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用替普罗单抗治疗的患者再治疗率:一项对119例患者进行1年随访的多中心研究。

The Rate of Re-treatment in Patients Treated with Teprotumumab: A Multicenter Study of 119 Patients with 1 Year of Follow-up.

作者信息

Ugradar Shoaib, Parunakian Emanuil, Malkhasyan Emil, Chiou Carolina A, Walsh Hannah L, Tolentino Joseph, Wester Sara T, Freitag Suzanne K, Douglas Raymond S

机构信息

Department of Orbital and Ophthalmic Plastic Surgery, Thrive Health, Beverly Hills, California.

Department of Ophthalmic Plastic Surgery, Massachusetts Eye and Ear, Harvard Medical School, Boston, Massachusetts.

出版信息

Ophthalmology. 2025 Jan;132(1):92-97. doi: 10.1016/j.ophtha.2024.07.018. Epub 2024 Jul 19.

DOI:10.1016/j.ophtha.2024.07.018
PMID:39032704
Abstract

PURPOSE

To determine the rate of re-treatment in patients who receive a full course of teprotumumab therapy for thyroid eye disease (TED) and drivers of re-treatment.

DESIGN

Multicenter retrospective study.

PARTICIPANTS

All patients who received a full course of treatment and had available data at 1 year after initial treatment were included.

METHODS

Charts were reviewed for the following information: age, sex, months since diagnosis of TED, smoking status, and prior treatments. Further, the clinical activity score (CAS), proptosis, and the Gorman diplopia score were reviewed at baseline, at the end of the first course, and at baseline for the second course in those who received it. A logistic regression model was created to review the drivers of re-treatment.

MAIN OUTCOME MEASURES

Rate of re-treatment and the drivers of re-treatment.

RESULTS

One hundred nineteen patients were included from 3 centers across the United States. The overall re-treatment rate was 24% (29/119). No difference was found among the 3 sites (P = 0.6). In univariable analyses, at baseline, no difference was found in proptosis (P = 0.07), diplopia score (P = 0.4), or duration of TED (P = 0.4) between patients who were re-treated and those not re-treated. From the re-treated group, 82% showed a significant proptosis response (≥ 2-mm reduction from baseline) after the initial course, whereas 68% of patients who were not re-treated showed a clinically significant proptosis response (P = 0.16). The mean ± standard deviation difference between the end of the first treatment and at baseline before the second treatment (in those who received it) was 2 ± 2 for CAS, 2 ± 4 mm for proptosis, and 1 ± 1 for diplopia score. Age was the only significant driver of re-treatment (P < 0.05). Re-treated patients were 7 years older than patients who were not re-treated (60 years vs. 53 years; P < 0.05).

CONCLUSIONS

In patients receiving a full course of teprotumumab therapy, the rate of re-treatment was 24%. Age was the only driver of re-treatment.

FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

摘要

目的

确定接受全程替普罗单抗治疗甲状腺眼病(TED)患者的再治疗率及再治疗的驱动因素。

设计

多中心回顾性研究。

参与者

纳入所有接受全程治疗且在初始治疗后1年有可用数据的患者。

方法

查阅病历以获取以下信息:年龄、性别、TED诊断后的月数、吸烟状况和既往治疗情况。此外,对接受再治疗患者的基线、第一疗程结束时以及第二疗程基线时的临床活动评分(CAS)、突眼度和戈尔曼复视评分进行评估。建立逻辑回归模型以分析再治疗的驱动因素。

主要观察指标

再治疗率及再治疗的驱动因素。

结果

来自美国3个中心的119例患者被纳入研究。总体再治疗率为24%(29/119)。3个研究点之间未发现差异(P = 0.6)。在单因素分析中,基线时,再治疗患者与未再治疗患者在突眼度(P = 0.07)、复视评分(P = 0.4)或TED病程(P = 0.4)方面未发现差异。在再治疗组中,82%的患者在初始疗程后突眼度有显著改善(较基线降低≥2 mm),而未再治疗的患者中有68%表现出临床上显著的突眼度改善(P = 0.16)。第一次治疗结束至第二次治疗前基线(接受第二次治疗的患者)时,CAS的平均±标准差差值为2±2,突眼度为2±4 mm,复视评分为1±1。年龄是唯一显著的再治疗驱动因素(P < 0.05)。再治疗患者比未再治疗患者大7岁(60岁对53岁;P < 0.05)。

结论

在接受全程替普罗单抗治疗的患者中,再治疗率为24%。年龄是唯一的再治疗驱动因素。

财务披露

本文末尾的脚注和披露中可能会有专有或商业披露信息。

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