Epicutaneous Immunotherapy for Food Allergy: A Randomized, Double-Blind, Placebo-Controlled Cross-Over Study

Koichi Yamaguchi, Shin Kawagoe, Kota Hirai, Maiko Miyahara, Seigo Shirakawa, Makoto Nonoda, Kei Masuda and Hiroyuki Mochizuki

Objective: Oral Immunotherapy (OIT) is widely practiced as a treatment option for food allergies. However, the evidence to support its clinical efficacy is insufficient, and the process is associated with serious side effects such as anaphylaxis; thus, it is not recommended as a general treatment modality. Epicutaneous Immunotherapy (EPIT) has lower risks of adverse effects upon comparison with OIT; nonetheless, clinical experience in the application of EPIT for treating food allergy is limited. Therefore, we performed a randomized, double-blind, placebo-controlled, cross-over study to evaluate the efficacy of EPIT in the treatment of pediatric food allergy.

Methods: The study population included 13 children with food allergies (egg: n=8; milk: n=5; age: 5-18 years). An allergen or a placebo was applied to the skin for 48 h, 3 times a week, for 8 weeks. The effects were evaluated according to the cumulative tolerated dose in an oral food challenge. At the end of the first and second periods, each subject underwent an oral food challenge in a hospital thrice before the study.

Results: In egg allergy, the cumulative tolerance dose increased significantly in the allergen-EPIT stage. An escalation in milk allergy was also noticed, but it was insignificant. Significant increase was not observed in either of the placebo-EPIT stages. In addition, no cases demonstrated serious systemic adverse events.

Conclusion: EPIT can be useful for the treatment of pediatric food allergies.