Di Bona Danilo, Paoletti Giovanni, Ordak Michal, Dragonieri Silvano, Cognet-Sice Josiane, Scurati Silvia, Canonica Giorgio Walter
Department of Medical and Surgical Sciences, University of Foggia, Italy.
Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy.
World Allergy Organ J. 2024 Oct 24;17(11):100985. doi: 10.1016/j.waojou.2024.100985. eCollection 2024 Nov.
In the realm of allergen immunotherapy (AIT), the quality of evidence varies across different products, making it unjustifiable to extend overall conclusions to all AIT products, as highlighted by WAO and EAACI.
To confirm the efficacy of the 300 IR 5-grass pollen sublingual AIT (SLIT)-tablet through a specific meta-analysis of randomized controlled trials (RCTs) involving patients with allergic rhino-conjunctivitis (ARC) with/without mild/intermittent asthma.
Data from published RCTs on the 300 IR 5-grass SLIT-tablet were gathered from electronic databases (MEDLINE, ISI Web of Science, LILACS, the Cochrane Library and ClinicalTrial.gov) and manual searches up to November 2023. Populations, treatments, and outcome data were combined. Efficacy was assessed based on symptom score (SS) and medication score (MS), measured as standardized mean difference (SMD) or mean difference (MD).
Results from 5 RCTs comprising 1468 patients revealed a significant reduction in SS (SMD, -0.36; 95%confidence interval [CI], -0.52 to -0.19; < 0.05) and MS (SMD, -0.29; 95%CI, -0.40 to -0.19; < 0.05) compared to placebo. The difference of -0.36 SMD for SS corresponds to a MD of -1.26 SS points, greater than the minimal important difference. Subgroup analysis did not show differences in efficacy according to age, asthma status, and geographic location of the study (USA, Canada, Europe, Russia). No safety issues were reported.
This product-specific meta-analysis reinforces the evidence of clinical benefits associated with the 300 IR 5-grass SLIT-tablet, suggesting its appropriateness as a therapeutic choice for patients with ARC, irrespective of concurrent asthma, and exhibiting a favorable safety profile.
在变应原免疫疗法(AIT)领域,不同产品的证据质量参差不齐,正如世界变态反应组织(WAO)和欧洲变态反应和临床免疫学会(EAACI)所强调的,将总体结论推广至所有AIT产品是不合理的。
通过对涉及伴有/不伴有轻度/间歇性哮喘的变应性鼻结膜炎(ARC)患者的随机对照试验(RCT)进行特定的荟萃分析,证实300 IR 5草花粉舌下AIT(SLIT)片剂的疗效。
从电子数据库(MEDLINE、ISI科学网、拉丁美洲和加勒比卫生科学数据库、考克兰图书馆和临床试验.gov)收集截至2023年11月已发表的关于300 IR 5草SLIT片剂的RCT数据,并进行手工检索。对人群、治疗方法和结局数据进行合并。基于症状评分(SS)和药物评分(MS)评估疗效,以标准化均数差(SMD)或均数差(MD)衡量。
5项RCT(共1468例患者)的结果显示,与安慰剂相比,SS(SMD,-0.36;95%置信区间[CI],-0.52至-0.19;P<0.05)和MS(SMD,-0.29;95%CI,-0.40至-0.19;P<0.05)显著降低。SS的-0.36 SMD差异相当于-1.26 SS分的MD,大于最小重要差异。亚组分析未显示根据年龄、哮喘状态和研究地理位置(美国、加拿大、欧洲、俄罗斯)的疗效差异。未报告安全问题。
这项针对特定产品的荟萃分析强化了与300 IR 5草SLIT片剂相关的临床益处的证据,表明其适合作为ARC患者的治疗选择,无论是否并发哮喘,且安全性良好。