Department of Rheumatology and Immunology, The First Affiliated Hospital of Anhui Medical University, Hefei, People's Republic of China.
Drug Des Devel Ther. 2022 Aug 22;16:2755-2765. doi: 10.2147/DDDT.S376406. eCollection 2022.
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.
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 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).
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.
非甾体抗炎药(NSAIDs)通常被视为治疗中轴型脊柱关节炎(axSpA)的一线治疗药物。Imrecoxib 是中国独立开发的选择性 COX-2 抑制剂。目前,只有一项单中心 RCT 试验表明,Imrecoxib 在治疗 axSpA 方面与塞来昔布等效。基于真实世界数据,本研究旨在探讨 Imrecoxib 与 TNF 抑制剂(TNFi)联合 Imrecoxib 或塞来昔布治疗 axSpA 的疗效。
从安徽医科大学第一附属医院 axSpA 真实世界数据库(AHSpA)中,选取 163 例 axSpA 患者,在 6 个月内有 2 次以上随访记录,接受 Imrecoxib/塞来昔布/TNFi 联合 Imrecoxib/TNFi 联合塞来昔布治疗,采用线性混合模型比较治疗前后和不同组间的疗效指标,调整基线测量值和随访时间。采用 Kaplan-Meier 生存分析比较不同治疗组在随访期累积临床缓解率的差异。
结果显示,Imrecoxib 组和塞来昔布组在 6 个月内 ASDAScrp 略有改善(p<0.05)。TNFi 联合 Imrecoxib 组和 TNFi 联合塞来昔布组在 6 个月内 CRP、ESR、BASDAI、ASDAScrp、BASFI、枕墙距和指地距均显著改善(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组的临床缓解率无显著差异(均 p>0.05)。
Imrecoxib 治疗后 6 个月内 ASDAScrp 略有改善,TNFi 联合 Imrecoxib 可显著改善 axSpA 患者的多项疗效指标。Imrecoxib 和塞来昔布治疗 axSpA 的疗效相当,与 TNFi 联合使用也具有相同的疗效。