دورية أكاديمية
A randomized, double-blind placebo-controlled study on the efficacy of Omalizumab on food allergy threshold in children with severe food allergy
| العنوان: | A randomized, double-blind placebo-controlled study on the efficacy of Omalizumab on food allergy threshold in children with severe food allergy |
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| المؤلفون: | Mortz, Charlotte G., Parke, Louise, Rasmussen, Helene M., Kjaer, Henrik Fomsgaard, Bindslev-Jensen, Carsten |
| المصدر: | Mortz , C G , Parke , L , Rasmussen , H M , Kjaer , H F & Bindslev-Jensen , C 2024 , ' A randomized, double-blind placebo-controlled study on the efficacy of Omalizumab on food allergy threshold in children with severe food allergy ' , Allergy: European Journal of Allergy and Clinical Immunology , vol. 79 , no. 4 , pp. 964-976 . https://doi.org/10.1111/all.16046Test |
| سنة النشر: | 2024 |
| المجموعة: | University of Southern Denmark: Research Output / Syddansk Universitet |
| مصطلحات موضوعية: | food allergy, Omalizumab, threshold value, treatment, Double-Blind Method, Humans, Asthma/drug therapy, Allergens/therapeutic use, Food Hypersensitivity/complications, Child, Omalizumab/therapeutic use, Food |
| الوصف: | Background: Food allergy is common in childhood with some children having a low threshold and being difficult to protect from accidental ingestion of the offending food. Therapies for this potentially life-threatening condition are highly needed. The aim of this study was to evaluate the efficacy of Omalizumab in food-allergic children. Methods: This is a single-center, double-blind, placebo-controlled study. Food allergic children with a cumulative threshold ≤443 mg food protein at DBPCFC were randomized to Omalizumab (asthma dose) or placebo (3:1). After 3 months, a second DBPCFC was performed (steps 3, 10, 30, 100, 300, 1000, and 3000 mg food protein), followed by a separate open challenge up to 10,000 and 30,000 mg food protein if negative. Responders were defined as ≥2-step increases in threshold. Non-responders received high-dose Omalizumab. A third DBPCFC was performed after 6 months. Skin testing, blood samples, and the severity of atopic co-morbidity were registered during the study and 3 months after treatment. Results: In total, 20 children were evaluated at 3 months (14 Omalizumab, 6 placebo). All treated with Omalizumab increased their threshold at least two steps and with a significant difference between the Omalizumab and the placebo group (p =.003), although the intended number of included children was not reached. The threshold before Omalizumab treatment was 13–443 mg food protein while the threshold after 3 months of treatment increased up to 44,000 mg (1143–44,000). In the placebo group, two children improved threshold during the study. Conclusion: An increase in the threshold level during Omalizumab treatment significantly improve patient safety and protected all children against small amount of allergen. |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| العلاقة: | https://portal.findresearcher.sdu.dk/da/publications/c05d27e7-afa8-441d-8737-5a309eb32556Test |
| DOI: | 10.1111/all.16046 |
| الإتاحة: | https://doi.org/10.1111/all.16046Test https://portal.findresearcher.sdu.dk/da/publications/c05d27e7-afa8-441d-8737-5a309eb32556Test https://findresearcher.sdu.dk/ws/files/257872280/Allergy_-_2024_-_Mortz_-_A_randomized_double_blind_placebo_controlled_study_on_the_efficacy_of_Omalizumab_on_food_allergy.pdfTest |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.9202EE7D |
| قاعدة البيانات: | BASE |
| DOI: | 10.1111/all.16046 |
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