Real-Life Safety of Japanese Cedar Pollen Sublingual Immunotherapy Tablets: A Post-Marketing Survey

IF 4.2 2区医学 Q2 ALLERGY

Clinical and Translational Allergy Pub Date : 2026-02-13 DOI:10.1002/clt2.70157

Minoru Gotoh, Yuriko Maekawa, Tsuyoshi Ando, Noboru Kato, Eiji Horikawa, Noriaki Nishino

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引用次数: 0

Abstract

Background

Japanese cedar (JC) pollen sublingual immunotherapy (SLIT)-tablets (5000 Japanese allergy units [JAU]) are licensed for the treatment of JC-pollinosis with no age restriction on the basis of the results of a 5-year clinical trial. However, there have been no large-scale surveys of 5000 JAU in an actual clinical setting.

Methods

This was a multicenter observational prospective study. We assessed the safety and effectiveness of the long-term use of 5000 JAU in patients with JC-pollinosis, with an observation period of two seasons of JC pollen dispersal, at clinical sites in Japan.

Results

Our safety analysis included 516 patients and the effectiveness analysis included 469 patients. Adverse drug reactions (ADRs) occurred in 68 patients (13.18%) and mainly comprised administration site-related events that occurred during the early phase of administration. Treatment discontinuation due to ADRs occurred in 18 patients (3.49%). No deaths, anaphylactic shock, or serious ADRs occurred. Regarding effectiveness, the severity of JC-pollinosis was rated as “almost asymptomatic + mild” in 82.19% of patients in Season 1 and 92.58% in Season 2. Quality of life was rated as “score 0 (Fine) + 1” in 75.83% of patients in Season 1 and 86.09% in Season 2. Overall improvement was rated as “improved + slightly improved” in 95.68% of patients in Season 1 and 96.38% in Season 2 following the initiation of JC pollen SLIT-tablets. Nasal and ocular symptom scores also decreased with increasing treatment duration. Treatment continuation rates were 89.53% in Season 1 and 78.29% in Season 2.

Conclusion

The JC pollen SLIT-tablets appear to be safe and effective in an actual clinical setting during two seasons. No new safety or effectiveness issues were identified, and no additional safety or effectiveness precautions were required.

Abstract Image

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日本雪松花粉舌下免疫治疗片的实际安全性：上市后调查。

背景：根据一项为期5年的临床试验结果，日本雪松（JC）花粉舌下免疫治疗（SLIT）片（5000个日本过敏单位[JAU]）被批准用于治疗JC花粉症，无年龄限制。然而，目前还没有在实际临床环境中对5000名JAU进行大规模调查。方法：这是一项多中心观察性前瞻性研究。我们在日本的临床站点评估了长期使用5000 JAU治疗JC-传粉症患者的安全性和有效性，观察期为两个季节的JC花粉传播。结果：安全性分析纳入516例患者，有效性分析纳入469例患者。发生药物不良反应（adr） 68例（13.18%），主要包括发生在给药早期的给药部位相关事件。18例（3.49%）患者因不良反应而停药。无死亡、过敏性休克或严重不良反应发生。在疗效方面，第1季82.19%的患者认为JC-pollinosis的严重程度为“几乎无症状+轻度”，第2季为92.58%。第一季75.83%的患者生活质量评分为0分(Fine) + 1分，第二季为86.09%。开始服用JC花粉片后，95.68%的患者在第一季和第二季的总体改善评分为“改善+轻微改善”，96.38%的患者在第二季的总体改善评分为“改善+轻微改善”。鼻和眼症状评分也随着治疗时间的延长而下降。治疗延续率第一季为89.53%，第二季为78.29%。结论：在两个季节的实际临床环境中，JC花粉裂片安全有效。没有发现新的安全性或有效性问题，也不需要额外的安全性或有效性预防措施。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical and Translational Allergy Immunology and Microbiology-Immunology

CiteScore

7.50

自引率

4.50%

发文量

117

审稿时长

12 weeks

期刊介绍： Clinical and Translational Allergy, one of several journals in the portfolio of the European Academy of Allergy and Clinical Immunology, provides a platform for the dissemination of allergy research and reviews, as well as EAACI position papers, task force reports and guidelines, amongst an international scientific audience. Clinical and Translational Allergy accepts clinical and translational research in the following areas and other related topics: asthma, rhinitis, rhinosinusitis, drug hypersensitivity, allergic conjunctivitis, allergic skin diseases, atopic eczema, urticaria, angioedema, venom hypersensitivity, anaphylaxis, food allergy, immunotherapy, immune modulators and biologics, animal models of allergic disease, immune mechanisms, or any other topic related to allergic disease.