EPIC peanut allergy trial launches at PCH
As waitlists for children with food allergy continue to expand, we are leading Australia by investigating the efficacy, safety and tolerability of adding inexpensive off-the-shelf peanut flour to home meals under medical direction to desensitise pre-schoolers with peanut allergy.
The oral immunotherapy (OIT) randomised controlled trial, called Early Peanut Immunotherapy in Children (EPIC), is the first-of-its kind in Australia and will focus on utilising a possible early “window of opportunity” to safely and gradually reintroduce a small amount of peanuts to desensitise and build up a degree of tolerance.
The aim is to prevent and limit severe allergic reactions and potentially life-threatening anaphylaxis that occur when there is accidental exposure.
Currently recruiting, the 12-month-long food-based trial will provide a small group of WA peanut allergy patients aged under five-years-old with access to world-class allergy treatment while also allowing treatment protocols to be developed that could be readily adopted across Australia.
The PCH Immunology research team has chosen to keep costs to a minimum by using off-the-shelf defatted peanut flour costing only $15 for a year’s supply of treatment.
If proven successful at improving quality of life while decreasing the burden of allergic disease on families and the health system, the PCH defatted flour OIT could be set to become the nation’s first peanut allergy treatment.
Currently in Australia, there are no approved treatments for peanut allergy, and the standard care for patients is strict allergen avoidance.
“The trial will measure if there is a ‘window of opportunity’ amongst those children who have a confirmed peanut allergy, to incrementally reintroduce peanut regularly in the form of oral immunotherapy.
The aim is to initially induce desensitisation and potentially ‘remission’ of the allergy after finishing OIT,” said PCH clinical immunologist and research trial leader Dr Michael O’Sullivan.
“We cannot be sure from a one-year study if this treatment is going to be of benefit for their whole life but the aim is to intervene early and try to change the course of the disease.”
Overseen by a PCH multidisciplinary team with clinical expertise in immunology, emergency medicine, nursing, dietetics, gastroenterology and psychology, the trial involves controlled regular exposure to peanuts via a strictly measured small daily dose of peanut flour added to home meals.
In launching the trial, Dr O’Sullivan said PCH was responding to demands from families across Australia for access to local treatment options for peanut allergy. Already some Australian families had opted to self-fund a six month move overseas to access OIT in Singapore, Canada and the USA.
“With this trial, we are responding to consumer demand to provide access to food allergy treatments in Australia that are currently available overseas, using a translatable approach that could be applied to other foods and underpin a future national approach to food OIT,” Dr O’Sullivan said.
“While there is increasing experience with OIT overseas, PCH will be the first hospital in Australia to offer a food-based approach. Our pragmatic approach to OIT uses an inexpensive and readily available food product, defatted peanut flour, rather than a pharmaceutical product to significantly reduce the potential costs associated with OIT to families and the health system”.
Kardinya mother Natasha Tonge is keen to enrol her four-year-old son Luca in the PCH trial now that the COVID-19 pandemic has put an end to plans to travel to Singapore for peanut oral immunotherapy.
“It is so important that we have treatment options here in Australia,” she said.
Luca was diagnosed with nut allergies, including a peanut allergy, after eating cashew nut butter at six-months-of-age and breaking out in hives, requiring him to be rushed to an emergency department.
“We have no food allergies in our family at all and I have found it all quite stressful to deal with,” Mrs Tonge said.
“It is not something you can see but it is still life threatening.
“We make sure we keep an eye on him at all times and unfortunately he can’t just wander off alone and play with the other kids,” she said.
Dr O’Sullivan said the PCH trial team is collaborating with basic science researchers to understand the mechanisms underlying effective desensitisation and development of tolerance.
“Through these studies we hope to identify both clinical and laboratory biomarkers to identify patients with the greatest likelihood of treatment success, and to guide when treatment may be discontinued while maintaining remission of the food allergy,” he said.
“We are working closely with allergy and immunology researchers at Telethon Kids Institute to collect and store samples (e.g. blood, stools and saliva) from children receiving OIT and, if funding is secured, are planning innovative experiments to better understand how OIT works and predict who is most likely to benefit from it.”
The trial has been funded by a $249,000 grant from the WA Child Research Fund, jointly established by the WA Department of Health and Channel 7 Telethon Trust.
Given the risk of side effects including severe allergic reactions, OIT should not be tried at home without the support of an experienced multidisciplinary team.
Find out more and register
Families interested in hearing more about this or other allergy research studies at PCH should email FoodAllergyResearch@health.wa.gov.au or register their interest here.