对接受生物治疗的风湿病患者的真实生活分析：来自土耳其生物制剂注册研究的数据。

A real-life analysis of patients with rheumatologic diseases on biological treatments: Data from TURKBIO Registry.

作者信息

Önen Fatoş, Can Gerçek, Çapar Sedat, Dalkılıç Ediz, Pehlivan Yavuz, Şenel Soner, Akar Servet, Koca Süleyman Serdar, Tufan Abdurrahman, Yazıcı Ayten, Yılmaz Sema, İnanç Nevsun, Sarı İsmail, Birlik Merih, Solmaz Dilek, Cefle Ayşe, Öztürk Mehmet Akif, Yolbaş Servet, Krogh Niels Steen, Yılmaz Neslihan, Erten Şükran, Bes Cemal, Gündüz Özgül Soysal, Göker Berna, Haznedaroğlu Seminur, Yavuz Şule, Yildirim Çetin Gözde, Yıldız Fatih, Direskeneli Haner, Akkoç Nurullah

机构信息

Division of Rheumatology, Dokuz Eylul University School of Medicine, Izmir, Turkey.

Department of Statistics, Dokuz Eylul University Faculty of Science, Izmir, Turkey.

出版信息

Eur J Rheumatol. 2022 Apr;9(2):82-87. doi: 10.5152/eurjrheum.2022.21060.

OBJECTIVE

TURKBIO registry, established in 2011, is the first nationwide biological database in Turkey. This study aimed to provide an overview of TURKBIO data collected by June 2018.

METHODS

The registry included adult patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), nonradiographic axial spondyloarthritis (nr-AxSpA), and psoriatic arthritis (PsA). Demographic and clinical features, disease activity markers, and other follow-up parameters, current and previous treat- ments, and adverse events were registered electronically at each visit using open-source software. The registration of patient-reported outcome measures was carried out electronically by the patients using touch screens.

RESULTS

TURKBIO registry included a total of 41,145 treatment series with biologicals. There were 2,588 patients with axSpA (2,459 AS and 129 nr-axSpA), 2,036 with RA, and 428 with PsA. The total number of patients, including those with other diagnoses, was 5,718. In the follow-up period, the number of patients and also visits steadily increased by years. The yearly mean number of visits per patient was found to be 2.3. Significant improvements in disease activity and health assessment parameters were observed following the biological treatments. Biologics were often given in combination with a con- ventional synthetic disease-modifying antirheumatic drug in patients with RA. Infections were the most commonly seen adverse events, followed by allergic reactions. Tuberculosis was observed in 12 patients, malignancy in 18, and treatment-related mortality in 31.

CONCLUSION

TURKBIO provided a valuable real-life experience with the use of biologics in rheumatic diseases in Turkey.

目的

TURKBIO注册库于2011年建立，是土耳其首个全国性生物数据库。本研究旨在概述截至2018年6月收集的TURKBIO数据。

方法

该注册库纳入了患有类风湿关节炎（RA）、强直性脊柱炎（AS）、非放射学中轴型脊柱关节炎（nr-AxSpA）和银屑病关节炎（PsA）的成年患者。人口统计学和临床特征、疾病活动标志物及其他随访参数、当前和既往治疗情况以及不良事件在每次就诊时使用开源软件进行电子登记。患者报告结局测量指标由患者通过触摸屏进行电子登记。

结果

TURKBIO注册库共纳入41,145个生物制剂治疗序列。有2,588例中轴型脊柱关节炎患者（2,459例AS和129例nr-axSpA），2,036例RA患者，428例PsA患者。包括其他诊断患者在内的患者总数为5,718例。在随访期间，患者数量和就诊次数逐年稳步增加。发现每位患者每年的平均就诊次数为2.3次。生物制剂治疗后疾病活动和健康评估参数有显著改善。在RA患者中，生物制剂常与传统合成改善病情抗风湿药联合使用。感染是最常见的不良事件，其次是过敏反应。观察到12例患者发生结核病，18例发生恶性肿瘤，31例发生治疗相关死亡。