Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark; DANBIO registry, Rigshospitalet, Glostrup, Denmark.
Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark; DANBIO registry, Rigshospitalet, Glostrup, Denmark.
Semin Arthritis Rheum. 2022 Oct;56:152081. doi: 10.1016/j.semarthrit.2022.152081. Epub 2022 Aug 10.
In patients with axial spondyloarthritis (axSpA) initiating their first tumor necrosis factor alpha-inhibitor (TNFi), we aimed to identify common baseline predictors of Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) inactive disease (primary objective) and clinically important improvement (CII) at 6 months, and drug retention at 12-months across 15 European registries.
Baseline demographic and clinical characteristics were collected. Outcomes were investigated per registry and in pooled data using logistic regression analyses on multiply imputed data.
The consistency of baseline predictors in individual registries justified pooling the data. In the pooled dataset (n = 21,196), the 6-month rates for ASDAS inactive disease and ASDAS CII were 26% and 51%, and the 12-month drug retention rate 65% in patients with available data (n = 9,845, n = 6,948 and n = 21,196, respectively). Nine common baseline predictors of ASDAS inactive disease, ASDAS CII and 12-month drug retention were identified, and the odds ratios (95%-confidence interval) for ASDAS inactive disease were: age, per year: 0.97 (0.97-0.98), men vs. women: 1.88 (1.60-2.22), current vs. non-smoking: 0.76 (0.63-0.91), HLA-B27 positive vs. negative: 1.51 (1.20-1.91), TNF start year 2015-2018 vs. 2009-2014: 1.24 (1.06-1.45), CRP>10 vs. ≤10 mg/l: 1.49 (1.25-1.77), one unit increase in health assessment questionnaire (HAQ): 0.77 (0.58-1.03), one-millimeter (mm) increase in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) fatigue and spinal pain: 0.99 (0.99-1.00) and 0.99 (0.99-1.99), respectively CONCLUSION: Common baseline predictors of treatment response and adherence to TNFi could be identified across data from 15 European registries, indicating that they may be universal across different axSpA populations.
在开始使用首种肿瘤坏死因子-α抑制剂(TNFi)的中轴型脊柱关节炎(axSpA)患者中,我们旨在确定在 15 个欧洲登记处中,常见的基线预测因子,以预测在 6 个月时达到强直性脊柱炎疾病活动评分(ASDAS-CRP)缓解(主要目标)和临床重要改善(CII),以及在 12 个月时的药物保留率。
收集基线人口统计学和临床特征。在个体登记处中对结局进行调查,并在汇集数据时,使用多重插补数据的逻辑回归分析进行调查。
个体登记处中基线预测因子的一致性证明可以合并数据。在汇集的数据集(n=21,196)中,6 个月时 ASDAS 缓解和 ASDAS CII 的比例分别为 26%和 51%,在有可用数据的患者(n=9,845、n=6,948 和 n=21,196)中,12 个月时的药物保留率为 65%。确定了 9 个常见的基线预测因子,用于 ASDAS 缓解、ASDAS CII 和 12 个月的药物保留率,ASDAS 缓解的优势比(95%置信区间)为:年龄,每年:0.97(0.97-0.98),男性与女性:1.88(1.60-2.22),当前吸烟者与非吸烟者:0.76(0.63-0.91),HLA-B27 阳性与阴性:1.51(1.20-1.91),TNFi 起始年份 2015-2018 与 2009-2014:1.24(1.06-1.45),C 反应蛋白>10 与≤10mg/L:1.49(1.25-1.77),健康评估问卷(HAQ)增加一个单位:0.77(0.58-1.03),Bath 强直性脊柱炎疾病活动指数(BASDAI)疲劳和脊柱疼痛增加 1mm:0.99(0.99-1.00)和 0.99(0.99-1.99)。
在 15 个欧洲登记处的数据中,确定了治疗反应和对 TNFi 依从性的常见基线预测因子,表明它们可能在不同的 axSpA 人群中具有普遍性。