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In the previously-reported Phase 3, double-blind, placebo-controlled EPITOPE study, 12 months of epicutaneous immunotherapy with a patch containing 250 µg peanut protein (VP250) resulted in a statistically significant treatment response vs placebo in 1-3-year-old peanut-allergic toddlers (n=362). Here we report interim analyses from the first year of the open-label extension study, EPOPEX.

Drug safety, quality, and efficacy may be affected by immunodominant allergen potency and contamination/impurity level in allergen immunotherapy. After completing phase 2 and phase 3 clinical trials, peanut (Arachis hypogaea) allergen powder-dnfp (PTAH) was approved by the US FDA and the EU European Commission for use in oral immunotherapy (OIT). Here we describe evaluation/standardization of the source material of peanut flour to the final drug product.

AbstractObjectives.To design a semi-quantitative food frequency questionnaire (FFQ) to estimate peanut consumption during pregnancy, and to determine reproducibility when this consumption was recalled after a 2-year period.Methods.An FFQ that lists commonly consumed peanut-containing products was developed. This was completed by a group of pregnant women, relating to their current diet (initial recall). Two years later the same women were asked to complete the same FFQ with reference to the period of their pregnancy (follow-up recall).Results.A total of 30 women completed both the initial and follow-up questionnaires. Follow-up recall was found to be an unbiased estimate of initial recall, with a correlation coefficient of 0.95. Confidence intervals were defined to allow prediction of the initial recall value from the follow-up recall value.Conclusion.Using our FFQ, retrospective recall of peanut consumption during pregnancy correlated well with data collected at the time. This FFQ will, when validated, provide a useful tool for investigating the role of maternal peanut consumption in later development of peanut allergy in children.