Peanut Oral Immunotherapy Using 30 and 300 mg Maintenance Doses.

Area of Science:

• Allergy and Immunology
• Pediatric Allergy
• Food Immunotherapy

Background:

• The optimal low-dose for peanut oral immunotherapy (P-OIT) remains undetermined.
• Investigating very low-dose P-OIT is crucial for developing safer and more accessible treatment protocols.

Purpose of the Study:

• To assess the safety and efficacy of a very low-dose (30 mg) P-OIT in increasing tolerated peanut protein (PP) doses.
• To evaluate the immunologic changes induced by very low-dose P-OIT.
• To compare the outcomes of 30 mg P-OIT with a 300 mg dose and a strict avoidance group.

Main Methods:

• A prospective, randomized, double-blind, placebo-controlled study involving peanut-allergic children.
• Participants were assigned to receive P-OIT with 30 mg or 300 mg maintenance doses, or open-label avoidance.
• Efficacy was measured by comparing cumulative tolerated doses of PP (≥443 mg and ≥1,043 mg) via double-blind placebo-controlled food challenges (DBPCFC) at one year. Safety and specific IgE/IgG4 levels were also assessed.

Main Results:

• In the 30 mg P-OIT group, 13/17 patients tolerated ≥443 mg PP and 7/17 tolerated ≥1,043 mg PP, significantly higher than the avoidance group (P < .001).
• The 30 mg group showed comparable efficacy to the 300 mg group in increasing tolerated PP doses, with significantly fewer systemic adverse events.
• Immunologic markers (specific IgE and IgG4) improved similarly in both P-OIT groups compared to the avoidance group.

Conclusions:

• A 30 mg maintenance dose of P-OIT is effective in significantly increasing the threshold for peanut protein tolerance compared to strict avoidance.
• This low-dose regimen appears clinically similar to a 300 mg dose, offering a potentially simplified and safer immunotherapy approach.
• The 30 mg dose may lead to fewer treatment dropouts and improved patient adherence due to its safety profile.