AP&T: 乌司奴单抗维持治疗对溃疡性结肠炎患者的有效性和安全性分析

2021-09-14 MedSci原创 MedSci原创

随着生物制剂的发展,越来越多的生物制剂开始进入临床实践中,如抗肿瘤坏死因子和维多珠单抗彻底改变了溃疡性结肠炎 (UC) 治疗方案。

      随着生物制剂的发展,越来越多的生物制剂开始进入临床实践中,如抗肿瘤坏死因子和维多珠单抗彻底改变了溃疡性结肠炎 (UC) 治疗方案。然而,目前这些疗法因缺乏有效性而受到限制,因为只有三分之一接受治疗的患者达到长期缓解。乌司奴单抗(Ustekinumab )是一种针对 IL-12/IL-23的全人源 IgG1 单克隆抗体,被批准用于治疗银屑病、银屑病关节炎和克罗恩病。III 期试验已经证明乌司奴单抗在溃疡性结肠炎 (UC) 中的有效性和安全性,但目前可用的现实生活中的长期数据很少。因此,本项研究旨在评估乌司奴单抗在 UC 患者中的真实的有效性和安全性。

 

      研究人员对2019 年 1 月至 9 月所有在 GETAID 中心接受乌司奴单抗治疗的连续活动性 UC 患者均纳入本项研究。在治疗的第 52 周对患者进行疾病严重程度的评估。疾病缓解定义为 Mayo Clinic 评分≤2。

 

      研究最后总共纳入了 103 名对免疫抑制剂、抗肿瘤坏死因子和/或维多珠单抗反应不足的 UC 患者(62 名男性;平均年龄:41.2 ± 16.2 岁;52% 为E3型全结肠炎)。在第 52 周时,45 名 (44%) 患者由于缺乏治疗有效性而停止使用乌司奴单抗。在 3、6、9 和 12 个月后,乌司奴单抗持续治疗的累积概率分别为 96.1%、81.6%、71.7% 和 58.4%。第 52 周的总体无类固醇临床缓解率为 32%,10 名患者在中位时间为 6.7 [4.3-10.6] 个月时接受了结肠切除术。在 15 名 (16.9%) 患者中观察到不良反应;4 人(4.5%)出现严重的不良反应,包括一名患者死于心肌梗塞。

图:

      本项研究证实52 周后,超过一半的难治性 UC 患者仍在接受乌司奴单抗治疗,三分之一患者可以长期处于无类固醇临床缓解期。

 

原始出处:

Mathurin Fumery. Et al. Effectiveness and safety of ustekinumab maintenance therapy in 103 patients with ulcerative colitis: a GETAID cohort study. Alimentary Pharmacology & Therapeutics.2021.

 

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    2021-12-30 nymo
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    2021-09-16 哈哈258

    乌司奴单抗

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    2021-09-15 ms2000000187312404

    积分

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