Real-world safety and effectiveness analysis of low-dose preschool sesame oral immunotherapy

BACKGROUND: Previous studies support the effectiveness of sesame oral immunotherapy (S-OIT) in patients >4 years old using maintenance doses of 1200 mg protein. However, tahini is often not palatable to children, and high-maintenance doses may not be possible for preschoolers. OBJECTIVE: We studied the safety and effectiveness outcomes of preschoolers with sesame allergy who underwent low-dose S-OIT of 200 mg protein. METHODS: Preschoolers with sesame allergy, with a history of objective reaction to sesame, and with either a positive skin prick test result (wheal diameter ≥3 mm) or sesame-specific IgE level ≥0.35 kU/L were included. Doses were escalated every 2 to 4 weeks until the maintenance dose of 200 mg of sesame protein was reached. The maintenance dose was continued daily for 1 year, followed by exit oral food challenge (OFC). Primary safety outcomes included allergic reactions grade 2 or higher and the need for epinephrine therapy during buildup. The primary effectiveness outcome was proportion of patients tolerating a minimum of 2000 mg sesame protein at exit OFC. RESULTS: Twenty-eight preschoolers (median age, 33.5 months) were enrolled to receive S-OIT. During the buildup phase, 9 subjects (32.1%) had no reaction, and 8 (28.6%) and 11 (39.3%) had grade 1 and 2 reactions, respectively. One patient (3.57%) received epinephrine for a grade 2 reaction. Twenty-one (91.3%) of 23 eligible subjects underwent exit OFC; 18 (85.7%) of these 21 patients successfully completed exit OFC. One (4.8%) and 2 (9.5%) subjects had grade 1 and 2 reactions, respectively, during OFC. CONCLUSIONS: A lower and age-appropriate maintenance dose is safe and effective in desensitizing preschoolers with sesame allergy.