Efficacy and Safety of Teprotumumab in Thyroid Eye Disease: A Systematic Review and Meta-Analysis.

IF 3.7 3区医学 Q2 ENDOCRINOLOGY & METABOLISM

Endocrine Practice Pub Date : 2025-02-12 DOI:10.1016/j.eprac.2025.01.012

Wenxin Huang, Xiaodan Ou, Shuzhen Lin, Wei Lin, Gang Chen, Huibin Huang, Junping Wen

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引用次数: 0

Abstract

Objective: Teprotumumab was approved by the US Food and Drug Administration (FDA) for treating Graves' orbitopathy in adults on January 21, 2020. This study evaluates its efficacy and safety in treating thyroid eye disease (TED).

Methods: We reviewed studies on teprotumumab for TED treatment from PubMed, Web of Science, EMBASE, Cochrane library, and Clinical trials. gov up to January 1, 2024. Outcomes included proptosis response, diplopia, Clinical Activity Score (CAS) score, and adverse events (AEs).

Results: Our analysis included 10 studies, 4 randomized controlled trials, and 6 observational studies. The randomized controlled trials involved 210 teprotumumab patients and 193 controls. Teprotumumab significantly improved proptosis response (relative risk [RR] 4.18, 2.72-6.43), diplopia regression (RR 2.29, 1.54-3.41), and CAS score (RR 3.09, 1.98-4.80) compared to placebo. A significant reduction in proptosis was observed (standardized mean difference -8.38, -9.25 - -7.52). The risk of AEs and serious AEs was higher with teprotumumab. The 6 observational studies included 211 patients, showing an 82% proptosis response rate, a -3.31 mm change in proptosis, a 0.58 diplopia improvement rate, and a 0.66 pooled effect size for CAS score. AE incidence was 0.78, and serious AEs were 0.31.

Conclusion: Teprotumumab effectively reduces proptosis, improves diplopia, and lowers disease activity in TED, regardless of previous treatments, severity, or dosage, albeit with increased AEs. It has the potential to become a vital first-line treatment for TED, enhancing patient quality of life.

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Teprotumumab治疗甲状腺眼病的疗效和安全性：一项系统综述和荟萃分析

目的：Teprotumumab于2020年1月21日被FDA批准用于治疗成人Graves眼病（GO）。本研究评价其治疗甲状腺眼病（TED）的疗效和安全性。方法：我们回顾了来自PubMed、Web of Science、EMBASE、Cochrane图书馆和Clinical trials.gov截至2024年1月1日的关于teprotumumab用于TED治疗的研究。结果包括预后、复视、CAS评分和不良事件（ae）。结果：我们的分析包括10项研究，4项随机对照试验（rct）和6项观察性研究。这些随机对照试验包括210名teprotumumab患者和193名对照组。与安慰剂相比，Teprotumumab显著改善了预后反应（RR 4.18, 2.72-6.43）、复视回归（RR 2.29, 1.54-3.41）和CAS评分（RR 3.09, 1.98-4.80）。观察到预后显著降低（SMD-8.38, -9.25 - -7.52）。teprotumumab组发生不良反应和严重不良反应的风险更高。这6项观察性研究包括211例患者，显示82%的显影缓解率，-3.31mm的显影改变，0.58的复视改善率，0.66的CAS评分综合效应大小。AE发生率为0.78，严重AE发生率为0.31。结论：Teprotumumab有效地降低了TED患者的畸形，改善了复视，降低了疾病活动性，与之前的治疗、严重程度或剂量无关，尽管ae增加。它有可能成为TED至关重要的一线治疗方法，提高患者的生活质量。

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

Endocrine Practice ENDOCRINOLOGY & METABOLISM-

CiteScore

7.60

自引率

2.40%

发文量

546

审稿时长

41 days

期刊介绍： Endocrine Practice (ISSN: 1530-891X), a peer-reviewed journal published twelve times a year, is the official journal of the American Association of Clinical Endocrinologists (AACE). The primary mission of Endocrine Practice is to enhance the health care of patients with endocrine diseases through continuing education of practicing endocrinologists.