Lustig-Barzelay Yael, Yagoda Daniel, Zunz Eran, Hamed-Azzam Shirin, Avisar Inbal, Kehat-Ophir Shay, Gur Zvi, Cukierman-Yaffe Tali, Agmon-Levin Nancy, Landau-Prat Daphna, Ben-Simon Guy J
Goldschleger Eye Institute, Sheba Medical Center, Tel Hashomer, Israel.
Department of Ophthalmology, Soroka Medical Center, Be'er Sheva, Israel.
Graefes Arch Clin Exp Ophthalmol. 2025 May 14. doi: 10.1007/s00417-025-06855-0.
Teprotumumab is the only FDA-approved medication for thyroid eye disease (TED), showing benefits in reducing proptosis, diplopia, clinical activity score (CAS), and improving quality of life. This study describes the clinical outcomes of TED patients treated with Teprotumumab across 5 medical centers in Israel and evaluates time-to-improvement.
A retrospective cohort study of electronic medical records for Israeli patients treated with Teprotumumab between 2021 and 2024 in five medical centers. The main outcome included changes in proptosis and diplopia.
Thirty-two TED patients (mean age 53.3, 19 females) received partial or complete treatment with Teprotumumab. All had previously failed IV glucocorticoids, and some also failed other biologics. Four patients had decompression surgery prior; 3 with optic neuropathy and 1 with proptosis improved after 1-7 doses. Proptosis decreased by 2.4mm (right) and 2.0mm (left) (p < 0.001, p = 0.002, paired sample t-test), with significant reductions in primary gaze diplopia (p = 0.015, chi-square test). Four patients (12.5%) had symptom recurrence 8-12 months post-treatment; one improved with additional treatment. Thirteen patients (40.6%) had significant improvement within 3 infusions. Adverse events included myalgia (n = 4), hyperglycemia (n = 3), diarrhea (n = 3), and hearing issues (n = 4). One patient developed encephalopathy, successfully treated with plasmapheresis.
Teprotumumab was effective in reducing diplopia and proptosis among Israeli TED patients, with rapid improvement in nearly half of the cases. Further studies are warranted to confirm these findings in real-world settings.
替普罗单抗是唯一经美国食品药品监督管理局（FDA）批准用于治疗甲状腺眼病（TED）的药物，在减轻眼球突出、复视、临床活动评分（CAS）以及改善生活质量方面显示出疗效。本研究描述了以色列5个医疗中心接受替普罗单抗治疗的TED患者的临床结局，并评估改善时间。
对2021年至2024年期间在5个医疗中心接受替普罗单抗治疗的以色列患者的电子病历进行回顾性队列研究。主要结局包括眼球突出和复视的变化。
32例TED患者（平均年龄53.3岁，19例女性）接受了替普罗单抗的部分或全部治疗。所有患者此前静脉注射糖皮质激素均无效，部分患者其他生物制剂治疗也无效。4例患者曾接受减压手术；3例视神经病变患者和1例眼球突出患者在接受1 - 7剂治疗后病情改善。眼球突出度右眼下降2.4毫米，左眼下降2.0毫米（配对样本t检验，p < 0.001，p = 0.002），原在位复视明显减轻（卡方检验，p = 0.015）。4例患者（12.5%）在治疗后8 - 12个月症状复发；1例经额外治疗后病情改善。13例患者（40.6%）在3次输注内有显著改善。不良事件包括肌痛（n = 4）、高血糖（n = 3）、腹泻（n = 3）和听力问题（n = 4）。1例患者发生脑病，经血浆置换成功治疗。
替普罗单抗在减轻以色列TED患者的复视和眼球突出方面有效，近半数病例病情迅速改善。有必要进行进一步研究以在实际环境中证实这些发现。
