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巴瑞替尼留存率:来自一个类风湿性关节炎患者单中心队列的“真实世界”数据。

Baricitinib retention rate: 'real-life' data from a mono-centric cohort of patients affected by rheumatoid arthritis.

作者信息

Baldi Caterina, Berlengiero Virginia, Falsetti Paolo, Cartocci Alessandra, Conticini Edoardo, D'Alessandro Roberto, D'Ignazio Emilio, Bardelli Marco, Fabbroni Marta, Cantarini Luca, Frediani Bruno, Gentileschi Stefano

机构信息

Rheumatology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy.

Department of Medical Biotechnologies, University of Siena, Siena, Italy.

出版信息

Front Med (Lausanne). 2023 Jun 28;10:1176613. doi: 10.3389/fmed.2023.1176613. eCollection 2023.

DOI:10.3389/fmed.2023.1176613
PMID:37448804
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10336222/
Abstract

OBJECTIVES

The aim of this retrospective study was to evaluate baricitinib retention rate in patients affected by rheumatoid arthritis. Secondary aims were to compare the impact on treatment persistence of monotherapy and other variables such as systemic corticosteroid use, line of treatment, disease duration, sex, biomarkers positivity, and Herpes Zoster virus infection.

MATERIALS AND METHODS

Patients with Rheumatoid Arthritis undergoing baricitinib were consecutively enrolled. Rheumatoid Arthritis diagnosis was performed with 2010 ACR/EULAR classification criteria. The cohort's demographic, clinical and therapeutical data were retrospectively collected. The whole follow-up duration was 104 weeks.

RESULTS

Ninety-five patients affected by rheumatoid arthritis and treated with baricitinib were consecutively enrolled. At the end of follow-up, the overall retention rate was 69.3%. No statistically significant difference in retention rate was observed between patients treated with baricitinib in monotherapy or in combination with methotrexate ( = 0.638) while patients undergoing a steroidal treatment showed a significantly reduced treatment retention ( = 0.028). Contrarily, patients treated with baricitinib as a first-line b/tsDMARD showed higher drug retention ( = 0.002) compared to further treatment lines. Steroid employment, steroid dosage and previous treatment with bDMARDs correlated with risk of treatment discontinuation and at univariate analysis ( = 0.028,  < 0.001, and  = 0.002 respectively). Multivariate analysis confirmed significance for higher steroid dosage and previous treatment with bDMARDs ( = 0.002 and  = 0.046). No adverse events such as deep venous thrombosis, pulmonary embolism or tubercular infection/reactivation were reported during the study observation.

CONCLUSION

Our data show a good baricitinib retention rate after 12 and 24 months of observation (75.1 and 69.3%, respectively). In our cohort, concomitant treatment with methotrexate did not influence treatment persistence while retention was reduced in patients undergoing a steroidal treatment and/or in multi-failure subjects.

摘要

目的

本回顾性研究旨在评估类风湿关节炎患者中巴瑞替尼的保留率。次要目的是比较单药治疗以及其他变量(如全身使用糖皮质激素、治疗线数、病程、性别、生物标志物阳性情况和带状疱疹病毒感染)对治疗持续性的影响。

材料与方法

连续纳入接受巴瑞替尼治疗的类风湿关节炎患者。根据2010年美国风湿病学会(ACR)/欧洲抗风湿病联盟(EULAR)分类标准进行类风湿关节炎诊断。回顾性收集该队列的人口统计学、临床和治疗数据。整个随访期为104周。

结果

连续纳入95例接受巴瑞替尼治疗的类风湿关节炎患者。随访结束时,总体保留率为69.3%。单药使用巴瑞替尼或与甲氨蝶呤联合使用巴瑞替尼的患者之间,保留率无统计学显著差异(P = 0.638),而接受甾体治疗的患者治疗保留率显著降低(P = 0.028)。相反,与后续治疗线相比,作为一线生物制剂改善病情抗风湿药物(b/tsDMARD)使用巴瑞替尼的患者药物保留率更高(P = 0.002)。在单因素分析中,甾体使用、甾体剂量和既往使用生物制剂改善病情抗风湿药物(bDMARDs)与治疗中断风险相关(分别为P = 0.028、P < 0.001和P = 0.002)。多因素分析证实较高的甾体剂量和既往使用bDMARDs具有显著性(P = 0.002和P = 0.046)。在研究观察期间,未报告深静脉血栓形成、肺栓塞或结核感染/再激活等不良事件。

结论

我们的数据显示,观察12个月和24个月后,巴瑞替尼的保留率良好(分别为75.1%和69.3%)。在我们的队列中,与甲氨蝶呤联合治疗不影响治疗持续性,而接受甾体治疗的患者和/或多次治疗失败的患者保留率降低。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ffa/10336222/c54b67f75021/fmed-10-1176613-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ffa/10336222/80ff73d02537/fmed-10-1176613-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ffa/10336222/c54b67f75021/fmed-10-1176613-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ffa/10336222/80ff73d02537/fmed-10-1176613-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ffa/10336222/c54b67f75021/fmed-10-1176613-g002.jpg

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