Miyagawa Ippei, Nakano Kazuhisa, Nakayamada Shingo, Iwata Shigeru, Hanami Kentaro, Fukuyo Shunsuke, Kubo Satoshi, Inoue Yoshino, Ueno Masanobu, Tanaka Yoshiya
The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyush, Japan.
Int J Rheum Dis. 2019 Mar;22(3):434-442. doi: 10.1111/1756-185X.13387. Epub 2018 Oct 18.
The effectiveness and safety of hydroxychloroquine (HCQ) have not been fully validated in Japanese patients with systemic lupus erythematosus (SLE) in the clinical setting. This study evaluated the short-term effectiveness and continuation rate of HCQ therapy in Japanese patients with SLE in the clinical setting for 12 months.
The primary endpoint was defined as the continuation rate up to 12 months after the introduction of HCQ in 122 patients with SLE. The secondary endpoints included changes in the SLE Disease Activity Index (SLEDAI) and the British Isles Lupus Assessment Group (BILAG) index, and the effect on concomitant corticosteroid (CS) dose reduction.
The primary endpoint, continuation rate up to 12 months after the introduction of HCQ, was 79.5%. Of 25 patients who discontinued HCQ, 23 patients terminated the therapy within 2 months. The secondary endpoints (SLEDAI, BILAG index, and concomitant CS dose [mg/day, prednisolone equivalent]) all showed a significant decrease. SLEDAI and BILAG index scores indicated significant improvement during the remission induction phase, maintenance phase, and HCQ monotherapy phase.
The results of this study suggested that, with attention paid to possible adverse events immediately after initiation, HCQ may be initiated as a mainstay of SLE therapy in Japanese patients, either as a concomitant medication in the remission induction phase, as a maintenance therapy, or as a monotherapy.
在临床环境中，羟氯喹（HCQ）对日本系统性红斑狼疮（SLE）患者的有效性和安全性尚未得到充分验证。本研究评估了临床环境中日本SLE患者接受HCQ治疗12个月的短期有效性和持续率。
主要终点定义为122例SLE患者开始使用HCQ后12个月的持续率。次要终点包括SLE疾病活动指数（SLEDAI）和不列颠群岛狼疮评估组（BILAG）指数的变化，以及对同时使用的皮质类固醇（CS）剂量减少的影响。
主要终点，即开始使用HCQ后12个月的持续率为79.5%。在25例停用HCQ的患者中，2个月内有23例终止治疗。次要终点（SLEDAI、BILAG指数和同时使用的CS剂量[毫克/天，泼尼松等效剂量]）均显著下降。SLEDAI和BILAG指数评分在缓解诱导期、维持期和HCQ单药治疗期均显示出显著改善。
本研究结果表明，在开始治疗后立即关注可能的不良事件的情况下，HCQ可以作为日本SLE患者治疗的主要药物启动，无论是在缓解诱导期作为联合用药、作为维持治疗还是作为单药治疗。
