Severe reactions prompt oral immunotherapy alert

4 minute read

While ASCIA still urges caution, it was forced to craft a position statement to address doctors who offer the treatment outside of clinical trials.

Australia’s leading allergy group has issued guardrails for providing oral immunotherapy for food allergies, despite heavily encouraging patients to only try it within the context of clinical trials.

Dr Lara Ford, chair of the Australasian Society of Clinical Immunology and Allergy (ASCIA) paediatric committee, stressed that oral immunotherapy wasn’t a recommended standard treatment for most people with food allergy.

She said the society was forced to update its position statement ahead of a planned update later this year, because “the reality is that [oral immunotherapy is happening] in situations that we wouldn’t recommend”.  

The NSW Anaphylaxis Education Program, of which Dr Ford is the clinical lead, has had reports of children experiencing severe reactions or needing adrenaline autoinjector use in public schools and day care, following immunotherapy at home that morning.

She said a communication breakdown was occurring somewhere. “You can have a reaction to any dose of your immunotherapy, even if you take all the precautions, but most people doing immunotherapy in a research setting would agree that subjects should be resting for half an hour before and two hours after their dose. And getting on a school bus and running around the playground doesn’t really count as resting,” she told TMR.

ASCIA’s position remains that oral immunotherapy is “an emerging treatment” for food allergy, “not a cure”. Strict avoidance of the allergen is recommended for most patients, because more data is needed on the safety, long-term effectiveness, impact on quality of life versus the benefit of desensitisation, and cost effectiveness of oral immunotherapy.

ASCIA “strongly supports” clinical trials and recommends that the treatment be undertaken in that context, but the statement acknowledges that “these opportunities may not always be available to patients”.

Given the lack of evidence for oral immunotherapy, the decision to start the therapy required input from a clinical immunology or allergy specialist, as well as with the patient and/or family who had informed consent around the risks and benefits.

“Quality of life is probably the main reason why immunotherapy is not ready for prime time in its current form,” said Dr Ford.

If the decision was made to try the experimental approach, ASCIA said it should only be provided under the supervision of the treating specialist, in a facility that could manage severe allergic reactions, and in consultation with other specialists for peer review.

“Studies show that a large proportion of people on oral immunotherapy have more reactions to their doses than they would have, were they strictly avoiding the food,” Dr Ford said.

“The price you pay for a minority of people getting benefit from the immunotherapy is that the majority are having side effects and not getting a long-lasting benefit.”

Dr Ford said that medical literature hadn’t yet discovered effective ways of identifying patients who might benefit from treatment ahead of time.

“So we’re asking this large group of people to go through a process that has significant harms, and only a minority of them are likely to benefit.”

The paper emphasised the importance of reporting of patient outcomes to address the current gaps in knowledge, and using standardised, peer reviewed, published protocols.

But there isn’t currently one standard protocol used in Australia.

Dr Ford said the National Allergy Centre of Excellence (NACE) was working towards standardisation as part of its living systematic review.

“There are a lot of protocols out there that involve modifying the foods in various ways and they’re not standard. They’re not backed by data.”

The statement also draws attention to areas where confusion may arise, emphasising the difference between oral immunotherapy and milk or egg ladders (used to help children with allergies they will eventually outgrow) and the need for confirmation of the allergy to avoid an unnecessary, onerous process.

ASCIA Position Paper: Oral Immunotherapy for Food Allergy

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