Efficacy and Safety of Switching from Adalimumab Originator to SB5, Adalimumab Biosimilar for Noninfectious Uveitis.

IF 2.6 4区医学 Q2 OPHTHALMOLOGY

Ocular Immunology and Inflammation Pub Date : 2024-10-01 Epub Date: 2024-01-09 DOI:10.1080/09273948.2023.2295544

Seok Hyeon Song, Se Joon Woo

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引用次数: 0

Abstract

Purpose: To evaluate the efficacy and safety of switching from adalimumab originator (Humira, AbbVie) to SB5, adalimumab biosimilar (Adalloce, Samsung Bioepis) in patients with noninfectious uveitis (NIU).

Methods: Fifteen patients (29 eyes) with NIU who were switched from adalimumab originator to SB5 and followed up for 6 months or longer were retrospectively included. Data consisted of best-corrected visual acuity (BCVA, logMAR), intraocular pressure (IOP, mmHg), anterior chamber (AC) cell grade, anterior vitreous (AV) cell grade, vitreous haze grade, central macular thickness (CMT, μm), and macular volume (MV, mm³) at pre-switching, 2, 4, and 6 months post-switching.

Results: There were no significant differences in BCVA, AC and AV cell grades, and vitreous haze grades at 2, 4, and 6 months post- compared with pre-switching, and no significant differences in CMT and MV at 2 and 6 months post-switching. CMT and MV decreased from 260.55 ± 67.44 μm and 8.37 ± 1.14 mm³ at pre-switching to 244.14 ± 60.31 μm (p = 0.032) and 8.11 ± 1.20 mm³ (p = 0.027) at 4 months post-switching, respectively. There was no recurrence of uveitis, as defined by AC cell grade, vitreous haze, or BCVA. Four patients (27%) were switched back to adalimumab originator after a mean of 9 weeks, due to discomfort during the injection (three patients) and technical difficulty with the new injection device (one patient). No other adverse events occurred after switching to SB5.

Conclusion: Switching from adalimumab originator to SB5 for NIU does not result in clinically significant differences in treatment efficacy and safety.

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非感染性葡萄膜炎患者从阿达木单抗原研药转用阿达木单抗生物仿制药 SB5 的疗效和安全性。

目的：评估非传染性葡萄膜炎（NIU）患者从阿达木单抗原研药（Humira，艾伯维公司）转用阿达木单抗生物类似物SB5（Adalloce，三星生物公司）的疗效和安全性：回顾性纳入了15名从阿达木单抗原研药转为SB5并随访6个月或更长时间的非感染性葡萄膜炎患者（29只眼）。数据包括切换前、切换后2、4和6个月的最佳矫正视力（BCVA，logMAR）、眼压（IOP，mmHg）、前房（AC）细胞等级、前玻璃体（AV）细胞等级、玻璃体混浊等级、黄斑中心厚度（CMT，μm）和黄斑体积（MV，mm3）：与切换前相比，切换后 2、4 和 6 个月的 BCVA、AC 和 AV 细胞等级以及玻璃体混浊等级没有明显差异，切换后 2 和 6 个月的 CMT 和 MV 也没有明显差异。CMT和MV分别从切换前的260.55 ± 67.44 μm和8.37 ± 1.14 mm3降至切换后4个月的244.14 ± 60.31 μm（p = 0.032）和8.11 ± 1.20 mm3（p = 0.027）。根据 AC 细胞分级、玻璃体混浊或 BCVA 的定义，葡萄膜炎没有复发。4名患者（27%）在平均9周后转回阿达木单抗原研药，原因是注射过程中出现不适（3名患者）和新注射装置出现技术故障（1名患者）。改用SB5后未发生其他不良事件：结论：从阿达木单抗原研药改用SB5治疗NIU不会在疗效和安全性方面产生显著的临床差异。

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.