Purpose: Non-steroidal anti-inflammatory drugs (NSAIDs) have generally been viewed as first-line therapy for axial spondyloarthritis (axSpA). Imrecoxib is a selective COX-2 inhibitor developed independently in China. At present, only one single-center RCT trial has shown that imrecoxib is equally effective as celecoxib in treating axSpA. Based on real-world data, our study aims to explore the efficiency of imrecoxib and TNF inhibitor (TNFi) combined with imrecoxib in treating axSpA.
Patients and Methods: A total of 163 patients with axSpA who had more than two follow-up records in 6 months and treated with imrecoxib/celecoxib/TNFi combined with imrecoxib/TNFi combined with celecoxib from the First Affiliated Hospital of Anhui Medical University SpA Real World Database (AHSpA) were selected for analysis of our study. The linear mixed model was used to compare efficacy indexes before and after treatment and between different groups, adjust baseline measurement value and follow-up time. The Kaplan–Meier survival analysis was used to identify the differences in cumulative clinical remission rates between groups with different treatment at the follow-up period.
Results: Results showed that after treatment ASDAScrp was slightly improved in imrecoxib group and celecoxib group within 6 months (p < 0.05). CRP, ESR, BASDAI, ASDAScrp, BASFI, occiput to wall distance and finger floor distance all significantly improved in TNFi combined with imrecoxib group and TNFi combined with celecoxib group within 6 months (all p < 0.05). According to the Kaplan–Meier survival curve and Log rank test analysis, the clinical remission rate was not significantly different between different treatment during 24-month follow-up (all p > 0.05).
Conclusion: ASDAScrp improved slightly within 6 months after treatment with imrecoxib, and TNFi combined with imrecoxib significantly improved multiple effect indexes in axSpA patients. The efficacy of imrecoxib and celecoxib in the treatment of axSpA is equivalent. Also, they have the same efficacy after being combined with TNFi.

Keywords: axial spondyloarthritis, imrecoxib, celecoxib, TNF inhibitor


中文翻译：

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伊姆瑞昔布对中轴型脊柱关节炎患者影响的真实世界研究

目的：非甾体抗炎药（NSAIDs）通常被视为中轴型脊柱关节炎（axSpA）的一线治疗。伊姆瑞昔布是我国自主研发的选择性COX-2抑制剂。目前，只有一项单中心 RCT 试验表明，在治疗 axSpA 方面，艾瑞昔布与塞来昔布同样有效。基于真实世界数据，我们的研究旨在探讨伊瑞昔布和 TNF 抑制剂 (TNFi) 联合伊瑞昔布治疗 axSpA 的疗效。
患者和方法：安徽医科大学第一附属医院SpA真实世界数据库（AHSpA）共163例6个月内有两次以上随访记录并接受伊瑞昔布/塞来昔布/TNFi联合伊瑞昔布/TNFi联合塞来昔布治疗的axSpA患者) 被选择用于分析我们的研究。采用线性混合模型比较治疗前后及各组间疗效指标，调整基线测量值及随访时间。Kaplan-Meier生存分析用于确定随访期间不同治疗组之间累积临床缓解率的差异。
结果：结果显示，治疗后6个月内，伊瑞昔布组和塞来昔布组的ASDAScrp略有改善（p < 0.05）。6个月内TNFi联合imrecoxib组和TNFi联合塞来昔布组CRP、ESR、BASDAI、ASDAScrp、BASFI、枕壁距离和指底距离均显着改善（均p < 0.05）。根据Kaplan-Meier生存曲线和Log rank检验分析，24个月随访期间不同治疗方案的临床缓解率差异无统计学意义（均p>0.05）。
结论：艾瑞昔布治疗后6个月内ASDAScrp略有改善，TNFi联合艾瑞昔布显着改善axSpA患者的多项疗效指标。艾瑞昔布和塞来昔布治疗axSpA的疗效相当。此外，它们与TNFi联合使用后具有相同的功效。

【关键词】：中轴型脊柱关节炎 艾瑞昔布 塞来昔布 TNF抑制剂