Aliment Pharm Therap:阿达木单抗谷水平对克罗恩病患者结局有何影响?

2017-11-16 应颖秋 环球医学

2017年11月,发表在《Aliment Pharmacol Ther》的一项由日本科学家进行的对DIAMOND试验的亚分析,考察了克罗恩病(CD)患者个体化药物代谢动力学的阿达木单抗血清谷水平和抗药物抗体测量的意义。

2017年11月,发表在《Aliment Pharmacol Ther》的一项由日本科学家进行的对DIAMOND试验的亚分析,考察了克罗恩病(CD)患者个体化药物代谢动力学的阿达木单抗血清谷水平和抗药物抗体测量的意义。

背景:监测阿达木单抗谷水平和抗阿达木单抗抗体(AAA)在CD患者疾病结局中的意义仍然未知。

目的:旨在DIAMOND试验的CD患者中,评估26周时的阿达木单抗谷水平和AAA与52周时临床缓解之间的相关性、硫唑嘌呤对AAA的影响、影响谷水平的因素。

方法:研究人员使用26周时的阿达木单抗谷水平、AAA和12周时的红细胞中的6硫鸟嘌呤核苷酸(TGN)进行了这项研究。多元回归模型和受试者操作特性分析用于鉴别影响阿达木单抗谷水平和AAA的因素,以及预测疾病活动度的阿达木单抗阈值。

结果:52周时疾病缓解和无疾病缓解的患者间,26周时的阿达木单抗谷水平具有显着性差异(7.7±3.3μg/mL vs 5.4±4.3μg/mL;P<0.001)。阿达木单抗谷水平为5.0μg/mL时,疾病缓解预测的敏感性和特异性最佳(分别为80.2%和55.6%)。26周时发生AAA可显着影响52周时的疾病缓解(P=0.021),与阿达木单抗谷水平强烈相关。女性和体重增加与较低的阿达木单抗谷水平独立相关,女性与AAA的发生相关。6TGN水平>222.5pmol/8×108RBC的临界点为AAA阴性的100%敏感性和60.6%的特异性。

结论:阿达木单抗谷水平和AAA的发生与临床缓解显着相关。较高的6TGN影响AAA阴性。联合治疗对于CD患者的一些相关方面具有获益。

原始出处:
Nakase H, Motoya S, Matsumoto T,et al.Significance of measurement of serum trough level and anti-drug antibody of adalimumab as personalised pharmacokinetics in patients with Crohn's disease: a?subanalysis of the DIAMOND trial.Aliment Pharmacol Ther. 2017 Nov;46(9):873-882. doi: 10.1111/apt.14318. Epub 2017 Sep 8.

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