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贝赫切特综合征难治性葡萄膜炎患者英夫利昔单抗单药治疗 10 年的随访结果。

A 10-year follow-up of infliximab monotherapy for refractory uveitis in Behçet's syndrome.

机构信息

Department of Ophthalmology & Visual Science, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.

Department of Ophthalmology, Nagano Prefectural Federation of Agricultural Cooperatives for Health and Welfare, Saku General Hospital, Nagano, Japan.

出版信息

Sci Rep. 2020 Dec 17;10(1):22227. doi: 10.1038/s41598-020-78718-z.

Abstract

Infliximab (IFX) was the first biologic introduced for refractory uveitis treatment in Behçet's syndrome (BS). However, there have been few reports on the safety and efficacy of IFX monotherapy over follow-up periods of more than 10 years. This retrospective study evaluated the 10-year safety and efficacy of IFX monotherapy compared to IFX combination therapies with colchicine or corticosteroid for refractory uveitis in BS patients. Monotherapy was performed in 30 eyes of 16 patients while combination therapies were performed in 20 eyes of 11 patients. Continuation of IFX occurred in 70.3% of enrolled patients for 10 years without any significant difference noted in the retention rate between the monotherapy and combination therapies (p = 0.86). Reduction of ocular inflammatory attacks and improvement of best corrected visual acuity occurred in the monotherapy group after 10 years, which was equivalent to that for the combination therapies. Although adverse events (AEs) or therapy discontinuation occurred during the initial 5 years in both therapies, no AEs were observed for either therapy after 6 years. Our results suggested that IFX monotherapy proved to be effective and not inferior to combination therapies over a 10-year follow-up. Although loss of response and AEs may be noticed during the initial 5-year period, a safe and effective continuation can be expected thereafter.

摘要

英夫利昔单抗(IFX)是用于治疗贝赫切特综合征(BS)难治性葡萄膜炎的第一种生物制剂。然而,关于 IFX 单药治疗超过 10 年的安全性和疗效的报道较少。本回顾性研究评估了 IFX 单药治疗与 IFX 联合秋水仙碱或皮质类固醇治疗 BS 患者难治性葡萄膜炎的 10 年安全性和疗效。单药治疗在 16 名患者的 30 只眼中进行,而联合治疗在 11 名患者的 20 只眼中进行。在 10 年内,70.3%的入组患者继续使用 IFX,单药治疗和联合治疗的保留率无显著差异(p=0.86)。单药治疗组在 10 年后出现眼部炎症发作减少和最佳矫正视力改善,与联合治疗组相当。尽管两种治疗方法在最初 5 年内均出现不良事件(AE)或治疗中断,但在 6 年后均未观察到 AE。我们的结果表明,IFX 单药治疗在 10 年随访中有效且不逊于联合治疗。尽管在最初的 5 年内可能会出现应答丢失和 AE,但此后可以预期安全有效的治疗。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2ca0/7747559/39d944e9ac3b/41598_2020_78718_Fig1_HTML.jpg

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