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炎症性肠病患者生物制剂使用模式的10年:治疗持续性、转换和剂量强化——一项基于全国人口的研究

10 years of biologic use patterns in patients with inflammatory bowel disease: treatment persistence, switching and dose intensification - a nationwide population-based study.

作者信息

Koo Hee Moon, Jun Yu Kyung, Choi Yonghoon, Shin Cheol Min, Park Young Soo, Kim Nayoung, Lee Dong Ho, Shin Young Kee, Yoon Hyuk

机构信息

Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, South Korea.

Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.

出版信息

Therap Adv Gastroenterol. 2023 Sep 29;16:17562848231201728. doi: 10.1177/17562848231201728. eCollection 2023.

Abstract

BACKGROUND

Treatments for inflammatory bowel diseases (IBD) have evolved in the era of biologics. However, the real-world data on their usage patterns and sequencing are still limited.

OBJECTIVES

We aimed to investigate treatment persistence and dose intensification of first- and second-line biologics in patients with IBD.

DESIGN

In this retrospective, cohort study using nationwide claims data, 13,087 patients with IBD initiating biologic therapy between 2010 and 2020 were identified.

METHODS

Treatment persistence and dose intensification during the first 2 years and switching patterns of biologics were analysed while identifying predictors of non-persistence.

RESULTS

As a first-line treatment of Crohn's disease (CD), ustekinumab had a lower risk for non-persistence compared to infliximab [adjusted hazard ratio (aHR), 0.69,  = 0.048]. Second-line ustekinumab and vedolizumab showed the highest and lowest persistence (79.2% and 54.9%), respectively. As a first-line treatment of ulcerative colitis (UC), golimumab had a higher risk for non-persistence compared to infliximab (aHR, 1.68,  < 0.001). Second-line golimumab also showed a significantly lower persistence rate than adalimumab and vedolizumab. The risk of non-persistence was higher in UC than in CD (first line: aHR, 1.97; second line: aHR, 1.39;  < 0.001), and in the second-line treatment than in the first-line treatment for CD (aHR, 1.55;  < 0.001). The cumulative rate of dose intensification was highest with ustekinumab for CD (first line, 43.3%, second line, 69.1%) and adalimumab for second-line UC (40.7%). It was significantly increased in second-line therapy in CD, but not in UC. Among switchers of first-line anti-tumour necrosis factor-α inhibitor therapy, after all biologics were approved, 69% of CD patients and 78.4% of UC patients switched to other classes of second-line treatment.

CONCLUSION

Ustekinumab had higher persistence in the first-line treatment of CD, while golimumab had lower persistence for first- and second-line treatments of UC. Dose intensification rates varied, with the highest cumulative rates observed for ustekinumab in CD and adalimumab in second-line UC.

摘要

背景

在生物制剂时代,炎症性肠病(IBD)的治疗方法不断发展。然而,关于其使用模式和用药顺序的真实世界数据仍然有限。

目的

我们旨在调查IBD患者一线和二线生物制剂的治疗持续性和剂量强化情况。

设计

在这项使用全国索赔数据的回顾性队列研究中,确定了2010年至2020年间开始生物治疗的13087例IBD患者。

方法

分析了前2年的治疗持续性、剂量强化情况以及生物制剂的转换模式,同时确定了治疗不持续的预测因素。

结果

作为克罗恩病(CD)的一线治疗药物,与英夫利昔单抗相比,优特克单抗治疗不持续的风险较低[调整后风险比(aHR),0.69,P = 0.048]。二线优特克单抗和维得利珠单抗的持续性最高和最低,分别为79.2%和54.9%。作为溃疡性结肠炎(UC)的一线治疗药物,与英夫利昔单抗相比,戈利木单抗治疗不持续的风险较高(aHR,1.68,P < 0.001)。二线戈利木单抗的持续性也显著低于阿达木单抗和维得利珠单抗。UC患者治疗不持续的风险高于CD患者(一线:aHR,1.97;二线:aHR,1.39;P < 0.001),且CD的二线治疗中治疗不持续的风险高于一线治疗(aHR,1.55;P < 0.001)。CD患者使用优特克单抗时剂量强化的累积率最高(一线为43.3%,二线为69.1%),二线UC患者使用阿达木单抗时剂量强化的累积率最高(40.7%)。CD的二线治疗中剂量强化显著增加,但UC中未增加。在一线抗肿瘤坏死因子-α抑制剂治疗的转换者中,在所有生物制剂获批后,69%的CD患者和78.4%的UC患者转换为其他类别的二线治疗。

结论

优特克单抗在CD的一线治疗中持续性较高,而戈利木单抗在UC的一线和二线治疗中持续性较低。剂量强化率各不相同,CD中优特克单抗和二线UC中阿达木单抗的累积率最高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d4d3/10541745/dd9a32818721/10.1177_17562848231201728-fig1.jpg

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