Section of Allergy and Clinical Immunology, National Heart and Lung Institute, Imperial College and Royal Brompton Hospital, London, United Kingdom.
J Allergy Clin Immunol. 2012 Mar;129(3):717-725.e5. doi: 10.1016/j.jaci.2011.12.973. Epub 2012 Jan 29.
The main aim of specific immunotherapy is sustained effect due to changes in the immune system that can be demonstrated only in long-term trials.
To investigate sustained efficacy and disease modification in a 5-year double-blind, placebo-controlled trial, including 2 years of blinded follow-up after completion of a 3-year period of treatment, with the SQ-standardized grass allergy immunotherapy tablet, Grazax (Phleum pratense 75,000 SQ-T/2,800 BAU,(∗) ALK, Denmark) or placebo.
A randomized, double-blind, placebo-controlled, multinational, phase III trial included adults with a history of moderate-to-severe grass pollen-induced allergic rhinoconjunctivitis, with or without asthma, inadequately controlled by symptomatic medications. Two hundred thirty-eight participants completed the trial. End points included rhinoconjunctivitis symptom and medication scores, combined scores, asthma symptom and medication scores, quality of life, days with severe symptoms, immunologic end points, and safety parameters.
The mean rhinoconjunctivitis daily symptom score was reduced by 25% to 36% (P ≤ .004) in the grass allergy immunotherapy tablet group compared with the placebo group over the 5 grass pollen seasons covered by the trial. The rhinoconjunctivitis DMS was reduced by 20% to 45% (P ≤ .022 for seasons 1-4; P = .114 for season 5), and the weighted rhinoconjunctivitis combined score was reduced by 27% to 41% (P ≤ .003) in favor of active treatment. The percentage of days with severe symptoms during the peak grass pollen exposure was in all seasons lower in the active group than in the placebo group, with relative differences of 49% to 63% (P ≤ .0001). Efficacy was supported by long-lasting significant effects on the allergen-specific antibody response. No safety issues were identified.
The results confirm disease modification by SQ-standardized grass allergy immunotherapy tablet in addition to effective symptomatic treatment of allergic rhinoconjunctivitis.
特异性免疫治疗的主要目的是通过免疫系统的改变产生持续的效果，而这种改变只有在长期试验中才能得到证明。
在一项为期 5 年的双盲、安慰剂对照试验中，调查持续疗效和疾病改善情况，包括在完成 3 年治疗期后进行 2 年的盲法随访，使用 SQ 标准化草过敏免疫治疗片剂 Grazax（Phleum pratense 75,000 SQ-T/2,800 BAU，（∗）ALK，丹麦）或安慰剂。
一项随机、双盲、安慰剂对照、多中心、III 期试验纳入了有中重度草花粉引起的变应性鼻结膜炎病史、且经对症药物治疗控制不佳的成年人，包括有或无哮喘。238 名参与者完成了试验。终点包括鼻炎症状和药物评分、综合评分、哮喘症状和药物评分、生活质量、严重症状天数、免疫学终点和安全性参数。
在试验涵盖的 5 个花粉季节中，与安慰剂组相比，草过敏免疫治疗片剂组的鼻炎每日症状评分降低了 25%至 36%（P ≤.004）。鼻炎 DMS 降低了 20%至 45%（第 1-4 季 P ≤.022；第 5 季 P =.114），加权鼻炎综合评分降低了 27%至 41%（P ≤.003），有利于活性治疗。在所有季节中，活性组在花粉高峰期的严重症状天数百分比均低于安慰剂组，相对差异为 49%至 63%（P ≤.0001）。疗效得到了过敏原特异性抗体反应的持久显著影响的支持。未发现安全性问题。
结果证实了 SQ 标准化草过敏免疫治疗片剂除了有效治疗变应性鼻炎结膜炎外，还能改善疾病。
