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Setting a higher threshold for patient with milk allergy, easier life

Published: November 12, 2022

The quality of life of food-allergic patients in general, and of milk-allergic children, is hampered by a restricted social life due to fear of inadvertent, accidental exposure to food "contaminated" by the allergen. Manufacturers liberally use the term "may contain" (and similar) to warn allergic individuals on potential presence of the allergenic protein in foods. For the past 30 years, attempts have been made to define a dose which most allergic patients could tolerate and that would comprise an "acceptable risk".

Since 2014, data on a minimal eliciting dose for milk were extracted from studies involving oral food challenges. The threshold for the estimated dose inducing a reaction in 1% of milk-allergic individuals, ED01, increased over the years from 0.1 mg in 2014 to 0.4 mg in 2022. This increase was a result of the increasing number of challenges studied. Still, the data was derived from many relatively small studies. Even more problematic is the fact that >15% of the individuals were left censors, i.e. reacted to the first dose of the challenge. Incorporating these individuals shifted the curve to the left.  
Katz and colleagues published in The Journal of Allergy and Clinical Immunology: In Practice, a study of a large group of 866 milk-allergic individuals who underwent open oral food challenges (OFCs) with no left censors. Ninety-three highly allergic patients underwent a modified OFC with 90-120 minute-intervals. The ED01 was 1.1-1.9 mg, which is more than fivefold higher than the above-mentioned figures. none reacted to the first dose of the challenge (0.3mg). Furthermore, in a subpopulation of "highly milk allergic individuals" who either reacted to a food that was declared not to contain milk as an ingredient, or who failed oral immunotherapy (OIT) to milk, all tolerated at least 1 mg of milk protein. Excluding participants who exhibited only subjective symptoms (mainly abdominal pain) did not affect the results, further validating them. This study also showed that a correctly performed open food challenge is as good as the much more complicated double-blind, placebo-controlled food challenge in threshold determination. The results of this study may make threshold determination by the industry easier to implement, and significantly improve the quality of life of milk-allergic individuals.  

The Journal of Allergy and Clinical Immunology: In Practice is an official journal of the AAAAI, focusing on practical information for the practicing clinician.

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