Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults
Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults
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DOI：
10.1016/j.jaad.2016.05.046
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发表时间：
2016-09-01
影响因子：
13.8
通讯作者：
Hebert, Adelaide A.
中科院分区：
文献类型：
--
作者：
Paller, Amy S.;Tom, Wynnis L.;Hebert, Adelaide A.
背景：特应性皮炎 (AD) 需要额外的局部治疗，既能缓解症状，又能最大程度地降低风险。目的：我们试图在两项 III 期 AD 研究（AD-301：NCT02118766；AD-302：NCT02118792）中评估 Crisaborole 软膏（一种磷酸二酯酶 4 抑制剂）的疗效和安全性。方法：两项设计相同、媒介对照、双盲研究纳入研究，随机分配（2：1，crisaborole：媒介物）2岁或以上、研究者静态总体评估（ISGA）评分为轻度或中度的患者，每日两次应用，持续28天。主要终点是第 29 天时的 ISGA 评分，与基线相比明显改善 (0)/几乎完全改善 (1)，且有 2 级或更大的改善。其他分析包括 ISGA 评分成功的时间、达到清除/几乎清除的患者百分比、AD 体征严重程度的减轻以及瘙痒改善的时间。结果：与媒介物治疗相比，更多的 crisaborole 治疗患者获得 ISGA 评分成功（清除/几乎清除，≥2 级改善；AD-301：32.8% vs 25.4%，P = 0.038；AD-302：31.4% vs 18.0%，P < .001），透明/几乎透明的比例更高（51.7% vs 40.6%，P = .005；48.5% vs 29.7%，P < .001）。 Crisaborole 治疗的患者比接受媒介物治疗的患者更早在 ISGA 评分和瘙痒改善方面取得成功（均 P
Background: Additional topical treatments for atopic dermatitis (AD) are needed that provide relief while minimizing risks.Objective: We sought to assess the efficacy and safety of crisaborole ointment, a phosphodiesterase 4 inhibitor, in two phase III AD studies (AD-301: NCT02118766; AD-302: NCT02118792).Methods: Two identically designed, vehicle-controlled, double-blind studies enrolled and randomly assigned (2: 1, crisaborole: vehicle) patients aged 2 years or older with an Investigator's Static Global Assessment (ISGA) score of mild or moderate for twice-daily application for 28 days. The primary end point was ISGA score at day 29 of clear (0)/almost clear (1) with 2-grade or greater improvement from baseline. Additional analyses included time to success in ISGA score, percentage of patients achieving clear/almost clear, reduction in severity of AD signs, and time to improvement in pruritus.Results: More crisaborole-than vehicle-treated patients achieved ISGA score success (clear/almost clear with >= 2-grade improvement; AD-301: 32.8% vs 25.4%, P = .038; AD-302: 31.4% vs 18.0%, P < .001), with a greater percentage with clear/almost clear (51.7% vs 40.6%, P = .005; 48.5% vs 29.7%, P < .001). Crisaborole-treated patients achieved success in ISGA score and improvement in pruritus earlier than those treated with vehicle (both P