The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan.
Int J Rheum Dis. 2020 Apr;23(4):549-558. doi: 10.1111/1756-185X.13792. Epub 2020 Feb 5.
In this retrospective study, the effect of hydroxychloroquine (HCQ) added to maintenance therapy according to the standard of care (SoC) was evaluated for 1 year in 101 patients with systemic lupus erythematosus (SLE).
The primary endpoint was the SLE Disease Activity Index (SLEDAI). The secondary endpoints were the British Isles Lupus Assessment Group index, serum complement activity (CH50) levels, anti-double-stranded DNA (dsDNA) antibody titer, concomitant corticosteroid (CS) dose, and Systemic Lupus International Collaborating Clinics (SLICC) damage index. These variables were compared between the SoC + HCQ (n = 42) and SoC (n = 59) groups.
The SLEDAI improved from 2 (0, 6) to 0 (0, 4) in the SoC + HCQ group (P = .038) but significantly deteriorated from 1 (0, 4) to 2 (0, 8) in the SoC group (P = .033). CH50, anti-dsDNA antibody titer, concomitant CS dose, and SLICC damage index did not significantly change. The increase in the SLEDAI and concomitant CS dose after 1 year were all significantly greater in the SoC group, and the proportion of patients with SLEDAI flare was significantly lower in the SoC + HCQ group (SoC + HCQ: 4.76% vs SoC: 25.4%, P = .006). Univariate logistic regression analyses identified HCQ as a predictive factor for no SLEDAI flare (P = .003, odds ratio 6.81, 95% confidence interval 1.77-45.00).
The use of HCQ effectively improved SLEDAI scores and was a predictive factor for the prevention of SLEDAI flare. Therefore, HCQ may be considered a potential mainstay of maintenance therapy.
在这项回顾性研究中，我们评估了在 101 例系统性红斑狼疮（SLE）患者中，根据标准治疗（SoC）添加羟氯喹（HCQ）进行维持治疗的效果，为期 1 年。
主要终点是 SLE 疾病活动指数（SLEDAI）。次要终点是不列颠群岛狼疮评估组指数、血清补体活性（CH50）水平、抗双链 DNA（dsDNA）抗体滴度、同时使用的皮质类固醇（CS）剂量以及系统性红斑狼疮国际合作临床中心（SLICC）损害指数。我们比较了 SoC+HCQ（n=42）和 SoC（n=59）两组之间这些变量的差异。
SoC+HCQ 组的 SLEDAI 从 2（0，6）降至 0（0，4）（P=.038），而 SoC 组则从 1（0，4）恶化至 2（0，8）（P=.033）。CH50、抗 dsDNA 抗体滴度、同时使用的 CS 剂量和 SLICC 损害指数无显著变化。SoC 组的 SLEDAI 和同时使用的 CS 剂量在 1 年后的增加均显著更大，而 SoC+HCQ 组的 SLEDAI 发作患者比例显著更低（SoC+HCQ：4.76% vs SoC：25.4%，P=.006）。单变量逻辑回归分析确定 HCQ 是 SLEDAI 无发作的预测因素（P=.003，优势比 6.81，95%置信区间 1.77-45.00）。
HCQ 的使用可有效改善 SLEDAI 评分，是预防 SLEDAI 发作的预测因素。因此，HCQ 可能被认为是维持治疗的潜在支柱。
