300 IR 屋尘螨舌下免疫治疗片剂对欧洲屋尘螨过敏性鼻炎患者的临床疗效：一项大型3期试验的事后分析
Clinical benefits with 300 IR HDM SLIT tablet in Europeans with house dust mite allergic rhinitis: Post hoc analysis of a large phase 3 trial.
作者信息
Pfaar Oliver, De Blay Frédéric, Canonica Giorgio Walter, Casale Thomas B, Gevaert Philippe, Hellings Peter W, Kowal Krzysztof, Passalacqua Giovanni, Tortajada-Girbés Miguel, Vidal Carmen, Worm Margitta, Bahbah Farah, Demoly Pascal
机构信息
Department of Otorhinolaryngology, Head and Neck Surgery, Section of Rhinology and Allergy, University Hospital Marburg, Philipps-Universität Marburg, D-35043 Marburg, Germany.
Chest Diseases Department, Federation of Translational Medicine EA 3072, Strasbourg University Hospital, 67000 Strasbourg, France.
出版信息
World Allergy Organ J. 2023 Dec 22;17(1):100849. doi: 10.1016/j.waojou.2023.100849. eCollection 2024 Jan.
BACKGROUND
House dust mite (HDM)-induced allergic rhinitis (AR) is a major cause of allergic respiratory disease. The efficacy and safety of the 300 IR HDM sublingual immunotherapy (SLIT) tablet in patients with moderate-to-severe HDM-AR was confirmed in a large, international, phase 3 randomized controlled trials (RCTs). Here, we analyzed the results in the European population.
METHODS
Data from 91 European centers that participated in the international, double-blind, RCT (EudraCT 2014-004223-46, NCT02443805) with the 300 IR HDM SLIT tablet versus placebo over 12 months were analyzed post hoc. The treatment effect in European adults and adolescents was notably assessed through the European Academy of Allergy and Clinical Immunology (EAACI)-recommended combined symptom and medication score (CSMS, pre-defined endpoint) and the total combined rhinitis score (TCRS, post hoc endpoint, also balanced) during the primary evaluation period (4 weeks at the end of treatment period) using analysis of covariance (ANCOVA).
RESULTS
There were 818 patients who comprised the modified full analysis set in Europe. Over the primary period, the differences in CSMS and TCRS between the 300 IR and placebo groups were statistically significant (p < 0.0001): -0.32 (95%CI [-0.46; -0.17]) and -1.28 (95%CI [-1.63; -0.94]), respectively, with relative differences of -20.9% and -21.2%. All post hoc and the rhinoconjunctivitis quality of life endpoints were significantly improved with 300 IR versus placebo. The 300 IR HDM tablet was generally well tolerated.
CONCLUSION
This RCT sub-analysis confirmed the 300 IR HDM SLIT tablet is an effective and safe treatment for European adults and adolescents with HDM-AR with clinically meaningful benefits from the patients' perspective.
TRIAL REGISTRATION
NCT02443805. Registered on April 29, 2015./EudraCT 2014-004223-46. Registered on September 16, 2015.
背景
屋尘螨（HDM）诱发的过敏性鼻炎（AR）是过敏性呼吸道疾病的主要病因。在一项大型国际3期随机对照试验（RCT）中证实了300 IR HDM舌下免疫治疗（SLIT）片剂治疗中重度HDM-AR患者的有效性和安全性。在此，我们分析了欧洲人群的结果。
方法
对参与国际双盲RCT（EudraCT 2014-004223-46，NCT02443805）的91个欧洲中心的数据进行事后分析，该试验比较了300 IR HDM SLIT片剂与安慰剂在12个月内的疗效。在主要评估期（治疗期结束时4周），通过欧洲变态反应和临床免疫学会（EAACI）推荐的综合症状和药物评分（CSMS，预定义终点）以及总鼻炎综合评分（TCRS，事后终点，也具有平衡性），使用协方差分析（ANCOVA）显著评估欧洲成人和青少年的治疗效果。
结果
欧洲有818例患者纳入改良全分析集。在主要评估期，300 IR组和安慰剂组之间CSMS和TCRS的差异具有统计学意义（p < 0.0001）：分别为-0.32（95%CI [-0.46；-0.17]）和-1.28（95%CI [-1.63；-0.94]），相对差异分别为-20.9%和-21.2%。与安慰剂相比，300 IR在所有事后分析以及鼻结膜炎生活质量终点方面均有显著改善。300 IR HDM片剂总体耐受性良好。
结论
这项RCT亚组分析证实，300 IR HDM SLIT片剂对欧洲患有HDM-AR的成人和青少年是一种有效且安全的治疗方法，从患者角度来看具有临床意义上的益处。
试验注册
NCT02443805。于2015年4月29日注册。/EudraCT 2014-004223-46。于2015年9月16日注册。
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