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溃疡性结肠炎中生物制剂的剂量升级和转换:真实世界证据的系统文献回顾。

Dose escalation and switching of biologics in ulcerative colitis: a systematic literature review in real-world evidence.

机构信息

Health Economics & Market Access (HEMA), Amaris Consulting Ltd , Barcelona , Spain.

Health Economics & Market Access (HEMA), Amaris Consulting Ltd , London , UK.

出版信息

Curr Med Res Opin. 2019 Nov;35(11):1911-1923. doi: 10.1080/03007995.2019.1631058. Epub 2019 Jul 19.

Abstract

Biologics used to treat ulcerative colitis (UC) may lose their effect over time, requiring patients to undergo dose escalation or treatment switching, and systematic literature reviews of real-world evidence on these topics are lacking. To summarize the occurrence and outcomes of dose escalation and treatment switching in UC patients in real-world evidence. Studies were searched through MEDLINE, MEDLINE IN PROCESS, Embase and Cochrane (2006-2017) as well as proceedings from three major scientific meetings. In total, 41 studies were included in the review among which 35 covered dose escalation and 12 covered treatment switching of biologics. Tumor necrosis factor antagonist (anti-TNF) escalation for all patients included at induction ranged from 5% (6 months) to 50% (median 0.67 years) and 15.2% to 70.8% (8 weeks) for anti-TNF induction responders. Mean/median time to dose escalation on anti-TNF ranged from 1.84 to 11 months. The most common switching pattern, infliximab → adalimumab, occurred in 3.8% (median 5.6 years) to 25.5% (mean 3.3 years) of patients. Dose escalation and treatment switching of biologics may be considered as indicators of suboptimal therapy suggesting a lack of long-term remission and response under current therapies.

摘要

生物制剂用于治疗溃疡性结肠炎(UC)可能会随着时间的推移失去疗效,需要患者增加剂量或更换治疗方案,但目前缺乏关于这些主题的真实世界证据的系统文献综述。 总结生物制剂在真实世界证据中治疗 UC 患者时的剂量增加和治疗转换的发生和结局。 通过 MEDLINE、MEDLINE IN PROCESS、Embase 和 Cochrane(2006-2017)以及三次主要科学会议的会议记录进行研究检索。 共纳入 41 项研究,其中 35 项研究涵盖了生物制剂的剂量增加,12 项研究涵盖了生物制剂的治疗转换。 在诱导期纳入的所有患者中,肿瘤坏死因子拮抗剂(anti-TNF)的升级范围从 5%(6 个月)到 50%(中位数 0.67 年)和 15.2%到 70.8%(8 周),用于诱导应答者的 anti-TNF 诱导。 anti-TNF 的剂量升级中位时间为 1.84 至 11 个月。最常见的转换模式是 infliximab → adalimumab,在 3.8%(中位数 5.6 年)至 25.5%(平均 3.3 年)的患者中发生。 生物制剂的剂量增加和治疗转换可能被认为是治疗效果不理想的指标,表明在当前治疗下缺乏长期缓解和应答。

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