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回顾性理赔分析间接比较炎症性肠病中静脉生物制剂和口服小分子药物的药物依从性和持久性。

Retrospective Claims Analysis Indirectly Comparing Medication Adherence and Persistence Between Intravenous Biologics and Oral Small-Molecule Therapies in Inflammatory Bowel Diseases.

机构信息

U.S. Medical Affairs, Takeda Pharmaceuticals U.S.A., Inc., Deerfield, IL, USA.

Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.

出版信息

Adv Ther. 2019 Sep;36(9):2260-2272. doi: 10.1007/s12325-019-01037-x. Epub 2019 Aug 5.

Abstract

INTRODUCTION

Patients' adherence to and persistence on treatment for inflammatory bowel disease (IBD) can vary, depending on type and distribution of disease and treatment modality. We aim to identify differences in adherence and persistence with treatments with different administration routes (intravenous vs oral) in IBD.

METHODS

A retrospective cohort analysis of a claims database of adult patients diagnosed with IBD or rheumatoid arthritis (RA) who began treatment with vedolizumab, tofacitinib, or infliximab from January 2015 through December 2015. Adherence evaluated by proportion of days covered (PDC) and cumulative days with gaps at least 20% beyond expected interval (CG20) using multivariable generalized linear equation models. Persistence assessed as time to treatment discontinuation over 12 months of follow-up using Kaplan-Meier estimates and Cox proportional hazards models; proportion of persistent patients determined via multivariable logistic regression. Indirect comparisons across disease states adjusted using infliximab data.

RESULTS

After indirect adjustment by disease, mean PDC difference was significantly higher (difference of 4.7%; P = 0.0376) and mean CG20 was lower (difference of 15 days; P = 0.0646) but not statistically significant in vedolizumab/IBD than tofacitinib/RA.

CONCLUSION

We describe a novel adjustment method for interdisease treatment differences using infliximab treatment patterns to bridge differences between IBD and RA. After adjustment, adherence was higher with infusions than oral medications, which may affect outcomes. Indirect comparisons between vedolizumab and tofacitinib are not generalizable and should be confirmed in tofacitinib-treated IBD patients.

FUNDING

Takeda Pharmaceuticals U.S.A., Inc.

摘要

简介

炎症性肠病(IBD)患者对治疗的依从性和持久性因疾病类型和分布以及治疗方式而异。我们旨在确定不同给药途径(静脉内与口服)的治疗方法在 IBD 中的依从性和持久性差异。

方法

这是一项回顾性队列分析,对 2015 年 1 月至 2015 年 12 月期间开始接受维得利珠单抗、托法替布或英夫利昔单抗治疗的 IBD 或类风湿关节炎(RA)成年患者的索赔数据库进行分析。通过比例天数覆盖(PDC)和累积天数超过预期间隔至少 20%(CG20)的差距来评估依从性,使用多变量广义线性方程模型。使用 Kaplan-Meier 估计和 Cox 比例风险模型评估 12 个月随访期间的治疗终止时间,通过多变量逻辑回归确定持续治疗患者的比例。使用英夫利昔单抗数据对疾病状态进行间接比较,并进行调整。

结果

在疾病状态进行间接调整后,与托法替布/RA 相比,维得利珠单抗/IBD 的平均 PDC 差异显著更高(差异为 4.7%;P=0.0376),平均 CG20 更低(差异为 15 天;P=0.0646),但差异无统计学意义。

结论

我们描述了一种使用英夫利昔单抗治疗模式进行跨疾病治疗差异调整的新方法,以弥合 IBD 和 RA 之间的差异。调整后,输注治疗的依从性高于口服药物,这可能会影响结果。维得利珠单抗和托法替布之间的间接比较不可推广,应在接受托法替布治疗的 IBD 患者中进行确认。

资助

武田制药美国公司。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/619b/6822974/a329e7a42d2a/12325_2019_1037_Fig1_HTML.jpg

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