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2015-2020 年丹麦基于人群的队列研究:生物治疗在克罗恩病和溃疡性结肠炎中的药物利用情况。

Drug utilization of biologic therapy in Crohn's disease and ulcerative colitis: a population-based Danish cohort study 2015-2020.

机构信息

Copenhagen Phase IV Unit (Phase4CPH), Department of Clinical Pharmacology and Center for Clinical Research and Prevention, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark.

Janssen Cilag AB, Solna, Sweden.

出版信息

Scand J Gastroenterol. 2023 Jul;58(7):726-736. doi: 10.1080/00365521.2023.2173988. Epub 2023 Feb 21.

Abstract

OBJECTIVE

The aim of the study was to characterize the drug utilization and switch patterns of biological treatment of ulcerative colitis (UC) and Crohn's disease (CD).

METHODS

Using Danish national registries, this nationwide study included individuals diagnosed with UC or CD, bio-naïve at the initiation of treatment with infliximab, adalimumab, vedolizumab, golimumab, or ustekinumab in 2015-2020. Hazard ratios of discontinuing the first treatment or switching to another biological treatment were explored using Cox regression.

RESULTS

Among 2995 UC patients and 3028 CD patients, infliximab was used as a first-line biologic treatment in 89% of UC patients and 85% of CD patients, followed by adalimumab with 6%, vedolizumab with 3%, and golimumab with 1% for UC, and adalimumab with 12%, vedolizumab with 2%, and ustekinumab with 0.4% for CD.When comparing adalimumab as the first treatment series to infliximab, there was a higher risk of treatment discontinuation (excluding switch) among UC patients (hazard ratio: 2.02 [95% confidence interval: 1.57; 2.60]) and CD patients (1.85 [1.52; 2.24]). When comparing vedolizumab to infliximab, there was a lower risk of discontinuation for UC patients (0.51 [0.29-0.89]), and for CD patients, although not significantly (0.58 [0.32-1.03]). We observed no significant difference in the risk of switching to another biologic treatment for any of the biologics.

CONCLUSION

More than 85% of UC and CD patients initiating biologic therapy had infliximab as their first-line biologic treatment, in accordance with official treatment guidelines. Future studies should explore the higher incidence of treatment discontinuation of adalimumab as the first treatment series.Key summarySeveral biologic therapies are available in the treatment of ulcerative colitis and Crohn's disease.Clinical guidelines stipulate that infliximab should be the first-line biologic therapy.Drug utilization studies comparing biologic therapies head-to-head are sparse.In Denmark, during 2015-2020 infliximab remained the most widely used biologic treatment, with adalimumab being second.One in four patients experienced more than one biologic during the study period.The risk of discontinuation of biologic treatment (and not starting a new biologic) was higher for initiators of adalimumab.Clinical and social background factors available from the registers could not account for the observed risk difference in discontinuation.

摘要

目的

本研究旨在描述溃疡性结肠炎(UC)和克罗恩病(CD)生物治疗的药物利用和转换模式。

方法

本项全国性研究使用丹麦国家登记处,纳入了 2015 年至 2020 年期间首次接受英夫利昔单抗、阿达木单抗、维得利珠单抗、戈利木单抗或乌司奴单抗治疗的 UC 或 CD 初治患者。采用 Cox 回归分析探讨停止首次治疗或转换为另一种生物治疗的风险比。

结果

在 2995 例 UC 患者和 3028 例 CD 患者中,89%的 UC 患者和 85%的 CD 患者首先使用英夫利昔单抗作为生物一线治疗,其次是阿达木单抗(分别为 6%和 12%)、维得利珠单抗(分别为 3%和 2%)和戈利木单抗(分别为 1%和 0.4%)。对于 UC 患者,与英夫利昔单抗相比,起始阿达木单抗治疗的停药(不包括转换)风险更高(风险比:2.02[95%置信区间:1.57;2.60]);对于 CD 患者,该风险比为 1.85[1.52;2.24]。对于 UC 患者,与英夫利昔单抗相比,起始维得利珠单抗治疗的停药风险较低(0.51[0.29-0.89]);对于 CD 患者,虽然没有显著差异(0.58[0.32-1.03])。对于任何一种生物制剂,我们均未观察到转换为另一种生物制剂治疗的风险存在显著差异。

结论

与官方治疗指南一致,超过 85%的 UC 和 CD 患者在开始生物治疗时使用英夫利昔单抗作为一线生物治疗药物。未来的研究应探讨起始阿达木单抗治疗的更高停药发生率。

关键总结

几种生物疗法可用于治疗溃疡性结肠炎和克罗恩病。临床指南规定,英夫利昔单抗应作为生物治疗的一线药物。头对头比较生物疗法药物利用的研究较少。在丹麦,2015-2020 年期间,英夫利昔单抗仍然是最广泛使用的生物治疗药物,阿达木单抗位居第二。在研究期间,四分之一的患者使用了不止一种生物制剂。起始阿达木单抗的患者,其生物治疗停药(而非开始新的生物治疗)风险更高。来自登记处的临床和社会背景因素无法解释观察到的停药风险差异。

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