Food challenge data may facilitate effective allergen risk management

19 Jun 2021

Data from food challenge studies can help regulators and business owners establish evidence-based allergen risk management systems, such as precautionary labelling of products, in order to protect their consumers, a recent study has found.

The researchers conducted a systematic review and individual participant data meta-analysis, ultimately retrieving 19 eligible studies (n=3,151) from online databases. Only those that employed a double-blind, placebo-controlled food challenge design were included. The selected studies enrolled participants with peanut allergies who responded to eliciting dose of an allergen expected to cause objective symptoms in 1 percent and 5 percent of the population with an allergy (ED01 and ED05, respectively).

Aggregate findings showed that overall, 4.5 percent of participants reacting to 5 mg or less of peanut protein would experience anaphylaxis.

Heterogeneity of evidence was moderate, prompting the researchers to conduct subsequent sensitivity analyses. The resulting estimate changed, but was not substantially different from the initial finding: anaphylaxis was expected to develop in 4.2 percent of participants who reacted to 5 mg or less of peanut protein.

Notably, 12 of the eligible studies employed an initial challenge dose of 1-mg peanut protein. A meta-analysis of these reports found that 4.2 percent of patients responding to 1 mg or less of the allergen would develop anaphylaxis.

“Around 5 percent of individuals reacting to an ED01 or ED05 level of exposure to peanut might develop anaphylaxis in response to that dose,” the researchers said. In absolute terms, this may mean 1 and 6 anaphylaxis events per 2,500 patients exposed to the respective doses.

“Currently, the use of risk-mitigating strategies (such as measures to reduce allergen cross-contamination on shared production lines and use of precautionary allergen labelling and food recalls) may not be evidence based,” the researchers said. “These data are crucial in developing an evidence-based approach to allergen risk management in food production.”

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