BackgroundAllergic rhinitis and/or conjunctivitis (AR/C) induced by tree pollen is common and negatively impacts quality of life in children and adolescents. This phase III trial investigated the efficacy and safety of the SQ tree SLIT‐tablet in a paediatric population (5–17 years) with moderate‐to‐severe AR/C induced by pollen from birch and trees in the birch homologous group.MethodsNine hundred and fifty‐two subjects were randomized (1:1) to daily treatment with SQ tree SLIT‐tablet or placebo for up to 52 weeks and had free access to AR/C symptom‐relieving medications. The primary endpoint was the average total combined score (TCS); sum of average daily symptom score (DSS) and average daily medication score (DMS) during the birch pollen season (BPS). Key secondary endpoints included average DSS and DMS during BPS and average TCS, DSS and DMS during tree pollen season (TPS).ResultsSQ tree SLIT‐tablet demonstrated a statistically significant and clinically relevant treatment effect compared with placebo for the TCS during BPS with an absolute treatment difference of 1.29 (95% CI: 0.58, 2.00; p = .0004) and a relative reduction of 21.9% (95% CI: 10.6, 31.9). Results were substantiated by reductions in both DSS and DMS versus placebo during the BPS and in DSS, DMS and TCS during the TPS. Treatment was generally well tolerated. Most treatment‐related adverse events were mild or moderate local administration site reactions.ConclusionThis is the first paediatric trial to provide robust evidence of efficacy and safety of the SQ tree SLIT‐tablet in tree pollen‐induced AR/C in a paediatric population (5–17 years).

中文翻译：

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SQ tree 舌下免疫治疗片剂在儿童中有效且耐受性良好——一项关键的 III 期试验


背景由树木花粉诱导的过敏性鼻炎和/或结膜炎 （AR/C） 很常见，会对儿童和青少年的生活质量产生负面影响。该 III 期试验调查了 SQ tree SLIT-片剂在桦树同源组中由桦树和树木花粉诱导的中度至重度 AR/C 的儿科人群（5-17 岁）的疗效和安全性。方法952 名受试者被随机分配 （1：1） 每天使用 SQ tree SLIT 片剂或安慰剂治疗长达 52 周，并且可以免费获得 AR/C 症状缓解药物。主要终点是平均总综合评分 （TCS）;桦树花粉季节 （BPS） 期间平均每日症状评分 （DSS） 和平均每日药物评分 （DMS） 的总和。关键次要终点包括 BPS 期间的平均 DSS 和 DMS 以及树木花粉季节 （TPS） 期间的平均 TCS 、 DSS 和 DMS。结果与安慰剂相比，SQ 树 SLIT 片剂在 BPS 期间对 TCS 的治疗效果具有统计学意义和临床相关性，绝对治疗差异为 1.29 （95% CI： 0.58， 2.00;p = .0004） 和相对降低 21.9% （95% CI： 10.6， 31.9）。BPS 期间 DSS 和 DMS 与安慰剂以及 TPS 期间 DSS 、 DMS 和 TCS 的减少证实了结果。治疗总体耐受性良好。大多数治疗相关不良事件是轻度或中度局部给药部位反应。结论这是第一项提供 SQ 树 SLIT 片剂在儿科人群（5-17 岁）树木花粉诱导的 AR/C 中的有效性和安全性的有力证据的儿科试验。