A 300 IR 5-grass pollen sublingual immunotherapy tablet-specific systematic review and meta-analysis confirms its clinical benefits for patients with allergic rhinoconjunctivitis with or without asthma

IF 3.9 2区医学 Q2 ALLERGY World Allergy Organization Journal Pub Date : 2024-10-24 DOI:10.1016/j.waojou.2024.100985

Danilo Di Bona MD, PhD , Giovanni Paoletti MD , Michal Ordak PhD , Silvano Dragonieri MD, PhD , Josiane Cognet-Sice PharmD , Silvia Scurati PhD , Giorgio Walter Canonica MD

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Abstract

Background

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.

Objective

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.

Methods

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

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; P < 0.05) and MS (SMD, −0.29; 95%CI, −0.40 to −0.19; P < 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.

Conclusion

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.

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一项针对 300 IR 5-禾本科花粉舌下免疫疗法片剂的系统综述和荟萃分析证实了该疗法对伴有或不伴有哮喘的过敏性鼻结膜炎患者的临床疗效

背景在过敏原免疫疗法（AIT）领域，不同产品的证据质量参差不齐，因此，正如 WAO 和 EAACI 所强调的那样，将总体结论推广到所有 AIT 产品是不合理的。目的通过对涉及过敏性鼻结膜炎（ARC）伴/不伴轻度/间歇性哮喘患者的随机对照试验（RCT）进行特定的荟萃分析，确认 300 IR 5-禾本科花粉舌下 AIT（SLIT）片剂的疗效。方法从电子数据库（MEDLINE、ISI Web of Science、LILACS、Cochrane 图书馆和 ClinicalTrial.gov）和截至 2023 年 11 月的人工搜索中收集已发表的有关 300 IR 5-grass SLIT 片剂的 RCT 数据。对人群、治疗方法和结果数据进行了合并。根据症状评分（SS）和用药评分（MS）评估疗效，以标准化均值差（SMD）或均值差（MD）衡量。结果5项RCT的结果显示，与安慰剂相比，1468名患者的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SMD为-0.36，相当于MD为-1.26 SS点，大于最小重要差异。分组分析显示，不同年龄、哮喘状况和研究地点（美国、加拿大、欧洲、俄罗斯）的疗效没有差异。结论这项针对特定产品的荟萃分析加强了与 300 IR 5-grass SLIT 片剂相关的临床疗效证据，表明该药物适合作为 ARC 患者的治疗选择，无论是否同时患有哮喘，并且具有良好的安全性。

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来源期刊

World Allergy Organization Journal Immunology and Microbiology-Immunology

CiteScore

9.10

自引率

5.90%

发文量

审稿时长

9 weeks

期刊介绍： The official pubication of the World Allergy Organization, the World Allergy Organization Journal (WAOjournal) publishes original mechanistic, translational, and clinical research on the topics of allergy, asthma, anaphylaxis, and clincial immunology, as well as reviews, guidelines, and position papers that contribute to the improvement of patient care. WAOjournal publishes research on the growth of allergy prevalence within the scope of single countries, country comparisons, and practical global issues and regulations, or threats to the allergy specialty. The Journal invites the submissions of all authors interested in publishing on current global problems in allergy, asthma, anaphylaxis, and immunology. Of particular interest are the immunological consequences of climate change and the subsequent systematic transformations in food habits and their consequences for the allergy/immunology discipline.