Li Yan, Li Kunpeng, Zhao Zheng, Wang Yanyan, Jin Jingyu, Guo Junhua, Zhang Jie, Zhang Jianglin, Zhu Jian, Huang Feng
Medical School of Chinese People's Liberation Army, Beijing, China.
Department of Rheumatology and Immunology, First Medical Center, General Hospital of Chinese People's Liberation Army, Beijing, China.
Front Med (Lausanne). 2021 Jun 2;8:678864. doi: 10.3389/fmed.2021.678864. eCollection 2021.
The effect of Iguratimod in the treatment of rheumatoid arthritis was confirmed in past studies. In terms of the mechanism of the effect and clinical application experience, Iguratimod has a potential value in the treatment of spondyloarthritis (SpA). This study evaluated the efficacy and safety of Iguratimod on active SpA. Subjects with active SpA were enrolled and randomly divided into two groups at a ratio of 1:2 (placebo vs. Iguratimod). On the basis of non-steroidal anti-inflammatory drugs, combined treatment with Iguratimod or placebo, followed by follow-up every 4 weeks for 24 weeks. The primary efficacy endpoint was to evaluate the alleviation rate of ASAS20; the important improvement of ASDAS and the efficacy of spinal mobility, physical function and quality of life at the 24th week. A total of 48 cases in the Iguratimod group and 25 cases in the placebo group were included in the final analysis. On the 24th week, the percentage of responders to ASAS20 (80 vs. 44%) and ASAS40 (56 vs. 20%) treated with Iguratimod were significantly higher than that in the placebo group ( < 0.05). Twelve cases had gastrointestinal discomfort, of which eight were in the Iguratimod group (16.7%, one case withdrew from the study due to diarrhoea) and four were in the placebo group (16.0%). No significant difference was found between the two groups ( < 0.05). Three cases of elevated transaminase were observed in the Iguratimod group and none in the placebo group, with no significant difference ( < 0.05). Iguratimod could significantly reduce the symptoms and signs of patients with active SpA. It could improve the physical function and quality of life of these patients and the overall safety and tolerance are good.
在过去的研究中已证实了艾拉莫德治疗类风湿关节炎的效果。就其作用机制和临床应用经验而言，艾拉莫德在治疗脊柱关节炎（SpA）方面具有潜在价值。本研究评估了艾拉莫德对活动性SpA的疗效和安全性。招募活动性SpA患者并按1:2的比例随机分为两组（安慰剂组与艾拉莫德组）。在使用非甾体抗炎药的基础上，联合使用艾拉莫德或安慰剂进行治疗，随后每4周随访1次，共随访24周。主要疗效终点是评估ASAS20的缓解率；ASDAS的显著改善以及第24周时脊柱活动度、身体功能和生活质量的疗效。最终分析纳入艾拉莫德组48例和安慰剂组25例。在第24周时，接受艾拉莫德治疗的患者中达到ASAS20（80%对44%）和ASAS40（56%对20%）缓解的百分比显著高于安慰剂组（P<0.05）。有12例出现胃肠道不适，其中艾拉莫德组8例（16.7%，1例因腹泻退出研究），安慰剂组4例（16.0%）。两组之间无显著差异（P<0.05）。艾拉莫德组观察到3例转氨酶升高，安慰剂组未观察到，差异无统计学意义（P<0.05）。艾拉莫德可显著减轻活动性SpA患者的症状和体征。它可以改善这些患者的身体功能和生活质量，总体安全性和耐受性良好。
