Intralymphatic immunotherapy improves grass pollen allergic rhinoconjunctivitis: A 3-year randomized placebo-controlled trial,Journal of Allergy and Clinical Immunology

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Intralymphatic immunotherapy improves grass pollen allergic rhinoconjunctivitis: A 3-year randomized placebo-controlled trial
Journal of Allergy and Clinical Immunology ( IF 11.4 ) Pub Date : 2020-07-15 , DOI: 10.1016/j.jaci.2020.07.002
Søren Helbo Skaarup ₁ , Johannes Martin Schmid ₁ , Tina Skjold ₁ , Ole Graumann ₂ , Hans Jürgen Hoffmann ₃

Affiliation

Background

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.

Objective

In a 3-year follow-up double-blind randomized placebo-controlled trial, we aimed to investigate the effect of intralymphatic allergen immunotherapy (ILIT).

Methods

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.

Results

A total of 36 patients were included. Log₁₀-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 IgG₄ to grass showed significant between-group difference and within-group change in the ILIT groups. No change in provocation test results was found.

Conclusions

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.

中文翻译：

淋巴内免疫疗法改善草花粉过敏性鼻结膜炎：一项为期 3 年的随机安慰剂对照试验

背景

过敏性鼻结膜炎是一个全球性的健康问题。市场上有不同的过敏原免疫治疗方案，但依从性低，因为它们昂贵、复杂且耗时。需要新的过敏原免疫疗法形式。

客观的

在一项为期 3 年的随访双盲随机安慰剂对照试验中，我们旨在研究淋巴管内过敏原免疫疗法 (ILIT) 的效果。

方法

草花粉鼻结膜炎患者在 1 年后接受 3 次 ILIT 注射和 ILIT 加强剂治疗，3 次 ILIT 注射和安慰剂加强剂，或 3 次安慰剂注射和安慰剂加强剂。主要结果是综合症状和药物评分 (cSMS) 的改善。开发了一种具有 cSMS 和草花粉计数线性回归模型的新型评估工具。次要结果是草特异性免疫球蛋白以及对草花粉的皮肤和鼻刺激试验的变化。

结果

共纳入 36 名患者。在整个 3 年随访期间，Log ₁₀转化的 cSMS 降低了 0.30（95% CI，0.11-0.49；P = .002），相当于 48.5%（95% CI，24.5%-62%），仅在第一个后续赛季中显着，而在第二个和第三个赛季中不显着。回归模型显示 cSMS 减少了 37% ( P < .001)。1年后的加强注射没有额外的效果。对草的 IgE 和 IgG _{4 的}二次重复测量显示 ILIT 组的组间差异和组内变化显着。没有发现激发试验结果的变化。