Mösges Ralph, Rohdenburg Christina, Eichel Andrea, Zadoyan Gregor, Kasche Elena-Manja, Shah-Hosseini Kija, Lehmacher Walter, Schmalz Petra, Compalati Enrico
Institute of Medical Statistics, Informatics and Epidemiology, Medical Faculty, University of Cologne, Cologne, Germany.
CRI - Clinical Research International Limited, Hamburg, Germany.
Immunotherapy. 2017 Nov;9(15):1225-1238. doi: 10.2217/imt-2017-0058.
To determine the optimal effective and safe dose of sublingual immunotherapy tablets containing carbamylated monomeric allergoids in patients with grass pollen-induced allergic rhinoconjunctivitis.
In this prospective, randomized, double-blind, active-controlled, multicenter, Phase II study, four different daily doses were applied preseasonally for 12 weeks.
Of 158 randomized adults, 155 subjects (safety population) received 300 units of allergy (UA)/day (n = 36), 600 UA/day (n = 43), 1000 UA/day (n = 39), or 2000 UA/day (n = 37). After treatment, 54.3, 47.6, 59.0 and 51.4% of patients, respectively, ceased to react to the highest allergen concentration in a conjunctival provocation test. Furthermore, the response threshold improved in 70.4, 62.9, 76.7 and 66.7% of patients, respectively. No serious adverse events occurred.
This study found 1000 UA/day to be the optimal effective and safe dose.
确定含氨甲酰化单体变应原制剂的舌下免疫治疗片治疗草花粉诱发的变应性鼻结膜炎患者的最佳有效安全剂量。
在这项前瞻性、随机、双盲、活性药物对照、多中心II期研究中，在花粉季节前应用四种不同的每日剂量，持续12周。
158例随机分组的成人中，155例受试者（安全人群）接受了每日300变应原单位（UA）（n = 36）、600 UA/日（n = 43）、1000 UA/日（n = 39）或2000 UA/日（n = 37）的治疗。治疗后，结膜激发试验中分别有54.3%、47.6%、59.0%和51.4%的患者对最高变应原浓度不再产生反应。此外，分别有70.4%、62.9%、76.7%和66.7%的患者反应阈值有所改善。未发生严重不良事件。
本研究发现每日1000 UA是最佳有效安全剂量。
