Safety of Mycophenolate Mofetil in the Treatment of Non-Infectious Uveitis and Sclerouveitis in Japanese Patients: A Feasibility Study.

IF 2.6 4区医学 Q2 OPHTHALMOLOGY

Ocular Immunology and Inflammation Pub Date : 2025-04-22 DOI:10.1080/09273948.2025.2492773

Tomona Hiyama, Kaori Komatsu, Yosuke Harada

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引用次数: 0

Abstract

Purpose: To evaluate the incidence rate and severity of adverse events associated with mycophenolate mofetil (MMF) in the treatment of non-infectious uveitis and sclerouveitis in Japanese patients.

Methods: This open-label, single-centre feasibility study was performed at Hiroshima University Hospital (jRCTs061220030). Patients started MMF at 1000 mg/day, increasing up to 3000 mg/day. Primary endpoints were the incidence rate and severity of adverse events associated with MMF. Secondary endpoints were the overall rate of treatment success (defined as controlled ocular inflammation according to the Standardization of Uveitis Nomenclature criteria for uveitis and standardised grading system for sclerouveitis in patients on oral prednisolone at ≤ 5 mg/day and/or topical betamethasone 0.1% up to twice daily) and the reason for discontinuation. Patients were followed up for 12 months.

Results: Ten patients (7 women; median age, 54.5 years) with Vogt-Koyanagi-Harada disease (n = 4), retinal vasculitis (n = 3) sarcoidosis (n = 1), sympathetic ophthalmia (n = 1), or sclerouveitis (n = 1) were enrolled. At 12 months, treatment was successful in 7 of the 10 patients. The reasons for treatment failure were lack of safety (n = 1) and insufficient therapeutic effect (n = 2). One patient discontinued MMF due to elevated liver enzymes. No serious adverse events (death, hospitalization, life-threatening events) or systemic symptoms (gastrointestinal issues, headache, fatigue) occurred. The median MMF dose was 2500 mg/day, with a maximum of 3000 mg/day.

Conclusion: MMF may be safely used as a steroid-sparing agent in Japanese patients with non-infectious uveitis or sclerouveitis.

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霉酚酸酯治疗日本非感染性葡萄膜炎和巩膜炎的安全性：可行性研究。

目的：评价霉酚酸酯（MMF）治疗日本非感染性葡萄膜炎和巩膜炎患者不良事件的发生率和严重程度。方法：这项开放标签、单中心可行性研究在广岛大学医院进行（jRCTs061220030）。患者开始时MMF为1000毫克/天，增加到3000毫克/天。主要终点是与MMF相关的不良事件的发生率和严重程度。次要终点是总体治疗成功率（定义为根据葡萄膜炎标准化命名标准葡萄膜炎和巩膜炎标准化分级系统控制的眼部炎症，口服强的松≤5mg /天和/或局部倍他米松0.1%，每日两次）和停药原因。随访12个月。结果：10例患者(女性7例；纳入了Vogt-Koyanagi-Harada病（n = 4）、视网膜血管炎（n = 3）、结节病（n = 1）、交感眼炎（n = 1）或巩膜炎（n = 1）患者，中位年龄为54.5岁。12个月时，10例患者中有7例治疗成功。治疗失败的原因是缺乏安全性（n = 1）和治疗效果不足（n = 2）。一名患者因肝酶升高而停用MMF。未发生严重不良事件（死亡、住院、危及生命的事件）或全身性症状（胃肠道问题、头痛、疲劳）。MMF的中位剂量为2500mg /天，最大值为3000mg /天。结论：MMF可安全用于日本非感染性葡萄膜炎或巩膜炎患者。

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

Ocular Immunology and Inflammation 医学-眼科学

CiteScore

6.20

自引率

15.20%

发文量

285

审稿时长

6-12 weeks

期刊介绍： Ocular Immunology & Inflammation ranks 18 out of 59 in the Ophthalmology Category.Ocular Immunology and Inflammation is a peer-reviewed, scientific publication that welcomes the submission of original, previously unpublished manuscripts directed to ophthalmologists and vision scientists. Published bimonthly, the journal provides an international medium for basic and clinical research reports on the ocular inflammatory response and its control by the immune system. The journal publishes original research papers, case reports, reviews, letters to the editor, meeting abstracts, and invited editorials.