Didier Alain, Campo Paloma, Moreno Francisco, Durand-Perdriel François, Marin Alicia, Chartier Antoine
Department of Respiratory Diseases, Larrey Hospital, Toulouse, France.
Int Arch Allergy Immunol. 2015;168(3):182-92. doi: 10.1159/000442467. Epub 2016 Jan 21.
House dust mite (HDM) immunotherapy has proven efficacy in treating allergic rhinitis (AR) symptoms. This trial evaluated the dose-response relationship of SLIToneULTRA® HDM mix based on immunological parameters and safety in subjects with moderate-to-severe HDM AR not controlled by symptomatic medication.
A randomized, parallel-group, open-label, clinical trial compared 50/150/300 standard reactivity unit (SRU) doses of SLIToneULTRA® HDM mix for 6 months. Subjects had moderate-to-severe HDM AR, positive skin prick and IgE against Dermatophagoides pteronyssinus/Dermatophagoides farinae (DP/DF). The primary end point was change from baseline in the IgE-blocking factor against DP after 6 months. Secondary end points measured changes in the IgE-blocking factor for DP at 3 months and for DF at 3 and 6 months, and in IgG4 and specific IgE to DP/DF after 3 and 6 months. Tolerability was assessed through the evaluation of all adverse events (AEs).
A total of 219 subjects were randomized and 196 completed the trial. Dose effect was significant on DP IgE-BF after 6 months (p = 0.018). The change in the DP IgE-blocking factor at a 300-SRU dose was higher than at other doses after 3 (p = 0.008) and 6 (p = 0005) months of treatment. Similar changes were observed for IgG4 and allergen-specific IgE. The number of AEs increased with the dose and were mild-to-moderate, with no severe treatment-related AEs reported. The most frequent AEs were oral/tongue pruritus, mouth oedema and abdominal upper pain.
Data showed a dose-response for immunological markers and safety with a better immunological response for 300 SRU. The highest dose (300 SRU daily) was considered as the optimal maintenance dose.
屋尘螨（HDM）免疫疗法已被证明对治疗过敏性鼻炎（AR）症状有效。本试验基于免疫参数和安全性，评估了SLIToneULTRA® HDM混合制剂在症状性药物治疗无法控制的中重度HDM AR患者中的剂量反应关系。
一项随机、平行组、开放标签的临床试验，比较了6个月内50/150/300标准反应单位（SRU）剂量的SLIToneULTRA® HDM混合制剂。受试者患有中重度HDM AR，对粉尘螨/户尘螨（DP/DF）皮肤点刺试验和IgE呈阳性。主要终点是6个月后针对DP的IgE阻断因子相对于基线的变化。次要终点测量了3个月时针对DP以及3个月和6个月时针对DF的IgE阻断因子的变化，以及3个月和6个月后针对DP/DF的IgG4和特异性IgE的变化。通过评估所有不良事件（AE）来评估耐受性。
共有219名受试者被随机分组，196名完成了试验。6个月后，剂量效应在DP IgE-BF上具有显著性（p = 0.018）。在治疗3个月（p = 0.008）和6个月（p = 0.005）后，300-SRU剂量组的DP IgE阻断因子变化高于其他剂量组。在IgG4和过敏原特异性IgE方面也观察到了类似变化。不良事件的数量随剂量增加，且为轻至中度，未报告严重的治疗相关不良事件。最常见的不良事件是口腔/舌部瘙痒、口腔水肿和上腹部疼痛。
数据显示免疫标志物和安全性存在剂量反应关系，300 SRU的免疫反应更佳。最高剂量（每日300 SRU）被认为是最佳维持剂量。
