Mizutani Satoshi, Kodera Hitoshi, Sato Yoshiko, Nanki Toshihiro, Yoshida Shunji, Yasuoka Hidekata
Division of Rheumatology, Department of Internal Medicine, School of Medicine, Fujita Health University, Toyoake, 470-1192, Aichi, Japan.
Department of Internal Medicine, Yokkaichi Hazu Medical Center, Yokkaichi, 510-0016, Mie, Japan.
Clin Rheumatol. 2021 Jan;40(1):123-132. doi: 10.1007/s10067-020-05208-y. Epub 2020 Jun 6.
Iguratimod (IGU) is a conventional synthetic disease-modifying drug that has been approved based on its additive effects with methotrexate (MTX) for the treatment of rheumatoid arthritis (RA). The objective of the study is to establish the effectiveness of IGU with versus IGU without MTX irrespective of whether MTX is well tolerated or not by the patients.
Disease activity scores in 177 RA patients treated using IGU were retrospectively evaluated at baseline and after 4, 12, and 24 weeks, and adverse events (AEs) were noted.
IGU reduced the disease activity parameters, disease activity score (DAS)-ESR, DAS-CRP, the simplified disease activity index (SDAI), and clinical disease activity index (CDAI) in the concomitant MTX and non-MTX, female and male, and young and elderly patient groups after 24 weeks. Multivariate analysis demonstrated that IGU was more effective with concomitant MTX and in elderly and male patients. Severe AEs were observed only in the elderly group: two cases of pneumonia, 1 of pneumocystis pneumonia, 1 of heart failure, and 1 of salivary gland adenoma.
IGU is effective for RA, especially with concomitant MTX, and in elderly and male patients. Key Points • Iguratimod is effective for RA, especially with concomitant MTX, and in elderly and male patients. • Since all serious adverse events were in the elderly group in this study, sufficient monitoring for adverse events, especially for elderly RA patients, is needed during iguratimod therapy.
艾拉莫德（IGU）是一种传统合成的改善病情药物，已基于其与甲氨蝶呤（MTX）联合使用对类风湿关节炎（RA）的治疗效果而获批。本研究的目的是确定无论患者对MTX耐受性如何，联合MTX与不联合MTX使用IGU的有效性。
回顾性评估了177例使用IGU治疗的RA患者在基线以及4周、12周和24周后的疾病活动评分，并记录不良事件（AE）。
24周后，IGU降低了联合MTX组和不联合MTX组、女性和男性、年轻和老年患者组的疾病活动参数、疾病活动评分（DAS）-血沉、DAS- CRP、简化疾病活动指数（SDAI）和临床疾病活动指数（CDAI）。多变量分析表明，IGU联合MTX使用时以及在老年和男性患者中更有效。仅在老年组观察到严重AE：2例肺炎、1例肺孢子菌肺炎、1例心力衰竭和1例涎腺腺瘤。
IGU对RA有效，尤其是联合MTX使用时，以及在老年和男性患者中。要点 • 艾拉莫德对RA有效，尤其是联合MTX使用时，以及在老年和男性患者中。• 由于本研究中所有严重不良事件均发生在老年组，因此在艾拉莫德治疗期间需要对不良事件进行充分监测，尤其是对老年RA患者。
