Inoue Asuka, Nozaki Yuji, Hirooka Yasuaki, Kinoshita Koji, Chiba Yasutaka, Funauchi Masanori, Matsumura Itaru
Department of Rheumatology, Kindai University Nara Hospital, Nara 630-0293, Japan.
Department of Hematology and Rheumatology, Kindai University School of Medicine, Osaka 589-8511, Japan.
Life (Basel). 2020 Oct 29;10(11):261. doi: 10.3390/life10110261.
(1) Background: We evaluated the clinical response of iguratimod (IGU) in patients with rheumatoid arthritis (RA) being treated with or without methotrexate (MTX) over 54 weeks. (2) Methods: 106 patients with RA undergoing IGU were retrospectively observed. RA patients were divided into those treated with MTX+IGU ( = 35) and those treated with IGU ( = 71). The primary endpoint was the clinical response of the Disease Activity Score assessing 28 joints with C-reactive protein (DAS28-CRP) differences in the changes from baseline to 54 weeks between MTX+IGU and IGU groups. Secondary endpoints, such as the clinical response, retention rate, and safety, were evaluated. (3) Results: The DAS28-CRP difference in the changes between the two groups were -0.2. DAS28-CRP were significantly reduced from the baseline in the MTX+IGU and IGU groups (-1.43 and -1.20 from baseline, respectively). The retention rates were 71.4% in the MTX+IGU groups and 59.2% in the IGU groups ( = 0.16). Adverse events were observed in a total of 6 (17.1%) MTX+IGU patients and 20 (28.2%) IGU patients ( = 0.21). (4) Conclusions: IGU therapy may be a useful treatment option for patients who cannot be treated with MTX.
（1）背景：我们评估了艾拉莫德（IGU）在接受或未接受甲氨蝶呤（MTX）治疗的类风湿关节炎（RA）患者中54周的临床反应。（2）方法：对106例接受IGU治疗的RA患者进行回顾性观察。RA患者分为接受MTX + IGU治疗的患者（n = 35）和接受IGU治疗的患者（n = 71）。主要终点是评估28个关节并结合C反应蛋白的疾病活动评分（DAS28-CRP）在MTX + IGU组和IGU组中从基线到54周变化的临床反应差异。评估了次要终点，如临床反应、保留率和安全性。（3）结果：两组变化中的DAS28-CRP差异为-0.2。MTX + IGU组和IGU组的DAS28-CRP均较基线显著降低（分别较基线降低-1.43和-1.20）。MTX + IGU组的保留率为71.4%，IGU组为59.2%（P = 0.16）。MTX + IGU组共有6例（17.1%）患者和IGU组20例（28.2%）患者观察到不良事件（P = 0.21）。（4）结论：对于无法使用MTX治疗的患者，IGU治疗可能是一种有用的治疗选择。
