Department of Dermatology, Rabin Medical Center, Tel Aviv University, Petah-Tikva, Israel.
J Eur Acad Dermatol Venereol. 2012 Mar;26(3):361-7. doi: 10.1111/j.1468-3083.2011.04078.x. Epub 2011 Apr 20.
CF101 demonstrated a marked anti-inflammatory effect in Phase 2 studies conducted in patients with rheumatoid arthritis and dry eye syndrome. The aim of this study was to evaluate the safety and efficacy of CF101 for the treatment of patients with moderate to severe plaque-type psoriasis.
This was a phase 2, multicentre, randomized, double-blind, dose-ranging, placebo-controlled study. Seventy five patients with moderate to severe plaque-type psoriasis were enrolled, randomized and treated with CF101 (1, 2, or 4 mg) or placebo administered orally twice daily for 12 weeks. Safety and change from base line of Psoriasis Area and Severity Index (PASI) score and physician's global assessment (PGA) score over 12 weeks.
In the 2 mg CF101-treated group, a progressive improvement in the mean change from baseline in the PASI score vs. placebo throughout the study period was observed, with a statistically significant difference on weeks 8 and 12 (P = 0.047; P = 0.031, respectively). In this group, 35.3% of the patients achieved PASI ≥ 50 response, and 23.5% of the patients achieved a PGA score of 0 or 1. CF101 was safe and well tolerated.
CF101 was well tolerated and demonstrated clear evidence of efficacy in patients with moderate to severe plaque psoriasis.
在类风湿关节炎和干眼症患者中进行的 2 期研究中，CF101 表现出显著的抗炎作用。本研究旨在评估 CF101 治疗中度至重度斑块型银屑病患者的安全性和疗效。
这是一项 2 期、多中心、随机、双盲、剂量范围、安慰剂对照研究。招募了 75 名中度至重度斑块型银屑病患者，进行随机分组并接受 CF101（1、2 或 4 mg）或安慰剂口服治疗，每日两次，持续 12 周。评估 12 周内的安全性和从基线开始的银屑病面积和严重程度指数（PASI）评分和医生整体评估（PGA）评分的变化。
在 2 mg CF101 治疗组中，与安慰剂相比，在整个研究期间，PASI 评分的平均变化从基线开始呈渐进性改善，在第 8 周和第 12 周有统计学显著差异（P = 0.047；P = 0.031）。在该组中，35.3%的患者达到 PASI≥50 缓解，23.5%的患者达到 PGA 评分 0 或 1。CF101 安全且耐受良好。
CF101 耐受良好，在中度至重度斑块型银屑病患者中显示出明确的疗效证据。
