Local Allergists Part Of Peanut Allergy Clinical Trials
Children with an extreme sensitivity to certain foods — peanuts particularly — can fall into anaphylactic shock upon the tiniest exposure.
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Updated Tuesday at 4:47 p.m.
There’s no consensus on why cases of food allergies have increased exponentially over the past generation or so, but Dr. Kevin Schaffer of Atlanta Allergy and Asthma in Sandy Springs says he’s definitely seen an uptick. A prevailing notion is that — over time — we’ve become sanitized and sensitized. It’s called the hygiene hypothesis.
“Many years ago, we didn’t have the immunization rates that we do now,” says Schaffer. “And people made an immune response that helped them deal with infections. Now, we’re all immunized, and so our body wants to do something different.”
Enter, allergies.
Schaffer says for many, an allergic response to a food item might involve little more than swelling. A nuisance? Sure. Uncomfortable? Yes. Deadly? Sometimes. Children especially with an extreme sensitivity to certain foods — peanuts particularly — can fall into anaphylactic shock upon the tiniest exposure. But soon, and for the first time, there could be an FDA-approved treatment for peanut allergies. By a seven-to-two vote, an advisory panel this month voted in favor of Palforzia’s effectiveness. Eight of the nine panellists, in a separate vote, felt the drug was safe to use in conjunction with additional safeguards.
A lot went into getting the drug to that point, and some of that work happened in metro Atlanta. Palforzia’s maker, Aimmune, tapped Atlanta Allergy and Asthma to conduct some of the clinical trials in children and teenagers.
“These are people who had to have a clinical reaction to ingestion of peanut, and not just, ‘We’ve avoided peanuts because we think that Johnny’s allergic,’ says Schaffer, indicating a common response from overly-concerned parents. “[Patients] had to have ingested [peanut] and then had a bad reaction. And, additionally, they have to then prove that they’re allergic by a blood test or a skin test to make absolutely certain,” says Schaffer.
Once that happens, they’re officially candidates.
“They come in, they answer lots of questions, they go through physical exams, and, if they meet all the criteria, ultimately they can be enrolled into the trial,” Schaffer adds.
To test the drug, patients were exposed to the allergen that caused their severe reaction. A microgram, or one one-millionth of a gram, was a starting point. The exposure amounts eventually built up to a dose of 300 milligrams — the equivalent one peanut.
“So it’s important to understand this is not a cure, but a treatment,” says Schaffer.
Patients would still have to carry an injection of epinephrine. And even attempting treatment carries risk. Schaffer says about a quarter of study participants had to drop out because their symptoms were too severe. Still, he says, the findings are a “game changer, because it’s the first product that we hope to have FDA approval for, as we move forward in this challenge.”
Baring any unexpected twist, Schaffer expects that approval will happen soon, with the new treatment on pharmacy shelves possibly by spring.
CORRECTION: This report has been updated to correct the spelling of Dr. Kevin Schaffer’s name.
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