a child's risk of severe reactions is reduced. The treatment will not get rid of the allergy entirely.
"It looks like maybe long term he'll either eat peanut powder every day or peanuts each day," Applegate said. "But, they're hoping that once you do that every day for five years, that eventually you won't have to do that anymore. So that's the hope, the glimmer of hope we have for the future."
Not all allergists are on board for this treatment awaiting FDA approval. Dr. Mark Holbreich, a pediatric allergist and immunologist with St. Vincent's hospital said if it is approved the decision will need to be made on an individual basis.
"I think a parent is going to have to decide in what we called "shared decision making" with their allergist whether or not they're going to take on the risks of a new medication that we don't have that much experience with," Dr. Holbreich said. "Or, continue what they've been doing for the last 20 years since peanut allergies have been a problem and that's just avoidance, and avoidance is not a bad option."
Dr. Holbreich said he believes Palforzia is the first of many new treatments the country will see as it relates to food allergies.
"I do think this will be the first treatment to desensitize children towards food, but I do think over the next fire years there will be other treatments," Dr. Holbreich said. "So, the question is, 'Do you do this first one and look at the risks, or do you take your time and look at what are next choices that come over the next four or five years?'"
For Applegate and her son, she believes Palforzia is the right decision for them. He is consuming 300 milligrams a day, and will continue to do that until the FDA directs them to do something different. The FDA is expected to make a decision on the treatment in January 2020.