与类风湿关节炎、中轴型脊柱关节炎和银屑病关节炎患者接受戈利木单抗治疗的长期保留相关的因素：西班牙 BIOBADASER 登记处的分析。
Factors associated with long-term retention of treatment with golimumab in rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis: an analysis of the Spanish BIOBADASER registry.
机构信息
Department of Rheumatology, Hospital Universitario de Santiago de Compostela, Rúa da Choupana, s/n, 15706 Santiago de Compostela, A Coruña, Spain.
Clinical Research Unit, Spanish Society of Rheumatology (SER), Madrid, Spain.
出版信息
Clin Rheumatol. 2021 Oct;40(10):3979-3988. doi: 10.1007/s10067-021-05742-3. Epub 2021 Apr 27.
BACKGROUND
Retention of biological treatment provides a marker of drug effectiveness and patient satisfaction. Retention of golimumab was high in clinical trial extensions and real-world studies up to 5 years in patients with immune-mediated rheumatic diseases.
OBJECTIVE
To assess the probability of real-world long-term retention of treatment with golimumab up to 7 years after treatment initiation.
METHODS
This retrospective noninterventional study involved analysis of the Spanish biological drugs registry, BIOBADASER. Adults who had ever received golimumab for rheumatoid arthritis (RA), axial spondyloarthritis (SpA), or psoriatic arthritis (PsA), and had initiated it > 6 months before the analysis date, were included.
RESULTS
Among 685 patients (28.5% RA, 42.9% SpA, 28.6% PsA), the overall probability of retention of golimumab treatment since initiation was 71.7% (95% confidence interval 68.1-74.9) at year 1, 60.5% (56.5-64.2%) at year 2, 55.6% (51.5-59.5%) at year 3, 50.6% (46.2-54.8%) at year 4, 45.1% (40.1-50.0%) at year 5, 44.2% (39.0-49.3) at year 6, and 39.5% (32.8-46.2) at year 7. Retention was greater in patients with axial SpA or PsA versus RA (p < 0.001) and when golimumab was used as first-line treatment versus third or later lines (p < 0.001). Factors associated with greater golimumab retention in Cox regression included use as first-line biological therapy, having axial SpA or PsA rather than RA, and concomitant methotrexate therapy. Steroids were associated with lower retention.
CONCLUSION
In this real-world study of RA, axial SpA, and PsA patients, the retention rate of golimumab was 39.5% at year 7. Key Points • Retention of biological treatment provides a marker of drug effectiveness and patient satisfaction. • This real-world study of 685 patients with rheumatoid arthritis (RA), axial spondyloarthritis (SpA), or psoriatic arthritis (PsA) showed that golimumab treatment had a retention rate up to 39.5% at year 7. • Greater golimumab retention was associated with use as first-line biological therapy, having axial SpA or PsA rather than RA, and concomitant methotrexate therapy.
背景
保留生物治疗提供了药物疗效和患者满意度的标志物。在免疫介导的风湿病患者中，戈利木单抗的临床试验扩展和真实世界研究中，5 年内的保留率很高。
目的
评估戈利木单抗治疗的真实世界长期保留率，在治疗开始后长达 7 年。
方法
这是一项回顾性非干预性研究，涉及西班牙生物药物登记处 BIOBADASER。纳入的患者为曾接受戈利木单抗治疗类风湿关节炎（RA）、轴性脊柱关节炎（SpA）或银屑病关节炎（PsA）的成年人，且在分析日期前至少 6 个月开始接受治疗。
结果
在 685 名患者（28.5%为 RA，42.9%为 SpA，28.6%为 PsA）中，自治疗开始以来戈利木单抗治疗的总体保留率为第 1 年 71.7%（95%置信区间 68.1-74.9），第 2 年 60.5%（56.5-64.2%），第 3 年 55.6%（51.5-59.5%），第 4 年 50.6%（46.2-54.8%），第 5 年 45.1%（40.1-50.0%），第 6 年 44.2%（39.0-49.3），第 7 年 39.5%（32.8-46.2）。与 RA 相比，SpA 或 PsA 的患者保留率更高（p<0.001），戈利木单抗作为一线治疗而非三线或以上治疗保留率更高（p<0.001）。Cox 回归分析中与戈利木单抗保留率增加相关的因素包括作为一线生物治疗、患有 SpA 或 PsA 而非 RA，以及同时接受甲氨蝶呤治疗。使用皮质类固醇与保留率降低相关。
结论
在这项针对 RA、SpA 和 PsA 患者的真实世界研究中，戈利木单抗的保留率为第 7 年 39.5%。
关键点
保留生物治疗提供了药物疗效和患者满意度的标志物。
这项针对 685 名类风湿关节炎（RA）、轴性脊柱关节炎（SpA）或银屑病关节炎（PsA）患者的真实世界研究表明，戈利木单抗的保留率高达第 7 年的 39.5%。
戈利木单抗保留率较高与作为一线生物治疗、患有 SpA 或 PsA 而非 RA，以及同时接受甲氨蝶呤治疗有关。
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