International Archives of Allergy and Immunology

Clinical Allergy – Research Article

Single-Center Noninferiority Randomized Trial on the Efficacy and Safety of Low- and High-Dose Rush Oral Milk Immunotherapy for Severe Milk Allergy

Takaoka Y.a · Yajima Y.b · Ito Y.M.c · Kumon J.a · Muroya T.d · Tsurinaga Y.a · Shigekawa A.a · Takahashi S.e · Iba N.f · Tsuji T.g · Nishikido T.h · Yoshida Y.a · Doi S.i · Kameda M.a

Author affiliations

aDepartment of Pediatrics, Osaka Habikino Medical Center, Habikino, Japan
bDepartment of Pediatrics, Tannan Regional Medical Center, Sabae, Japan
cDepartment of Biostatics, Hokkaido University Hospital Clinical Research and Medical Innovation Center, Sapporo, Japan
dDepartment of Pediatrics, Suita Municipal Hospital, Suita, Japan
eDepartment of Pediatrics, Sumitomo Hospital, Osaka, Japan
fDepartment of Pediatrics, Arida Municipal Hospital, Arida, Japan
gDepartment of Pediatrics, Okinawa Chubu Hospital, Uruma, Japan
hDepartment of Respiratory and Allergy, Osaka Women’s and Children’s Hospital, Izumi, Japan
iFaculty of Education, Shitennoji University, Habikino, Japan

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Int Arch Allergy Immunol 2020;181:699–705

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Article / Publication Details

First-Page Preview
Abstract of Clinical Allergy – Research Article

Received: February 21, 2020
Accepted: May 13, 2020
Published online: June 22, 2020
Issue release date: September 2020

Number of Print Pages: 7
Number of Figures: 1
Number of Tables: 2

ISSN: 1018-2438 (Print)
eISSN: 1423-0097 (Online)

For additional information: https://www.karger.com/IAA

Abstract

Introduction: Oral immunotherapy (OIT) has been reported to be effective but associated with a risk of severe symptoms. Thus, an OIT method with decreased risk is required. Objectives: We aimed to evaluate the efficacy and safety of low- and high-dose OIT regimens in children with severe milk allergy. Methods: Overall, 33 participants (median age, 9 years; median final dose of the milk oral food challenge [OFC], 2 mL) were included. The participants were randomly assigned to groups that received either a low (20 mL; n = 19) or high (100 mL; n = 14) maintenance target dose of OIT. The dose was gradually increased to the target dose in the rush escalation phase and was then maintained daily at home. The primary endpoint was the final OFC dose at 6 months of OIT. Adverse events during OIT were evaluated. Results: The final OFC dose after OIT was significantly higher than that before OIT in both groups (low-dose, p = 0.000; high-dose, p = 0.006), but there was no significant difference in the final OFC dose between the 2 groups (p = 0.767). In the maintenance phase, the high-dose group had significantly more severe symptoms than did the low-dose group (0.5%, 11/2,355 total intake events vs. 0.1%, 4/3,230 total intake events; p = 0.018). Conclusions: An equally increased dose effect was observed for maintenance OIT doses of 20 and 100 mL in children with severe milk allergy. The risk of severe symptoms in the maintenance phase was lower in the low-dose group. A low-dose OIT regimen is recommended for severe milk allergy.

© 2020 S. Karger AG, Basel




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References

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Article / Publication Details

First-Page Preview
Abstract of Clinical Allergy – Research Article

Received: February 21, 2020
Accepted: May 13, 2020
Published online: June 22, 2020
Issue release date: September 2020

Number of Print Pages: 7
Number of Figures: 1
Number of Tables: 2

ISSN: 1018-2438 (Print)
eISSN: 1423-0097 (Online)

For additional information: https://www.karger.com/IAA


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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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