Evaluation of oral immunotherapy efficacy and safety by maintenance dose dependency: A multicenter randomized study

Autor: Norio Kawamoto, Naoyuki Kando, Kazuko Sugai, Masami Taniguchi, Komei Ito, Rumiko Shibata, Yoko Murakami, Masanori Ikeda, Osamu Uchida, Yasuto Kondo, Mitsuyoshi Urashima, Takanori Imai, Sakura Sato, Ikuya Tsuge, Kiyotake Ogura, Noriyuki Yanagida, Naomi Kondo, Takao Fujisawa, Atsuo Urisu, Motohiro Ebisawa, Mizuho Nagao
Rok vydání: 2020
Předmět:
lcsh:Immunologic diseases. Allergy
Pulmonary and Respiratory Medicine
medicine.medical_specialty
Food hypersensitivity
Dose-response relationship
medicine.medical_treatment
CM
cow’s milk
Immunology
sIgE
specific immunoglobulin E
Desensitization
Immunoglobulin E
Gastroenterology
Article
SU
sustained unresponsiveness
law.invention
03 medical and health sciences
0302 clinical medicine
Randomized controlled trial
Food allergy
law
Internal medicine
medicine
Immunology and Allergy
Ingestion
030223 otorhinolaryngology
StU
short-term unresponsiveness
Desensitization (medicine)
biology
Oral food challenge
business.industry
Maintenance dose
HE
hens’ egg
food and beverages
OIT
oral immunotherapy
SLIT
sublingual immunotherapy
medicine.disease
OFC
oral food challenge
sIgG4
specific immunoglobulin G4
sIgG
specific immunoglobulin G
Dose–response relationship
EPIT
epicutaneous immunotherapy
030228 respiratory system
FA
food allergy
biology.protein
Immunotherapy
lcsh:RC581-607
business
Zdroj: World Allergy Organization Journal, Vol 13, Iss 10, Pp 100463-(2020)
The World Allergy Organization Journal
ISSN: 1939-4551
DOI: 10.1016/j.waojou.2020.100463
Popis: Background: Generally, oral immunotherapy (OIT) aims for daily administration. Recently, the efficacy of treatment with OIT at a low dose has been reported. However, the optimal dose and the evaluation of dose-dependent OIT outcome have not been described. Methods: A multicenter, parallel, open-labeled, prospective, non-placebo controlled, randomized study enrolled 101 Japanese patients for treatment with OIT. We hypothesized that target dose OIT would induce short-term unresponsiveness (StU) earlier than reduced dose OIT. StU was defined as no response to 6200 mg whole egg, 3400 mg milk, and 2600 mg wheat protein, as evaluated by oral food challenge after 2-week ingestion cessation. To compare the two doses of OIT efficacy, the maximum ingestion doses during the maintenance phase of OIT were divided into 100%-dose or 25%-dose groups against their target StU dose, respectively. A total of 51 patients were assigned to the 100%-dose group [hen's egg (HE) = 26, cow's milk (CM) = 13, wheat = 12] and 50 to the 25%-dose group (HE = 25, CM = 13, wheat = 12). Primary outcome was established by comparing StU at 1 year. Secondary outcome was StU at 2 years and established by comparing allergic symptoms and immunological changes. Results: The year 1 StU rates (%) for the 100%- and 25%-dose groups were 26.9 vs. 20.0 (HE), 7.7 vs. 15.4 (CM), and 50.0 vs. 16.7 (wheat), respectively. The year 2 StU rates were 30.8 vs. 36.0 (HE), 7.7 vs. 23.1 (CM), and 58.3 vs. 58.3 (wheat), respectively. There were no statistically significant differences in StU between years 1 and 2. The total allergic symptom rate in the 25%-dose group was lower than that in the 100%-dose group for egg, milk, and wheat. Antigen-specific IgE levels for egg-white, milk, and wheat decreased at 12 months. Conclusions: Reduced maintenance dose of egg OIT showed similar therapeutic efficacy to the target dose. However, we were not able to clearly demonstrate the efficacy, particularly for milk and wheat. Reducing the maintenance dose for eggs, milk, and wheat may effectively lower the symptoms associated with their consumption compared to the target OIT dose. Furthermore, aggressive reduction of the maintenance dose might be important for milk and wheat, compared to the 25%-dose OIT. Trial registration: UMIN000009373, Multicenter Oral Immunotherapy for Hen's Egg, Cow's Milk, and Wheat-Allergic Children at Outpatient Clinic.
Databáze: OpenAIRE
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