罗氟司特乳膏局部治疗慢性斑块型银屑病疗效显
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罗氟司特乳膏局部治疗慢性斑块型银屑病疗效显

浏览次数:    时间:2020-07-19

本期文章:《新英格兰医学杂志》:Vol.383 No.3

美国西奈山伊坎医学院Mark G. Lebwohl团队分析了罗氟司特乳膏治疗慢性斑块型银屑病的效果。2020年7月16日,该成果发表在《新英格兰医学杂志》上。

口服全身性4型磷酸二酯酶(PDE-4)抑制剂可有效治疗银屑病。罗氟司特乳膏中含有PDE-4抑制剂,该药局部治疗银屑病的效果正在研究。

在这项临床2b期双盲试验中,研究组招募了331例患有斑块型银屑病的成年人,按1:1:1随机分配,其中109例每天使用0.3%罗氟司特乳膏,113例每天使用0.15%罗氟司特乳膏,109例每天使用赋形剂(安慰剂)乳膏,持续12周。主要疗效结局是第6周时研究者全球评估(IGA)的疾病根除或几乎根除状态。

0.3%罗氟司特组中28%的患者在第6周时IGA评分表明银屑病已根除或几乎根除,0.15%罗氟司特组中有23%,安慰剂组中有8%,罗氟司特组均显著高于安慰剂组。大约15%的患者基线检查时至少有轻微严重的关节型银屑病,0.3%罗氟司特组中73%的这类患者在第6周IGA评分显示疾病根除或几乎根除,且关节间区域IGA评分至少改善2级,0.15%罗氟司特组中有44%,安慰剂组中有29%。

0.3%罗氟司特组的平均基线银屑病面积和严重程度指数(PASI)评分为7.7分,0.15%罗氟司特组为8.0分,安慰剂组为7.6分;治疗第6周与基线相比各组分别降低了50.0%、9.0%和17.8%。罗氟司特组和安慰剂组的用药部位反应发生率相差不大。

总之,每天一次对银屑病患处涂抹罗氟司特乳膏优于赋形剂乳膏,可在6周时根除病情或几乎根除。

附:英文原文

Title: Trial of Roflumilast Cream for Chronic Plaque Psoriasis

Author: Mark G. Lebwohl, M.D.,, Kim A. Papp, M.D., Ph.D.,, Linda Stein Gold, M.D.,, Melinda J. Gooderham, M.D.,, Leon H. Kircik, M.D.,, Zoe D. Draelos, M.D.,, Steven E. Kempers, M.D.,, Mathew Zirwas, M.D.,, Kathleen Smith, M.B.A.,, David W. Osborne, Ph.D.,, Marie-Louise Trotman, M.S.,, Lynn Navale, M.S.,, Charlotte Merritt, M.B.A.,, David R. Berk, M.D.,, and Howard Welgus, M.D.

Issue&Volume: 2020-07-15

Abstract: Abstract

Background

Systemic oral phosphodiesterase type 4 (PDE-4) inhibitors have been effective in the treatment of psoriasis. Roflumilast cream contains a PDE-4 inhibitor that is being investigated for the topical treatment of psoriasis.

Methods

In this phase 2b, double-blind trial, we randomly assigned adults with plaque psoriasis in a 1:1:1 ratio to use roflumilast 0.3% cream, roflumilast 0.15% cream, or vehicle (placebo) cream once daily for 12 weeks. The primary efficacy outcome was the investigator’s global assessment (IGA) of a status of clear or almost clear at week 6 (assessed on a 5-point scale of plaque thickening, scaling, and erythema; a score of 0 indicates clear, 1 almost clear, and 4 severe). Secondary outcomes included an IGA score indicating clear or almost clear plus a 2-grade improvement in the IGA score for the intertriginous area and the change in the Psoriasis Area and Severity Index (PASI) score (range, 0 to 72, with higher scores indicating worse disease). Safety was also assessed.

Results

Among 331 patients who underwent randomization, 109 were assigned to roflumilast 0.3% cream, 113 to roflumilast 0.15% cream, and 109 to vehicle cream. An IGA score indicating clear or almost clear at week 6 was observed in 28% of the patients in the roflumilast 0.3% group, in 23% in the roflumilast 0.15% group, and in 8% in the vehicle group (P<0.001 and P=0.004 vs. vehicle for roflumilast 0.3% and 0.15%, respectively). Among the approximately 15% of patients overall who had baseline intertriginous psoriasis of at least mild severity, an IGA score at week 6 indicating clear or almost clear plus a 2-grade improvement in the intertriginous-area IGA score occurred in 73% of the patients in the roflumilast 0.3% group, 44% of those in the roflumilast 0.15% group, and 29% of those in the vehicle group. The mean baseline PASI scores were 7.7 in the roflumilast 0.3% group, 8.0 in the roflumilast 0.15% group, and 7.6 in the vehicle group; the mean change from baseline at week 6 was 50.0%, 49.0%, and 17.8%, respectively. Application-site reactions occurred with similar frequency in the roflumilast groups and the vehicle group.

Conclusions

Roflumilast cream administered once daily to affected areas of psoriasis was superior to vehicle cream in leading to a state of clear or almost clear at 6 weeks. Longer and larger trials are needed to determine the durability and safety of roflumilast in psoriasis.

DOI: 10.1056/NEJMoa2000073

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2000073

期刊信息

The New England Journal of Medicine:《新英格兰医学杂志》,创刊于1812年。隶属于美国麻省医学协会,最新IF:70.67
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