J Rheumatol:苏金单抗在银屑病关节炎和强直性脊柱炎患者中的免疫原性

2019-06-28 xiangting MedSci原创

在PsA和AS患者中,使用苏金单抗的免疫原性发生率低(<1%)。

苏金单抗是一种全人类源抗白介素-17A单克隆抗体,可以有效治疗银屑病关节炎(PsA)和强直性脊柱炎(AS)。这项研究探讨了长达52周内苏金单抗在PsA和AS患者中的免疫原性。

使用抗体桥接测定评估苏金单抗在PsA(FUTURE 1-3研究)和AS(MEASURE 1-4研究)患者中的免疫原性。在基线(BL)和第16(仅AS)、24和52周进行评估。治疗后出现抗药抗体(TE-ADA)定义为基线阴性的患者≥1个治疗后样本ADA信号阳性。分析阳性样本的药物中和力和TE-ADA对苏金单抗药代动力学的影响、免疫原性相关不良事件以及对52周疗效的影响。

在有可用于免疫原性评估样本的1414例PsA患者和1164例AS患者中,分别有5例(0.35%)和8例(0.69%)出现了TE-ADA。除1例PsA患者外,所有患者都为生物制剂初治;5例PsA患者中2例和8例AS患者中1例同时接受了甲氨蝶呤治疗,8例AS患者中2例同时接受了柳氮磺胺吡啶。未观察到TE-ADA与苏金单抗剂量、频率或给药方式之间存在关联。除1例PsA患者外,所有TE-ADA均为非中和抗体。TE-ADA与不良事件无关。所有TE-ADA均与正常的苏金单抗药代动力学相关,并且与苏金单抗失效无关。

在PsA和AS患者中,使用苏金单抗的免疫原性发生率低(<1%)。

原始出处:

A. Deodhar. Secukinumab immunogenicity over 52 weeks in patients with psoriatic arthritis and ankylosing spondylitis. J Rheumatol. 15 June 2019.

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    2020-04-02 zywlvao
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    2019-06-30 lmm397
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