Identification of predictive clinical factors of long-term treatment response may contribute to improved management of non-radiographic axSpA (nr-axSpA) patients. This analysis aims to identify whether any baseline characteristics or Week 12 clinical outcomes in nr-axSpA patients with elevated C-reactive protein (CRP) and/or sacroiliitis on magnetic resonance imaging (MRI) enrolled in the C-axSpAnd study are predictive of achieving clinical response after 1 year of certolizumab pegol (CZP). C-axSpAnd (NCT02552212) was a phase 3, multicentre study, including a 52-Week double-blind, placebo-controlled period. Enrolled patients were randomised to CZP 200 mg Q2W or placebo. Predictors of Week 12 (CZP group only) and Week 52 clinical response were identified using a multivariate stepwise logistic regression analysis. Response variables included Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI), Assessment of SpondyloArthritis International Society 40% response (ASAS40), Bath Ankylosing Spondylitis Disease Activity Index 50% response (BASDAI50) and ASDAS inactive disease (ASDAS-ID). Predictive factors assessed included demographic and baseline characteristics and clinical outcomes at Week 12. A p-value <0.05 was required for forward selection into the model and p ≥0.1 for backward elimination. Missing data or values collected after switching to open-label treatment were accounted for using non-responder imputation. Sensitivity analyses accounted for patients with changes in non-biologic background medication. Of 317 enrolled patients, 159 and 158 were randomised to CZP and placebo, respectively. Younger age and male sex were identified as predictors of Week 12 response across all assessed efficacy outcomes in CZP-treated patients. Consistent predictors of Week 52 response, measured by ASDAS-MI, ASAS40 and BASDAI50, included human leukocyte antigen (HLA)-B27 positivity and sacroiliitis on MRI at baseline. MRI positivity was also predictive of achieving ASDAS-ID at Week 52. Sensitivity analyses were generally consistent with the primary analysis. In placebo-treated patients, no meaningful predictors of Week 52 response were identified. In this 52-Week, placebo-controlled study in nr-axSpA patients with elevated CRP and/or active sacroiliitis on MRI at baseline, MRI sacroiliitis and HLA-B27 positivity, but not elevated CRP or responses at Week 12, were predictive of long-term clinical response to CZP. Findings may support rheumatologists to identify patients suitable for TNFi treatment. ClinicalTrials.gov, NCT02552212 . Registered on 15 September 2015

中文翻译：

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接受 certolizumab pegol 的非放射学中轴​​性脊柱关节炎患者长期临床反应的预测因素

确定长期治疗反应的预测性临床因素可能有助于改善非放射学 axSpA (nr-axSpA) 患者的管理。该分析旨在确定 C-axSpAnd 研究中 C-反应蛋白 (CRP) 升高和/或骶髂关节炎患者的任何基线特征或第 12 周临床结果是否可预测certolizumab pegol (CZP) 1 年后的临床反应。C-axSpAnd (NCT02552212) 是一项 3 期多中心研究，包括为期 52 周的双盲、安慰剂对照期。入选患者随机接受 CZP 200 mg Q2W 或安慰剂。使用多变量逐步逻辑回归分析确定第 12 周（仅 CZP 组）和第 52 周临床反应的预测因子。响应变量包括强直性脊柱炎疾病活动评分主要改善 (ASDAS-MI)、国际脊柱关节炎协会评估 40% 响应 (ASAS40)、巴斯强直性脊柱炎疾病活动指数 50% 响应 (BASDAI50) 和 ASDAS 非活动性疾病 (ASDAS-ID)。评估的预测因素包括第 12 周的人口统计学和基线特征以及临床结果。向前选择进入模型需要 p 值 <0.05，向后消除需要 p ≥ 0.1。使用无反应者插补来解释转换到开放标签治疗后收集的缺失数据或值。敏感性分析考虑了非生物背景药物变化的患者。在 317 名登记患者中，159 名和 158 名分别随机接受 CZP 和安慰剂治疗。在 CZP 治疗的患者中，所有评估的疗效结果中，较年轻的年龄和男性被确定为第 12 周反应的预测因子。通过 ASDAS-MI、ASAS40 和 BASDAI50 测量的第 52 周反应的一致预测因子包括基线时 MRI 上的人类白细胞抗原 (HLA)-B27 阳性和骶髂关节炎。MRI 阳性也可预测第 52 周达到 ASDAS-ID。敏感性分析与主要分析大体一致。在安慰剂治疗的患者中，没有确定第 52 周反应的有意义的预测因子。在这项为期 52 周的安慰剂对照研究中，在基线时 CRP 升高和/或活动性骶髂关节炎的 nr-axSpA 患者中，MRI 骶髂关节炎和 HLA-B27 阳性，但在第 12 周时 CRP 或反应未升高，预示着长期- 对 CZP 的长期临床反应。研究结果可能支持风湿病学家确定适合 TNFi 治疗的患者。ClinicalTrials.gov，NCT02552212。2015 年 9 月 15 日注册