Efficacy and safety of low- and high-dose slow oral egg immunotherapy for hen’s egg allergy: Single-center non-inferiority randomized trial

Yuri Takaoka,¹ Yoichi M Ito,² Junko Kumon,¹ Tomohiro Yamaguchi,¹ Rumi Ueno,¹ Yuki Tsurinaga,¹ Tamana Nakano,³ Yohei Fukasawa,¹ Amane Shigekawa,¹ Yukinori Yoshida,¹ Makoto Kameda,¹ Satoru Doi⁴

Affiliations:
¹ Department of Pediatrics, Osaka Habikino Medical Center, Osaka, Japan
² Data Science Center, Promotion Unit, Institute of Health Science Innovation for Medical Care, Hokkaido University Hospital, Hokkaido, Japan
³ Children’s Medical Center, Kitakyushu City Yahata Hospital, Fukuoka, Japan
⁴ Shitennoji University, Osaka, Japan

Abstract

Background: Low-dose oral immunotherapy (OIT) is a safe treatment for hen’s egg allergy; however, comparison of its therapeutic effects with those of high-dose OIT has not been reported.
Objective: To compare the efficacy of low- and high-dose boiled egg-white (EW) OIT for hen’s egg allergy.
Methods: Patients with hen’s egg allergy were randomly assigned to two groups: OIT using hard-boiled EW with a maximum maintenance dose of 2 and 20 g in the low-dose (L-D) and high-dose (H-D) groups, respectively. The intake dose was ingested twice a week, increased by approximately 20% per week until reaching the target maintenance dose (2 or 20 g hard-boiled EW), and maintained thereafter according to the schedule. The threshold was confirmed via oral food challenge (OFC) after 6 months, and the difference in the proportion of subjects passing the exit OFC between groups was evaluated.
Results: Fifty-two patients (L-D, n = 23; H-D, n = 29) were enrolled. Thirty-three patients (L-D, n = 17; H-D, n = 16) completed the 6-month OIT and underwent an exit OFC. In total, three (L-D, 3/17; H-D, 3/16) patients in each group tested negative for an exit OFC with a 20-g reactive dose (p = 1.000). EW-specific IgE levels in both groups decreased significantly after OIT (L-D, p < 0.001; H-D, p = 0.002).
Conclusion: A threshold-elevating effect was observed in the L-D group, not inferior to that in the H-D group. Low-dose OIT may be appropriate to treat hen’s egg allergy for the first 6 months.
Key words: oral immunotherapy, egg allergy, safety, efficacy, low dose