Fiechtner J J, Montroy T
Fiechtner Research, Lansing, MI, USA
Fiechtner Research, Lansing, MI, USA.
Lupus. 2014 Aug;23(9):905-12. doi: 10.1177/0961203314532562. Epub 2014 May 2.
Alternative therapeutic options are needed for patients with systemic lupus erythematosus (SLE) not adequately controlled with or intolerant to traditional treatments. This study evaluated the efficacy of Acthar® Gel (ACTH(1-39)) for reducing active SLE severity among patients receiving underlying conventional maintenance therapies.
Ten females (mean age = 49 yrs, disease duration = 7 yrs, Systemic Lupus Erythematosus Disease Activity Index-2000 [SLEDAI-2 K] = 10) currently on maintenance self-administered ACTH(1-39) gel 1 mL (80 U/mL) for 7-15 days and were assessed weekly for 28 days. Outcome measures included Physician and Patient Global Assessments, SLEDAI-2 K, Lupus Quality of Life scale, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale, erythrocyte sedimentation rate, and C-reactive protein. Student's t-test compared data obtained at days 7, 14, and 28 with those from baseline.
The primary endpoint of SLEDAI-2 K improvement was reached at all observation times (p < 0.05) and statistically significant improvements were observed for most other parameters. No treatment-related serious or unexpected adverse events were observed.
The trial results reveal that among SLE patients in need of therapeutic alternatives, ACTH(1-39) gel may provide significant disease activity reduction.
对于系统性红斑狼疮（SLE）患者，若传统治疗无法充分控制病情或患者不耐受，则需要其他治疗选择。本研究评估了Acthar®凝胶（促肾上腺皮质激素(1-39)）在接受基础传统维持治疗的患者中降低SLE活动度的疗效。
10名女性（平均年龄 = 49岁，病程 = 7年，系统性红斑狼疮疾病活动指数-2000[SLEDAI-2K]=10），目前正在自我皮下注射1毫升（80单位/毫升）促肾上腺皮质激素(1-39)凝胶，持续7至15天，并在28天内每周进行评估。观察指标包括医生和患者整体评估、SLEDAI-2K、狼疮生活质量量表、慢性病治疗功能评估-疲劳（FACIT-疲劳）量表、红细胞沉降率和C反应蛋白。采用学生t检验比较第7、14和28天的数据与基线数据。
在所有观察时间均达到了SLEDAI-2K改善的主要终点（p<0.05），并且在大多数其他参数上观察到了具有统计学意义的改善。未观察到与治疗相关的严重或意外不良事件。
试验结果表明，在需要替代治疗的SLE患者中，促肾上腺皮质激素(1-39)凝胶可能显著降低疾病活动度。
