ARD:巴瑞替尼治疗复发性巨细胞动脉炎:一项52周的前瞻性开放标签试验研究

2022-07-01 MedSci原创 MedSci原创

这项概念验证研究中,4 mg/天的巴瑞替尼耐受性良好,大多数复发性巨细胞动脉炎(GCA)患者允许停用糖皮质激素。需要更大规模的随机临床试验来确定JAK抑制在GCA中的效用。

目的巨细胞动脉炎(GCA)是一种慢性风湿性疾病,在糖皮质激素减量期间复发率很高。托珠单抗已被证明在GCA管理中有效;然而,接受托珠单抗治疗时出现15%26%的复发,停药后出现约50%的复发,突显了对额外治疗的需求未满足。临床前血管炎症模型已证明通过抑制Janus激酶3JAK1可有效抑制动脉壁病变T细胞。然而,尚未对巨细胞动脉炎(GCA)患者的JAK抑制进行前瞻性研究。

方法研究人员对巴瑞替尼(4 mg/天)进行了一项前瞻性、开放标签的试点研究,在复发性 GCA 患者中使用分级糖皮质激素(GC)并加速减量。

结果入组 15

名患者(11名,73%为女性),平均入组年龄为72.4SD 7.2)岁,GCA 中位持续时间为9IQR 7-21)个月,以前复发的中位数为11-2)次。4(27%)患者使用30 mg/天的泼尼松,6(40%) 使用20 mg/天的患者和5 (33%)位使用10 mg/天的患者进入研究。14名患者完成了52周的巴瑞替尼治疗。在第52周,14/15 (93%)的患者出现≥1 次不良事件(AE),其中最常见的事件包括不需要抗生素治疗的感染(n=8)、需要抗生素治疗的感染(n=5)、恶心(n= 6)、腿部肿胀(n=2)、疲劳(n=2)和腹泻(n=1)。一名受试者因AE需要停用巴瑞替尼。记录了一个严重的不良事件。在研究期间,14名患者中只有1(7%)复发。其余13名患者在52周的研究期间实现了类固醇停药并保持疾病缓解。

结论在这项概念验证研究中,4 mg/天的巴瑞替尼耐受性良好,大多数复发性GCA患者允许停用GC。需要更大规模的随机临床试验来确定JAK抑制在GCA中的效用。

出处:Koster MJ, Crowson CS, Giblon RE, et al. Baricitinib for relapsing giant cell arteritis: a prospective open-label 52-week pilot study. Annals of the Rheumatic Diseases 2022;81:861-867.

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    2023-02-26 xsm927
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    2022-07-03 wwzzly
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    2022-07-01 医鸣惊人

    认真学习了

    0

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