Efficacy and safety of topical WBI-1001 in patients with mild to severe atopic dermatitis: results from a 12-week, multicentre, randomized, placebo-controlled double-blind trial
Efficacy and safety of topical WBI-1001 in patients with mild to severe atopic dermatitis: results from a 12-week, multicentre, randomized, placebo-controlled double-blind trial
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DOI：
10.1111/j.1365-2133.2011.10775.x
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发表时间：
2012-04-01
影响因子：
10.3
通讯作者：
Lyle, M.
中科院分区：
文献类型：
--
作者：
Bissonnette, R.;Poulin, Y.;Lyle, M.
研究背景：目前需要开发治疗特应性皮炎（AD）的脐部非甾体类外用药物。目的：主要目的是评价WBI-1001治疗轻度至重度AD 6周以上的疗效。方法：将AD累及3-20%体表面积且研究者总体评估（伊加）为2-4的患者随机分组，（1 ∶ 1：1）接受安慰剂、WBI-1001 0.5%或WBI-1001 1.0%的乳膏制剂，每天施用两次，持续6周。在该阶段结束时，接受WBI-1001的患者继续接受相同的治疗额外6周。接受安慰剂的患者进入6周双盲期，重新随机化（1：1）至WBI-1001 0.5%或1.0%乳膏。主要目的是评价WBI-1001治疗轻度至重度AD 6周的疗效。主要终点是第42天（第6周）伊加较基线的平均变化。结果总共有148例患者随机分为安慰剂组（51例）、WBI-1001 0.5%组（50例）和WBI-1001 1.0%组（47例）。分别降低1.3 [43%; P < 0.001; 95%置信区间（CI）-1.2至0.5]和1.8在WBI-1001 0.5 A中，在第42天伊加中的（56.3%; P < 0.001; 950 CI -1.6至-0.9）;和1.0%组，而安慰剂组下降0.5（14.7%）。不良反应包括少量毛囊炎和接触性皮炎。结论WBI-1001是一种治疗AD的新型外用抗炎分子。
Background There is a need for the development of navel nonsteroidal topical drugs for the treatment of atopic dermatitis (AD).Objectives The primary objective was to evaluate the efficacy of WBI-1001 over 6 weeks of treatment of mild to severe AD.Methods Patients with AD affecting 3-20% of their body surface area and with an Investigator's Global Assessment (IGA) of 2-4 were randomized (1 : 1 : 1) to receive placebo, WBI-1001 0.5% or WBI-1001 1.0% in a cream formulation applied twice daily for 6 weeks. At the end of this phase, patients receiving WBI-1001 continued the same treatment for an additional 6 weeks. Patients receiving placebo entered into a 6-week double-blind phase with re-randomization (1 : 1) to WBI-1001 0.5% or 1.0% cream. The primary objective was to evaluate the efficacy of WBI-1001 over 6 weeks of treatment of mild to severe AD. The primary endpoint was the mean change from baseline in IGA at day 42 (week 6).Results In total, 148 patients were randomized and analysed in the placebo (51), WBI-1001 0.5% (50) and WBI-1001 1.0% (47) groups. There was a decrease of 1.3 [43%; P < 0.001; 95% confidence interval (CI) -1.2 to 0.5] and 1.8 (56.3%; P < 0.001; 950 CI -1.6 to -0.9) in IGA at day 42 in the WBI-1001 0.5 A; and 1.0% groups, respectively, as compared with a decrease of 0.5 (14.7%) in the placebo group. Adverse drug reactions included a few cases of folliculitis and contact dermatitis.Conclusions WBI-1001 is an efficacious novel topical anti-inflammatory molecule for the treatment of AD.