Earlier in the month The Journal of Allergy and Immunology: In Practice reported on on a trial which demonstrated that peanut oral immunotherapy is still effective after one year of maintenance in children from 7 months to 6 years old.
A total of 117 of the 161 eligible patients completed the trial and received the follow-up. Among them, 92 (78.6%) were able to tolerate a cumulative peanut protein dose of 4,000mg – around 28 peanuts. A total of 115 (98.3%) tolerated a cumulative 1,000mg dose (7 peanuts). This would most certainly protect them against accidental peanut exposures – thus easing greatest concern of the parents of peanut allergic children.
Worth noting was the fact that adrenaline/epinephrine was only needed by two participants during the maintenance phase, only one patient needed to go to the emergency department due to an allergic reaction and only 10.5% of participants experienced any allergic reactions at all.
And then today I received a press release announcing that Aimmune Therapeutics’ PALFORZIA drug has now received approval for use across Europe. PALFORZIA, to quote the press release is:
‘…a complex biologic drug used with a structured dosing approach that builds on a century of oral immunotherapy (OIT) research. With OIT, the specific allergenic proteins are ingested initially in very small quantities, followed by incrementally increasing amounts, that can result in the ability to mitigate allergic reactions to the allergen over time. PALFORZIA is a rigorously developed, pharmaceutical-grade OIT for peanut allergy with a well-defined allergen profile to assure the consistency of every dose, from 0.5 mg (equivalent to 1/600th of a peanut) to 300 mg.’
PALFORZIA has undergone very similar trials to those reported in the JACI with very similar outcomes. For more information on the PALISADE trial see the New England Journal of Medicine here and for the ARTEMIS trial see PubMed here.
“Results from landmark Phase 3 clinical trials have shown more than half of patients treated with PALFORZIA were able to tolerate the equivalent of seven to eight peanut kernels after up to nine months of treatment. These compelling data highlight its potential to mitigate against severe allergic reactions, including anaphylaxis in the event of unintended exposure to peanut protein,” said Prof. George du Toit, Professor of Paediatric Allergy at Evelina London Children’s Hospital, Guy’s and St Thomas’ NHS Foundation Trust.
However, while this is very good news for the long term treatment and management of peanut (and possibly other) allergies, those with peanut allergies (and parents of peanut allergic children) must remember that the treatment ‘is not intended for, and does not provide, immediate relief of allergic symptoms….’ It should not be used for emergency treatment of allergic reactions when adrenaline should always be available and be used.