Gappa Monika, Gagnon Rémi, Horak Fritz, Cichocka-Jarosz Ewa, Dalgaard Terrie, Hargreaves Kate, Mikler Jan, Emeryk Andrzej, Hansen Kirsten Skamstrup, Pfaar Oliver
Center for Paediatric and Adolescent Medicine, Evangelic Hospital Düsseldorf, Düsseldorf, Germany.
Clinique spécialisée en allergie de la capitale, Québec City, Québec, Canada.
Allergy. 2025 Mar;80(3):795-806. doi: 10.1111/all.16363. Epub 2024 Nov 4.
Allergic 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.
Nine 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).
SQ 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.
This 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).
由树花粉引起的变应性鼻炎和/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。这项III期试验研究了SQ树花粉舌下含片在患有由桦树花粉和桦树同源组中的树木花粉引起的中重度AR/C的儿科人群（5至17岁）中的疗效和安全性。
952名受试者被随机（1:1）分配，接受每日一次的SQ树花粉舌下含片或安慰剂治疗，为期52周，并可自由使用缓解AR/C症状的药物。主要终点是平均总综合评分（TCS）；桦树花粉季节（BPS）期间的平均每日症状评分（DSS）和平均每日药物评分（DMS）之和。关键次要终点包括BPS期间的平均DSS和DMS以及树花粉季节（TPS）期间的平均TCS、DSS和DMS。
与安慰剂相比，SQ树花粉舌下含片在BPS期间对TCS显示出具有统计学显著性和临床相关性的治疗效果，绝对治疗差异为1.29（95%CI：0.58，2.00；p = 0.0004），相对降低21.9%（95%CI：r0.6，31.9）。在BPS期间DSS和DMS与安慰剂相比均降低，以及在TPS期间DSS、DMS和TCS降低，均证实了该结果。治疗总体耐受性良好。大多数与治疗相关的不良事件为轻度或中度局部给药部位反应。
这是第一项在儿科人群（5至17岁）中提供有力证据证明SQ树花粉舌下含片在树花粉诱导的AR/C中疗效和安全性的儿科试验。
