Evidence regarding allergen immunotherapy (AIT) in pediatric population is scarce. We have assessed safety and effectiveness of subcutaneous AIT with a microcrystalline tyrosine (MCT)-associated mite allergoid, Acarovac Plus®, in children and adolescents with allergic rhinitis (AR), with and without asthma, in the real-world setting. This was a retrospective, multicenter study including children and adolescents aged 5 years to 17 years with AR, with and without asthma, and sensitized to mites, receiving AIT with Acarovac Plus® during ≥6 months. Primary and secondary objectives were safety and effectiveness, respectively. Effectiveness variables were assessed during 12 months before and after AIT and included unscheduled visits to the healthcare center and emergency room admissions, rhinitis and asthma symptoms according to ARIA and GEMA classifications, respectively, medication use, and patients' and physicians' disease perception graded on a visual analog scale (VAS). All 79 patients included had a mean (SD) age of 12.7 (3.3) years. Two patients experienced systemic adverse reactions (none severe). Unscheduled visits to the healthcare center and emergency room admissions decreased (mean (SD) 3.02 [2.48] and 0.63 [1.35] vs. 1.08 [1.38] and 0.09 [0.38], before and after treatment, p < 0.001 and p = 0.001, respectively). After AIT, rhinitis and asthma classification changed (p < 0.0001 for all classifications), showing improvements in symptoms and a significant decrease in rhinitis and use of medication for asthma and VAS scores grading patients' and physicians' disease perception (p < 0.001). In conclusion, these results show that AIT with an MCT-associated mite allergoid appears safe and effective in children and adolescents with AR treated in the real-world setting.

中文翻译：

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儿童和青少年过敏性鼻炎微晶酪氨酸相关螨类过敏的真实世界安全性和有效性证据。

关于儿科人群过敏原免疫治疗 (AIT) 的证据很少。我们已经评估了皮下 AIT 与微晶酪氨酸 (MCT) 相关螨类过敏原 Acarovac Plus® 在现实世界环境中对患有或不患有哮喘的过敏性鼻炎 (AR) 儿童和青少年的安全性和有效性。这是一项回顾性、多中心研究，包括 5 至 17 岁患有 AR、有或没有哮喘、对螨虫敏感的儿童和青少年，在≥6 个月内接受 AIT 和 Acarovac Plus®。主要和次要目标分别是安全性和有效性。在 AIT 之前和之后的 12 个月内评估了有效性变量，包括不定期访问医疗中心和急诊室入院，鼻炎和哮喘症状分别根据 ARIA 和 GEMA 分类，药物使用，以及患者和医生的疾病感知，按视觉模拟量表 (VAS) 分级。包括的所有 79 名患者的平均 (SD) 年龄为 12.7 (3.3) 岁。两名患者出现全身不良反应（均不严重）。不定期去医疗中心和急诊室就诊减少（平均 (SD) 3.02 [2.48] 和 0.63 [1.35] vs. 1.08 [1.38] 和 0.09 [0.38]，治疗前后，p < 0.001 和 p = 0.001，分别）。AIT 后，鼻炎和哮喘分类发生变化（所有分类的 p < 0.0001），显示症状改善，鼻炎和哮喘药物使用显着减少，VAS 评分对患者和医生的疾病感知进行分级（p < 0.001）。