Yang Bei-Bei, Xiao Hua, Li Xiao-Jie, Zheng Min
Department of Dermatology, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310009, China.
These authors contributed equally to this article.
Discov Med. 2018 Jan;25(135):14-20.
To evaluate the safety and efficacy of etanercept (ETN) plus methotrexate (MTX) in patients with rhupus without using corticosteroids.
Twenty rhupus patients [meeting the criteria for both rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE)] who had never been treated with corticosteroids, DMARDs, or biological agents with a 28-joint Disease Activity Score (DAS28) >3.2 and lupus nephritis determined from histopathological specimens were enrolled. All patients were treated with MTX plus ETN, and monitored for 24 weeks of treatment. Clinical efficacy was evaluated using the DAS28 and Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K). Demographic characteristics, clinical parameters, and treatment data were analyzed at baseline (BL) and after 4, 8, 16, and 24 weeks of treatment. The incidence of adverse events (AEs) was evaluated.
The 20 patients had a mean age of 44.3±8 years and a disease duration of 5.4±3.1 years. At week 24, treatment with ETN plus MTX resulted in a significant improvement in DAS28 (3.3±0.1 vs. 6.0±0.1 /BL; p<0.001), tender joint count (2.9±0.2 vs. 10.75±0.8/BL; p<0.001), swollen joint count (2.7±0.2 vs. 8.5±0.5/BL; p<0.001), Visual Analog Scale for pain (27.0±2.6 mm vs. 66.5±3.1 mm/BL; p<0.001), and SLEDAI-2K (6.30±0.36 vs. 13.7±0.48/BL; p<0.001). During the study, the most frequent AEs were upper respiratory tract infections (10%), injection site reactions (10%), and cutaneous rashes (5%); there were no serious AEs. No deaths, malignancies, or tuberculosis or other serious infections were reported.
Without corticosteroids, combination therapy of ETN plus MTX was relatively safe and effective in rhupus patients, which indicates efficacy of non-corticosteroid treatment for rhupus.
评估在不使用糖皮质激素的情况下，依那西普（ETN）联合甲氨蝶呤（MTX）治疗重叠性狼疮患者的安全性和有效性。
纳入20例重叠性狼疮患者[符合类风湿关节炎（RA）和系统性红斑狼疮（SLE）的标准]，这些患者从未接受过糖皮质激素、改善病情抗风湿药（DMARDs）或生物制剂治疗，28个关节疾病活动评分（DAS28）>3.2，且根据组织病理学标本确定有狼疮性肾炎。所有患者均接受MTX联合ETN治疗，并进行24周的治疗监测。使用DAS28和系统性红斑狼疮疾病活动指数2000（SLEDAI - 2K）评估临床疗效。在基线（BL）以及治疗4、8、16和24周后分析人口统计学特征、临床参数和治疗数据。评估不良事件（AE）的发生率。
20例患者的平均年龄为44.3±8岁，病程为5.4±3.1年。在第24周时，ETN联合MTX治疗使DAS28（3.3±0.1 vs. 6.0±0.1 /BL；p<0.001）、压痛关节数（2.9±0.2 vs. 10.75±0.8/BL；p<0.001）、肿胀关节数（2.7±0.2 vs. 8.5±0.5/BL；p<0.001）、视觉模拟疼痛量表评分（27.0±2.6 mm vs. 66.5±3.1 mm/BL；p<0.001）和SLEDAI - 2K（6.30±0.36 vs. 13.7±0.
