Sun Aimin, Wang Xing, Qu Jinfeng, Wu Yuan
Department of Ophthalmology, Peking University First Hospital, Peking University, Beijing, 100000, China.
Department of Ophthalmology, Peking University Peoples' Hospital, Peking University, Beijing, 100000, China.
J Clin Endocrinol Metab. 2025 Feb 18;110(3):e886-e896. doi: 10.1210/clinem/dgae711.
This study aims to evaluate the efficacy and safety of intravenous (IV) tocilizumab (TCZ) in the treatment of Graves' ophthalmopathy (GO).
A comprehensive search was conducted across the Web of Science, PubMed, Embase, Cochrane Library, World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov databases from inception to April 2024. Randomized controlled trials and cohort studies that used IV TCZ for treating GO were included.
Twelve studies encompassing 219 patients with active, steroid-resistant GO were analyzed. The meta-analysis demonstrated significant improvements in Clinical Activity Score (CAS) response (effect size [ES] = 0.98; 95% confidence interval [CI], 0.93-1.00), proptosis response (ES = 0.50; 95% CI, 0.27-0.73), and diplopia response (ES = 0.48; 95% CI, 0.24-0.74). The ES for adverse events was 0.27 (95% CI, 0.22-0.33), with only 3 severe cases necessitating treatment discontinuation, and a low reactivation rate (ES = 0.01; 95% CI, 0.00-0.04). TCZ treatment led to a mean CAS reduction of 4.60 points (95% CI, 3.88-5.32) across 10 studies, a mean proptosis reduction of 2.04 mm (95% CI, 1.42-2.65) across 7 studies, and a mean decrease in TSH receptor antibodies levels of 10.62 IU (95% CI, 4.67-10.62) across 5 studies.
This meta-analysis provides robust evidence supporting the efficacy and safety of IV TCZ in patients with GO who are resistant to glucocorticoid therapy. The results highlight TCZ's comparable efficacy to glucocorticoids and suggest that TCZ could significantly expand clinical management options for GO. In the future, more high-quality, large-scale randomized controlled trials are still needed to confirm these findings.
本研究旨在评估静脉注射托珠单抗（TCZ）治疗格雷夫斯眼病（GO）的疗效和安全性。
对科学网、PubMed、Embase、Cochrane图书馆、世界卫生组织国际临床试验注册平台和ClinicalTrials.gov数据库进行全面检索，检索时间从建库至2024年4月。纳入使用静脉注射TCZ治疗GO的随机对照试验和队列研究。
分析了12项研究，共219例活动性、类固醇抵抗性GO患者。荟萃分析表明，临床活动评分（CAS）反应有显著改善（效应量[ES]=0.98；95%置信区间[CI]，0.93 - 1.00），眼球突出反应（ES = 0.50；95% CI，0.27 - 0.73），以及复视反应（ES = 0.48；95% CI，0.24 - 0.74）。不良事件的ES为0.27（95% CI，0.22 - 0.33），只有3例严重病例需要停药，且再激活率较低（ES = 0.01；95% CI，0.00 - 0.04）。在10项研究中，TCZ治疗使CAS平均降低4.60分（95% CI，3.88 - 5.32）；在7项研究中，使眼球突出平均减少2.04 mm（95% CI，1.42 - 2.65）；在5项研究中，使促甲状腺素受体抗体水平平均降低10.62 IU（95% CI，4.67 - 10.62）。
这项荟萃分析提供了有力证据，支持静脉注射TCZ对糖皮质激素治疗抵抗的GO患者的疗效和安全性。结果突出了TCZ与糖皮质激素相当的疗效，并表明TCZ可显著扩展GO的临床管理选择。未来仍需要更多高质量、大规模的随机对照试验来证实这些发现。
