Efficacy and safety of Tocilizumab for thyroid eye disease: a systemic review and Meta-analysis.

IF 5.4 2区医学 Q1 Medicine

Journal of Endocrinological Investigation Pub Date : 2025-04-30 DOI:10.1007/s40618-025-02595-4

Shuzhen Lin, Xiaodan Ou, Liangchun Cai, Wenxin Huang, Junping Wen

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引用次数: 0

Abstract

Purpose: This study aims to investigate efficacy and safety of TCZ in TED.

Methods: Performing a meta-analysis of included studies. PubMed, Web of Science, Embase, Cochrane Library, and Clinicatrials.gov databases were retrieved to identify all related published literatures as of May 2024. When I² > 50%, the random effect model was used; otherwise, the fixed model was used.

Results: This meta-analysis included 413 patients with TED. Therapeutic effect of TCZ was evaluated by various metrics, including clinical activity score (CAS), response rate, inactivation rate, proptosis, visual acuity (VA), TRAB/TSI levels, diplopia, eye motility, intraocular pressure (IOP), and relapse rate. The final analysis revealed that TCZ significantly reduced CAS (-4.47, 95%CI [-5.14, -3.79]), with high response rate (0.93, 95%CI [0.88, 0.97]) and inactivation rate (0.90, 95%CI [0.83, 0.96]). Significant improvements were also observed in proptosis (2.05 mm reduction, 95%CI [-2.42, -1.67]) and diplopia (0.56 improvement rate, 95% CI [0.40, 0.72]). Regarding safety, the pooled incidence of adverse events (AEs) was 0.31(95%CI [0.15, 0.48]). Hyperlipidemia was the most prevalent AE, followed by neutropenia and infection. Furthermore, subgroup analysis demonstrated TCZ's superior performance in terms of inactivation rate, antibody decline rate, relapse rate, and safety.

Conclusions: According to the best available evidence, TCZ appears to be an acceptable alternative for moderate to severe TED patients due to its significant efficacy, well-tolerability, and low relapse rate. Larger sample size and controlled studies are warranted to promote the position of TCZ in TED treatment.

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托珠单抗治疗甲状腺眼病的疗效和安全性：一项系统评价和荟萃分析

目的：探讨TCZ治疗TED的疗效和安全性。方法：对纳入的研究进行荟萃分析。检索PubMed、Web of Science、Embase、Cochrane Library和Clinicatrials.gov数据库，确定截至2024年5月的所有相关已发表文献。当I2 bb0 50%时，采用随机效应模型；否则，采用固定模型。结果：这项荟萃分析纳入了413例TED患者。通过临床活动评分（CAS）、反应率、失活率、眼球突出、视力（VA）、TRAB/TSI水平、复视、眼动、眼压（IOP）、复发率等指标评价TCZ的疗效。最终分析显示，TCZ显著降低了CAS (-4.47, 95%CI[-5.14, -3.79])，具有较高的有效率（0.93,95%CI[0.88, 0.97]）和失活率（0.90,95%CI[0.83, 0.96]）。在视力（减少2.05 mm, 95%CI[-2.42, -1.67]）和复视（改善0.56,95%CI[0.40, 0.72]）方面也有显著改善。在安全性方面，不良事件（ae）的总发生率为0.31（95%CI[0.15, 0.48]）。AE以高脂血症最为常见，其次为中性粒细胞减少症和感染。此外，亚组分析表明TCZ在失活率、抗体下降率、复发率和安全性方面表现优越。结论：根据现有的最佳证据，TCZ疗效显著，耐受性好，复发率低，是中重度TED患者可接受的替代方案。需要更大的样本量和对照研究来提升TCZ在TED治疗中的地位。

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

Journal of Endocrinological Investigation ENDOCRINOLOGY & METABOLISM-

CiteScore

8.10

自引率

7.40%

发文量

242

期刊介绍： The Journal of Endocrinological Investigation is a well-established, e-only endocrine journal founded 36 years ago in 1978. It is the official journal of the Italian Society of Endocrinology (SIE), established in 1964. Other Italian societies in the endocrinology and metabolism field are affiliated to the journal: Italian Society of Andrology and Sexual Medicine, Italian Society of Obesity, Italian Society of Pediatric Endocrinology and Diabetology, Clinical Endocrinologists’ Association, Thyroid Association, Endocrine Surgical Units Association, Italian Society of Pharmacology.