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特罗替珠单抗:首次获批

Teprotumumab: First Approval.

机构信息

Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

出版信息

Drugs. 2020 Apr;80(5):509-512. doi: 10.1007/s40265-020-01287-y.

DOI:10.1007/s40265-020-01287-y
PMID:32157641
Abstract

Teprotumumab (teprotumumab-trbw; TEPEZZA™ - Horizon Therapeutics) is a monoclonal antibody insulin-like growth factor-I receptor (IGF-IR) antagonist developed for the treatment of thyroid eye disease (Graves ophthalmopathy/orbitopathy, thyroid-associated ophthalmopathy). Based on positive results from two multinational clinical trials teprotumumab was recently approved for this indication in the US. This article summarizes the milestones in the development of teprotumumab leading to this first approval for thyroid eye disease.

摘要

特普替尼(teprotumumab-trbw;TEPEZZA ™-Horizon Therapeutics)是一种单克隆抗体胰岛素样生长因子-I 受体(IGF-IR)拮抗剂,用于治疗甲状腺眼病(格雷夫斯眼病/眼眶病、甲状腺相关眼病)。基于两项多中心临床试验的积极结果,特普替尼最近在美国获得了该适应证的批准。本文总结了特普替尼开发过程中的重要里程碑,最终使其获得了甲状腺眼病的首个批准。

相似文献

1
Teprotumumab: First Approval.特罗替珠单抗:首次获批
Drugs. 2020 Apr;80(5):509-512. doi: 10.1007/s40265-020-01287-y.
2
Teprotumumab (Tepezza): from the discovery and development of medicines to USFDA approval for active thyroid eye disease (TED) treatment.特普替尼单抗(特泽萨):从药物的发现和开发到获得美国食品药品监督管理局批准用于治疗活动性甲状腺眼病(TED)。
Int Ophthalmol. 2021 Apr;41(4):1549-1561. doi: 10.1007/s10792-021-01706-3. Epub 2021 Jan 22.
3
Teprotumumab for the treatment of thyroid eye disease.特普替尼单抗治疗甲状腺眼病。
Expert Rev Clin Immunol. 2020 Aug;16(8):739-743. doi: 10.1080/1744666X.2020.1801421. Epub 2020 Aug 9.
4
Teprotumumab in Thyroid-Associated Ophthalmopathy: Rationale for Therapeutic Insulin-Like Growth Factor-I Receptor Inhibition.特罗特鲁单抗在甲状腺相关眼病中的应用:治疗胰岛素样生长因子-I 受体抑制的原理。
J Neuroophthalmol. 2020 Mar;40(1):74-83. doi: 10.1097/WNO.0000000000000890.
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Teprotumumab: a novel therapeutic monoclonal antibody for thyroid-associated ophthalmopathy.特普替尼单抗:一种用于甲状腺相关眼病的新型治疗性单克隆抗体。
Expert Opin Investig Drugs. 2020 Jul;29(7):645-649. doi: 10.1080/13543784.2020.1772752. Epub 2020 Jun 10.
6
Teprotumumab: Interpreting the Clinical Trials in the Context of Thyroid Eye Disease Pathogenesis and Current Therapies.特罗特单抗:从甲状腺眼病发病机制和现有疗法的角度解读临床试验。
Ophthalmology. 2021 Nov;128(11):1627-1651. doi: 10.1016/j.ophtha.2021.04.024. Epub 2021 Apr 28.
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Insulin-Like Growth Factor Pathway and the Thyroid.胰岛素样生长因子通路与甲状腺。
Front Endocrinol (Lausanne). 2021 Jun 4;12:653627. doi: 10.3389/fendo.2021.653627. eCollection 2021.
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Thyroid Eye Disease, Teprotumumab, and Hearing Loss: An Evolving Role for Otolaryngologists.甲状腺眼病、替普罗单抗与听力损失:耳鼻喉科医生的角色演变
Otolaryngol Head Neck Surg. 2021 Dec;165(6):757-758. doi: 10.1177/01945998211004240. Epub 2021 Mar 30.
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Teprotumumab for the Treatment of Active Thyroid Eye Disease.特罗特鲁单抗治疗活动性甲状腺眼病。
N Engl J Med. 2020 Jan 23;382(4):341-352. doi: 10.1056/NEJMoa1910434.
10
Teprotumumab as a Novel Therapy for Thyroid-Associated Ophthalmopathy.特罗特鲁单抗治疗甲状腺相关眼病的新疗法。
Front Endocrinol (Lausanne). 2020 Dec 17;11:610337. doi: 10.3389/fendo.2020.610337. eCollection 2020.

引用本文的文献

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Front Mol Biosci. 2025 Jul 23;12:1580062. doi: 10.3389/fmolb.2025.1580062. eCollection 2025.
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An Atypical Presentation of Thyroid Eye Disease in a Patient With a Remote History of Graves' Disease.一名有格雷夫斯病既往史患者的甲状腺眼病非典型表现。
Cureus. 2025 Jun 23;17(6):e86621. doi: 10.7759/cureus.86621. eCollection 2025 Jun.
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Teprotumumab for Thyroid Eye Disease: Mechanism, Clinical Efficacy, and Current Challenges.

本文引用的文献

1
Teprotumumab for the Treatment of Active Thyroid Eye Disease.特罗特鲁单抗治疗活动性甲状腺眼病。
N Engl J Med. 2020 Jan 23;382(4):341-352. doi: 10.1056/NEJMoa1910434.
2
Teprotumumab for Thyroid-Associated Ophthalmopathy.替普罗单抗治疗甲状腺相关性眼病
N Engl J Med. 2017 May 4;376(18):1748-1761. doi: 10.1056/NEJMoa1614949.
替普罗单抗治疗甲状腺眼病:作用机制、临床疗效及当前挑战
Antibodies (Basel). 2025 Jun 30;14(3):55. doi: 10.3390/antib14030055.
4
Natural active ingredients targeted inflammatory cytokines and major blinding eye diseases: a two-sample Mendelian randomization and molecular docking analysis.针对炎性细胞因子和主要致盲眼病的天然活性成分:两样本孟德尔随机化和分子对接分析
Front Med (Lausanne). 2025 Jul 4;12:1427144. doi: 10.3389/fmed.2025.1427144. eCollection 2025.
5
Thyroid-related orbitopathy: clinical overview, novel medical treatments and the role of orbital surgery.甲状腺相关眼病:临床概述、新型药物治疗及眼眶手术的作用
Int Ophthalmol. 2025 May 3;45(1):160. doi: 10.1007/s10792-025-03535-0.
6
Teprotumumab for thyroid eye disease in patients with hypothyroid/euthyroid state: a multicenter case series.甲状腺功能减退/甲状腺功能正常状态患者使用替普罗单抗治疗甲状腺眼病:一项多中心病例系列研究
Graefes Arch Clin Exp Ophthalmol. 2025 Jan;263(1):225-230. doi: 10.1007/s00417-024-06599-3. Epub 2024 Aug 13.
7
Postmarketing Safety Concerns of Teprotumumab: A Real-World Pharmacovigilance Assessment.替普罗珠单抗的上市后安全性问题:一项真实世界药物警戒评估。
J Clin Endocrinol Metab. 2024 Dec 18;110(1):159-165. doi: 10.1210/clinem/dgae417.
8
Side Effects and Adverse Events After Treatment With Teprotumumab for Thyroid Eye Disease: A Retrospective Observational Case Series.替普罗单抗治疗甲状腺眼病后的副作用和不良事件:一项回顾性观察病例系列研究
Cureus. 2024 Apr 19;16(4):e58585. doi: 10.7759/cureus.58585. eCollection 2024 Apr.
9
Teprotumumab in thyroid eye disease.替普罗单抗治疗甲状腺眼病
Saudi J Ophthalmol. 2024 Mar 29;38(1):29-33. doi: 10.4103/sjopt.sjopt_179_23. eCollection 2024 Jan-Mar.
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Long-Term Follow-Up of a Case of Severe Hyperglycemia Requiring Hospitalization after Third Dose of Teprotumumab: A Case Report.托珠单抗第三剂后出现需要住院治疗的严重高血糖病例的长期随访:病例报告
Case Rep Ophthalmol. 2024 Feb 5;15(1):115-121. doi: 10.1159/000536153. eCollection 2024 Jan-Dec.