Peanut oral immunotherapy using 30 mg and 300 mg maintenance doses

Julia E M Upton¹, Diana Toscano Rivero², Danbing Ke³, Alireza Berenjy⁴, Duncan Lejtenyi⁵, Liane Beaudette⁶, Xiaojun Yin⁷, Carmen Hong Li⁸, Lucy Y Duan⁹, Casey Cohen¹⁰, Vy Kim¹¹, Shireen Marzouk¹², Eyal Grunebaum¹³, Christine T McCusker¹⁴, Bruce Mazer¹⁵, Thomas Eiwegger¹⁶, Moshe Ben-Shoshan¹⁷

Affiliations

¹ The Hospital for Sick Children; Division of Immunology and Allergy, Department of Paediatrics, University of Toronto, Toronto, Canada, SickKids Research Institute, Toronto Ont Canada. Electronic address: Julia.upton@sickkids.ca.
² Division of Experimental Medicine, Department of Medicine, McGill University and the Research Institute of the McGill University Health Centre, Montreal, Canada. Electronic address: diana.toscanorivero@mail.mcgill.ca.
³ Division of Allergy and Immunology, Department of Pediatrics, Montreal Children's Hospital, Research Institute of the McGill University Health Centre, Montreal, Canada. Electronic address: Danbing.Ke@mail.mcgill.ca.
⁴ Translational Medicine Program, SickKids Research Institute, Division of Immunology & Allergy, The Hospital for Sick Children, Toronto Ontario Canada. Electronic address: alireza.berenjy@sickkids.ca.
⁵ Division of Allergy and Immunology, Department of Pediatrics, Montreal Children's Hospital, Montreal, Canada. Electronic address: duncan.lejtenyi@muhc.mcgill.ca.
⁶ Division of Allergy and Immunology, Department of Pediatrics, Montreal Children's Hospital, Montreal, Canada Liane. Electronic address: Beaudette@MUHC.MCGILL.CA.
⁷ Translational Medicine Program, SickKids Research Institute, The Hospital for Sick Children, Toronto ON Canada. Electronic address: xiaojun.yin@sickkids.ca.
⁸ Translational Medicine Program, SickKids Research Institute, The Hospital for Sick Children, Toronto, ON, Canada Institute of Medical Sciences, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada. Electronic address: carmen.li@sickkids.ca.
⁹ The Hospital for Sick Children, Division of Immunology and Allergy, Department of Paediatrics, Toronto Canada. Electronic address: lucy.duan@sickkids.ca.
¹⁰ Division of Experimental Medicine, Department of Medicine, McGill University and the Research Institute of the McGill University Health Centre Montreal Children's Hospital, Montreal Canada. Electronic address: casey.cohen2@mail.mcgill.ca.
¹¹ The Hospital for Sick Children; Division of Immunology and Allergy, Department of Paediatrics, Toronto, Canada. Electronic address: vy.kim@sickkids.ca.
¹² Department of Community Pediatrics, University of Toronto, NHLI, Imperial College of London, London, UK. Electronic address: smarzouk@mun.ca.
¹³ Division of Immunology and Allergy, The Hospital for Sick Children; Department of Paediatrics, Toronto, Canada. Electronic address: eyal.grunebaum@sickkids.ca.
¹⁴ Division of Experimental Medicine, Department of Medicine, The Department of Pediatrics, McGill University and the Research Institute of the McGill University Health Centre, Montreal Children's Hospital, Montreal Canada. Electronic address: christine.mccusker@mcgill.ca.
¹⁵ Division of Experimental Medicine, Department of Medicine, Department of Pediatrics, McGill University and the Research Institute of the McGill University Health Centre, Montreal Children's Hospital, Montreal Canada. Electronic address: bruce.mazer@mcgill.ca.
¹⁶ Department of Pediatric and Adolescent Medicine, University Hospital St. Pölten, St. Pölten, Austria; Translational Medicine Program, SickKids Research Institute, The Hospital for Sick Children, Toronto, Ont, Canada; Department of Immunology, Temerty Faculty of Medicine, University of Toronto, Toronto, Ont, Canada; Karl Landsteiner University of Health Sciences, Krems, Austria. Electronic address: thomas.eiwegger@sickkids.ca.
¹⁷ Division of Experimental Medicine, Department of Medicine, Division of Pediatric Allergy Clinical Immunology and Dermatology, Department of Pediatrics, Montreal Children's Hospital, McGill University and the Research Institute of the McGill University Health Centre. Electronic address: moshebenshoshan@gmail.com.

PMID: 41109568
DOI: 10.1016/j.jaip.2025.10.007

Free article

Peanut oral immunotherapy using 30 mg and 300 mg maintenance doses

Julia E M Upton et al. J Allergy Clin Immunol Pract. 2025.

Free article

. 2025 Oct 16:S2213-2198(25)00958-4.

doi: 10.1016/j.jaip.2025.10.007. Online ahead of print.

Authors

Affiliations

¹ The Hospital for Sick Children; Division of Immunology and Allergy, Department of Paediatrics, University of Toronto, Toronto, Canada, SickKids Research Institute, Toronto Ont Canada. Electronic address: Julia.upton@sickkids.ca.
² Division of Experimental Medicine, Department of Medicine, McGill University and the Research Institute of the McGill University Health Centre, Montreal, Canada. Electronic address: diana.toscanorivero@mail.mcgill.ca.
³ Division of Allergy and Immunology, Department of Pediatrics, Montreal Children's Hospital, Research Institute of the McGill University Health Centre, Montreal, Canada. Electronic address: Danbing.Ke@mail.mcgill.ca.
⁴ Translational Medicine Program, SickKids Research Institute, Division of Immunology & Allergy, The Hospital for Sick Children, Toronto Ontario Canada. Electronic address: alireza.berenjy@sickkids.ca.
⁵ Division of Allergy and Immunology, Department of Pediatrics, Montreal Children's Hospital, Montreal, Canada. Electronic address: duncan.lejtenyi@muhc.mcgill.ca.
⁶ Division of Allergy and Immunology, Department of Pediatrics, Montreal Children's Hospital, Montreal, Canada Liane. Electronic address: Beaudette@MUHC.MCGILL.CA.
⁷ Translational Medicine Program, SickKids Research Institute, The Hospital for Sick Children, Toronto ON Canada. Electronic address: xiaojun.yin@sickkids.ca.
⁸ Translational Medicine Program, SickKids Research Institute, The Hospital for Sick Children, Toronto, ON, Canada Institute of Medical Sciences, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada. Electronic address: carmen.li@sickkids.ca.
⁹ The Hospital for Sick Children, Division of Immunology and Allergy, Department of Paediatrics, Toronto Canada. Electronic address: lucy.duan@sickkids.ca.
¹⁰ Division of Experimental Medicine, Department of Medicine, McGill University and the Research Institute of the McGill University Health Centre Montreal Children's Hospital, Montreal Canada. Electronic address: casey.cohen2@mail.mcgill.ca.
¹¹ The Hospital for Sick Children; Division of Immunology and Allergy, Department of Paediatrics, Toronto, Canada. Electronic address: vy.kim@sickkids.ca.
¹² Department of Community Pediatrics, University of Toronto, NHLI, Imperial College of London, London, UK. Electronic address: smarzouk@mun.ca.
¹³ Division of Immunology and Allergy, The Hospital for Sick Children; Department of Paediatrics, Toronto, Canada. Electronic address: eyal.grunebaum@sickkids.ca.
¹⁴ Division of Experimental Medicine, Department of Medicine, The Department of Pediatrics, McGill University and the Research Institute of the McGill University Health Centre, Montreal Children's Hospital, Montreal Canada. Electronic address: christine.mccusker@mcgill.ca.
¹⁵ Division of Experimental Medicine, Department of Medicine, Department of Pediatrics, McGill University and the Research Institute of the McGill University Health Centre, Montreal Children's Hospital, Montreal Canada. Electronic address: bruce.mazer@mcgill.ca.
¹⁶ Department of Pediatric and Adolescent Medicine, University Hospital St. Pölten, St. Pölten, Austria; Translational Medicine Program, SickKids Research Institute, The Hospital for Sick Children, Toronto, Ont, Canada; Department of Immunology, Temerty Faculty of Medicine, University of Toronto, Toronto, Ont, Canada; Karl Landsteiner University of Health Sciences, Krems, Austria. Electronic address: thomas.eiwegger@sickkids.ca.
¹⁷ Division of Experimental Medicine, Department of Medicine, Division of Pediatric Allergy Clinical Immunology and Dermatology, Department of Pediatrics, Montreal Children's Hospital, McGill University and the Research Institute of the McGill University Health Centre. Electronic address: moshebenshoshan@gmail.com.

PMID: 41109568
DOI: 10.1016/j.jaip.2025.10.007

Abstract

Background: 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.

Keywords: low-dose; peanut allergy; peanut oral immunotherapy.

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Peanut oral immunotherapy using 30 mg and 300 mg maintenance doses

Affiliations

Peanut oral immunotherapy using 30 mg and 300 mg maintenance doses

Authors

Affiliations

Abstract

Associated data

LinkOut - more resources

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Medical

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