摘要
背景：在儿童哮喘中，屋尘螨（HDM）致敏是发生过敏性哮喘的重要促成因素。HDM过敏原免疫治疗已在成人过敏性哮喘中证实具有疗效与安全性，但其在儿童哮喘中的证据仍相对有限。本研究（MT-11）旨在评估SQ-HDM（ Standardized Quality-HDM）舌下免疫治疗（SLIT）片剂在5–17岁HDM过敏性哮喘儿童中的疗效与安全性。
方法：本研究为III期、随机、双盲、安慰剂对照试验，共纳入了533名既往近期有哮喘急性加重史、尽管接受吸入性糖皮质激素（ICS）和/或长效 β₂ 受体激动剂（LABA）治疗仍控制不充分的患儿，按 1:1 随机分配为每日接受 SQ-HDM SLIT 片剂或安慰剂，治疗持续24–30个月。主要终点为“临床相关哮喘急性加重”年化发生率并持续记录整个研究期间不良事件（AEs）。
结果：临床相关哮喘急性加重年化发生率的率比为 0.89（95% 置信区间：0.60–1.31），结果倾向于 SQ-HDM SLIT 片剂组，但未能证实其相较安慰剂的优效性。多数治疗相关不良事件（TRAEs）为轻度或中度，少数受试者（＜2%）因TRAEs停药终止。最常见的TRAEs为给药部位局部反应，如口腔瘙痒、咽喉刺激、耳部瘙痒和上腹痛。研究未发现SLIT组哮喘相关事件增加，也未报告过敏性休克或肾上腺素使用。
结论：受新冠肺炎（COVID-19）疫情的影响，哮喘急性加重发生率显著低于预期，可能是主要终点未达成的重要原因。控制不充分的儿童 HDM 过敏性哮喘人群中，SQ-HDM SLIT 片剂总体耐受性良好。
关键词：过敏原免疫治疗；过敏性哮喘；儿童；屋尘螨；舌下免疫治疗。
Abstract
Background: In children, house dust mite (HDM) sensitisation is a contributing factor for developing allergic asthma. HDM allergen immunotherapy has demonstrated efficacy and safety in adults with allergic asthma; however, evidence for its use in children is limited. MT-11 evaluated the efficacy and safety of the SQ HDM sublingual immunotherapy (SLIT) tablet in children (5-17 years) with HDM allergic asthma.
Methods: This phase III, randomised, double-blind, placebo-controlled trial randomised 533 children with a recent history of asthma exacerbations, despite treatment with inhaled corticosteroids and/or long-acting beta-agonists, to daily treatment with SQ HDM SLIT-tablet or placebo for 24-30 months. The primary endpoint was the annualised rate of clinically relevant asthma exacerbations. Adverse events (AEs) were reported throughout the trial.
Results: The rate ratio for the annualised rate of clinically relevant asthma exacerbations was 0.89 (95% CI: 0.60, 1.31), in favour of the SQ HDM-SLIT tablet; superiority over placebo was not established. Most treatment-related AEs (TRAEs) were of mild or moderate severity, and few subjects discontinued due to TRAEs (< 2%). The most common TRAEs were local application site reactions (oral pruritus, throat irritation, ear pruritus, and upper abdominal pain). There was no increased incidence of asthma-related events, and no anaphylaxis or adrenaline use in the SQ HDM SLIT-tablet group.
Conclusion: As a result of the coronavirus disease 2019 pandemic, asthma exacerbation rates were much lower than expected, contributing to the primary endpoint not being met. The SQ HDM SLIT-tablet was well tolerated in a paediatric population with inadequately controlled HDM allergic asthma.
Keywords: allergen immunotherapy; allergic asthma; children; house dust mite; sublingual immunotherapy.
背景：在儿童哮喘中，屋尘螨（HDM）致敏是发生过敏性哮喘的重要促成因素。HDM过敏原免疫治疗已在成人过敏性哮喘中证实具有疗效与安全性，但其在儿童哮喘中的证据仍相对有限。本研究（MT-11）旨在评估SQ-HDM（ Standardized Quality-HDM）舌下免疫治疗（SLIT）片剂在5–17岁HDM过敏性哮喘儿童中的疗效与安全性。
方法：本研究为III期、随机、双盲、安慰剂对照试验，共纳入了533名既往近期有哮喘急性加重史、尽管接受吸入性糖皮质激素（ICS）和/或长效 β₂ 受体激动剂（LABA）治疗仍控制不充分的患儿，按 1:1 随机分配为每日接受 SQ-HDM SLIT 片剂或安慰剂，治疗持续24–30个月。主要终点为“临床相关哮喘急性加重”年化发生率并持续记录整个研究期间不良事件（AEs）。
结果：临床相关哮喘急性加重年化发生率的率比为 0.89（95% 置信区间：0.60–1.31），结果倾向于 SQ-HDM SLIT 片剂组，但未能证实其相较安慰剂的优效性。多数治疗相关不良事件（TRAEs）为轻度或中度，少数受试者（＜2%）因TRAEs停药终止。最常见的TRAEs为给药部位局部反应，如口腔瘙痒、咽喉刺激、耳部瘙痒和上腹痛。研究未发现SLIT组哮喘相关事件增加，也未报告过敏性休克或肾上腺素使用。
结论：受新冠肺炎（COVID-19）疫情的影响，哮喘急性加重发生率显著低于预期，可能是主要终点未达成的重要原因。控制不充分的儿童 HDM 过敏性哮喘人群中，SQ-HDM SLIT 片剂总体耐受性良好。
关键词：过敏原免疫治疗；过敏性哮喘；儿童；屋尘螨；舌下免疫治疗。
（南方医科大学南方医院 凌嘉骏 樊可可 赵海金）
（Roberts G, Just J, et al. SQ House Dust Mite Sublingual Immunotherapy Tablet in Children With Allergic Asthma: A Randomised Phase III Trial. Allergy. 2025 Dec;80(12):3401-3411. doi: 10.1111/all.70073. Epub 2025 Oct 9. PMID: 41064908; PMCID: PMC12666737.）
（Roberts G, Just J, et al. SQ House Dust Mite Sublingual Immunotherapy Tablet in Children With Allergic Asthma: A Randomised Phase III Trial. Allergy. 2025 Dec;80(12):3401-3411. doi: 10.1111/all.70073. Epub 2025 Oct 9. PMID: 41064908; PMCID: PMC12666737.）
Abstract
Background: In children, house dust mite (HDM) sensitisation is a contributing factor for developing allergic asthma. HDM allergen immunotherapy has demonstrated efficacy and safety in adults with allergic asthma; however, evidence for its use in children is limited. MT-11 evaluated the efficacy and safety of the SQ HDM sublingual immunotherapy (SLIT) tablet in children (5-17 years) with HDM allergic asthma.
Methods: This phase III, randomised, double-blind, placebo-controlled trial randomised 533 children with a recent history of asthma exacerbations, despite treatment with inhaled corticosteroids and/or long-acting beta-agonists, to daily treatment with SQ HDM SLIT-tablet or placebo for 24-30 months. The primary endpoint was the annualised rate of clinically relevant asthma exacerbations. Adverse events (AEs) were reported throughout the trial.
Results: The rate ratio for the annualised rate of clinically relevant asthma exacerbations was 0.89 (95% CI: 0.60, 1.31), in favour of the SQ HDM-SLIT tablet; superiority over placebo was not established. Most treatment-related AEs (TRAEs) were of mild or moderate severity, and few subjects discontinued due to TRAEs (< 2%). The most common TRAEs were local application site reactions (oral pruritus, throat irritation, ear pruritus, and upper abdominal pain). There was no increased incidence of asthma-related events, and no anaphylaxis or adrenaline use in the SQ HDM SLIT-tablet group.
Conclusion: As a result of the coronavirus disease 2019 pandemic, asthma exacerbation rates were much lower than expected, contributing to the primary endpoint not being met. The SQ HDM SLIT-tablet was well tolerated in a paediatric population with inadequately controlled HDM allergic asthma.
Keywords: allergen immunotherapy; allergic asthma; children; house dust mite; sublingual immunotherapy.
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