Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre for Head and Orthopedics, Rigshospitalet Glostrup, Copenhagen, Denmark
Division of Rheumatology, Department of Medicine, Hospital of Southern Norway Trust, Kristiansand, Norway.
RMD Open. 2020 Sep;6(3). doi: 10.1136/rmdopen-2020-001280.
To explore 6-month and 12-month secukinumab effectiveness in patients with axial spondyloarthritis (axSpA) overall, as well as across (1) number of previous biologic/targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs), (2) time since diagnosis and (3) different European registries.
Real-life data from 13 European registries participating in the European Spondyloarthritis Research Collaboration Network were pooled. Kaplan-Meier with log-rank test, Cox regression, χ² and logistic regression analyses were performed to assess 6-month and 12-month secukinumab retention, inactive disease/low-disease-activity states (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) <2/<4, Ankylosing Spondylitis Disease Activity Score (ASDAS) <1.3/<2.1) and response rates (BASDAI50, Assessment of Spondyloarthritis International Society (ASAS) 20/40, ASDAS clinically important improvement (ASDAS-CII) and ASDAS major improvement (ASDAS-MI)).
We included 1860 patients initiating secukinumab as part of routine care. Overall 6-month/12-month secukinumab retention rates were 82%/72%, with significant (p<0.001) differences between the registries (6-month: 70-93%, 12-month: 53-86%) and across number of previous b/tsDMARDs (b/tsDMARD-naïve: 90%/73%, 1 prior b/tsDMARD: 83%/73%, ≥2 prior b/tsDMARDs: 78%/66%). Overall 6-month/12-month BASDAI<4 were observed in 51%/51%, ASDAS<1.3 in 9%/11%, BASDAI50 in 53%/47%, ASAS40 in 28%/22%, ASDAS-CII in 49%/46% and ASDAS-MI in 25%/26% of the patients. All rates differed significantly across number of previous b/tsDMARDs, were numerically higher for b/tsDMARD-naïve patients and varied significantly across registries. Overall, time since diagnosis was not associated with secukinumab effectiveness.
In this study of 1860 patients from 13 European countries, we present the first comprehensive real-life data on effectiveness of secukinumab in patients with axSpA. Overall, secukinumab retention rates after 6 and 12 months of treatment were high. Secukinumab effectiveness was consistently better for bionaïve patients, independent of time since diagnosis and differed across the European countries.
探索司库奇尤单抗在总体上、以及在（1）既往生物/靶向合成改善病情抗风湿药物（b/tsDMARDs）数量、（2）诊断后时间和（3）不同欧洲登记处的情况下，治疗强直性脊柱炎（axSpA）患者的 6 个月和 12 个月的疗效。
汇总了来自参与欧洲脊柱关节炎研究协作网络的 13 个欧洲登记处的真实数据。采用 Kaplan-Meier 对数秩检验、Cox 回归、χ²和逻辑回归分析，评估 6 个月和 12 个月时司库奇尤单抗的保留率、无疾病/低疾病活动状态（Bath 强直性脊柱炎疾病活动指数（BASDAI）<2/<4、强直性脊柱炎疾病活动评分（ASDAS）<1.3/<2.1）和应答率（BASDAI50、评估强直性脊柱炎国际协会（ASAS）20/40、ASDAS 临床重要改善（ASDAS-CII）和 ASDAS 主要改善（ASDAS-MI））。
我们纳入了 1860 例作为常规治疗一部分起始司库奇尤单抗治疗的患者。总体而言，6 个月/12 个月司库奇尤单抗的保留率分别为 82%/72%，各登记处之间（6 个月：70-93%，12 个月：53-86%）和既往 b/tsDMARDs 数量之间（b/tsDMARD 初治患者：90%/73%，既往使用 1 种 b/tsDMARD：83%/73%，既往使用≥2 种 b/tsDMARD：78%/66%）存在显著差异（p<0.001）。总体而言，51%/51%的患者达到 6 个月/12 个月时 BASDAI<4，9%/11%的患者达到 ASDAS<1.3，53%/47%的患者达到 BASDAI50，28%/22%的患者达到 ASAS40，49%/46%的患者达到 ASDAS-CII，25%/26%的患者达到 ASDAS-MI。所有这些比率在既往 b/tsDMARDs 数量上均存在显著差异，初治患者的比率更高，且在各登记处间存在显著差异。总体而言，诊断后时间与司库奇尤单抗的疗效无关。
在这项来自 13 个欧洲国家的 1860 例患者的研究中，我们首次提供了司库奇尤单抗治疗 axSpA 患者的疗效的全面真实世界数据。总体而言，治疗 6 个月和 12 个月后司库奇尤单抗的保留率较高。司库奇尤单抗的疗效对于初治患者更好，独立于诊断后时间且在欧洲国家间存在差异。
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