Improved Tolerability and Continued Immunomodulation Among Subjects Aged 4-17 Years Following 12 or 18 Months of Daily Therapeutic AR101 Dosing

Abstract

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.

Oral Immunotherapy in Children: Clinical Considerations and Practical Management

“… 16 Participants from PALISADE entered a follow-up study to assess the effects of AR101 dosing for an additional 12 or 18 months. 17 Participants displayed continued immunological changes, including decreases in peanut sIgE, suggesting progressive desensitization and immunomodulation driven by increased duration of allergen exposure. After 2 years, 80.8% of children who continued daily dosing were found to tolerate 2000 mg peanut protein during the end-of-study OFC – a drastic increase from the baseline mean tolerated dose.…”