Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus, Denmark.
Department of Radiology, Odense University Hospital, Odense, Denmark; Research and Innovation Unit of Radiology, University of Southern Denmark, Odense, Denmark.
J Allergy Clin Immunol. 2021 Mar;147(3):1011-1019. doi: 10.1016/j.jaci.2020.07.002. Epub 2020 Jul 15.
Allergic rhinoconjunctivitis is a global health problem. Different allergen immunotherapy regimes are marketed but have low adherence because they are expensive, complex, and time-consuming. New allergen immunotherapy forms are needed.
In a 3-year follow-up double-blind randomized placebo-controlled trial, we aimed to investigate the effect of intralymphatic allergen immunotherapy (ILIT).
Patients with grass pollen rhinoconjunctivitis were treated with 3 ILIT injections and an ILIT booster 1 year later, 3 ILIT injections and a placebo booster, or 3 placebo injections and a placebo booster. Primary outcome was improvement in a combined symptom and medication score (cSMS). A novel evaluation tool with a linear regression model of cSMS and grass pollen counts was developed. Secondary outcomes were changes in grass specific immunoglobulins and skin and nasal provocation tests to grass pollen.
A total of 36 patients were included. Log-transformed cSMS was reduced by 0.30 (95% CI, 0.11-0.49; P = .002), equaling 48.5% (95% CI, 24.5%-62%), in the entire 3-year follow-up period, significant only in the first follow-up season but not in the second and third seasons. The regression model showed a 37% (P < .001) reduction in cSMS. The booster injection 1 year later had no additional effect. Secondary, repeated measures of IgE and IgG to grass showed significant between-group difference and within-group change in the ILIT groups. No change in provocation test results was found.
ILIT gives a substantial reduction in grass pollen allergy symptoms and use of rescue medication, significant in the first season after treatment. A booster injection had no additional effect.
过敏性鼻结膜炎是一个全球性的健康问题。不同的过敏原免疫治疗方案已经上市，但由于其昂贵、复杂和耗时，患者的依从性较低。需要新的过敏原免疫治疗形式。
在一项为期 3 年的双盲随机安慰剂对照试验中，我们旨在研究皮内免疫治疗（ILIT）的效果。
患有草花粉性鼻结膜炎的患者接受 3 次 ILIT 注射和 1 年后的 ILIT 加强注射、3 次 ILIT 注射和安慰剂加强注射、或 3 次安慰剂注射和安慰剂加强注射。主要结局是综合症状和药物评分（cSMS）的改善。开发了一种新的评估工具，该工具采用 cSMS 和草花粉计数的线性回归模型。次要结局为草特异性免疫球蛋白以及皮肤和鼻草花粉激发试验的变化。
共纳入 36 例患者。经对数转换的 cSMS 降低了 0.30（95%CI，0.11-0.49；P=0.002），在整个 3 年随访期间相当于 48.5%（95%CI，24.5%-62%），仅在第一个随访季节有显著差异，而在第二个和第三个季节则没有。回归模型显示 cSMS 降低了 37%（P<0.001）。1 年后的加强注射没有额外效果。次要的、重复的草特异性 IgE 和 IgG 测量显示，在 ILIT 组中存在组间差异和组内变化。激发试验结果没有变化。
ILIT 可显著减轻草花粉过敏症状和缓解药物的使用，在治疗后的第一个季节效果显著。加强注射没有额外效果。
