Teo Honeylen Maryl, Smith Terry J, Joseph Shannon S
Eye Institute, St. Luke's Medical Center, Metro Manila, Philippines.
Department of Ophthalmology and Visual Sciences, W.K. Kellogg Eye Center, University of Michigan Medical School, Ann Arbor, MI, USA.
Ther Clin Risk Manag. 2021 Nov 25;17:1219-1230. doi: 10.2147/TCRM.S303057. eCollection 2021.
Thyroid eye disease (TED; also known as thyroid-associated ophthalmopathy) is an autoimmune condition with disabling and disfiguring consequences. Teprotumumab is the first and only medication approved by the United States Food and Drug Administration for the treatment of TED. We review the efficacy and safety of teprotumumab in TED, highlighting results from the 2 randomized, double-masked, placebo-controlled trials. Post-approval case reports of teprotumumab use in patients with compressive optic neuropathy (CON) and inactive TED were similarly favorable to those from the trials. The preliminarily results of teprotumumab for CON and inactive TED should be investigated in formal clinical trials. Teprotumumab should be avoided in pregnancy. Evidence also suggests that teprotumumab may exacerbate pre-existing inflammatory bowel disease, worsen hyperglycemia, and be associated with hearing impairment. Patients at risk for these adverse events need to be closely monitored with baseline and periodic assessments.
甲状腺眼病(TED;也称为甲状腺相关性眼病)是一种具有致残和毁容后果的自身免疫性疾病。替普罗单抗是美国食品药品监督管理局批准的首个也是唯一用于治疗TED的药物。我们回顾了替普罗单抗治疗TED的疗效和安全性,重点介绍了两项随机、双盲、安慰剂对照试验的结果。替普罗单抗用于治疗压迫性视神经病变(CON)和静止期TED患者的批准后病例报告结果与试验结果相似。替普罗单抗治疗CON和静止期TED的初步结果应在正式临床试验中进行研究。妊娠期间应避免使用替普罗单抗。有证据还表明,替普罗单抗可能会加重已有的炎症性肠病、使高血糖恶化,并与听力障碍有关。有这些不良事件风险的患者需要通过基线和定期评估进行密切监测。