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西班牙类风湿关节炎患者使用巴瑞替尼与其他疗法治疗的患者概况及结局:RA-BE-REAL研究

Patient Profile and Outcomes Among Patients with Rheumatoid Arthritis Treated with Baricitinib Versus Other Therapies in Spain: The RA-BE-REAL Study.

作者信息

García-Vivar Mª Luz, Prior-Español Águeda, Fakhouri Walid, Díaz-Cerezo Silvia, Aguirregabiria Itxaso, Moyano Sebastián, Cobo Amelia, Ogwu Samuel, Trenor Pilar

机构信息

Reumatology Department, Basurto University Hospital, Bilbao, Basque Country, Spain.

Reumatology Department, Germans Trias i Pujol University Hospital, Barcelona, Spain.

出版信息

Rheumatol Ther. 2025 Jul 7. doi: 10.1007/s40744-025-00781-7.

Abstract

INTRODUCTION

Rheumatoid arthritis (RA) is a chronic autoimmune disorder characterized by joint inflammation and pain. Baricitinib, a targeted JAK inhibitor indicated for moderate to severe RA, has shown efficacy and safety, but real-world data on effectiveness and discontinuation rates are limited. This study aimed to report time to discontinuation, effectiveness, and patient-reported outcomes in patients initiating baricitinib or other biologic/targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) in the Spanish clinical practice.

METHODS

The subgroup from 11 Spanish hospitals in the multinational prospective RA-BE-REAL study was analysed. Patients treated for the first time with baricitinib or other b/tsDMARD were included. The primary objective was time to all-cause discontinuation of treatment at 24 months. Secondary objectives included assessing baseline characteristics, treatment patterns, and effectiveness on disease activity, health-related quality of life (HRQoL) and pain. Statistical analyses were descriptive in nature.

RESULTS

Eighty patients initiating baricitinib (cohort A, n = 31) or any b/tsDMARD (cohort B, n = 49) were included. Most patients were women, with mean age 62.6 and 57.0 years, respectively; 58.1% in cohort A and 40.8% in cohort B had prior b/tsDMARD treatment. After 24 months, 61.3% and 44.9% continued their initial treatment, respectively. Main reason for discontinuation was secondary loss of response (19.4% and 26.5%, respectively). After 3 months, both cohorts showed improvements in disease activity, swollen and tender joint counts, physician and patient global assessments, disability, pain, and HRQoL. This trend to improvement was maintained for up to 24 months, suggesting a rapid and sustained response. At 24 months, 46.4% and 29.3% achieved low disease activity; 10.7% and 26.8% achieved remission, respectively.

CONCLUSION

The study suggests that baricitinib, despite being used in an older and more treatment-experienced cohort, shows comparable effectiveness and a trend towards lower discontinuation rates for up to 24 months, reinforcing its potential as a treatment option.

摘要

引言

类风湿性关节炎(RA)是一种以关节炎症和疼痛为特征的慢性自身免疫性疾病。巴瑞替尼是一种用于治疗中度至重度RA的靶向JAK抑制剂,已显示出疗效和安全性,但关于其有效性和停药率的真实世界数据有限。本研究旨在报告西班牙临床实践中开始使用巴瑞替尼或其他生物制剂/靶向合成改善病情抗风湿药(b/tsDMARD)的患者的停药时间、有效性和患者报告的结局。

方法

对多国前瞻性RA-BE-REAL研究中来自11家西班牙医院的亚组进行分析。纳入首次接受巴瑞替尼或其他b/tsDMARD治疗的患者。主要目标是24个月时全因停药时间。次要目标包括评估基线特征、治疗模式以及对疾病活动、健康相关生活质量(HRQoL)和疼痛的有效性。统计分析本质上是描述性的。

结果

纳入了80例开始使用巴瑞替尼(A组,n = 31)或任何b/tsDMARD(B组,n = 49)的患者。大多数患者为女性,平均年龄分别为62.6岁和57.0岁;A组58.1%和B组40.8%的患者曾接受过b/tsDMARD治疗。24个月后,分别有61.3%和44.9%的患者继续接受初始治疗。停药的主要原因是继发性反应丧失(分别为19.4%和26.5%)。3个月后,两组患者的疾病活动、肿胀和压痛关节计数、医生和患者整体评估、残疾、疼痛及HRQoL均有改善。这种改善趋势持续至24个月,表明反应迅速且持久。24个月时,46.4%和29.3%的患者达到低疾病活动度;分别有10.7%和26.8%的患者达到缓解。

结论

该研究表明,尽管巴瑞替尼用于年龄较大且治疗经验较多的队列,但在长达24个月的时间里,其有效性相当且停药率有降低趋势,强化了其作为一种治疗选择的潜力。

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