In the U.S., “a food allergy reaction sends someone to the emergency room every three minutes”, says Chicago paediatrician Christina Ciaccio. She was part of an international study on the immunotherapy of children with peanut allergies, in which researchers from Charité Universitätsmedizin Berlin were also involved. Most food allergy emergencies and deaths in the U.S. are due to peanut allergies.
In January 2020, the US Food and Drug Administration (FDA) approved the first product for the immunotherapy of peanut allergy. It is marketed in the USA under the name Palforzia. “I can’t stress enough what a game changer it will be for allergists and patients to have an FDA-approved product for peanut allergy treatment,” says Ciaccio.
European study in progress
However, another study is required for approval in the EU because too few European patients were examined in the international PALISADE study, explained Kirsten Beyer at the Online Allergy Day of the German Allergy and Asthma Association in June 2020.
Beyer is head of the Children’s Allergy Study Centre at Charité University Medicine Berlin.
However, initial data from this additional study for European approval show very similar results. “Based on these data, we hope that there will soon be a European approval,” said Beyer, “but EU approval does not mean that the costs will be covered by health insurance companies.”
Families in Germany who are interested in participating in the study can contact the Children’s Allergy Study Centre at the Charité directly. Currently, a study is underway on oral immunotherapy therapy for children with peanut allergies aged between one and three years. Although the recruitment of participants was interrupted due to the pandemic, it will soon be resumed, said Beyer.
The study, published in the prestigious New England Journal of Medicine, investigated whether very small amounts of peanut protein ingested regularly by children and teenagers with a peanut allergy would reduce their symptoms. The study is also known by its abbreviation, PALISADE, which stands for ‘Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization’. AR101 is a medication based on peanut protein. It is taken orally and therefore swallowed.
How did the team conduct the study?
Three quarters of the 496 study participants aged between 4 and 17 years received the medication, while a quarter received a placebo. The dosage of the medication was increased every two weeks for the patients treated with AR10. At the end of the trial, all participants were given peanuts and monitored for allergy symptoms and their severity.
What were the findings of the study?
At the end of the trial, 67 per cent of the children and teenagers who received the medication were able to tolerate a small amount of peanuts. The dose at which no allergy symptoms appeared was equivalent to about two peanut kernels.
Only four per cent of the participants who received the placebo were able to tolerate two peanut kernels without symptoms.
However, treatment with AR101 caused adverse effects such as gastrointestinal, skin and respiratory problems. As a result, one in ten patients withdrew early from the study.
How can the findings help?
The treatment cannot ‘cure’ a peanut allergy, but it could mean that people with a peanut allergy who have received peanut protein treatment may not automatically wind up in the emergency room with life-threatening symptoms if they accidentally ingest a small amount of peanuts. Oral immunotherapy was previously not recommended due to insufficient data from earlier studies, explain the authors of the PALISADE study.
„Lebensmittel-Allergie – Neue Therapien eröffnen Chancen“ – Presentation by Kirsten Beyer at Online-Allergietag des DAAB e.V. on 21.6.2020
PALISADE Group of Clinical Investigators. AR101 Oral Immunotherapy for Peanut Allergy. N Engl J Med. 2018 Nov 22;379(21):1991-2001
FDA approves peanut allergy treatment for children and teens https://www.uchicagomedicine.org/forefront/pediatrics-articles/peanut-allergy-immunotherapy