Ishiguro Naoki, Shibata Kai, Yoshimura Akiko, Ikeuchi Satoshi, Ishii Mika
Department of Orthopaedic Surgery, Graduate School & Faculty of Medicine, Nagoya University, Nagoya, Japan.
Clinical Planning and Development Department, Medical HQs, Eisai Co., Ltd, Bunkyō, Japan.
Mod Rheumatol. 2020 Jul;30(4):626-632. doi: 10.1080/14397595.2019.1649110. Epub 2019 Aug 8.
The treatment response according to patient disease activity during Iguratimod therapy for rheumatoid arthritis has not been sufficiently assessed. A analysis of post-marketing surveillance was performed. The treatment effect was evaluated using the European League against Rheumatism (EULAR) response criteria. Disease Activity Score (DAS) 28 was assessed at various time points. Patients showing a moderate or good response according to the EULAR response criteria at 24 weeks after the start of Iguratimod therapy were considered Responders. Propensity score matching was also performed, after which the factors with the greatest effect on the treatment evaluation were investigated. The mean DAS28 at the start of administration and after 24 weeks was 4.31 and 2.52, respectively, in the Responder and 3.48 and 3.48, respectively, in the Non-responder. After propensity score matching for patient characteristics, the primary factors found to be related to being a Responder were concomitant use of methotrexate (MTX) with Iguratimod, and prior treatment with MTX before the start of Iguratimod. As factors related to the treatment effect, the concomitant use of MTX may contribute to achieving a better effect, and this study has shown that real-world are consistent with the results of clinical trials.
在类风湿关节炎患者接受艾拉莫德治疗期间，根据疾病活动度的治疗反应尚未得到充分评估。进行了一项上市后监测分析。使用欧洲抗风湿病联盟（EULAR）反应标准评估治疗效果。在不同时间点评估疾病活动评分（DAS）28。在艾拉莫德治疗开始24周后，根据EULAR反应标准显示中度或良好反应的患者被视为反应者。还进行了倾向评分匹配，之后研究了对治疗评估影响最大的因素。反应者组给药开始时和24周后的平均DAS28分别为4.31和2.52，无反应者组分别为3.48和3.48。在对患者特征进行倾向评分匹配后，发现与成为反应者相关的主要因素是艾拉莫德与甲氨蝶呤（MTX）联合使用，以及在艾拉莫德开始前先用MTX治疗。作为与治疗效果相关的因素，MTX联合使用可能有助于取得更好的效果，并且本研究表明真实世界的情况与临床试验结果一致。
