Fumaric acid ester treatment in cutaneous lupus erythematosus (CLE): a prospective, open-label, phase II pilot study
Fumaric acid ester treatment in cutaneous lupus erythematosus (CLE): a prospective, open-label, phase II pilot study
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DOI：
10.1177/0961203316644335
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发表时间：
2016-10-01
期刊：
影响因子：
2.6
通讯作者：
Bonsmann, G.
中科院分区：
文献类型：
--
作者：
Kuhn, A.;Landmann, A.;Bonsmann, G.
目的评价富马酸酯（FAE）治疗皮肤型红斑狼疮（CLE）的有效性和安全性。结果与治疗前相比，治疗12周后，FAE治疗组的RCLASI活动度评分和RCLASI活动度评分均明显改善，与治疗前相比，治疗12周后，FAE治疗组的RCLASI活动度评分和RCLASI活动度评分均明显改善，与治疗前相比，治疗12周后，FAE治疗组的RCLASI活动度评分和RCLASI活动度评分均明显改善（分别为p=0.002，p=0.002）和第24周（分别为p=0.009，p=0.009）。最常见的不良事件包括腹部绞痛和headach.Conclusions FAE可能是一种替代和安全的治疗方法，在治疗难治性CLE患者，但是，随机对照试验是必要的，以评估FAE在这种疾病的疗效和安全性。
Objective The aim of the study was to assess the efficacy and safety of fumaric acid esters (FAEs) in patients with cutaneous lupus erythematosus (CLE).Methods In this 24-week, prospective, open-label, phase II pilot study, 11 patients with CLE, refractory to topical corticosteroids, were included. The primary endpoint of the study was the evaluation of the efficacy of FAEs after 24 weeks of treatment as assessed by the Revised Cutaneous Lupus Disease Area and Severity Index (RCLASI).Results Compared to baseline, significant improvement in the mean total RCLASI activity score and the mean RCLASI activity score for skin lesions was observed in week 12 (p=0.002, p=0.002, respectively) and in week 24 (p=0.009, p=0.009, respectively). Most common adverse events included abdominal cramps and headache.Conclusions FAEs could be an alternative and safe treatment in patients with therapy-refractory CLE; however, randomized controlled trials are warranted to evaluate the efficacy and safety of FAEs in this disease.