The FDA has announced the approval of the first product for the treatment of food allergy. Palforzia is a premeasured package system of peanut protein designed to desensitize and induce a greater state of tolerance in peanut-allergic individuals. This is the first commercially approved product for food oral immunotherapy.
Here are some facts and some of our personal thoughts on the release of this product.
Food Oral Immunotherapy (OIT) is a medical treatment for food allergies. The procedure involves giving increasing doses of the food to which you or your child is allergic in order to achieve a state of immunologic tolerance (desensitization). The immune system is re-trained to handle and not react to food proteins/allergens through regular eating of small amounts of the food.
There is controversy in the allergy community on whether this should be done at this time or whether more research studies should be done first. The process takes many months and requires daily dosing and frequent visits to an allergist.
The studies on Palforzia demonstrated that 67% of patients who participated were able to tolerate the equivalent of 2 peanuts in a challenge. Most patients did experience adverse effects considered mild to moderate but a few experienced anaphylaxes and significant gastrointestinal adverse effects including vomiting, esophageal reflux, and abdominal pain or discomfort. There is a condition called eosinophilic esophagitis that involves these symptoms.
We don’t know how much this product will cost, but it will be very expensive. The goal is to be able to tolerate accidental ingestion, not eat peanuts. It is NOT a cure.
Our practice and several others have begun to use food oral immunotherapy on select patients. This therapeutic treatment can be done for any food but it seems to work best on peanut-allergic patients in the initial studies. We have personally treated peanut-allergic individuals and some tree nut, egg, and cow milk allergic patients as well. The success rate is generally about 80% for highly motivated patients and families in the published studies and we are seeing similar results. A significant number of patients drop out due to time commitment and adverse effects. It is time-consuming and expensive. Patients need to come in every week or two as they increase doses and must take their food doses at home every day without fail and avoid exercise for 2 hours after a dose. The major risks are anaphylaxis and eosinophilic esophagitis(inflammation of the tube extending from the mouth to the stomach). However, patients who undergo a desensitization process may be able to consume the food in normal amounts if they would like to do that. For successful patients, it is clearly life-changing as the risk of allergic reactions decreases dramatically as well as the accompanying anxiety and fear. There are very few allergy practices (approximately 200 in the US) doing this but we are sure the number will grow.
At present, we are not sure about the clinical usefulness of the commercial product Palforzia over the current method we use of measuring and mixing peanut flour on our own. It is another option and welcome addition to this area of medicine where treatment is in great demand. This is a quickly evolving area of medicine.