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生物治疗起始的炎症性肠病患者在治疗依从性和持久性方面的种族或民族差异。

Racial or ethnic differences on treatment adherence and persistence among patients with inflammatory bowel diseases initiated with biologic therapies.

机构信息

Janssen Scientific Affairs, LLC, 1125 Trenton Harbourton Rd, Titusville, NJ, 08560, USA.

Janssen Scientific Affairs, LLC, 800 Ridgeview Drive, Horsham, PA, 19044, USA.

出版信息

BMC Gastroenterol. 2022 Dec 29;22(1):545. doi: 10.1186/s12876-022-02560-y.

Abstract

BACKGROUND

Inflammatory bowel disease (IBD) is a chronic disease with the potential for significant morbidity in case of suboptimal treatment (e.g. low treatment adherence). In spite of immense research in IBD, literature on association of IBD with race/ethnicity is fragmented. In this study, we aimed to evaluate the association between race/ethnicity and treatment adherence and persistence among patients with Crohn's disease (CD) or ulcerative colitis (UC) initiated with biologic therapies.

METHODS

This observational, retrospective study utilized the Optum Clinformatics (Optum) Extended Data Mart Socioeconomic Status (SES) database. Adult patients with ≥ 2 medical claims for CD or UC diagnosis, ≥ 1 medical or pharmacy claim for corresponding FDA-approved biologic therapy, and a ≥ 12-month pre-index (index date: date of the first biologic medical/pharmacy claim) continuous health plan enrollment were included. Treatment adherence was measured as the proportion of days covered of ≥ 80% and treatment persistence by the number of days from the index date to the biologics discontinuation date. Switching among biologics was allowed for both treatment adherence and treatment persistence. Multivariable regression analyses were performed to evaluate the association between race/ethnicity and treatment adherence/persistence.

RESULTS

Among patients with CD (N = 1430) and UC (N = 1059) included, majority were White (CD: 80.3%, UC: 78.3%), followed by African Americans (AA; CD: 10.5%, UC: 9.7%). Among patients with CD, AA were significantly less likely to adhere to biologics (adjusted OR [95%CI]: 0.61 [0.38; 0.99]) and more likely to discontinue biologics earlier (adjusted HR [95%CI]: 1.52 [1.16; 2.0]) during the follow-up period compared to Whites, after adjusting for other patient sociodemographic and clinical characteristics. Among patients with UC, no significant differences in the treatment adherence/persistence were observed between different races/ethnicities.

CONCLUSIONS

Patients with CD were found to display racial differences in the treatment adherence and persistence of biologics, with significantly lower adherence and earlier discontinuation in AA compared to Whites. Such differences were not observed in patients with UC. Future studies are warranted to understand the possible reasons for racial differences, particularly in patients with CD.

摘要

背景

炎症性肠病(IBD)是一种慢性病,如果治疗效果不理想(例如治疗依从性低),可能会导致严重的发病率。尽管在 IBD 方面进行了大量研究,但关于 IBD 与种族/民族的关联的文献仍然很分散。在这项研究中,我们旨在评估种族/民族与接受生物治疗的克罗恩病(CD)或溃疡性结肠炎(UC)患者的治疗依从性和持久性之间的关联。

方法

这是一项观察性、回顾性研究,利用了 Optum Clinformatics(Optum)扩展数据集市社会经济地位(SES)数据库。纳入了至少有 2 次 CD 或 UC 诊断的医疗索赔、至少有 1 次相应的 FDA 批准的生物治疗的医疗或药房索赔,以及索引日期(首次生物医学/药房索赔日期)前至少 12 个月连续健康计划参保的成年患者。治疗依从性的衡量标准是≥80%的天数覆盖率,治疗持久性的衡量标准是从索引日期到生物制剂停药日期的天数。对于治疗依从性和治疗持久性,均允许在生物制剂之间进行转换。采用多变量回归分析评估种族/民族与治疗依从性/持久性之间的关联。

结果

在纳入的 CD 患者(N=1430)和 UC 患者(N=1059)中,大多数是白人(CD:80.3%,UC:78.3%),其次是非裔美国人(AA;CD:10.5%,UC:9.7%)。与白人相比,CD 患者中的 AA 明显不太可能遵守生物制剂治疗(调整后的比值比[95%CI]:0.61[0.38;0.99]),并且在随访期间更有可能提前停用生物制剂(调整后的 HR[95%CI]:1.52[1.16;2.0]),在调整了其他患者的社会人口统计学和临床特征后。在 UC 患者中,不同种族/民族之间的治疗依从性/持久性没有观察到显著差异。

结论

发现 CD 患者在生物制剂的治疗依从性和持久性方面存在种族差异,与白人相比,AA 的依从性明显较低,停药时间更早。在 UC 患者中没有观察到这种差异。需要进一步研究以了解种族差异的可能原因,特别是在 CD 患者中。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/05ea/9801546/1ba7ecb5c4c9/12876_2022_2560_Fig1_HTML.jpg

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