Effectiveness and safety of oral immunotherapy for severe food allergy

概要

1. Effectiveness and Safety of Double-Blind, Placebo-Control1ed, Low-Dose Oral Immunotherapy with Low Allergen Egg-Containing Cookies for Severe Hen’ s Egg Allergy： A Single-Center Analysis

(Abstract)
[Introduction] To evaluate the efficacy and safety of OIT with low allergen cookies (LACs) containing a low dose of hen’ s egg.
[Methods] Thirty-three patients with severe hen’ s egg allergy were randomly administered either OIT with LACs (n= 21)or placebo (λ =12). Two patients in the LACs group withdrew before completing OIT. The primary endpoint was the number of good responders (G-R), patients with negative results in the oral food challenge (OFC) with a final dose of 2 g hardboiled egg whites after 4 months of OIT, in each group. Total OFC Aichi score for anaphylaxis/cumulative protein dose (TS/Pro) as the marker of severity of food allergy was also compared. Adverse events during OIT were evaluated using patients* diaries.
[Results] The proportion of G-R in the LACs group was higher than in the placebo group (7/19 [37%] vs. 1/12 [8%], % 2 test ； p = 0. 077). The TS/Pro after OIT in the LACs group was lower than in the placebo gro叩(median score, 44. 2 vs. 104.1,p = 0. 059； Mann-Whitney U test). The threshold and TS/Pro before and after OIT significantly improved in the LACs group (p = 0. 015, p = 0.027, respectively； Wilcoxon signed-rank test). There were 99 recorded incidences of symptoms of 1,938 intake events in the LACs group during OIT. Of these, 90 were mild； no severe symptoms occurred.
[Conclusion] OIT with LACs potentially increases the OFC threshold and decreases allergy severity and is a relatively safe treatment modality.

2. Single-Center Noninferiority Randomized Trial on the Efficacy and Safety of Low- and High-Dose Rush Oral Milk Immunotherapy for Severe Milk Allergy

(Abstract)
[Introduction] Oral immunotherapy (OIT) has been reported to be effective but associated with a risk of severe symptoms. Thus, an OIT method with decreased risk is required.
[Purpose] We aimed to evaluate the efficacy and safety of low- and high-dose OIT regimens in children with severe milk allergy.
[Methods] Overall,33 participants (median age, 9 years； median final dose of the milk oral food challenge [OFC], 2 mL) were included. The participants were randomly assigned to groups that received either a low (20 mL; n =19) or high (100 mL； n =14) maintenance target dose of OIT. The close was gradually increased to the target dose in the rush escalation phase and was then maintained daily at home. The primary endpoint was the final OFC dose at 6 months of OIT. Adverse events during OIT were evaluated.
[Results] The final OFC dose after OIT was significantly higher than that before OIT in both groups (low-dose, p =0. 000； high-dose, p = 0. 006), but there was no significant difference in the final OFC dose between the 2 groups (p = 0.767). In the maintenance phase, the high-dose group had significantly more severe symptoms than did the low-dose group (0. 5%,11/2, 355 total intake events vs. 0.1%, 4/3, 230 total intake events； p=0.018).
[Conclusion] An equally increased dose effect was observed for maintenance OIT doses of 20 and 100 mL in children with severe milk allergy. The risk of severe symptoms in the maintenance phase was lower in the low-dose group. A low-dose OIT regimen is recommended for severe milk allergy.