Safety and Efficacy of Lenabasum, a Cannabinoid Receptor Type 2 Agonist, in Patients with Dermatomyositis with Refractory Skin Disease: A Randomized Clinical Trial.
Safety and Efficacy of Lenabasum, a Cannabinoid Receptor Type 2 Agonist, in Patients with Dermatomyositis with Refractory Skin Disease: A Randomized Clinical Trial.
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DOI：
10.1016/j.jid.2022.03.029
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发表时间：
2022-10
影响因子：
6.5
通讯作者：
White, Barbara
中科院分区：
文献类型：
--
作者：
Werth, Victoria P.;Hejazi, Emily;Pena, Sandra M.;Haber, Jessica;Zeidi, Majid;Reddy, Nithin;Okawa, Joyce;Feng, Rui;Bashir, Muhammad M.;Gebre, Kirubel;Jadoo, Arvin S.;Concha, Josef Symon S.;Dgetluck, Nancy;Constantine, Scott;White, Barbara
皮肌炎 (DM) 皮肤病的治疗选择有限。 Lenabasum 是一种大麻素受体 2 型激动剂，可引发炎症消退。评估 lenabasum 在难治性皮肤糖尿病患者中的安全性和有效性。本研究是一项单中心、双盲、随机、安慰剂对照的 2 期研究，于 2015 年 7 月至 2017 年 8 月进行。受试者年龄≥18 岁，皮肤皮肌炎疾病面积和严重程度指数 (CDASI) 活性至少为中度活性 DM 皮肤活性≥14，且对羟氯喹失败或不耐受。参与者每天服用 lenabasum 20 毫克，持续 28 天，然后每天两次服用 20 毫克，持续 56 天，或服用安慰剂。主要结果是 CDASI 活动的变化。安全性和其他次要疗效评估进行至第 113 天。22 名受试者被随机分配至 lenabasum (n=11) 或安慰剂 (n=11)。没有与 lenabasum 相关的严重或严重不良事件 (AE)，也没有参与者停止研究。 lenabasum 的 CDASI 活性调整后的最小二乘平均值下降更多，并且差异在第 113 天显着（最小二乘平均值 [SE] 差异 -6.5 [3.1]，p = 0.038）。 lenabasum 的多项次要疗效结果和生物标志物在数值上有更大的改善。 Lenabasum 治疗耐受性良好，并且与 CDASI 活性和多种疗效结果的更大改善相关。 ClinicalTrials.gov 标识符：NCT02466243
Treatment options are limited for skin disease in dermatomyositis (DM). Lenabasum is a cannabinoid receptor type 2 agonist that triggers resolution of inflammation. Evaluate the safety and efficacy of lenabasum in patients with refractory cutaneous DM. This study was a single-center, double-blind, randomized, placebo-controlled Phase 2 study conducted from July 2015 to August 2017. Subjects ≥ 18 years of age with at least moderately active DM skin activity by Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) activity ≥ 14 and failure or intolerance to hydroxychloroquine. Participants received lenabasum 20 mg daily for 28 days, then 20 mg BID for 56 days, or placebo. The primary outcome was change in CDASI activity. Safety and other secondary efficacy assessments were performed to Day 113. 22 subjects were randomized to lenabasum (n=11) or placebo (n=11). No serious or severe adverse events (AEs) were related to lenabasum, and no participants discontinued the study. The adjusted least squares mean for CDASI activity decreased more for lenabasum, and the difference was significant at Day 113 (least squares mean [SE] difference −6.5 [3.1], p = 0.038). Numerically greater improvements were seen in multiple secondary efficacy outcomes and biomarkers with lenabasum. Lenabasum treatment was well tolerated and was associated with greater improvement in CDASI activity and multiple efficacy outcomes. ClinicalTrials.gov Identifier: NCT02466243
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影响因子：
13.8
作者：
Chansky, Peter B.;Olazagasti, Jeannette M.;Feng, Rui;Werth, Victoria P.
通讯作者：
Werth, Victoria P.
影响因子：
20.3
作者：
Carayon, P;Marchand, J;Casellas, P
通讯作者：
Casellas, P
影响因子：
10.3
作者：
Huard, C.;Gulla, S. V.;Greenberg, S. A.
通讯作者：
Greenberg, S. A.
影响因子：
12.8
作者：
Iaccarino, Luca;Ghirardello, Anna;Doria, Andrea
通讯作者：
Doria, Andrea
DOI：
10.1111/bjd.13915
发表时间：
2015-10
期刊：
The British journal of dermatology
影响因子：
--
作者：
Anyanwu CO;Fiorentino DF;Chung L;Dzuong C;Wang Y;Okawa J;Carr K;Propert KJ;Werth VP
通讯作者：
Werth VP