Available online 16 October 2025

Author links open overlay panelJulia E.M. Upton MD, MPH ∗, Diana Toscano Rivero MD, Danbing Ke PhD, Alireza Berenjy MD, Duncan Lejtenyi MSc, Liane Beaudette RN, Xiaojun Yin pHD, Carmen Hong Li MSc, Lucy Y. Duan MD, Casey Cohen pHD, Vy Kim MD MScCH, Shireen Marzouk MD, MSc, Eyal Grunebaum MD, Christine T. McCusker MD MSc, Bruce Mazer MD, Thomas Eiwegger MD ∗∗, Moshe Ben-Shoshan MD ∗∗Show moreHighlights box:•

What is already known about this topic?: Peanut OIT is effective to desensitize but requires significant medical resources and is often stopped for allergic reactions, poor progression, or distaste.

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What does this article add to our knowledge? Maintenance doses of only 1/8 peanut (30 mg peanut protein) provide large increases in desensitization and favorable immunological changes versus avoidance with improved safety versus 300 mg doses.

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How does this study impact current management guidelines: Maintenance doses can be much lower and still provide threshold increases. Low doses may help compliance and improve safety.

AbstractBackground

The lowest dose of peanut oral immunotherapy (P-OIT) has not been determined.

Objective

To evaluate if very low dose OIT (30mg) may safely and effectively increase tolerated doses and induce immunological changes.

Methods

Peanut-allergic children reactive to </=444mg peanut protein (PP) in double-blind placebo-controlled food challenges (DBPCFC) were prospectively enrolled and randomly assigned to 3 groups: two groups were double-blinded P-OIT groups escalating to 30mg (Group-30mg) or 300mg (Group-300mg) PP maintenance doses. A third group followed open-label avoidance (Group-Avoid). Cumulative tolerated doses of >/=443 and >/=1043mg PP were compared to Group-Avoid by DBPCFC planned at 1yr. Safety and laboratory parameters (sIgE, sIgG4) were assessed.

Results

We enrolled 51 children (26 (51%) male, median age 10yrs (IQR 7-13)), with initial cumulative-tolerated dose of 44mg (IQR 14-144). In Group-30mg, 15/17 completed DBPCFC (2/17 withdrawn). In Group-300mg, 12/17 completed DBPCFC (5/17 withdrawn). In Group-Avoid, 12/17 completed DBPCFC (5/17 lost to follow-up). By intention to treat, Group-30mg, 13/17 (p<<0.001 vs. Group-Avoid) tolerated >/=443 and 7/17 (p=0.007 vs. Group-Avoid) tolerated >/=1043mg PP. In the Group-300mg 10/17 (p=<0.001 vs. Group-Avoid) tolerated >/=443 and 8/17 (p=0.003 vs Group-Avoid) tolerated >/=1043mg PP. No Group-Avoid (0/17) tolerated >/=443 or >/=1043mg PP. Laboratory parameters (sIgE, sIgG4) were similar between Group-30mg and Group-300mg and significantly improved from Group-Avoid. Systemic adverse events were fewer in Group-30mg vs Group-300mg.

Conclusions

A 30mg maintenance dose for P-OIT significantly increases threshold over strict avoidance, clinically similarly to 300mg, and may allow for a simplified and safer OIT regimen and less treatment drop-outs. NCT03532360

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Funding. SickKids Food Allergy and Anaphylaxis Program, CIHR, Montreal Children’s Hospital Foundation, US peanut advisory board

COI

JU: Reports grants or contracts from DBV Technologies, Regeneron, Sanofi, ALK-Abelló, CIHR, SickKids Food Allergy and Anaphylaxis Program, and Innovation Fund Denmark; honoraria from Pear Healthcare, AstraZeneca, Viatris and Pfizer; participation on advisory board for Pfizer, Bausch Health, Pharming, and ALK-Abelló; has a leadership role in Food Allergy Canada, CSACI, Allergy (editorial board), Annals of Allergy, Asthma & Immunology (editorial board), and AACI (associate editor); and receipt of drug (omalizumab) from Novartis for research study, all outside the submitted work.

TE reports DBV Technologies; grants or contracts from ALK, Stallergenes Greer, and Novartis; consulting fees from ALK; honoraria from Aimmune Therapeutics, Thermo Fisher Scientific, Nutricia/Danone, ALK, Novartis, and MADx; payment for expert testimony from Aimmune Therapeutics; support for attending meetings from Sanofi; participation on a data safety monitoring board or advisory board from ALK, Aimmune Therapeutics, Stallergenes Greer, and Nutricia/Danone; leadership or fiduciary for EAACI; and receipt of equipment, materials, drugs, medical writing, gifts, or other services from MADX.

MBS Reports Grants from commercial organizations from ALK-Abello, consultant fees from Pfizer, ALK Abello, Bausch Health, Kaleo, Sanofi, Food Allergy Canada, all outside the submitted work.

All other authors have nothing to disclose.

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Co-first author

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co-last author

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© 2025 Published by Elsevier Inc. on behalf of the American Academy of Allergy, Asthma & Immunology