Goldberg Hila, Malik Amina I
Department of Ophthalmology, Blanton Eye institute, Houston Methodist Hospital, Houston, Texas, USA.
Department of Plastic Surgery, Orbital Oncology and Ophthalmic Plastic Surgery, The University of Texas M. D. Anderson Cancer Center, Houston, Texas, USA.
Saudi J Ophthalmol. 2024 Mar 29;38(1):29-33. doi: 10.4103/sjopt.sjopt_179_23. eCollection 2024 Jan-Mar.
Thyroid eye disease (TED) is an inflammatory condition involving the periocular and orbital soft tissues, affecting most commonly patients with hyperthyroid disorders. Traditional treatments used for the active phase of the disease range from conservative lubrication for mild symptoms to systemic immunomodulating drugs for moderate-to-severe symptoms. Teprotumumab (Tepezza) is a monoclonal antibody with an inhibitory effect on insulin-like growth factor 1 and is the first Food and Drug Administration (FDA) approved targeted medical therapy for reducing the inflammatory signs and symptoms associated with TED. Two large multicenter, randomized, double-masked, placebo-controlled trials have confirmed the efficacy and safety of teprotumumab in patients with active, moderate-to-severe TED. Recent reports and publications have also demonstrated the efficacy of teprotumumab in a wider range of patients. In this review, we summarize the clinical features and pathophysiology of TED, disease course, and traditional management methods. We further detail the development of teprotumumab, the founding studies that brought it to its FDA approval, adverse events profile, and ongoing as well as future investigations.
甲状腺眼病（TED）是一种累及眼周和眼眶软组织的炎症性疾病，最常影响甲状腺功能亢进症患者。用于该疾病活动期的传统治疗方法范围广泛，从针对轻度症状的保守润滑治疗到针对中重度症状的全身免疫调节药物治疗。替普罗单抗（Tepezza）是一种对胰岛素样生长因子1具有抑制作用的单克隆抗体，是美国食品药品监督管理局（FDA）批准的首个用于减轻与TED相关的炎症体征和症状的靶向药物治疗。两项大型多中心、随机、双盲、安慰剂对照试验已证实替普罗单抗在活动性中重度TED患者中的有效性和安全性。近期的报告和出版物也证明了替普罗单抗在更广泛患者群体中的有效性。在本综述中，我们总结了TED的临床特征、病理生理学、疾病进程和传统管理方法。我们进一步详细介绍了替普罗单抗的研发情况、使其获得FDA批准的基础研究、不良事件概况以及正在进行的和未来的研究。
