Aspire Allergy & Sinus, Austin, Texas.
Pharma Initiatives Consulting, Chapel Hill, North Carolina.
Ann Allergy Asthma Immunol. 2020 Sep;125(3):311-318.e2. doi: 10.1016/j.anai.2020.04.030. Epub 2020 May 11.
Allergen immunotherapy can provide long-term benefits, including symptomatic relief and reduced disease progression, but it requires a lengthy regimen that presents barriers to patient adherence. Thus, there is a need for improved approaches to immunotherapy. Recently, several clinical trials have reported successful results from intralymphatic immunotherapy.
To evaluate the efficacy, safety, and tolerability of intralymphatic immunotherapy for allergies caused by mountain cedar pollen in a proof-of-concept study.
A total of 21 patients with allergic rhinoconjunctivitis because of mountain cedar pollen were randomized to receive 3 monthly intralymphatic injections of allergenic extract or placebo before the 2018-2019 mountain cedar pollen season. Safety was monitored during treatment to the end of the pollen season using structured and spontaneous reports. Clinical efficacy information was collected using a daily electronic diary of symptoms and allergy medication. Allergen-specific serum immunoglobulin E was assessed before treatment and at the end of the study.
There were no serious adverse events or systemic reactions in either group. A total of 4 patients experienced mild injection-site reactions. Patients receiving intralymphatic immunotherapy experienced a significant improvement in allergy symptoms and medication use relative to patients receiving placebo (P < .001), and the active treatment group had lower average total combined scores on 20 of 27 days during the peak pollen season (P < .05). There was no significant difference among groups in changes to mean mountain cedar-specific serum immunoglobulin E levels.
In this proof-of-concept trial, intralymphatic immunotherapy was well tolerated and improved the symptoms and medication use associated with allergic rhinoconjunctivitis caused by mountain cedar pollen.
This study was registered at ClinicalTrials.gov under the registration number NCT03682965 before the enrollment of the first subject.
变应原免疫疗法可提供长期益处，包括症状缓解和减少疾病进展，但它需要一个漫长的疗程，这给患者的依从性带来了障碍。因此，需要改进免疫疗法。最近，几项临床试验报告了鼻内免疫疗法治疗成功的结果。
在一项概念验证研究中评估鼻内免疫疗法治疗雪松花粉引起的过敏的疗效、安全性和耐受性。
共有 21 例因雪松花粉引起的过敏性鼻结膜炎患者被随机分为两组，在 2018-2019 年雪松花粉季节前，分别接受 3 次每月的变应原提取物或安慰剂鼻内免疫治疗。在治疗期间和花粉季节结束时，通过结构化和自发报告监测安全性。使用症状和过敏药物的每日电子日记收集临床疗效信息。在治疗前和研究结束时评估过敏原特异性血清免疫球蛋白 E。
两组均无严重不良事件或全身反应。共有 4 例患者出现轻度注射部位反应。与接受安慰剂的患者相比，接受鼻内免疫治疗的患者过敏症状和药物使用明显改善（P <.001），在花粉高峰期的 27 天中有 20 天，活性治疗组的平均总综合评分较低（P <.05）。两组间平均雪松特异性血清免疫球蛋白 E 水平的变化无显著差异。
在这项概念验证试验中，鼻内免疫疗法耐受性良好，改善了雪松花粉引起的过敏性鼻结膜炎的症状和药物使用。
这项研究在纳入首例患者之前在 ClinicalTrials.gov 上注册，注册号为 NCT03682965。
