Treatment of moderately to severely active systemic lupus erythematosus with adrenocorticotropic hormone: a single-site, open-label trial.

Treatment of moderately to severely active systemic lupus erythematosus with adrenocorticotropic hormone: a single-site, open-label trial.
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DOI:
10.1177/0961203314532562
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发表时间:
2014-08
期刊:
影响因子:
2.6
通讯作者:
Montroy T
Montroy T
中科院分区:
医学4区
文献类型:
--
作者:
Fiechtner JJ;Montroy T

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对于传统治疗未能充分控制或不耐受的系统性红斑狼疮 (SLE) 患者,需要替代治疗选择。本研究评估了 Acthar® Gel (ACTH(1-39)) 在接受基础常规维持治疗的患者中降低活动性 SLE 严重程度的功效。 10 名女性(平均年龄 = 49 岁,疾病持续时间 = 7 岁,系统性红斑狼疮疾病活动指数-2000 [SLEDAI-2 K] = 10)目前正在自我维持 ACTH(1–39) 凝胶 1 mL (80 U/mL),持续 7–15 天,并每周进行评估28天。结果指标包括医师和患者总体评估、SLEDAI-2 K、狼疮生活质量量表、慢性病治疗疲劳功能评估 (FACIT-疲劳) 量表、红细胞沉降率和 C 反应蛋白。学生的 t 检验将第 7 天、第 14 天和第 28 天获得的数据与基线数据进行了比较。在所有观察时间均达到了 SLEDAI-2 K 改善的主要终点 (p < 0.05),并且大多数其他参数都观察到了统计上显着的改善。没有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,ACTH(1-39) 凝胶可以显着降低疾病活动度。
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.
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发表时间: 2013-04-01
期刊: LUPUS
影响因子: 2.6
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