Division of Rheumatology, Department of Medicine, New York University School of Medicine, New York, NY, USA.
Department of Population Medicine, Harvard Medical School, Boston, MA, USA.
Arthritis Res Ther. 2020 Aug 17;22(1):191. doi: 10.1186/s13075-020-02282-0.
Although hydroxychloroquine (HCQ) is a mainstay of treatment for patients with systemic lupus erythematosus (SLE), ocular toxicity can result from accumulated exposure. As the longevity of patients with SLE improves, data are needed to balance the risk of ocular toxicity and the risk of disease flare, especially in older patients with quiescent disease. Accordingly, this study was initiated to examine the safety of HCQ withdrawal in older SLE patients.
Data were obtained by retrospective chart review at three major lupus centers in New York City. Twenty-six patients who discontinued HCQ and thirty-two patients on HCQ matched for gender, race/ethnicity, and age were included in this study. The primary outcome was the occurrence of a lupus flare classified by the revised version of the Safety of Estrogens in Lupus Erythematosus: National Assessment version of the Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) Flare composite index, within 1 year of HCQ withdrawal or matched time of continuation.
Five patients (19.2%) in the HCQ withdrawal group compared to five (15.6%) in the HCQ continuation group experienced a flare of any severity (odds ratio [OR] = 1.28; 95% CI 0.31, 5.30; p = 0.73). There were no severe flares in either group. The results were similar after adjusting for length of SLE, number of American College of Rheumatology criteria, low complement levels, and SELENA-SLEDAI score, and in a propensity score analysis (OR = 1.18; 95% CI 0.23, 6.16; p = 0.84). The analysis of time to any flare revealed a non-significant earlier time to flare in the HCQ withdrawal group (log-rank p = 0.67). Most flares were in the cutaneous and musculoskeletal systems, but one patient in the continuation group developed pericarditis. The most common reason for HCQ withdrawal was retinal toxicity (42.3%), followed by patient's preference (34.6%), other confirmed or suspected adverse effects (15.4%), ophthalmologist recommendation for macular degeneration (3.8%), and rheumatologist recommendation for quiescent SLE (3.8%).
In this retrospective study of older stable patients with SLE on long-term HCQ, withdrawal did not significantly increase the risk of flares.
尽管羟氯喹 (HCQ) 是治疗系统性红斑狼疮 (SLE) 患者的主要药物,但累积暴露可能会导致眼部毒性。随着 SLE 患者寿命的延长,需要权衡眼部毒性风险和疾病发作风险,尤其是在病情稳定的老年患者中。因此,本研究旨在检查老年 SLE 患者停用 HCQ 的安全性。
通过在纽约市三个主要狼疮中心进行回顾性病历审查获得数据。本研究纳入了 26 例停用 HCQ 的患者和 32 例性别、种族/民族和年龄匹配的继续接受 HCQ 治疗的患者。主要结局是在停用 HCQ 后 1 年内或继续治疗的匹配时间内,根据修订后的 Safety of Estrogens in Lupus Erythematosus: National Assessment 版本的系统性红斑狼疮疾病活动指数 (SELENA-SLEDAI) 发作综合指数,发生狼疮发作的情况。
停用 HCQ 组的 5 例(19.2%)患者与继续接受 HCQ 组的 5 例(15.6%)患者发生任何严重程度的发作(比值比 [OR] = 1.28;95%置信区间 0.31,5.30;p = 0.73)。两组均无严重发作。在调整 SLE 持续时间、美国风湿病学会标准数、低补体水平和 SELENA-SLEDAI 评分以及倾向评分分析后,结果相似(OR = 1.18;95%置信区间 0.23,6.16;p = 0.84)。任何发作时间的分析显示,停用 HCQ 组的发作时间更早,但无统计学意义(对数秩检验 p = 0.67)。大多数发作发生在皮肤和肌肉骨骼系统,但继续治疗组的 1 例患者发生了心包炎。停用 HCQ 的最常见原因是视网膜毒性(42.3%),其次是患者的偏好(34.6%)、其他已确认或疑似不良反应(15.4%)、眼科医生建议黄斑变性(3.8%)和风湿病医生建议治疗静止性 SLE(3.8%)。
在这项针对长期接受 HCQ 治疗的稳定老年 SLE 患者的回顾性研究中,停药并未显著增加发作风险。