Department of Medicine, Division of Allergy and Immunology, National Jewish Health Center, Denver, CO 80206, USA.
Curr Med Res Opin. 2012 Jun;28(6):1043-51. doi: 10.1185/03007995.2012.684676. Epub 2012 May 9.
Specific immunotherapy with the grass allergy immunotherapy tablet (AIT) has been developed as an effective, well tolerated, and convenient treatment for grass pollen induced seasonal allergic rhinoconjunctivitis (ARC). Six phase II/III randomized, placebo-controlled trials with the duration of a single grass pollen season of treatment using the SQ-standardized grass AIT, Grazax (Phleum pratense, 75,000 SQ-T/2,800 BAU, ALK, Denmark), have been published previously. This review compares results from these trials.
As outcome measures and methods of assessing them were similar across the trials, we have summarized the main efficacy findings (Total Combined Score [TCS], average daily rhinoconjunctivitis symptom and medication scores, percentage of well days, quality of life scores) during a single season of treatment with grass AIT in adults and children with seasonal ARC.
The results of the European and North American trials were similar. Compared with the placebo group, who received symptomatic medications only, treatment with grass AIT resulted in fewer rhinoconjunctivitis symptoms, a lower intake of symptomatic medication, better patient self-rated quality of life and a greater percentage of well days during the entire grass pollen season. The data indicate that grass AIT treatment is equally effective in adults and children; the measured effect varies with pollen exposure, but is comparable across regions and continents, with a consistent difference compared with placebo in TCS that was above 20% for all trials. Local adverse events were experienced by the majority of patients. These reactions were generally mild to moderate in severity and transient in duration. Systemic adverse events were rare.
This review confirms SQ-standardized grass AIT as a suitable therapeutic option for seasonal use in patients aged 5 years or older with grass pollen induced ARC.
针对草花粉引起的季节性变应性鼻结膜炎(ARC),开发了特异性免疫疗法,即采用草过敏免疫治疗片剂(AIT)进行治疗,这种治疗方法具有疗效确切、耐受性良好且方便的特点。先前已经发表了六次 II/III 期随机、安慰剂对照试验,采用 SQ 标准化草 AIT(Phleum pratense,75000 SQ-T/2800 BAU,ALK,丹麦),治疗时间为一个单一的花粉季节。本综述比较了这些试验的结果。
由于各试验的结局测量和评估方法相似,我们总结了在单一花粉季节中,成人和儿童季节性 ARC 患者接受草 AIT 治疗的主要疗效发现(总联合评分[TCS]、平均每日鼻结膜炎症状和药物评分、缓解天数百分比、生活质量评分)。
欧洲和北美的试验结果相似。与仅接受对症药物治疗的安慰剂组相比,接受草 AIT 治疗的患者鼻结膜炎症状更少,需要使用对症药物的次数更少,患者自我报告的生活质量更好,整个花粉季节的缓解天数更多。数据表明,草 AIT 治疗在成人和儿童中同样有效;测量的效果因花粉暴露而异,但在不同地区和大洲之间具有可比性,与安慰剂相比,TCS 的差异始终保持在 20%以上,所有试验均如此。大多数患者都经历了局部不良反应。这些反应通常为轻度至中度,持续时间短暂。全身性不良反应罕见。
本综述证实 SQ 标准化草 AIT 是一种适合 5 岁及以上因草花粉引起的 ARC 患者季节性使用的治疗选择。