JCEM:利妥昔单抗辅助治疗在青年Graves病中的探索性试验

2021-11-28 从医路漫漫 MedSci原创

Graves甲亢(Graves disease,GD)对年轻人和他们的家人来说是一种具有挑战性的疾病。标准抗甲状腺药物(ATD)治疗1-3年后的缓解率较低,约为20%-30%,因此建议延长治疗时间。

背景:Graves甲亢(Graves disease,GD)对年轻人和他们的家人来说是一种具有挑战性的疾病。标准抗甲状腺药物(ATD)治疗1-3年后的缓解率较低,约为20%-30%,因此建议延长治疗时间。对于大多数在ATD治疗后仍然复发的患者来说,可以选择继续ATD治疗,或者选择手术(全甲状腺切除术)或放射性碘(RI)治疗。这些患者长期服用甲状腺素(T4)并不理想,因为与对照组相比,促甲状腺素(TSH)浓度正常的成年人在甲状腺激素替代治疗方面的幸福感会降低,而接受RI或甲状腺切除术治疗GD的患者的生活质量也会下降。研究的目的是探讨短程使用B淋巴细胞耗竭剂利妥昔单抗(RTX)联合ATD是否能提高GD缓解率。

方法:本试验的主要目的是确定500mg剂量的RTX与为期12个月的硫酰胺类药物(他巴唑[CBZ]或丙基硫氧嘧啶[PTU])一起服用是否会显著改善Graves甲亢患者达到长期缓解的比例。次要目标是通过确定不良事件(AEs)的性质和发生频率来检查试验治疗方案的安全性,并检查24个月后缓解/复发状态与以下参数之间的关系:1.注射RTX时的TRAb效价2.免疫细胞反应,特别是28周和52周的B细胞数量(CD19+细胞),以基线值的百分比表示3.ATD的累积剂量4.游离T4(FT4)和游离3,5.3’-三碘甲状腺原氨酸(FT3)在RTX注射后恢复正常所需的时间。这是一项开放标签、多中心的2期试验,对象为12-20岁的Graves甲亢患者。出现Graves甲亢的参与者接受了500 mg的RTX和12个月的ATD,根据甲状腺功能进行评价。ATDS在12个月后停止,并在24个月时评估主要结果。如果促甲状腺激素被抑制而游离3’-三碘甲状腺原氨酸(FT3)升高,参与者在24个月时复发;他们在12到24个月间接受ATD治疗;或者他们接受甲状腺手术/放射性碘治疗。临床医生根据临床和生化指标诊断GD,其中包括诊断时血清TSH水平被抑制(根据当地参考范围,TSH水平无法记录,因此低于检测阈值)和血清游离甲状腺激素浓度(高于当地参考范围),以及TRAb升高。参与者距离第一次开始抗甲状腺药物治疗(CBZ或PTU)不到6周,并且以前没有自身免疫性甲状腺疾病的病史。患有严重心肺疾病、肾脏或肝脏疾病(包括乙型肝炎和丙型肝炎)的患者被排除在外。

结果:总共招募了27名参与者,并完成了试验,没有出现与治疗相关的严重副作用。在27名参与者中,有21名在12个月时他巴唑的日剂量低于5mg。27名参与者中有13名在24个月时处于缓解状态(48%,90%单侧CI,35%-100%);这超过了实验设计的临界值,并提供了缓解证据。28周时的B淋巴细胞计数,以基线的百分比表示,与缓解的可能性有关。

表1 纳入和排除标准

表2 患者生物化学及缓解状况总结

图1 甲状腺受体抗体(TRAb)水平在基线、12个月和24个月集中测定。复发的病人用红色表示。

图2 箱式图显示了缓解期和非缓解期患者在28周时B细胞淋巴细胞计数的分布,以基线值的百分比表示:红线表示中位数。

表3 试验参与者经历的严重不良反应

表4 按系统器官类别报告的每个非严重不良事件或不良反应的所有参与者人数和百分比(N = 27)

结论:辅助剂RTX配合12个月的ATD疗程,可能会增加青年Graves甲亢患者缓解的可能性。在患有甲状腺功能亢进症的年轻人中进行辅助剂RTX的随机试验是有必要的。

原文出处:

Cheetham T,  Cole M,  Abinun M,et al.Adjuvant Rituximab - exploratory trial in young people with Graves' disease.J Clin Endocrinol Metab 2021 Oct 23

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    2022-06-16 仁者大医
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    2022-04-25 achengzhao
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