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评估阿达木单抗在真实世界 IBD 队列中对客观疾病监测和结局的依从性。

Assessing adherence to objective disease monitoring and outcomes with adalimumab in a real-world IBD cohort.

机构信息

McGill University, Division of Gastroenterology Department of Medicine, Montreal, Canada; University of Miami, Division of Gastroenterology, Miami, Florida, United States.

McGill University, Division of Gastroenterology Department of Medicine, Montreal, Canada.

出版信息

Dig Liver Dis. 2021 Aug;53(8):980-986. doi: 10.1016/j.dld.2021.02.006. Epub 2021 Feb 24.

Abstract

BACKGROUND

Data suggests that tight objective monitoring may improve clinical outcomes in IBD.

AIM

To assess the adherence to serial tight objective monitoring(clinical and biomarkers) and its effect on clinical outcomes.

METHODS

We retrospectively reviewed the chart of 428 consecutive IBD patients started on adalimumab between January 1,2015-January 1,2019 [338 Crohn's disease(CD), 90 ulcerative colitis(UC)]. Clinical symptoms(assessed by Harvey-Bradshaw-Index,partial Mayo),C-Reactive Protein(CRP), and fecal calprotectin(FCAL) assessments were captured at treatment initiation and at 3,6,9, and12 months. Dose optimization and drug sustainability curves were plotted by Kaplan-Meier method.

RESULTS

Clinical evaluation was available in nearly all patients at 3(CD-UC:95-94%), 6(90-83%), 9(86-85%) and 12(96-89%) months. CRP testing frequency decreased in CD patients over time. Compliance to serial FCAL testing was low. Clinical remission at one-year was higher in patients adherent to early assessment visit at 3 months(p = 0.001 for CD and UC). Adherence to early follow-up resulted in earlier dose optimization in CD and UC patients(pLogrank=0.026 for UC & p = 0.09 for CD). Overall drug sustainability did not differ.

CONCLUSION

Clinical & CRP, but not FCAL, were frequently assessed in patients starting adalimumab. Adherence to early objective combined follow-up visits resulted in earlier dose optimization, improved one-year clinical outcomes but did not change drug sustainability.

摘要

背景

数据表明,严格的目标监测可能改善 IBD 的临床结果。

目的

评估连续严格的目标监测(临床和生物标志物)的依从性及其对临床结果的影响。

方法

我们回顾性分析了 2015 年 1 月 1 日至 2019 年 1 月 1 日期间开始接受阿达木单抗治疗的 428 例连续 IBD 患者的图表[338 例克罗恩病(CD),90 例溃疡性结肠炎(UC)]。在治疗开始时以及 3、6、9 和 12 个月时,评估临床症状(采用 Harvey-Bradshaw 指数、部分 Mayo 评分)、C 反应蛋白(CRP)和粪便钙卫蛋白(FCAL)。通过 Kaplan-Meier 法绘制剂量优化和药物持续时间曲线。

结果

近所有患者在 3 个月(CD-UC:95-94%)、6 个月(90-83%)、9 个月(86-85%)和 12 个月(96-89%)时均有临床评估结果。CD 患者的 CRP 检测频率随时间降低。连续 FCAL 检测的依从性较低。在 3 个月时进行早期评估访视的患者在一年内达到临床缓解的比例更高(CD 和 UC 患者的 p 值均为 0.001)。CD 和 UC 患者坚持早期随访可更早地进行剂量优化(UC 的 pLogrank 值为 0.026,CD 的 p 值为 0.09)。总体药物可持续性没有差异。

结论

在开始使用阿达木单抗的患者中,经常评估临床和 CRP,但不评估 FCAL。坚持早期的客观联合随访可更早地进行剂量优化,改善一年的临床结果,但不会改变药物可持续性。

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