日本用于神经脊髓炎视谱系障碍视神经炎慢性治疗的生物制剂的使用状况。

IF 2.1 3区 医学 Q2 OPHTHALMOLOGY
Yohei Takahashi, Takeshi Kezuka, Keigo Shikishima, Akiko Yamagami, Hideki Chuman, Makoto Nakamura, Satoshi Ueki, Akiko Kimura, Masato Hashimoto, Sonoko Tatsui, Kimiyo Mashimo, Hitoshi Ishikawa
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引用次数: 0

摘要

目的:调查日本用于慢性视神经炎(包括视神经炎谱系障碍)治疗的生物制剂的使用情况:多中心回顾性病例系列:方法:在日本的 30 家医疗机构中,对 2020 年 1 月至 2022 年 8 月期间确诊为抗喹波素 4 抗体(AQP4-Ab)阳性视神经炎并开始使用生物制剂(沙妥珠单抗、依库珠单抗和伊奈珠单抗)的患者进行识别。对这些患者口服类固醇剂量的变化、视神经炎复发以及开始使用生物制剂后的不良反应进行了调查:结果:共纳入88名AQP4-Ab阳性视神经炎患者,他们开始使用生物制剂。萨妥珠单抗是最常用的生物制剂(79 例),其次是依库珠单抗(6 例)和伊奈珠单抗(3 例)。在观察期(10.0±7.0 个月)至 2023 年 2 月期间,萨妥珠单抗组的口服类固醇剂量从开始时的 13.8±8.6 毫克/天大幅减少至 5.3±4.8 毫克/天(p < 0.001)。79名患者中有76名(96.2%)在开始使用萨曲珠单抗后未发现视神经炎复发。此外,在开始使用萨曲珠单抗后 8.5 ± 5.8 个月内成功停用类固醇的 15 名患者中,在整个观察期间均未观察到视神经炎复发。7名使用沙特珠单抗的患者和2名使用依库珠单抗的患者出现了不良反应,但未观察到严重感染:结论:萨曲珠单抗是日本治疗 AQP4-Ab 阳性视神经炎最常用的生物制剂。这项研究证明了萨他珠单抗在预防视神经炎复发方面的有效性和安全性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Usage status of biologics for the chronic treatment of optic neuritis in neuromyelitis optica spectrum disorders in Japan.

Purpose: To investigate the usage status of biologics for the chronic treatment of optic neuritis including neuromyelitis optica spectrum disorders in Japan.

Design: Multicenter retrospective case series.

Methods: Patients diagnosed with anti-aquaporin 4 antibody (AQP4-Ab) positive optic neuritis and had been initiated on biologics (satralizumab, eculizumab, and inebilizumab) between January 2020 and August 2022 were identified at 30 facilities in Japan. These patients were investigated regarding changes in oral steroid doses, optic neuritis relapse, and adverse events after initiation of biologics.

Results: Eighty-eight patients with AQP4-Ab positive optic neuritis initiated on biologics were included. Satralizumab was the most common biologic used (79 patients), followed by eculizumab (6 patients) and inebilizumab (3 patients). In the satralizumab group, during the observation period (10.0±7.0 months) until February 2023, the oral steroid dose was reduced significantly from 13.8 ± 8.6 mg/day at the time of initiation to 5.3 ± 4.8 mg/day (p < 0.001). No relapse of optic neuritis was observed in 76 of 79 patients (96.2%) after initiation of satralizumab. Furthermore, in 15 patients who succeeded in discontinuing steroids during 8.5 ± 5.8 months after initiation of satralizumab, no relapse of optic neuritis was observed throughout the observation period. Adverse events occurred in 7 patients with satralizumab and 2 patients with eculizumab, but no serious infections were observed.

Conclusions: Satralizumab was the most commonly used biologic for AQP4-Ab positive optic neuritis in Japan. This study demonstrates the efficacy and safety of satralizumab in preventing the relapse of optic neuritis.

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来源期刊
CiteScore
4.80
自引率
8.30%
发文量
65
审稿时长
6-12 weeks
期刊介绍: The Japanese Journal of Ophthalmology (JJO) was inaugurated in 1957 as a quarterly journal published in English by the Ophthalmology Department of the University of Tokyo, with the aim of disseminating the achievements of Japanese ophthalmologists worldwide. JJO remains the only Japanese ophthalmology journal published in English. In 1997, the Japanese Ophthalmological Society assumed the responsibility for publishing the Japanese Journal of Ophthalmology as its official English-language publication. Currently the journal is published bimonthly and accepts papers from authors worldwide. JJO has become an international interdisciplinary forum for the publication of basic science and clinical research papers.
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