Rudwaleit Martin, Navarro-Compán Victoria, Russ Hagen, Panni Tommaso, Filippi Erica, Nassab Mani Haschemi, Liu-Leage Soyi, Goëb Vincent, Ciccia Francesco, Dudler Jean
Department of Rheumatology, Klinikum Bielefeld, Medical School and University Center OWL, Bielefeld University, Bielefeld, Germany.
Department of Rheumatology, University Hospital La Paz, IdiPAZ, Madrid, Spain.
Rheumatol Adv Pract. 2025 Jan 29;9(2):rkaf012. doi: 10.1093/rap/rkaf012. eCollection 2025.
To explore the relationship between Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Axial Spondyloarthritis Disease Activity Score (ASDAS) used in clinical practice and the Assessment of SpondyloArthritis international Society 40% (ASAS40) response, the primary endpoint in clinical trials in axial spondyloarthritis (axSpA).
Data from COAST-V, a phase 3 trial of ixekizumab placebo in biologic-naïve radiographic axSpA (r-axSpA) patients, were analysed. Patients treated with ixekizumab every 4 weeks were categorized using the ASAS40 response at week 16 and 52. The association between BASDAI and ASDAS disease states, respectively, and ASAS40 response achieved/not achieved was investigated. Additionally, back pain, fatigue, Bath Ankylosing Spondylitis Functional Index, ASAS Health Index and 36-item Short Form Health Survey Physical Component Summary scores corresponding to these states were assessed. Results were reported descriptively.
After 16 weeks, 48.1% (39/81) of patients achieved an ASAS40 response. Among them, 71.8% ( = 28) and 43.6% ( = 17) achieved BASDAI <3 and BASDAI <2, respectively; 76.9% ( = 30) and 33.3% ( = 13) attained ASDAS <2.1 and ASDAS <1.3, respectively. Among ASAS40 responders at week 52 [53.1% (43/81)], 83.8% ( = 36) and 51.2% ( = 22) of patients achieved BASDAI <3 and BASDAI <2, respectively; 93.1% ( = 40) and 41.9% ( = 18) attained ASDAS <2.1 and ASDAS <1.3. Lower BASDAI and ASDAS disease states corresponded well with less back pain, fatigue and functioning impairment and better health-related quality of life.
More than 70% of biologic-naïve r-axSpA patients who achieved an ASAS40 response, also attained low disease activity or inactive disease as measured by the BASDAI or ASDAS. Findings may help clinicians translate results from clinical trials into daily practice.
探讨临床实践中使用的巴斯强直性脊柱炎疾病活动指数（BASDAI）与轴性脊柱关节炎疾病活动评分（ASDAS）之间的关系，以及脊柱关节炎国际协会40%反应（ASAS40），这是轴性脊柱关节炎（axSpA）临床试验中的主要终点。
分析了COAST-V的数据，这是一项在未使用过生物制剂的放射学阳性axSpA（r-axSpA）患者中进行的ixekizumab与安慰剂对比的3期试验。每4周接受一次ixekizumab治疗的患者在第16周和第52周时根据ASAS40反应进行分类。分别研究了BASDAI和ASDAS疾病状态与是否达到ASAS40反应之间的关联。此外，还评估了与这些状态相对应的背痛、疲劳、巴斯强直性脊柱炎功能指数、ASAS健康指数和36项简明健康调查问卷身体成分总结得分。结果进行了描述性报告。
16周后，48.1%（39/81）的患者达到了ASAS40反应。其中，分别有71.8%（n = 28）和43.6%（n = 17）的患者BASDAI<3和BASDAI<2；分别有76.9%（n = 30）和33.3%（n = 13）的患者ASDAS<2.1和ASDAS<1.3。在第52周达到ASAS40反应的患者中[53.1%（43/81）]，分别有83.8%（n = 36）和51.2%（n = 22）的患者BASDAI<3和BASDAI<2；分别有93.1%（n = 40）和41.9%（n = 18）的患者ASDAS<2.1和ASDAS<1.3。较低的BASDAI和ASDAS疾病状态与较少的背痛、疲劳和功能损害以及较好的健康相关生活质量相对应。
在达到ASAS40反应的未使用过生物制剂的r-axSpA患者中，超过70%的患者根据BASDAI或ASDAS测量也达到了低疾病活动或疾病不活动状态。这些发现可能有助于临床医生将临床试验结果转化为日常实践。
