Safety of Multifood Oral Immunotherapy in Children Aged 1 to 18 Years at an Academic Pediatric Clinic.

BACKGROUND: Oral immunotherapy (OIT) aims to increase the reaction threshold to a food allergen and decrease the risk of a potentially life-threatening allergic reaction in the event of an accidental ingestion. Whereas single-food OIT is the most extensively studied, data on multifood OIT are limited. OBJECTIVE: Our study aimed to examine the safety and feasibility of single-food and multifood immunotherapy in a large cohort in an outpatient pediatric allergy clinic setting. METHODS: A retrospective review of patients enrolled in single-food and multifood OIT between September 1, 2019, and September 30, 2020, and data collection of those patients until November 19, 2021, were performed. RESULTS: There were 151 patients who underwent either an initial dose escalation (IDE) or a standard oral food challenge. Seventy-eight patients were receiving single-food OIT with 67.9% reaching maintenance. Fifty patients were undergoing multifood OIT with 86% reaching maintenance to at least 1 OIT food and 68% reaching maintenance for all their foods. Of the 229 IDEs, there were low frequencies of failed IDEs (10.9%), epinephrine administration (8.7%), emergency department referrals (0.4%), and hospital admission (0.4%). Cashew accounted for one-third of failed IDEs. Epinephrine administration during home dosing occurred in 8.6% of patients. Eleven patients discontinued OIT owing to symptoms during up-dosing. No patients discontinued once reaching maintenance. CONCLUSIONS: Desensitization to 1 food or multiple foods simultaneously through OIT appears to be safe and feasible using the OIT protocol that has been established. The most common adverse reaction causing discontinuation of OIT was gastrointestinal symptoms.

Cognitive-behavioral intervention for anxiety associated with food allergy in a clinical sample of children: Feasibility, acceptability, and proof-of-concept in children.

BACKGROUND: Multiple reviews have identified a lack of evidence-based treatments for excessive anxiety in the context of food allergy (FAA) as an unmet need. OBJECTIVE: To evaluate the feasibility, acceptability, and proof of concept of Food Allergy Bravery (FAB), a brief, novel, manualized cognitive-behavioral-based intervention for anxiety in a clinical sample of children with FAA. METHODS: A total of 3 cohorts of children (aged 8 to 12 years) with clinically impairing FAA and their parents were offered a course of FAB delivered in a group format. Ratings of anxiety severity and quality of life were collected at pretreatment, posttreatment, and 2- to 4-month follow-up. RESULTS: All families offered treatment completed the full course of FAB, attended at least 5 of 6 active treatment sessions, and rated the intervention as highly satisfactory. All children were rated as very much improved or much improved on the Clinician Global Impression scale at posttreatment. Anxiety severity scores on the Scale of Food Allergy Anxiety and the Scale of Child Anxiety-Related Emotional Disorders significantly declined per both child and parent reports. Scores on the Food Allergy Quality of Life Questionnaire-Parent Form were significantly improved. Gains were maintained at follow-up. CONCLUSION: This is the first study of an outpatient manualized psychosocial treatment for FAA in a clinically ascertained sample of children. Findings provide initial evidence of feasibility, acceptability, and proof of concept for the FAB intervention protocol. Randomized controlled trials are needed.

Development of the Child- and Parent-Rated Scales of Food Allergy Anxiety (SOFAA).

BACKGROUND: Anxiety can be excessive and impairing in children with food allergy (FA). There is no accepted condition-specific measure of anxiety for this population. OBJECTIVE: To evaluate the validity and reliability of new child- and parent-rated measures of FA-related anxiety in youth. METHODS: Items for the Scale of Food Allergy Anxiety (SOFAA) were developed by a cognitive-behavioral therapist specializing in pediatric anxiety, in consultation with FA medical professionals and parents of children with FA. Dyads (n = 77) of children with FA (aged 8-18 years; 42.9% females) and their parents (95.5% females) completed full versions of the SOFAA (21 items; scored 0-4) via online survey. RESULTS: The child-rated SOFFA-C mean score was 29.1 ± 18.3; the parent-rated SOFAA-P mean score was 33.9 ± 16.1. Higher scores indicate higher reported anxiety. Coefficient alphas were 0.94 and 0.92. Factor analyses and item-response theory analyses supported the creation of the 14-item SOFAA-C-brief and the 7-item SOFAA-P-brief, accounting for 93% and 79% of total variance, respectively. Correlations revealed strong convergence between child- and parent-report for both the full (r = 0.85) and brief (r = 0.79) versions. Correlations with a generic measure of child anxiety (Screen for Child Anxiety Related Disorders) and the Food Allergy Quality of Life Questionnaire ranged from moderate to strong, whereas those with a generic measure of child eating problems (About Your Child's Eating) were weak to moderate, supporting convergent and divergent validity. Scores of 48 dyads who completed SOFAAs at time 2 (mean, 16.0 days) appeared stable over time, supporting test-retest reliability. CONCLUSIONS: The 21-item SOFAA-C and SOFAA-P are reliable and valid scales for measuring condition-specific anxiety in youth with FA. As shorter screening measures, the SOFAA-C-brief and the SOFAA-P-brief are also reliable and valid.

Efficacy of Epicutaneous Immunotherapy in Children With Milk-Induced Eosinophilic Esophagitis.

BACKGROUND & AIMS: Eosinophilic esophagitis (EoE) is caused by an immune response to specific food allergens. There are no approved therapies beyond avoidance of the allergen(s) or treatment of inflammation. Epicutaneous immunotherapy (EPIT) reduces features of eosinophilic gastrointestinal disease in mice and pigs. We performed randomized, placebo-controlled study to determine the safety and efficacy of EPIT with Viaskin milk in children with milk-induced EoE. METHODS: In a double-blind study, 20 children (4-17 years old) with milk-induced EoE were randomly assigned to groups given EPIT with Viaskin milk (n = 15) or placebo (n = 5) for 9 months during a milk-free period, followed by milk-containing diet for 2 months with EPIT. Then, subjects underwent upper endoscopy analysis, biopsies were collected, and maximum esophageal eosinophil counts were determined and was the primary endpoint. After upper endoscopy, patients were given open-label EPIT for 11 months (open-label phase). The subjects were allowed to consume milk if they had maximum values of fewer than 10 eosinophils/high-power field (eos/hpf); otherwise, they remained on a milk-free diet until the last 2 months of the open-label phase. RESULTS: In the intent to treat population, there was no significant difference between the Viaskin milk group in mean eos/hpf (50.1 ± 43.97 eos/hpf) vs the placebo group (48.20 ± 56.98 eos/hpf). However, in the per-protocol population (7 patients given Viaskin milk and 2 patients given placebo), patients given Viaskin milk patients had a significantly lower mean eos/hpf count (25.57 ± 31.19) than patients given placebo (95.00 ± 63.64) (p = .038). At the end of the open-label phase, 9 of 19 evaluable subjects had mean values of fewer than 15 eos/hpf (47% response). The number of adverse events did not differ significantly between the Viaskin milk and placebo groups; there was 1 serious adverse event in the placebo group. CONCLUSIONS: In a pilot study of pediatric patients with EoE given EPIT with Viaskin milk or placebo for 11 months, we found no significant difference between groups for the maximum eosinophil count at the end of the study. However, findings from a per-protocol analysis indicate that Viaskin milk can reduce eos/hpf. At study completion, 47% of patients who continued open-label Viaskin milk for an additional 11 months had mean values of fewer than 15 eos/hpf. ClinicalTrials.gov no: NCT02579876.