Is baked milk oral immunotherapy safe and efficacious in baked-milk-reactive allergic patients?

Published Online: July 17, 2015

Oral immunotherapy (OIT) is an emerging treatment modality for IgE-mediated cow’s milk allergy (IgE-CMA), which is currently being investigated worldwide. Up to two thirds of patients with IgE-CMA tolerate baked milk (heat-denatured) products with minimal side effects. Furthermore, during baked milk OIT, up to 60% of these patients with baked milk tolerance become desensitized to unheated milk as well. Thus, while heat-denatured milk may have decreased unwanted side effects, it still may be efficacious to induce tolerance. No study to date, however, has tested the feasibility of heat-denatured-food OIT in the heat-denatured-food reactive population.

In a prospective treatment trial recently published in The Journal of Allergy and Clinical Immunology (JACI), Goldberg et al. evaluated the safety and efficacy of baked-milk OIT in the baked-milk-reactive population. Fifteen patients (>4 years) who previously failed unheated milk OIT were enrolled into a baked milk OIT trial. A dose of baked milk below the eliciting dose was increased 50% monthly while under medical supervision, until the primary outcome dose of 1.3 gram baked milk daily was achieved. Immunological parameters such as basophil reactivity and milk protein specific IgE were analyzed at T0-T12 months.

The authors demonstrated that in terms of the primary outcome, only three out of 14 (21%) patients tolerated the 1.3 gram baked milk daily dose. Eight failed due to IgE-mediated reactions including two who required intramuscular adrenaline while on home therapy. Three failed due to non-IgE mediated factors. In the three patients who successfully reached maintenance, a limited increase in challenge threshold to unheated milk was achieved. This was associated with a decrease in milk-specific IgE reactivity. Furthermore, these patients had a greater proportion of basophil-reactivity against conformational epitopes, as compared to the native protein, at T0.

The studies presented demonstrate that subjects who are baked milk-reactive are at high risk of adverse allergic reactions throughout their course of baked-milk therapy. Therefore, the risk-benefit ratio of such treatment should be evaluated for each individual patient, since only limited, albeit for these patients perhaps significant, increases in the challenge threshold to unheated milk were achieved.
The Journal of Allergy and Clinical Immunology (JACI) is an official scientific journal of the AAAAI, and is the most-cited journal in the field of allergy and clinical immunology.

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