300IR 屋尘螨舌下含片的安全性，来自临床试验和上市后的汇总数据

IF 4.3 3区材料科学 Q1 ENGINEERING, ELECTRICAL & ELECTRONIC ACS Applied Electronic Materials Pub Date : 2024-07-01 DOI:10.1016/j.waojou.2024.100924

Margitta Worm MD , Pascal Demoly MD, PhD , Yoshitaka Okamoto MD, PhD , Carmen Vidal MD, PhD , Katia Daghildjian PharmD, PhD , Kwok Yan MD , Thomas B. Casale MD , Karl-Christian Bergmann MD, PhD

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引用次数: 0

摘要

背景300IR屋尘螨（HDM）舌下免疫疗法（SLIT）片剂被批准用于治疗HDM诱发的过敏性鼻炎（AR）。根据随机对照试验（RCT）的汇总数据和上市后（PM）的药物警戒数据，对 300IR HDM-SLIT 片剂的安全性进行全面回顾。方法在 8 项随机对照试验中，用 300IR 或安慰剂对确诊为 HDM-AR 并伴有或不伴有哮喘的受试者（5-65 岁）进行治疗。汇总并描述性分析了成人/青少年和儿童子集中报告的治疗突发不良事件（TEAEs）。此外，还分析了自首次获得上市许可以来通过药物警戒系统从自发报告和 PM 研究中收集的不良反应 (ADR)。在成人/青少年和儿童（以哮喘状况为准）这两个子群体中，与治疗相关的 TEAEs 在活性组和安慰剂组中的发生率较高，大多为轻度或中度局部用药部位反应。这些反应主要发生在治疗的最初几天，随后逐渐减少。4例严重的喉咽反应（2例需要肾上腺素/肾上腺素）和1例中度湿疹被认为是严重的，用药后迅速缓解；没有过敏性休克的报告。在 PM 环境中，235,000 多名患者报告的 ADR 与 RCT 研究结果一致。严重的全身反应很少发生；12 例过敏性反应安全缓解（5 例使用肾上腺素）。临床试验注册NCT00674700；2008 年 5 月 6 日回顾性注册。NCT01199133；追溯注册2010年9月09日.NCT01527188；追溯注册2012年2月01日.NCT02443805；注册2015年4月29日/EudraCT 2014-004223-46；注册2015年9月16日.jRCT2080221872/JapicCTI-121917；注册2012年8月01日.jRCT2080222929/JapicCTI-15298；注册2015年8月04日。

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Safety of 300IR house dust mite sublingual tablet from pooled clinical trial and post-marketing data

Background

The 300IR house dust mite (HDM) sublingual immunotherapy (SLIT) tablet is approved for treatment of HDM-induced allergic rhinitis (AR). To provide a comprehensive review of the 300IR HDM-SLIT tablet safety profile based on randomized controlled trial (RCT) pooled data and post-marketing (PM) pharmacovigilance data.

Methods

Subjects (5–65 years) with confirmed HDM-AR with or without controlled asthma were treated with 300IR or placebo in 8 RCTs. Reported treatment-emergent adverse events (TEAEs) were pooled and analyzed descriptively in subsets of adults/adolescents and children. Adverse reactions (ADRs) collected from spontaneous reporting and PM studies through a pharmacovigilance system since the first marketing authorization were also analyzed.

Results

Across RCTs, 1853 subjects were treated with the 300IR HDM-SLIT tablet and 1846 with placebo. In both subsets of adults/adolescents and children whichever their asthma status, treatment-related TEAEs of higher incidence in active groups vs placebo were mostly consistent with mild or moderate local application-site reactions. They were mainly reported on the first days of treatment and decreased over time. 4 severe laryngopharyngeal reactions (2 requiring adrenaline/epinephrine) and 1 moderate eczema considered serious rapidly resolved with medications; no anaphylaxis was reported. In PM settings, ADRs reported in more than 235,000 patients were in line with RCT findings. Severe systemic reactions occurred rarely; 12 anaphylactic reactions resolved safely (5 with adrenaline). No new safety signal was raised.

Conclusion

Safety data from RCTs and more than 7 years of real-life experience confirmed the favorable safety profile of 300IR HDM-SLIT tablet in patients across different regions, regardless of age and asthma status.