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巴瑞替尼对难治性类风湿关节炎患者是否有效且安全?与非难治性类风湿关节炎组的比较数据。

Is Baricitinib Effective and Safe for Patients with Difficult-to-Treat Rheumatoid Arthritis? Comparative Data with the Rheumatoid Arthritis Group of Rheumatoid Arthritis Not Difficult to Treat.

作者信息

Ekin Ali, Misirci Salim, Görünen Ahmet, Coskun Belkis Nihan, Yagiz Burcu, Dalkilic Ediz, Pehlivan Yavuz

机构信息

Division of Rheumatology, Department of Internal Medicine, Uludag University Faculty of Medicine, Bursa, Turkey.

Department of Internal Medicine, Uludag University Faculty of Medicine, Bursa, Turkey.

出版信息

Med Princ Pract. 2025;34(1):75-86. doi: 10.1159/000541488. Epub 2024 Sep 17.

Abstract

OBJECTIVE

This study investigates the efficacy and safety of baricitinib, an oral targeted synthetic disease-modifying antirheumatic drugs (DMARDs), in patients with difficult-to-treat rheumatoid arthritis (D2T RA) compared to those without, aiming to determine its potential as an alternative treatment for D2T RA.

SUBJECT AND METHODS

A total of 78 patients participated in this retrospective cohort study, with 33 meeting the D2T RA criteria and 45 in the non-D2T RA group. Various clinical and laboratory parameters, adverse events, and disease activity indices were assessed, alongside drug efficacy and survival rates.

RESULTS

Patients with D2T RA exhibited higher seronegativity, prior use of b-DMARDs and c-DMARDs, and longer disease duration. Both groups experienced reductions in VAS and DAS28 scores, as well as SDAI, CDAI, HAQ, CRP, and ESR levels at baseline and 3, 6, and 12 months post-baricitinib initiation, with sustained efficacy observed over 12 months. The most prevalent adverse event was infection (28.21%). Although initial drug survival rates were similar between groups, the non-D2T RA group demonstrated higher rates at 24 months (46.70% vs. 59.40%). Subgroup analyses showed comparable survival rates between D2T RA and non-D2T RA groups, whether treated with baricitinib alone or in combination with methotrexate or leflunomide.

CONCLUSION

Despite potential treatment resistance, patients meeting the D2T RA criteria shared similar safety and efficacy profiles with those non-D2T RA. Baricitinib emerges as a promising treatment option for D2T RA patients, offering effectiveness and safety comparable to the non-D2T RA group.

OBJECTIVE

This study investigates the efficacy and safety of baricitinib, an oral targeted synthetic disease-modifying antirheumatic drugs (DMARDs), in patients with difficult-to-treat rheumatoid arthritis (D2T RA) compared to those without, aiming to determine its potential as an alternative treatment for D2T RA.

SUBJECT AND METHODS

A total of 78 patients participated in this retrospective cohort study, with 33 meeting the D2T RA criteria and 45 in the non-D2T RA group. Various clinical and laboratory parameters, adverse events, and disease activity indices were assessed, alongside drug efficacy and survival rates.

RESULTS

Patients with D2T RA exhibited higher seronegativity, prior use of b-DMARDs and c-DMARDs, and longer disease duration. Both groups experienced reductions in VAS and DAS28 scores, as well as SDAI, CDAI, HAQ, CRP, and ESR levels at baseline and 3, 6, and 12 months post-baricitinib initiation, with sustained efficacy observed over 12 months. The most prevalent adverse event was infection (28.21%). Although initial drug survival rates were similar between groups, the non-D2T RA group demonstrated higher rates at 24 months (46.70% vs. 59.40%). Subgroup analyses showed comparable survival rates between D2T RA and non-D2T RA groups, whether treated with baricitinib alone or in combination with methotrexate or leflunomide.

CONCLUSION

Despite potential treatment resistance, patients meeting the D2T RA criteria shared similar safety and efficacy profiles with those non-D2T RA. Baricitinib emerges as a promising treatment option for D2T RA patients, offering effectiveness and safety comparable to the non-D2T RA group.

摘要

目的

本研究调查了口服靶向合成抗风湿药物(DMARDs)巴瑞替尼在难治性类风湿关节炎(D2T RA)患者与非难治性患者中的疗效和安全性,旨在确定其作为D2T RA替代治疗的潜力。

受试者与方法

共有78名患者参与了这项回顾性队列研究,其中33名符合D2T RA标准,45名在非D2T RA组。评估了各种临床和实验室参数、不良事件以及疾病活动指数,同时评估了药物疗效和生存率。

结果

D2T RA患者表现出更高的血清阴性、先前使用过b - DMARDs和c - DMARDs以及更长的病程。两组在基线以及开始使用巴瑞替尼后的3个月、6个月和12个月时,视觉模拟评分(VAS)和疾病活动度评分28(DAS28)以及简化疾病活动指数(SDAI)、临床疾病活动指数(CDAI)、健康评估问卷(HAQ)、C反应蛋白(CRP)和红细胞沉降率(ESR)水平均有所降低,且在12个月内观察到持续疗效。最常见的不良事件是感染(28.21%)。尽管两组初始药物生存率相似,但非D2T RA组在24个月时的生存率更高(46.70%对59.40%)。亚组分析显示,无论单独使用巴瑞替尼还是与甲氨蝶呤或来氟米特联合使用,D2T RA组和非D2T RA组的生存率相当。

结论

尽管存在潜在的治疗抵抗,但符合D2T RA标准的患者与非D2T RA患者具有相似的安全性和疗效特征。巴瑞替尼成为D2T RA患者一种有前景的治疗选择,其有效性和安全性与非D2T RA组相当。

目的

本研究调查了口服靶向合成抗风湿药物(DMARDs)巴瑞替尼在难治性类风湿关节炎(D2T RA)患者与非难治性患者中的疗效和安全性,旨在确定其作为D2T RA替代治疗的潜力。

受试者与方法

共有78名患者参与了这项回顾性队列研究,其中33名符合D2T RA标准,45名在非D2T RA组。评估了各种临床和实验室参数、不良事件以及疾病活动指数,同时评估了药物疗效和生存率。

结果

D2T RA患者表现出更高的血清阴性、先前使用过b - DMARDs和c - DMARDs以及更长的病程。两组在基线以及开始使用巴瑞替尼后的3个月、6个月和12个月时,视觉模拟评分(VAS)和疾病活动度评分28(DAS28)以及简化疾病活动指数(SDAI)、临床疾病活动指数(CDAI)、健康评估问卷(HAQ)、C反应蛋白(CRP)和红细胞沉降率(ESR)水平均有所降低,且在12个月内观察到持续疗效。最常见的不良事件是感染(28.21%)。尽管两组初始药物生存率相似,但非D2T RA组在24个月时的生存率更高(46.70%对59.40%)。亚组分析显示,无论单独使用巴瑞替尼还是与甲氨蝶呤或来氟米特联合使用,D2T RA组和非D2T RA组的生存率相当。

结论

尽管存在潜在的治疗抵抗,但符合D2T RA标准的患者与非D2T RA患者具有相似的安全性和疗效特征。巴瑞替尼成为D2T RA患者一种有前景的治疗选择,其有效性和安全性与非D2T RA组相当。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e787/11805541/fb6400d05414/mpp-2025-0034-0001-541488_F01.jpg

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