Peanut oral immunotherapy using 30 mg and 300 mg maintenance doses

Julia E M Upton; Diana Toscano Rivero; Danbing Ke; Alireza Berenjy; Duncan Lejtenyi; Liane Beaudette; Xiaojun Yin; Carmen Hong Li; Lucy Y Duan; Casey Cohen; Vy Kim; Shireen Marzouk; Eyal Grunebaum; Christine T McCusker; Bruce Mazer; Thomas Eiwegger; Moshe Ben-Shoshan

doi:10.1016/j.jaip.2025.10.007

Peanut oral immunotherapy using 30 mg and 300 mg maintenance doses

Julia E M Upton, Diana Toscano Rivero, Danbing Ke, Alireza Berenjy, Duncan Lejtenyi, Liane Beaudette, Xiaojun Yin, Carmen Hong Li, Lucy Y Duan, Casey Cohen, Vy Kim, Shireen Marzouk, Eyal Grunebaum, Christine T McCusker, Bruce Mazer, Thomas Eiwegger, Moshe Ben-Shoshan

Research output: Journal article (peer-reviewed) › Journal article

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 In Group-30mg, 15/17 completed DBPCFC (2/17 withdrawn). In Group-300mg, 12/17 completed DBPCFC (5/17 withdrawn).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.

Original language	English
Journal	Journal of Allergy and Clinical Immunology: In Practice
DOIs	https://doi.org/10.1016/j.jaip.2025.10.007
Publication status	E-pub ahead of print - 16 Oct 2025

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10.1016/j.jaip.2025.10.007

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Upton, J. E. M., Rivero, D. T., Ke, D., Berenjy, A., Lejtenyi, D., Beaudette, L., Yin, X., Li, C. H., Duan, L. Y., Cohen, C., Kim, V., Marzouk, S., Grunebaum, E., McCusker, C. T., Mazer, B., Eiwegger, T., & Ben-Shoshan, M. (2025). Peanut oral immunotherapy using 30 mg and 300 mg maintenance doses. Journal of Allergy and Clinical Immunology: In Practice. Advance online publication. https://doi.org/10.1016/j.jaip.2025.10.007

@article{fd51582ad41b468f808cfd9f1184b08b,

title = "Peanut oral immunotherapy using 30 mg and 300 mg maintenance doses",

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 /=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.",

author = "Upton, \{Julia E M\} and Rivero, \{Diana Toscano\} and Danbing Ke and Alireza Berenjy and Duncan Lejtenyi and Liane Beaudette and Xiaojun Yin and Li, \{Carmen Hong\} and Duan, \{Lucy Y\} and Casey Cohen and Vy Kim and Shireen Marzouk and Eyal Grunebaum and McCusker, \{Christine T\} and Bruce Mazer and Thomas Eiwegger and Moshe Ben-Shoshan",

note = "Copyright {\textcopyright} 2025. Published by Elsevier Inc.",

year = "2025",

month = oct,

day = "16",

doi = "10.1016/j.jaip.2025.10.007",

language = "English",

journal = "Journal of Allergy and Clinical Immunology: In Practice",

issn = "2213-2198",

publisher = "American Academy of Allergy, Asthma and Immunology",

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TY - JOUR

T1 - Peanut oral immunotherapy using 30 mg and 300 mg maintenance doses

AU - Upton, Julia E M

AU - Rivero, Diana Toscano

AU - Ke, Danbing

AU - Berenjy, Alireza

AU - Lejtenyi, Duncan

AU - Beaudette, Liane

AU - Yin, Xiaojun

AU - Li, Carmen Hong

AU - Duan, Lucy Y

AU - Cohen, Casey

AU - Kim, Vy

AU - Marzouk, Shireen

AU - Grunebaum, Eyal

AU - McCusker, Christine T

AU - Mazer, Bruce

AU - Eiwegger, Thomas

AU - Ben-Shoshan, Moshe

PY - 2025/10/16

Y1 - 2025/10/16

N2 - 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 /=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.

AB - 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 /=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.

U2 - 10.1016/j.jaip.2025.10.007

DO - 10.1016/j.jaip.2025.10.007

M3 - Journal article

C2 - 41109568

SN - 2213-2198

JO - Journal of Allergy and Clinical Immunology: In Practice

JF - Journal of Allergy and Clinical Immunology: In Practice

ER -

Peanut oral immunotherapy using 30 mg and 300 mg maintenance doses

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