Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, 321 Zhongshan Road, Nanjing, 210008, Jiangsu, China.
School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, 639 Longmian Avenue, Jiangning, Nanjing, 211198, China.
Clin Rheumatol. 2020 Jul;39(7):2139-2150. doi: 10.1007/s10067-020-04986-9. Epub 2020 Feb 20.
This study aims to compare the efficacy and the safety of the iguratimod with placebo and other disease-modifying antirheumatic drugs (DMARDs) in adults with rheumatoid arthritis.
Two authors independently searched and selected randomized controlled trials from Cochrane library, Medline (through Pubmed), and Chinese databases, and then assessed the risk of bias (using ROB 2 tool), and graded the certainty of evidence (using the GRADEpro GDT software). We applied the RevMan 5 software for performing meta-analyses of the final consensus data.
We identified 12 trials involving 1938 participants. Ten trials had an overall high risk of bias. Although iguratimod had superior efficacy than placebo, the incidence of adverse events was also higher. Inferring to non-inferiority analysis with other DMARD therapy (primarily comprising methotrexate), iguratimod is likely to result in similar treatment response (20% (OR 1.04, 95% CI 0.79 to 1.36), 50% and 70% improvement in American College of Rheumatology criteria) and functional ability at 24 weeks. Although the disease state was slightly better with iguratimod (MD - 0.55, 95% CI - 0.85 to - 0.25), a clinically important improvement was not achieved. Iguratimod may have lower C-reactive protein and erythrocyte sedimentation rate values. Swollen joint count, tender joint count, pain intensity, and patient's and physician's global assessment of disease state may be comparable between the therapies. Both the therapies are likely to have similar odds (OR 0.91, 95% CI 0.67 to 1.26) of adverse events.
Our evidence suggests that iguratimod may be considered a potential alternative to methotrexate to treat rheumatoid arthritis.Key Points• The Asia Pacific League of Association for Rheumatology (APLAR) has recommended that iguratimod may be used a first-line drug for rheumatoid arthritis in specific cases.• Patients on iguratimod may have similar treatment response, functional ability, disease state, and adverse event profile at 24 weeks compared with those on methotrexate.• Iguratimod may be considered a better alternative to methotrexate in RA patients having high CRP and ESR values.• Future clinical trials in diverse population comparing the efficacy and safety of iguratimod in monotherapy or combination therapy with DMARDs (other than methotrexate) are warranted.
本研究旨在比较依那西普与安慰剂和其他改善病情的抗风湿药物（DMARDs）在成人类风湿关节炎患者中的疗效和安全性。
两位作者独立从 Cochrane 图书馆、Medline（通过 Pubmed）和中文数据库中搜索和选择随机对照试验，然后评估偏倚风险（使用 ROB 2 工具），并使用 GRADEpro GDT 软件对证据质量进行分级。我们应用 RevMan 5 软件对最终共识数据进行荟萃分析。
我们确定了 12 项涉及 1938 名参与者的试验。其中 10 项试验总体上存在高偏倚风险。虽然依那西普的疗效优于安慰剂，但不良反应的发生率也更高。推断到与其他 DMARD 治疗（主要包括甲氨蝶呤）的非劣效性分析，依那西普可能会导致相似的治疗反应（24 周时 20%（OR 1.04，95%CI 0.79 至 1.36）、50%和 70%的美国风湿病学会标准改善）和功能能力。尽管依那西普的疾病状态稍好（MD -0.55，95%CI -0.85 至 -0.25），但并未达到临床重要改善。依那西普可能具有较低的 C 反应蛋白和红细胞沉降率值。肿胀关节计数、压痛关节计数、疼痛强度以及患者和医生对疾病状态的总体评估在两种治疗方法之间可能相似。两种治疗方法发生不良反应的可能性也相似（OR 0.91，95%CI 0.67 至 1.26）。
我们的证据表明，依那西普可能被认为是治疗类风湿关节炎的甲氨蝶呤的潜在替代药物。
亚太风湿病学会联盟（APLAR）已建议，在某些情况下，依那西普可作为类风湿关节炎的一线药物。
与甲氨蝶呤相比，依那西普治疗的患者在 24 周时的治疗反应、功能能力、疾病状态和不良反应情况可能相似。
对于 CRP 和 ESR 值较高的类风湿关节炎患者，依那西普可能是甲氨蝶呤的更好替代药物。
有必要在不同人群中进行比较依那西普单药或与 DMARDs（除甲氨蝶呤外）联合治疗的疗效和安全性的临床试验。
