Anaphylaxis is severe, sometimes life-threatening, allergic reaction that can be caused by food allergies, most frequently by a peanut allergy. Learn about the FDA approved PALFORZIA to help lessen the risk of these serious reactions.
Peanut allergy is one of the three most common food allergies in children, and the one most likely to result in life-threatening anaphylaxis. Fortunately, the FDA approved PALFORZIA, a dosing regimen of peanut powder designed to help lessen the likelihood of severe peanut allergy reactions, in January 2020.
Several trials, including the most recent Phase 3 trial in Europe, show that PALFORZIA is a safe and effective way to desensitize children to peanut (increase the amount of peanut required to cause peanut allergy reactions in children who already have peanut allergies). Here's what parents need to know about the latest trial of PALFORZIA.
What is PALFORZIA?
PALFORZIA is the first FDA-approved peanut allergy treatment. It was developed by Aimmune Therapeutics, and it is made up of carefully selected doses of peanut powder taken by mouth. It is designed for children and teens ages 4-17 with existing peanut allergies.
PALFORZIA's purpose is to desensitize children to peanut. When children and teens with peanut allergies are desensitized, they can tolerate larger amounts of peanut, without experiencing symptoms of an allergic reaction. As a result, they're less likely to experience a peanut allergy reaction when they are accidentally exposed to peanuts.
PALFORZIA is not a cure for peanut allergies, so it doesn't enable a child to start eating peanut regularly. Rather, it's only meant to help protect against accidental peanut exposure. Young people taking PALFORZIA must still strictly avoid peanut in their everyday diet.
Learn more from Dr. Pramod Kelkar about Palforzia for peanut allergy patients:
What is the PALFORZIA Phase 3 European trial?
The Phase 3 European trial is the last of three Phase 3 PALFORZIA trials. This trial is called the ARTEMIS trial (AR101 Trial in Europe Measuring Oral Immunotherapy Success), because in Europe, PALFORZIA is known as AR101. (PALFORZIA is not currently approved for peanut allergy treatment in Europe; it is still under review there with the European Medicines Agency.)
Like the other Phase 3 trials, the ARTEMIS trial was randomized, placebo-controlled, and double-blind (meaning participants and researchers didn't know whether each participant was receiving the actual PALFORZIA treatment or the placebo.)
Children and teens ages 4-17 who had confirmed peanut allergies, from 18 hospitals across 6 European countries, participated in the trial. Before being enrolled in the trial, all these youth developed significant peanut allergy symptoms after eating one kernel of peanut (or less than one kernel).
This trial tested whether a nine-month treatment regimen of PALFORZIA was safe and effective for reducing the likelihood of peanut allergy reactions, and whether PALFORZIA improved the quality of life for youth with peanut allergies.
During the trial, the participants' doses of PALFORZIA (or the placebo) were slowly increased until they reached 300mg. For those receiving the peanut protein, this was the equivalent of the peanut protein in one peanut kernel.
After nine months of treatment, the participants were given a food challenge of 1000mg peanut protein (the protein in seven peanut kernels) to see if they developed significant ("dose-limiting") symptoms of an allergic reaction.
PALFORZIA Phase 3 European Trial: Key Findings
The European Phase 3 trial of PALFORZIA's results show that PALFORZIA does effectively desensitize children and teens with peanut allergies.
During the study's final food challenge, after the nine-month treatment period:
- 58% of the children and teens treated with PALFORZIA were able to tolerate a single 1,000 mg dose of peanut protein (equal to approximately seven peanut kernels). Meanwhile, only 2% of the participants in the placebo group were able to tolerate that dosage of peanut protein.
- 68% of participants treated with PALFORZIA tolerated a 600 mg dose of peanut protein, but only 9% of the participants in the placebo group were able to tolerate that dose of peanut protein.
- 74% of participants treated with PALFORZIA tolerated a 300 mg dose of peanut protein, but only 16% of the participants in the placebo group were able to tolerate that dose of peanut protein.
These results show that PALFORZIA helps children with peanut allergies tolerate larger amounts of peanut, so they'll be less likely to experience a severe allergic reaction if accidentally exposed.
"There were clear improvements in self- and caregiver proxy-reported quality-of-life measures." - Daniel Adelman, M.D., Chief Medical Officer of Aimmune Therapeutics
PALFORZIA was also shown to be a safe treatment, when this trial's results were compared to other desensitization trials.
- Compared to the placebo group, the PALFORZIA-treated participants were "significantly less likely" to develop symptoms of a severe allergic reaction during the final food challenge.
- In this trial, PALFORZIA's safety profile was shown to be consistent with previous PALFORZIA trials, based on how frequently and how severely allergic reactions occurred.
- Although over 98% of participants experienced symptoms of an allergic reaction, symptoms were mild or moderate in all cases. Usually, these symptoms involved the skin, GI tract, and respiratory system.
- The frequency, type, and severity of symptoms in this trial were very similar to other desensitization trials (some allergic reaction symptoms are expected, since trials like these require youth with peanut allergies to ingest peanut).
- No severe systemic allergic reactions (no cases of anaphylaxis) were reported during the trial.
In addition, children and teens with peanut allergies (or their parents, reporting by proxy) shared that they felt PALFORZIA improved their quality of life, since they didn't have to worry as much about developing a severe allergic reaction.
- As Aimmune reports, "PALFORZIA-treated participants... recorded greater improvements in quality-of-life measures compared to the placebo group, as assessed via the Food Allergy Quality- of-Life Questionnaires (FAQLQs) and the Food Allergy Independent Measure (FAIM)."
- PALFORZIA-treated participants shared that they were less worried about developing a severe allergic reaction when accidentally exposed to peanut, and less worried about future accidental peanut exposure as a whole.
"Improvements in quality-of-life measures in PALFORZIA-treated participants were reported, most notably in how treatment affected the perceived likelihood of future accidental exposure and risk of severe reactions." - Aimmune Therapeutics
All health-related content on this website is for informational purposes only and does not create a doctor-patient relationship. Always seek the advice of your own pediatrician in connection with any questions regarding your baby’s health.
See the FDA Peanut Allergy Qualified Health Claim at the bottom of our homepage.