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作者

Lili Zhi, Yan Bai, Wang Liao, Guohua Chen, Tingting Gao, Xia Wan, Jiawen Liang, Lingling Liu, Liang Chen, Wenna Zhang, Jun Bai

作者单位

Affiliations ¹ Department of Allergy, The First Affiliated Hospital of Shandong First Medical University, Jinan, 250014, China. ² Department of Pediatrics, Union Hospital, Tongji Medical College of Huazhong University of Science & Technology, Wuhan, 430022, China. ³ Department of Pediatrics, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, Foshan, 528000, China.

刊名

Heliyon

年份

2024

卷号

Vol.10 No.8

页码

e29450

ISSN

2405-8440

关键词

Accelerated dose escalation Children House dust mites Safety Subcutaneous immunotherapy.

摘要

Background: Allergen immunotherapy is still the only treatment that may affect the natural cause of allergic disease. This study is to investigate whether an accelerated up-dosing scheme for subcutaneous allergen immunotherapy using a native house dust mite allergen extract is as safe as the standard 3-strengths dose-escalation scheme in children with moderate to severe allergic rhinitis or rhinoconjunctivitis with or without asthma in China. Methods: In this multicenter, open label, randomiz...更多

Background: Allergen immunotherapy is still the only treatment that may affect the natural cause of allergic disease. This study is to investigate whether an accelerated up-dosing scheme for subcutaneous allergen immunotherapy using a native house dust mite allergen extract is as safe as the standard 3-strengths dose-escalation scheme in children with moderate to severe allergic rhinitis or rhinoconjunctivitis with or without asthma in China. Methods: In this multicenter, open label, randomized controlled trial, the children aged 5-14 years were randomized 1:1 either to One Strength group or the Standard group. The dose escalation scheme for patients in the One Strength group included 6 injections of strength 3, whereas the Standard group comprised 14 injections using strength 1, 2, and 3. All treatment-emergent adverse events were recorded and analyzed. The 5-point Likert scale was used to assess tolerability . Results: Overall, 101 children were included in the Safety Set . A total of 26 TEAEs were reported for 15 children. TEAEs related to AIT occurred in 10 % of the children in the One Strength group and 11.8 % of the Standard group. The number of systemic adverse reactions was comparable in both groups . No serious TEAEs was recorded for either group. 90.0 % of patients in the One Strength group reached the maintenance dose without an interventional dose adjustment due to adverse events, compared to 78.4 % in the Standard group. All patients who completed the dose-escalation phase reached the recommended maintenance dose of 1.0 ml of strength 3.Investigators and patients rated the tolerability of the One Strength regimen slightly better than the Standard scheme. Conclusions: This exploratory study suggests that the accelerated One Strength dose-escalation scheme is comparable in safety and tolerability to the Standard regimen. However, due to the preliminary nature and small sample size, further research with larger sample sizes and robust study designs is necessary for confirmation.收起

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期刊