Abstract
PURPOSE: To compare the efficacy and safety of two sesame protein maintenance doses (300 mg vs 1200 mg) in pediatric oral immunotherapy (OIT) for sesame allergy. PATIENTS AND METHODS: In this randomized, single-center, open-label trial (NCT05158413), 26 children aged 4-17 years with confirmed sesame allergy were allocated 1:1 to receive either 300 mg or 1200 mg sesame protein as maintenance therapy following dose escalation. Inclusion criteria included positive skin prick test (SPT) and/or elevated sesame-specific IgE (sIgE), as well as clinical reactivity during oral food challenge (OFC). The primary endpoint was the proportion of patients tolerating 4000 mg of sesame protein at the end-of-treatment OFC. Secondary outcomes included changes in immunologic markers (SPT wheal size, sIgE, IgG4) and safety. RESULTS: The rate of negative OFCs in our study (81.8% in the high-dose group and 69.2% in the low-dose group; p = 0.649) was comparable to outcomes reported in previous sesame OIT trials (19-22), indicating similar efficacy across different maintenance dose regimens. Both groups showed significant reductions in SPT wheal size and increases in sesame-specific IgG4 (p < 0.005), with no significant changes in sIgE levels. The rate of World Allergy Organization (WAO) grade I adverse events per dose was comparable between groups (4.74% vs 3.88%, p = 0.706), with three WAO grade II events (2 high-dose, 1 low dose) and no grade III or adrenaline-requiring reactions reported. CONCLUSION: This interim analysis, based on a limited sample size, suggests that both low- and high-dose sesame OIT regimens are consistent with being effective and well tolerated in children, with similar immunologic responses and a favorable safety profile. Given the pilot nature of the study, the results should be interpreted as preliminary and hypothesis-generating, warranting confirmation in larger, long-term trials to optimize sesame OIT dosing strategies.