Department of Otorhinolaryngology, Head and Neck Surgery, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.
Center for Rhinology and Allergology Wiesbaden, Wiesbaden, Germany.
Clin Exp Allergy. 2017 Nov;47(11):1445-1455. doi: 10.1111/cea.12977. Epub 2017 Oct 16.
Subcutaneous allergen immunotherapy with grass pollen allergoids has been proven to be effective and safe in the treatment of patients with allergic rhinoconjunctivitis. Based on the extensive cross-reactivity among Pooideae species, it has been suggested that grass pollen extracts could be prepared from a single species, rather than from a multiple species mixture.
To find the optimal dose of a Phleum pratense (P. pratense) allergoid preparation and compare its efficacy and safety to a 6-grass pollen allergoid preparation.
In this double-blind, placebo-controlled study (EudraCT: 2011-000674-58), three doses of P. pratense allergoid (1800 therapeutic units (TU), standard-dose 6000 TU and 18 000 TU) were compared with placebo and the marketed 6-grass pollen allergoid (6000 TU). In a pre-seasonal dosing regimen, 102 patients were randomized to five treatment groups and received nine subcutaneous injections. The primary efficacy endpoint was the change in weal size (late-phase reaction [LPR]) in response to the intracutaneous testing (ICT) before and after treatment, comparing the active allergoids to placebo. Secondary outcomes were the change in Total Nasal Symptom Score (TNSS) assessed in the allergen exposure chamber (AEC), the changes in P. pratense-serum-specific IgG and the incidence of adverse events (AEs).
All three doses of the P. pratense and the 6-grass pollen allergoid preparations were significantly superior to placebo for the primary outcome, whereas there were no significant differences in the change in TNSS. Compared to the standard-dose, the high-dose of P. pratense did not produce any additional significant benefit, but showed a slight increase in AEs. Yet this increase in AEs was lower than for the 6-grass pollen preparation.
CONCLUSIONS & CLINICAL RELEVANCE: The standard-dose of the new P. pratense allergoid was comparable to the marketed 6-grass pollen preparation at equal dose for the parameters measured.
草花粉变应原免疫治疗已被证明对过敏性鼻结膜炎患者有效且安全。基于 Pooideae 物种之间广泛的交叉反应，建议可以从单一物种而非多种物种混合物中制备草花粉提取物。
寻找 Phleum pratense (P. pratense) 变应原制剂的最佳剂量，并比较其疗效和安全性与 6 种花粉变应原制剂的疗效和安全性。
在这项双盲、安慰剂对照研究（EudraCT：2011-000674-58）中，将三种剂量的 P. pratense 变应原（1800 治疗单位（TU）、标准剂量 6000 TU 和 18000 TU）与安慰剂和市售的 6 种花粉变应原（6000 TU）进行比较。在季节性前给药方案中，102 名患者被随机分为五组，并接受九次皮下注射。主要疗效终点是治疗前后皮内试验（ICT）后风团大小（晚期反应[LPR]）的变化，将活性变应原与安慰剂进行比较。次要结局是在过敏原暴露室（AEC）中评估的总鼻部症状评分（TNSS）的变化、P. pratense 血清特异性 IgG 的变化以及不良事件（AE）的发生率。
P. pratense 的三种剂量和 6 种花粉变应原制剂均显著优于安慰剂，主要结局显著，而 TNSS 的变化无显著差异。与标准剂量相比，高剂量的 P. pratense 并没有产生任何额外的显著益处，但不良反应略有增加。然而，这种不良反应的增加低于 6 种花粉制剂。
新的 P. pratense 变应原标准剂量与市售的 6 种花粉制剂在同等剂量下，在测量的参数方面相当。
