Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, 50200, Thailand.
Division of Rheumatology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Clin Rheumatol. 2019 Sep;38(9):2461-2471. doi: 10.1007/s10067-019-04587-1. Epub 2019 May 19.
To evaluate the efficacy and safety of diacerein in patients with rheumatoid arthritis (RA) who are methotrexate inadequate responders (MTX-IR).
In this pilot, multicenter, double-blind, placebo-controlled trial, MTX-IR RA patients were randomized to either diacerein or matching placebo as add-on treatment to MTX for 24 weeks. Efficacy and safety were evaluated every 4 weeks until week 28. Primary and secondary efficacy endpoints were the percentage of patients achieving the ACR20 criteria and a moderate EULAR response at week 24, respectively.
Forty patients were equally randomized to both study treatments; 16 and 19 participants completed the study in the diacerein and the placebo arms, respectively. Baseline characteristics were similar in both groups, except that tender joint count, DAS28-ESR score, and non-steroidal anti-inflammatory drug consumption were higher in the placebo arm. The ACR20 response at week 24 was similar in the diacerein and placebo groups (65% vs 45%, P = .20). However, treatment response according to the EULAR criteria was better in patients taking diacerein (75% vs 25% of moderate response, P = .002). In the 35 patients with assessments through week 28, diacerein was superior to placebo in ACR20 at weeks 24 and 28 (both 81% vs 47%, P = .04). Incidence of adverse events was comparable in both arms, with only chromaturia being more common with diacerein than placebo (40% vs 10%, P = .03).
These preliminary results show the potential benefits of diacerein on pain, joint function, and disease activity in MTX-IR RA patients.
ClinicalTrials.gov Identifier: NCT01264211 Key Points • Diacerein has shown positive effects on rheumatoid arthritis symptoms. • A good safety profile of diacerein has been observed when it was administered as add-on therapy to methotrexate in patients with rheumatoid arthritis.
评估二乙酰氨己酸治疗甲氨蝶呤应答不足的类风湿关节炎（RA）患者的疗效和安全性。
在这项试点、多中心、双盲、安慰剂对照试验中，将甲氨蝶呤应答不足的 RA 患者随机分配至二乙酰氨己酸或匹配安慰剂，作为甲氨蝶呤的附加治疗，治疗 24 周。每 4 周评估一次疗效和安全性，直至第 28 周。主要和次要疗效终点分别为第 24 周时达到 ACR20 标准的患者比例和中度 EULAR 反应。
40 名患者被平均随机分配至两组研究治疗中；16 名和 19 名参与者分别完成了二乙酰氨己酸和安慰剂组的研究。两组的基线特征相似，除了安慰剂组的压痛关节数、DAS28-ESR 评分和非甾体抗炎药的使用量较高。第 24 周时，二乙酰氨己酸组和安慰剂组的 ACR20 反应相似（65%对 45%，P=0.20）。然而，根据 EULAR 标准，二乙酰氨己酸组的治疗反应更好（75%对 25%为中度反应，P=0.002）。在第 28 周时有评估的 35 名患者中，二乙酰氨己酸在第 24 周和第 28 周时优于安慰剂（均为 81%对 47%，P=0.04）。两组的不良反应发生率相当，只有二乙酰氨己酸组比安慰剂组更常见色素尿（40%对 10%，P=0.03）。
这些初步结果表明，二乙酰氨己酸对甲氨蝶呤应答不足的 RA 患者的疼痛、关节功能和疾病活动可能有积极的影响。
ClinicalTrials.gov 标识符：NCT01264211
关键点
• 二乙酰氨己酸对类风湿关节炎症状有积极影响。
• 二乙酰氨己酸作为甲氨蝶呤的附加治疗药物，在类风湿关节炎患者中具有良好的安全性。
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