BackgroundAllergen immunotherapy (AIT) aims at modulating the immune response by administration of allergen preparations at regular intervals over several years (1). For subcutaneous AIT (SCIT), the treatment is initiated with a dose escalation phase followed by a maintenance dose administration. Over the last decade, there has been a trend towards shortening dose escalation regimens to increase patient adherence. This open‐label, phase II trial aimed to investigate the safety and tolerability of a house dust mites (HDMs) SCIT product when used in a newly designed one‐strength dose escalation scheme.MethodPatients, aged 12–65, suffering from HDM‐allergic rhinitis/rhinoconjunctivitis ± asthma were included. Patients were randomized to the one‐strength (6 injections from the highest strength 3) or the Standard dose escalation regimen (14 injections from strengths 1 to 3) using the HDMs‐SCIT product. All adverse events were reported. Tolerability was assessed on the Likert scale.ResultsOne hundred and forty‐three patients were randomized, 79 adults and 64 adolescents. In total, the one‐strength regimen caused more adverse drug reactions (ADRs) than the Standard regimen (p = .0457). With both regimens most ADRs were local reactions which occurred more often in the one‐strength group (p = .0393). But there was no significant difference in the number of patients affected by systemic or serious ADRs between both regimens. No relevant differences occurred between the two age groups and no other risks were observed for adolescents compared to adults.ConclusionThe safety and tolerability of both regimens can be considered comparable, as most ADRs were local reactions, primarily rated as mild in intensity. Nevertheless, the one‐strength regimen caused more ADRs. Reducing the number of injections from 14 to 6 while using only one strength offers the potential to improve patient adherence which further might increase clinical efficacy. Future trials could confirm this hypothesis.

中文翻译：

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用于皮下免疫治疗的屋尘螨储存产品的 One-strength 剂量递增是安全且可耐受的


背景过敏原免疫疗法 （AIT） 旨在通过在几年内定期施用过敏原制剂来调节免疫反应 （1）。对于皮下 AIT （SCIT），治疗从剂量递增阶段开始，然后是维持剂量给药。在过去十年中，出现了缩短剂量递增方案以提高患者依从性的趋势。这项开放标签的 II 期试验旨在研究屋尘螨 （HDM） SCIT 产品在新设计的单一强度剂量递增方案中使用时的安全性和耐受性。方法纳入 12-65 岁，患有 HDM 过敏性鼻炎/鼻结膜炎±哮喘的患者。使用 HDMs-SCIT 产品，患者被随机分配到单强度（最高强度 3 注射 6 次）或标准剂量递增方案（强度 1 至 3 注射 14 次）。报告了所有不良事件。根据李克特量表评估耐受性。结果随机纳入 143 例患者，其中 79 例成人和 64 例青少年。总的来说，单强度方案比标准方案引起更多的药物不良反应 （ADR） （p = .0457）。在这两种方案中，大多数 ADR 都是局部反应，在单强度组中更常见 （p = .0393）。但两种方案之间受全身性或严重 ADR 影响的患者数量没有显著差异。两个年龄组之间没有发生相关差异，与成人相比，青少年没有观察到其他风险。结论两种方案的安全性和耐受性可认为具有可比性，因为大多数 ADRs 是局部反应，主要被评为轻度。尽管如此，单一强度方案导致了更多的 ADRs。 将注射次数从 14 次减少到 6 次，同时仅使用一种强度，有可能提高患者的依从性，从而进一步提高临床疗效。未来的试验可以证实这一假设。