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七种生物制剂治疗 Takayasu 动脉炎患者的药物保留和停药原因。

Drug retention and discontinuation reasons between seven biologics in patients with Takayasu arteritis.

机构信息

Unit of Immunology, Rheumatology, Allergy and Rare diseases, IRCCS San Raffaele Hospital, Milan, Italy; Vita-Salute San Raffaele University, Via Olgettina 60, 20132 Milan, Italy.

Unit of Immunology, Rheumatology, Allergy and Rare diseases, IRCCS San Raffaele Hospital, Milan, Italy; Vita-Salute San Raffaele University, Via Olgettina 60, 20132 Milan, Italy.

出版信息

Semin Arthritis Rheum. 2020 Jun;50(3):509-514. doi: 10.1016/j.semarthrit.2020.01.005. Epub 2020 Jan 25.

Abstract

OBJECTIVE

We retrospectively investigated drug retention rate (DRR) and reasons for discontinuation of seven biologic disease-modifying anti-rheumatic drugs (bDMARDs) in Takayasu's arteritis (TA) in a real-world setting.

METHODS

TA patients followed-up in our center fulfilling the 1990 ACR criteria and treated with ≥1 bDMARD were selected. Data about disease duration, number of bDMARDs, reasons for bDMARDs discontinuation, and concomitant conventional synthetic (cs)DMARDs were collected. Survival curves were examined by the Kaplan-Meier method and compared using a stratified log-rank test. 24-month DRR was calculated. Hazard ratio (HR) for concomitant csDMARDs and for previous bDMARDs was evaluated. A comparative sub-analysis between anti-TNFα drugs and tocilizumab was performed.

RESULTS

We identified 50 patients and 86 bDMARD-courses. No significant differences were observed in age and disease duration between the seven groups. Infliximab was the most frequent first-line bDMARD (78.6%). At bDMARDs initiation, all patients were prescribed prednisone (mean dose, 13.5 ± 10.3 mg/day) and 85.2% concomitant csDMARD therapy. 43% of treatment courses were stopped by 24 months. Golimumab had the highest DRR (71.4%), followed by infliximab (69%), adalimumab (56.3%), abatacept (50%), tocilizumab (41.1%), anakinra (0%) and rituximab (0%), p = 0.016. Concomitant csDMARDs therapy showed positive effects on DRR (HR=2.87, 95% CI=1.19-6.92, p = 0.019). Anti-TNFα drugs had significantly higher DRR compared to tocilizumab (67.2% vs 41.1%, p = 0.028). Even in these subgroups, csDMARDs showed positive effects on DRR (HR=3.79, 95% CI=1.49-9.6, p = 0.005).

CONCLUSIONS

Anti-TNFα agents had the highest DRR overall and a higher DRR in a head-to-head comparison with tocilizumab. Concomitant csDMARDs had a significant positive effect on bDMARDs DRR.

摘要

目的

我们回顾性调查了七种生物疾病修正抗风湿药物(bDMARDs)在 Takayasu 动脉炎(TA)中的药物保留率(DRR)和停药原因。

方法

选择在我院就诊并符合 1990 年 ACR 标准且接受至少一种 bDMARD 治疗的 TA 患者。收集疾病持续时间、bDMARD 数量、bDMARD 停药原因和同时使用的传统合成(cs)DMARD 数据。通过 Kaplan-Meier 法检查生存曲线,并通过分层对数秩检验进行比较。计算 24 个月的 DRR。评估同时使用 csDMARD 和既往 bDMARD 的风险比(HR)。对 TNF-α 拮抗剂和托珠单抗进行了比较亚组分析。

结果

我们确定了 50 名患者和 86 例 bDMARD 疗程。在七个组之间,年龄和疾病持续时间没有明显差异。英夫利昔单抗是最常用的一线 bDMARD(78.6%)。在 bDMARD 开始时,所有患者均接受泼尼松(平均剂量 13.5±10.3mg/天)和 85.2%的同时使用 csDMARD 治疗。43%的疗程在 24 个月内停止。戈利木单抗的 DRR 最高(71.4%),其次是英夫利昔单抗(69%)、阿达木单抗(56.3%)、阿巴西普(50%)、托珠单抗(41.1%)、阿那白滞素(0%)和利妥昔单抗(0%),p=0.016。同时使用 csDMARD 治疗对 DRR 有积极影响(HR=2.87,95%CI=1.19-6.92,p=0.019)。TNF-α 拮抗剂与托珠单抗相比,DRR 显著更高(67.2%比 41.1%,p=0.028)。即使在这些亚组中,csDMARD 对 DRR 也有积极影响(HR=3.79,95%CI=1.49-9.6,p=0.005)。

结论

TNF-α 拮抗剂总体上具有最高的 DRR,并且与托珠单抗的头对头比较中具有更高的 DRR。同时使用 csDMARD 对 bDMARD 的 DRR 有显著的积极影响。

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