在患有活跃结性脊柱炎的患者中使用upadacitinib的疗效和安全性 (SELECT- AXIS 1):多中心,随机,双盲,安慰剂对照的2/3期试验
在PubMed上查看摘要
概括
此摘要是机器生成的。与安慰剂相比,Upadacitinib 15 mg在治疗活跃椎炎方面表现出显著的疗效. 在NSAID反应不足的患者中,JAK1抑制剂耐受性良好,显示出良好的安全性.
科学领域
- 关节病学
- 免疫学
- 药理学
背景情况
- 脊髓炎是一种慢性炎症性疾病.
- 亚努斯酶 (JAK) 途径与AS的发病有关.
- 针对JAK1使用选择性抑制剂如upadacitinib是一种潜在的治疗策略.
研究的目的
- 评估15毫克乌帕达西提尼的有效性和安全性在患有活跃椎炎的成年患者中.
- 在对非类固醇抗炎药物 (NSAIDs) 反应不充分或不耐受的患者中评估upadacitinib的有效性.
主要方法
- 进行了一项多中心,随机,双盲,安慰剂控制的2/3期研究 (SELECT- AXIS 1).
- 187名患有活跃AS的患者随机分别接受15毫克或安慰剂,每天服用一次,持续14周.
- 主要终点是第14周国际脊椎关节炎协会 (ASAS40) 的反应评估.
主要成果
- 在第14周 (p=0. 0003) 获得ASAS40反应的患者数量显著增加 (52%),而非安慰剂 (26%)
- 在upadacitinib组的62%和安慰剂组的55%报告了不良事件.
- 在upadacitinib组中,肌酸酶增加是最常见的不良事件;没有报告严重感染,恶性瘤或死亡.
结论
- 在NSAID反应不足的患者中,Upadacitinib 15 mg是有效的,耐受性良好.
- 这些研究结果支持进一步研究Upadacitinib用于轴性脊柱关节炎的治疗.
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