我们处于靶向治疗时代吗？来自 BioStaR 全国注册研究的真实证据：中轴型脊柱关节炎患者缓解和药物转换的预测因素。
Where we are in treat to target era? Predictive factors for remission and drug switching in patients with axial spondyloarthritis: a real-life evidence from BioStaR nationwide registry.
机构信息
Department of Physical Medicine and Rehabilitation, Ankara City Hospital, Ankara, Turkey.
Department of Physical Medicine and Rehabilitation, Division of Rheumatology, Faculty of Medicine, Ankara University, Ankara, Turkey.
出版信息
Clin Rheumatol. 2022 Jul;41(7):2053-2063. doi: 10.1007/s10067-022-06145-8. Epub 2022 Mar 30.
OBJECTIVES
Factors associated with disease activity of axial spondyloarthritis (axSpA) and switching of biologic disease-modifying anti-rheumatic drugs have not been clearly defined. We aimed to evaluate clinical characteristics of patients with axSpA, factors related to remission in treat to target era and predictive factors for biologic disease-modifying anti-rheumatic drug switching.
METHOD
A multicenter, observational cross-sectional study was performed between February 2019 and August 2019. We included all consecutive patients ≥ 18 years with axSpA. Demographic and clinical variables were prospectively recorded. Clinical tools included Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Metrology Index (BASMI), and Maastricht Ankylosing Spondylitis Enthesitis Score (MASES).
RESULTS
There were 969 patients with a mean age of 43.4 ± 10.8 years. There were 143 patients (14.8%) with remission and 223 (23.1%) patients with low disease activity. Male sex (p = 0.021), positive family history (p = 0.036), and human leukocyte antigen-B27 (p = 0.011) were predictors of remission by ASDAS-CRP. There were 654 patients (67.5%) who did not switch to another drug. The highest BASMI and MASES scores were calculated in patients with very high disease activity (p < 0.05). In patients with drug switching, the disease duration was significantly higher (p < 0.001) and the age at diagnosis was significantly lower (p = 0.016). There were significantly more patients with uveitis and higher scores of MASES and BASMI in patients who switch to another biologic disease-modifying anti-rheumatic drugs (p = 0.003, p = 0.009, and p = 0.004, respectively).
CONCLUSIONS
In patients with axSpA, male sex, younger age, and HLA-B27 positivity are associated with remission, while longer disease duration and accompanied uveitis appear to be related with drug switching.
CLINICAL TRIAL REGISTRATION NUMBER AND DATE
NCT04139954/25.10.2019.
目的
与轴性脊柱关节炎（axSpA）疾病活动相关的因素和生物改善病情抗风湿药物的转换尚未明确。本研究旨在评估 axSpA 患者的临床特征、靶向治疗时代缓解的相关因素以及生物改善病情抗风湿药物转换的预测因素。
方法
这是一项于 2019 年 2 月至 8 月间进行的多中心、观察性、横断面研究。我们纳入了所有符合 axSpA 诊断标准且年龄≥18 岁的连续患者。前瞻性地记录了人口统计学和临床变量。临床工具包括 C 反应蛋白（ASDAS-CRP）的强直性脊柱炎疾病活动评分、巴斯强直性脊柱炎疾病活动指数（BASDAI）、巴斯强直性脊柱炎度量指数（BASMI）和马斯特里赫特强直性脊柱炎附着点炎评分（MASES）。
结果
共有 969 例患者，平均年龄为 43.4±10.8 岁。143 例（14.8%）患者处于缓解状态，223 例（23.1%）患者疾病活动度低。男性（p=0.021）、阳性家族史（p=0.036）和人类白细胞抗原-B27（p=0.011）是通过 ASDAS-CRP 预测缓解的因素。654 例（67.5%）患者未转换为另一种药物。在疾病活动度极高的患者中，最高的 BASMI 和 MASES 评分（p<0.05）。在药物转换的患者中，疾病持续时间显著更长（p<0.001），诊断年龄显著更低（p=0.016）。在转换为另一种生物改善病情抗风湿药物的患者中，虹膜炎的发生率更高，MASES 和 BASMI 评分也更高（p=0.003，p=0.009，p=0.004）。
结论
在 axSpA 患者中，男性、年龄较小和 HLA-B27 阳性与缓解相关，而较长的疾病持续时间和伴发的虹膜炎似乎与药物转换相关。
临床试验注册号和日期
NCT04139954/25.10.2019.
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