Increasing Clinical Peanut Thresholds Through Immunotherapy: Quantitative Assessment of the Safety Benefits Associated with Achieving a 300 or 1000 mg Peanut Protein Threshold.

Peanut immunotherapy studies aim to decrease the sensitivity of patients to peanut exposure. The clinical relevance of increasing individual’s threshold to 300 or 1000 mg peanut protein, potential endpoints of successful immunotherapy, is not well characterized. Our objective was to quantify the clinical benefit of an increased threshold for peanut-allergic patients. Quantitative risk assessment was performed by matching modeled exposure to peanut protein with individual threshold levels. Exposure was modeled by pairing U.S. consumption data for various food product categories with potential contamination levels of peanut that have been demonstrated to be present on occasion in such food products. Cookies, ice cream, doughnuts/snack cakes, and snack chip mixes were considered in the risk assessment. Peanut-allergic individuals with an initial threshold of 1, 3, or 10 mg peanut protein before immunotherapy that successfully increased their threshold dose to ≥300 mg peanut protein during treatment would decrease their risk of an allergic reaction 67- to 5089-fold for all of the diverse products examined that may contain peanut residue. For patients with a baseline threshold of 30, 100, or 300 mg of peanut protein that reach at least a 1000 mg peanut protein threshold post-immunotherapy, this range of risk reduction is 74- to 4750-fold. We conclude that achieving a threshold of 300 or 1000 mg of peanut protein by peanut immunotherapy is clinically relevant. Peanut allergic patients that have achieved this increased threshold benefit from a clinically meaningful reduction in the risk of an allergic reaction occurring upon exposure to trace peanut residue.