Sesame eliciting and safe doses in a large sesame allergic population

• Published in: Allergy (Copenhagen) 2023-12, Vol.78 (12), p.3212-3220
• Main Authors: Nachshon, Liat, Westerhout, Joost, Blom, W. Marty, Remington, Benjamin, Levy, Michael B., Goldberg, Michael R., Epstein‐Rigbi, Naama, Katz, Yitzhak, Elizur, Arnon
• Format: Article
• Language: English
• Subjects: adverse reactions; Allergens; eliciting dose; Food; Food allergies; Food Hypersensitivity - diagnosis; Food Hypersensitivity - epidemiology; Food Hypersensitivity - therapy; Food industry; Humans; Immunotherapy; Immunotherapy - adverse effects; Population studies; Pruritus; reaction threshold; safe dose; sesame allergy; Sesamum; Sesamum - adverse effects
• ISSN: 0105-4538; 1398-9995
• DOI: 10.1111/all.15863

Background Sesame is a significant food allergen causing severe and even fatal reactions. Given its increasing prevalence in western diet, sesame is listed as an allergenic food requiring labeling in the United States and EU. However, data on the population reaction doses to sesame are limited. Methods All sesame oral food challenges (OFCs), performed either for diagnosis or for threshold identification before the beginning of sesame oral immunotherapy (OIT) between November 2011 and July 2021 in Shamir medical center were analyzed for reaction threshold distribution. Safe‐dose challenges with 90–120 min intervals were also analyzed. Results Two hundred and fifty patients underwent 338 positive OFCs, and additional 158 safe‐dose OFCs were performed. The discrete and cumulative protein amounts estimated to elicit an objective reaction in 1% (ED01) of the entire cohort (n = 250) were 0.8 mg (range 0.3–6.3) and 0.7 mg (range 0.1–7.1), respectively, and those for 5% of the population (ED05) were 3.4 mg (range 1.2–20.6) and 4.5 mg (range 1.2–28.8), respectively. Safe‐dose OFCs showed similar values of ED01 (0.8, 0.4–7.5 mg) and ED05 (3.4, 1.2–22.9 mg). While doses of ≤1 mg sesame protein elicited oral pruritus in 11.6% of the patients, no objective reaction was documented to this amount in any of the challenges, including safe‐dose OFCs. Conclusions This study provides data on sesame reaction threshold distribution in the largest population of allergic patients studied, with no right or left censored data, and with validation using a safe‐dose OFC. It further supports the current methods for ED determination as appropriate for establishing safety precautions for the food industry. Two hundred and fifty patients underwent sesame OFCs (diagnostic, n = 127; pre‐OIT, n = 123). Safe‐dose (based on identified SHTD) challenges with 90–120 min intervals were analyzed in a subgroup of 158 patients. The discrete ED01 and ED05 of the entire cohort were 0.8 mg and 3.4 mg, respectively, and estimated values of discrete ED01 and ED05 from safe‐dose OFCs were similar. Importantly, no objective reaction was documented to a dose of ≤1 mg sesame protein.Abbreviations: ED01/05, eliciting dose in 1% and 5% of patients, respectively; OFC, oral food challenge; OIT, oral immunotherapy; SHTD, single highest tolerated dose; Min, minutes.