Abstract：
BACKGROUND: Teprotumumab, a novel IGF-1R antibody was recently shown to significantly reduce the signs of acute and chronic thyroid eye disease (TED) related to hyperthyroidism. Given the lower incidence of TED associated with hypothyroidism / euthyroidism, there is a paucity of data regarding the efficacy of teprotumumab in this group.
METHODS: In this multicenter study, consecutive patients who had been diagnosed with TED, presenting with either hypothyroidism or euthyroidism as their baseline thyroid dysfunction and treated with teprotumumab were included. All patients had measurements of proptosis, clinical activity scores (CAS), diplopia scores and four-point strabismus scores before and after therapy.
RESULTS: Twenty-six patients met the inclusion criteria. Mean age was 48 ± 14 years old and mean duration of TED prior to treatment was 31 ± 43 months. All patients received 8 infusions. Mean (SD) reduction in proptosis for study orbits was 2.7 mm (1.8) (p < 0.05) and 1.8 mm (2.0) for the fellow orbit (p < 0.05). In the study orbit, mean (SD) CAS was 2.3 (1.3) before therapy and 1.0 (1.0) following therapy (p < 0.05). At baseline, mean (SD) diplopia score was 1.2 (1.1) and 0.9 (1.1) following therapy (p < 0.05).
CONCLUSIONS: Teprotumumab reduces proptosis and inflammation in patients presenting with TED associated with hypothyroidism and euthyroidism. The results of this study highlight the potential for teprotumumab therapy in this subgroup and also provide a unique insight into the potential role of the IGF-1R in these patients.
METHODS: In this multicenter study, consecutive patients who had been diagnosed with TED, presenting with either hypothyroidism or euthyroidism as their baseline thyroid dysfunction and treated with teprotumumab were included. All patients had measurements of proptosis, clinical activity scores (CAS), diplopia scores and four-point strabismus scores before and after therapy.
RESULTS: Twenty-six patients met the inclusion criteria. Mean age was 48 ± 14 years old and mean duration of TED prior to treatment was 31 ± 43 months. All patients received 8 infusions. Mean (SD) reduction in proptosis for study orbits was 2.7 mm (1.8) (p < 0.05) and 1.8 mm (2.0) for the fellow orbit (p < 0.05). In the study orbit, mean (SD) CAS was 2.3 (1.3) before therapy and 1.0 (1.0) following therapy (p < 0.05). At baseline, mean (SD) diplopia score was 1.2 (1.1) and 0.9 (1.1) following therapy (p < 0.05).
CONCLUSIONS: Teprotumumab reduces proptosis and inflammation in patients presenting with TED associated with hypothyroidism and euthyroidism. The results of this study highlight the potential for teprotumumab therapy in this subgroup and also provide a unique insight into the potential role of the IGF-1R in these patients.
摘要：
背景：Teprotumumab，最近发现一种新的IGF-1R抗体可显著降低与甲状腺功能亢进相关的急性和慢性甲状腺眼病(TED)的体征.鉴于TED与甲状腺功能减退/甲状腺功能正常相关的发生率较低，关于teprotumumab在该组中的疗效的数据很少.
方法：在这项多中心研究中，连续被诊断为TED的患者，以甲状腺功能减退症或甲状腺功能正常作为基线甲状腺功能异常,并接受teprotumumab治疗.所有患者都有眼球突出的测量值，临床活动评分（CAS），治疗前后复视评分和四点斜视评分。
结果：26例患者符合纳入标准。平均年龄为48±14岁，治疗前TED的平均持续时间为31±43个月。所有患者接受8次输液。研究轨道的眼球突出度平均减少（SD）为2.7mm（1.8）（p<0.05），对等轨道为1.8mm（2.0）（p<0.05）。在研究轨道上，治疗前平均（SD）CAS为2.3（1.3），治疗后为1.0（1.0）（p<0.05）。在基线,治疗后平均(SD)复视评分分别为1.2(1.1)和0.9(1.1)(p<0.05).
结论：Teprotumumab可降低患有TED的甲状腺功能减退和甲状腺功能正常患者的眼球突出和炎症。这项研究的结果突出了teprotumumab治疗在这个亚组的潜力，也提供了对IGF-1R在这些患者中的潜在作用的独特见解。
方法：在这项多中心研究中，连续被诊断为TED的患者，以甲状腺功能减退症或甲状腺功能正常作为基线甲状腺功能异常,并接受teprotumumab治疗.所有患者都有眼球突出的测量值，临床活动评分（CAS），治疗前后复视评分和四点斜视评分。
结果：26例患者符合纳入标准。平均年龄为48±14岁，治疗前TED的平均持续时间为31±43个月。所有患者接受8次输液。研究轨道的眼球突出度平均减少（SD）为2.7mm（1.8）（p<0.05），对等轨道为1.8mm（2.0）（p<0.05）。在研究轨道上，治疗前平均（SD）CAS为2.3（1.3），治疗后为1.0（1.0）（p<0.05）。在基线,治疗后平均(SD)复视评分分别为1.2(1.1)和0.9(1.1)(p<0.05).
结论：Teprotumumab可降低患有TED的甲状腺功能减退和甲状腺功能正常患者的眼球突出和炎症。这项研究的结果突出了teprotumumab治疗在这个亚组的潜力，也提供了对IGF-1R在这些患者中的潜在作用的独特见解。
