BackgroundSubcutaneous immunotherapy has emerged as an effective option for treating allergic diseases. Here, we assessed the clinical impact of the mannan‐conjugated birch pollen polymerized allergoid T502 in birch pollen‐induced allergic rhinoconjunctivitis.MethodsIn this prospective, randomized, double‐blind placebo‐controlled phase III trial, 298 birch pollen–allergic adult patients were treated across 28 trial sites in Germany. Patients received either placebo or 23,000 mTU T502 subcutaneously over five pre‐seasonal visits. Efficacy was assessed by comparing the combined symptom and medication score (CSMS) between placebo and T502 during the peak birch pollen season 2022. Safety, tolerability and immunologic effects were also analyzed.ResultsDuring the peak birch pollen season, the median CSMS of the T502 group was reduced by 33% (p = 0.002) compared to placebo. The median daily symptom score and daily medication score were reduced by 30.4% (p < 0.001) and 56.3% (p = 0.045), respectively. Health related quality of life improved as reflected by reduction of RQLQ values by 31.5% (p < 0.0001). Production of Bet v 1 sIgG4 and Bet v 1 sIgG increased up to 6.2‐fold and 3‐fold respectively in the T502 group (p < 0.0001). The sIgE/sIgG4 ratio was strongly reduced in the T502 group at V7 (−62.9%, p < 0.0001).No fatalities nor serious adverse events were reported. In total, 16 systemic allergic reactions occurred (Grade I/II).ConclusionsTreatment with T502 significantly reduced symptoms and medication need in rhinoconjunctivitis patients. The treatment is well tolerated and safe.

中文翻译：

---

桦树花粉过敏的短程皮下治疗大大改善了桦树过敏的症状和药物评分


背景皮下免疫疗法已成为治疗过敏性疾病的有效选择。在这里，我们评估了甘露聚糖共轭桦树花粉聚合过敏症 T502 对桦树花粉诱导的过敏性鼻结膜炎的临床影响。方法在这项前瞻性、随机、双盲安慰剂对照 III 期试验中，在德国的 28 个试验地点接受了 298 名白桦花粉过敏成年患者的治疗。患者在 5 次季前就诊中接受安慰剂或 23,000 mTU T502 皮下注射。通过在 2022 年桦树花粉高峰季节比较安慰剂和 T502 之间的综合症状和药物评分 （CSMS） 来评估疗效。还分析了安全性、耐受性和免疫学影响。结果在桦树花粉高峰季节，与安慰剂组相比，T502 组的中位 CSMS 降低了 33% （p = 0.002）。每日症状评分和每日用药评分的中位数分别降低了 30.4% （p < 0.001） 和 56.3% （p = 0.045）。RQLQ 值降低 31.5% 反映了与健康相关的生活质量的改善 （p < 0.0001）。在 T502 组中，Bet v 1 sIgG4 和 Bet v 1 sIgG 的产生分别增加了 6.2 倍和 3 倍 （p < 0.0001）。T502 组在 V7 时 sIgE/sIgG4 比值强烈降低 （-62.9%，p < 0.0001）。没有死亡或严重不良事件的报告。总共发生了 16 例全身过敏反应 （I/II 级）。结论T502 治疗可显著减轻鼻结膜炎患者的症状和药物需求。治疗耐受性良好且安全。