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台湾单中心经验:利妥昔单抗治疗类风湿关节炎的真实世界疗效和安全性。

Real-world effectiveness and safety of rituximab in the treatment of rheumatoid arthritis: A single-center experience in Taiwan.

机构信息

Division of Allergy, Immunology and Rheumatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.

Faculty of Medicine, National Yang-Ming University School of Medicine, Taipei, Taiwan.

出版信息

Int J Rheum Dis. 2019 May;22(5):860-868. doi: 10.1111/1756-185X.13511. Epub 2019 Feb 13.

Abstract

AIM

To assess the real-world effectiveness and safety of rituximab (RTX) at 24 months in patients with established rheumatoid arthritis (RA) and to identify predictors of low disease activity/remission and a good European League Against Rheumatism (EULAR) response.

METHODS

Seventy RTX-treated RA patients were enrolled. Predictors for low disease activity/remission and a good EULAR response at 24 months were identified by multivariate analyses.

RESULTS

At 24 months, the mean Disease Activity Score of 28 joints-erythrocyte sedimentation rate (DAS28-ESR) decreased from 6.88 ± 0.85 at baseline to 3.47 ± 0.85. Twenty-nine patients (41.4%) reached low disease activity/remission, while all patients had a moderate/good EULAR response. After adjustment by multivariate analyses, we found concomitant methotrexate at a dosage >10 mg/week (odds ratio [OR] 5.17; 95% CI 1.34-19.93; P = 0.017) predicted low disease activity/remission, and baseline DAS28 ≤6.5 (OR 4.97; 95% CI 1.22-20.30; P = 0.026) predicted good EULAR response at 24 months. The most common adverse events were infusion-related (5.7%), and there was no incidence of malignancy or mortality during the treatment.

CONCLUSIONS

RTX was effective and safe in real-life management of RA patients with high disease activity. Patients taking concomitant methotrexate and with lower baseline DAS28-ESR were more likely to benefit from RTX.

摘要

目的

评估利妥昔单抗(RTX)在已确诊的类风湿关节炎(RA)患者中 24 个月的真实世界疗效和安全性,并确定低疾病活动/缓解和良好的欧洲抗风湿病联盟(EULAR)反应的预测因素。

方法

共纳入 70 例接受 RTX 治疗的 RA 患者。通过多变量分析确定 24 个月时低疾病活动/缓解和良好 EULAR 反应的预测因素。

结果

24 个月时,28 个关节红细胞沉降率的疾病活动评分(DAS28-ESR)从基线时的 6.88±0.85 降至 3.47±0.85。29 例(41.4%)达到低疾病活动/缓解,而所有患者均有中度/良好的 EULAR 反应。经多变量分析调整后,我们发现同时使用甲氨蝶呤剂量>10mg/周(比值比[OR] 5.17;95%置信区间[CI] 1.34-19.93;P=0.017)预测低疾病活动/缓解,而基线 DAS28≤6.5(OR 4.97;95% CI 1.22-20.30;P=0.026)预测 24 个月时良好的 EULAR 反应。最常见的不良事件是输液相关(5.7%),在治疗过程中无恶性肿瘤或死亡发生。

结论

RTX 在高疾病活动的 RA 患者的真实世界管理中是有效且安全的。同时使用甲氨蝶呤和基线 DAS28-ESR 较低的患者更有可能从 RTX 中获益。

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