南方医科大学学报

南方医科大学学报 ›› 2021, Vol. 41 ›› Issue (5): 633-639.doi: 10.12122/j.issn.1673-4254.2021.05.01

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强直性脊柱炎患者减停TNF-α抑制剂后的复发情况及预测因素：52周前瞻性临床随访

唐翠萍，陈飞龙，郑松塬，吴利生，陈世贤，朱俊卿，李 娟   

  • 出版日期:2021-05-20 发布日期:2021-06-11

Relapse of ankylosing spondylitis and its predictors after withdrawal of tumor necrosis factor-α inhibitors: a 52-week follow-up study

  • Online:2021-05-20 Published:2021-06-11

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摘要： 目的 观察经标准剂量阿达木单抗（ADA）治疗缓解的强直性脊柱炎（AS）患者减停肿瘤坏死因子-α抑制剂（TNFi）后病情复发情况及预测因素。方法 前瞻性纳入经ADA（40 mg/2周）连续治疗12次以上，达到ASAS20改善且Bath疾病活动指数（BASDAI）<4后并维持8周以上，减停TNFi的AS患者63例。每隔12周随访1次，共随访52周，记录患者的年龄、性别、骶髂关节X片分级、病程等基线资料及治疗情况，记录并分析病情复发情况及BASDAI、强直性脊柱炎疾病活动评分（ASDAS）、腰背痛评分（LBP）、Bath强直性脊柱炎测量指数（BASMI）、C反应蛋白（CRP）、血沉（ESR）等变化情况。通过Cox回归模型及绘制ROC曲线分析复发的危险因素。结果 共57例患者完成随访，52周内有22例（38.6%）复发，复发中位时间31周。完全停药患者复发率（89.0%）高于TNFi减量、TNFi停药患者（P<0.001）；而TNFi停药患者与减量患者复发率比较，差异无统计学意义（χ2=0.071，P=0.791）。Cox回归模型分析结果示基线期LBP高（HR=1.438，P=0.027）、BASMI评分高（HR=1.29，P=0.049）是减停TNFi后复发的危险因素，随访期维持药物治疗是复发的保护因素（HR=0.209，P=0.001）。复发ROC曲线结果显示基线LBP、BASMI评分及随访期治疗情况三者的联合因素对复发具有高预测能力（AUC=0.819，敏感度0.772，特异度0.718）。结论 经TNFi治疗缓解的AS患者减停TNFi后复发率较高。基线高LBP和BASMI评分及无药维持治疗是减停TNFi后复发的危险因素。

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Abstract: Objective To investigate the recurrence of ankylosing spondylitis (AS) that has been relieved by standard-dose adalimumab (ADA) after dose reduction or withdrawal of tumor necrosis factor-α inhibitor (TNFi) and explore the factors that predict AS occurrence. Methods This study was conducted among 63 patients with AS who reduced the dose of or discontinued TNFi after completing at least 12 treatment cycles with ADA (40 mg/2 weeks) to achieve ASAS20 improvement with a BATH disease activity index (BASDAI) <4 for more than 8 weeks. The patients were followed up every 12 weeks for a total of 52 weeks, and the recurrence of AS, changes of BASDAI, C-reactive protein (CRP)-based disease activity score (ASDAS-CRP), low back pain (LBP) score, Bath Ankylosing Spondylitis Metrology Index (BASMI), CRP and ESR were recorded and analyzed. Cox regression model and ROC curve analyses were performed to analyze the risk factors of AS relapse after dose reduction or discontinuation of TNFi. Results Of the 63 patients enrolled, 57 completed the follow-up study, among whom 22 (38.6%) patients experienced AS relapse within 52 weeks, with a median clinical recurrence time of 31 weeks. The recurrence rate of AS was significantly higher in patients with complete withdrawal of medications (89.0%) than in those with TNFi dose reduction and TNFi discontinuation (P<0.001), and did not differ significantly between the latter two groups of patients (χ2= 0.071, P=0.791). The Cox regression model showed that a high baseline LBP score (HR=1.438, P=0.027) and a high BASMI score (HR=1.29, P=0.049) were the risk factors for AS recurrence after TNFi dose reduction or discontinuation, while maintenance of medication during follow-up was a protective factor (HR=0.209, P=0.001). ROC curve analysis showed that the combination of baseline LBP score, BASMI and medication during follow-up had a good predictive value for AS relapse (AUC=0.819) with a sensitivity of 0.772 and a specificity of 0.718. Conclusion Dose reduction or discontinuation of TNFi is associated with a high recurrence rate of AS that has been relieved by TNFi treatment. A high LBP score, a high BASMI score and discontinuation of maintenance medication are the risk factors for AS recurrence in patients after dose reduction or withdrawal of TNFi.

Key words: ankylosing spondylitis; tumor necrosis factor-α inhibitor; recurrence; risk factors