Introduction

Real-world evidence of the safety and effectiveness of recombinant human thyroid-stimulating hormone (rhTSH; thyrotropin alfa) in Japanese patients is lacking.

Methods

This was a post-marketing surveillance study that included all Japanese patients who received thyrotropin alfa, either as a supporting diagnostic from January 2009 to December 2016, or as adjunctive treatment for ablation from May 2012 to October 2018. Information was collected on patient demographics, thyroid cancer characteristics, adverse drug reactions (ADRs), scintigraphy, serum thyroglobulin (Tg) testing, and hypothyroidism symptoms.

Results

A total of 9268 patients were included in the safety analysis and 9031 in the effectiveness analysis. In the safety analysis set, 3444 patients received thyrotropin alfa as a diagnostic and 5822 received it as treatment. ADRs occurred in 7.1% (n = 660) of patients, including 9.4% (n = 324) of patients who received thyrotropin alfa as a diagnostic and 5.8% (n = 336) of patients who received it as treatment. Nausea was the most common ADR (4.0% of overall safety population). Among patients who received thyrotropin alfa as a diagnostic (n = 1835), the Tg test was positive in 53.6% after the second dose. The scintigram was rated as “readable” in 3023 of the 3054 patients included in this analysis (99.0%). Of the 765 patients who were included in the assessment of response to ablation at 6 months to 1 year after the procedure, 621 (81.2%) were considered to have had “treatment success”. There were no significant differences in the proportions of patients who had hypothyroidism symptoms before the first and after the second dose of thyrotropin alfa.

Conclusion

In this large post-marketing surveillance study, thyrotropin alfa was well tolerated and showed effectiveness that was comparable to that observed in randomised, controlled trials.

中文翻译：

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日本患者使用促甲状腺素阿尔法的长期安全性和有效性：一项上市后监测研究

介绍

日本患者缺乏重组人促甲状腺激素（rhTSH；促甲状腺激素α）安全性和有效性的真实世界证据。

方法

这是一项上市后监测研究，包括所有接受促甲状腺素 α 的日本患者，无论是作为 2009 年 1 月至 2016 年 12 月的辅助诊断，还是作为 2012 年 5 月至 2018 年 10 月的消融辅助治疗。收集了有关患者人口统计数据的信息，甲状腺癌特征、药物不良反应 (ADR)、闪烁显像、血清甲状腺球蛋白 (Tg) 检测和甲状腺功能减退症状。

结果

安全性分析共纳入 9268 名患者，有效性分析纳入 9031 名患者。在安全性分析集中，3444 名患者接受促甲状腺素 α 作为诊断，5822 名患者接受治疗。ADR 发生在 7.1% ( n  = 660) 的患者中，其中 9.4% ( n  = 324) 接受促甲状腺素 α 诊断的患者和 5.8% ( n  = 336) 接受治疗的患者。恶心是最常见的 ADR（占总体安全人群的 4.0%）。在接受促甲状腺素 α 诊断的患者中（n = 1835)，第二次给药后 Tg 测试阳性率为 53.6%。该分析中包括的 3054 名患者中有 3023 名（99.0%）的闪烁图被评为“可读”。在手术后 6 个月至 1 年评估消融反应的 765 名患者中，621 名（81.2%）被认为“治疗成功”。在第一次和第二次服用促甲状腺素α之前和之后出现甲状腺功能减退症状的患者比例没有显着差异。

结论

在这项大型上市后监测研究中，促甲状腺素 α 的耐受性良好，并显示出与随机对照试验中观察到的效果相当的有效性。