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炎症性肠病患者自我注射生物制剂治疗依从性的多中心研究:危险因素与结局

Multicenter Study of Nonadherence to Self-Injectable Biologic Therapy in Patients With Inflammatory Bowel Disease: Risk Factors and Outcomes.

作者信息

George Lauren A, Causey Erin, Shah Nisha B, Slaughter James C, Jerabek Jonah, Zuckerman Autumn D, Chhen Susan, Scoville Elizabeth, Dalal Robin, Beaulieu Dawn B, Pabla Baldeep, Schwartz David A, Cross Raymond K, Vaughn Byron P, Horst Sara

机构信息

Division of Gastroenterology & Hepatology, University of Maryland School of Medicine, Baltimore, Maryland.

Vanderbilt Specialty Pharmacy, Vanderbilt University Medical Center, Nashville, Tennessee.

出版信息

Gastro Hep Adv. 2023 Jan 30;2(4):601-607. doi: 10.1016/j.gastha.2023.01.016. eCollection 2023.

Abstract

BACKGROUND AND AIMS

This study aimed to evaluate adherence to subcutaneous biologic therapy and impact of nonadherence including risk factors and outcomes in academic centers with integrated specialty pharmacies for patients with inflammatory bowel disease (IBD).

METHODS

This was a multicenter, retrospective cohort analysis of patients aged ≥18 years receiving care in 3 tertiary care outpatient IBD clinics with integrated specialty pharmacies. Subjects were prescribed injectable anti-TNF therapy (adalimumab, certolizumab, golimumab) or anti-IL 12/23 therapy (ustekinumab) with at least 3 consecutive prescription claims. The primary outcomes were medication possession ratio (MPR), percent achieving optimal adherence (MPR > 0.86); in addition, we sought to verify a prior risk factor model including smoking status, narcotic use, psychiatric history, and prior biologic use. Secondary outcomes included emergency department visits (ED) and IBD-related hospitalizations. Statistical analysis was performed using Wilcox rank sum test, Pearson's Chi-squared test, and logistic regression model as an unordered, factor variable to flexibly estimate the probabilities of adherence.

RESULTS

Six hundred eight subjects were included. Overall median MPR was 0.95 (interquartile range 0.47, 1) and adherence was 68%-70%. When the number of risk factors for nonadherence increased, the likelihood of nonadherence increased ( < .05). In unadjusted and adjusted analysis, nonadherence increased the likelihood of ED visits [rate ratio 1.45 (95% confidence interval 1.05, 1.97)] and hospitalizations [rate ratio 1.60 (95% confidence interval 1.16, 2.10)].

CONCLUSION

Academic centers with integrated pharmacies had high adherence. Prior risk factors for nonadherence remained significant in this multicenter model. Nonadherence was associated with higher likelihood of hospitalizations and ED visits.

摘要

背景与目的

本研究旨在评估炎症性肠病(IBD)患者在设有综合专科药房的学术中心接受皮下生物治疗的依从性以及不依从的影响,包括危险因素和结局。

方法

这是一项多中心回顾性队列分析,纳入年龄≥18岁、在3家设有综合专科药房的三级护理门诊IBD诊所接受治疗的患者。受试者接受了至少3次连续处方的注射用抗TNF治疗(阿达木单抗、赛妥珠单抗、戈利木单抗)或抗IL 12/23治疗(乌司奴单抗)。主要结局为药物持有率(MPR)、达到最佳依从性(MPR>0.86)的百分比;此外,我们试图验证一个先前的危险因素模型,包括吸烟状况、麻醉药品使用、精神病史和先前的生物制剂使用情况。次要结局包括急诊就诊(ED)和IBD相关住院。使用Wilcox秩和检验、Pearson卡方检验以及逻辑回归模型进行统计分析,将其作为无序因素变量以灵活估计依从性概率。

结果

共纳入608名受试者。总体MPR中位数为0.95(四分位间距0.47,1),依从率为68%-70%。当不依从的危险因素数量增加时,不依从的可能性增加(P<.05)。在未调整和调整分析中,不依从增加了急诊就诊的可能性[率比1.45(95%置信区间1.05,1.97)]和住院的可能性[率比1.60(95%置信区间1.16,2.10)]。

结论

设有综合药房的学术中心依从性较高。在这个多中心模型中,先前的不依从危险因素仍然具有显著性。不依从与更高的住院和急诊就诊可能性相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b311/11308063/89ced4966bbf/gr1.jpg

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