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

IF 3.9 2区医学 Q2 ALLERGY

World Allergy Organization Journal 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

Abstract

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.

Clinical trial registrations

NCT00674700; Retrospectively registered 06 May 2008.

NCT01199133; Retrospectively registered 09 September 2010.

NCT01527188; Retrospectively registered 01 February 2012.

NCT02443805; Registered 29 April 2015/EudraCT 2014-004223-46; Registered 16 September 2015.

jRCT2080221872/JapicCTI-121917; Registered 01 August 2012.

jRCT2080222929/JapicCTI-15298; Registered 04 August 2015.

查看原文本刊更多论文

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

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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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.