Brian P. Vickery, MD

Disclosures

Curr Opin Allergy Clin Immunol. 2012;12(3):278-282. 

In This Article

Randomized Clinical Trials

Further evidence of the transience of desensitization after short-term therapy was previously shown in one of the earliest randomized controlled trials of OIT for food allergy. In this study, 45 German children were randomized by Staden et al.[23] to receive egg (maintenance dose 1.6 g/day) or milk (3.5 g/day) OIT or usual care (e.g. strict avoidance diet). They assessed the persistence of any treatment effect, operationally defined as clinical tolerance, by performing oral food challenges 2 months after stopping OIT. After a median of 21 months of therapy, the rate of permanent tolerance was 36% in the OIT group, and 35% in the avoidance group, suggesting that the OIT-treated patients that developed tolerance had independently outgrown their allergy, which is the expected natural history of egg and milk allergy. However, an additional 28% of the treated group also experienced clinical improvement, which returned to baseline once treatment was stopped and thus was considered to be desensitized, an important potential benefit of OIT. Interestingly, among those patients who become fully tolerant, the egg-specific IgE declined over time regardless of whether they received OIT or outgrew their allergy.

In the largest and most definitive trial of egg OIT to date, 55 children aged 5–18 years were enrolled in a randomized and double-blinded clinical trial at five US centers in the Consortium of Food Allergy Research.[24] Although this study is currently ongoing, interim results were reported at the 2010 annual meeting of the American Academy of Allergy, Asthma and Immunology.[25] After 10 months of maintenance treatment with a maximum dose of 2 g of egg white powder per day, 21/40 (52.5%) of patients receiving egg OIT passed an oral food challenge and were considered desensitized, compared with zero of fifteen (0%) on placebo OIT; 30/40 (75%) had achieved desensitization after an additional year of therapy. This is the first large multicenter study designed and powered to formally test the safety and efficacy of OIT for egg allergy by using a placebo control, and using clinical tolerance of egg OIT as the primary endpoint. As such, the clinical and mechanistic results are eagerly awaited in 2012 and beyond.

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