With peanut allergy therapies under development, peanutallergic children are completing clinical trials wishing to maintain desensitization. We describe our experience transitioning children to real food equivalents of peanut following trial completion. METHODS: Children who completed peanut clinical trials with interest in continuing (post-oral immunotherapy [OIT]) or starting (post-epicutaneous immunotherapy [EPIT]) daily peanut ingestion were offered an oral food challenge (OFC) for the starting dose, which was determined based on study dose/eliciting dose during exit OFC. Dose-escalation to 2000 mg peanut protein was offered. The charts of post-study participants transitioned to daily peanut ingestion from May 2016-May 2019 were reviewed. Families without recent follow-up were contacted by telephone. This study was IRB approved. RESULTS: Twenty children (80% male; median age 7.6 years, range 4-15 years; n55 post-EPIT, n515 post-OIT) were transitioned to daily peanut ingestion. The median starting dose was 300 mg (post-EPIT: 100 mg [range 30-300 mg]; post-OIT: 400 mg [range 30-2000 mg]). Four participants started at 2000 mg; 11/16 dose-escalated. Thirteen participants reached a daily dose >1000 mg. Median follow-up was 1.7 years. Seventeen participants (85%) continued dosing for at least one year or were confirmed to currently actively dose if transitioned in the past year. Two participants discontinued due to side effects (gastrointestinal, hives, wheezing); one was lost to follow-up. CONCLUSIONS: Most post-study children transitioned to daily peanut reached a maintenance dose of >1000 mg and continued dosing long-term with real food equivalents. This suggests that families are motivated to followthrough with daily peanut to maintain desensitization after study completion.
Food allergy quality of life questionnaires (FAQLQ) are the most common instruments used in food allergy research to assess health-related quality of life (HRQL). With the increase in food allergy treatment trials, it is important to determine which items within the FAQLQ are most and least useful in this context. We sought to assess which items of the FAQLQ-child form (CF) were most discriminative, using item response theory (IRT), which examines relations between item responses and underlying construct (in this case, HRQL). METHODS: PEPITES was a phase 3 randomised, placebo-controlled trial that studied the safety and efficacy of Viaskin Peanut 250 mg in children aged 4-11 years. Children who participated in PEPITES, aged ≥8 years, completed the FAQLQ-CF at baseline and at 12 months. FAQLQ-CF items were analysed using IRT, considering items' discrimination values, difficulty levels, and item information curve. RESULTS: 92 children (mean age 5 8.47 years, SD 1.7) completed the FAQLQ-CF. By IRT analysis, 14 of 30 total items contained in the FAQLQ presented very high discrimination levels (a > 1.7), with the highest levels relating to items that assessed 'fear'. All the items presented difficulty level within the recommended range (mean across b1-b6 < 2+1.5), being neither too easy, nor too difficult. CONCLUSIONS: We have identified 14 items contained within the FAQLQ-CF by IRT approach that best discriminate and assess HRQL in a treatment context. These findings may provide a novel and reliable framework for measurement of changes in HRQL in future food immunotherapy clinical trials.
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