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2% 克立硼罗软膏:治疗轻度至中度特应性皮炎的综述。

Crisaborole Ointment 2%: A Review in Mild to Moderate Atopic Dermatitis.

机构信息

Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand.

出版信息

Am J Clin Dermatol. 2017 Dec;18(6):837-843. doi: 10.1007/s40257-017-0327-4.

Abstract

Crisaborole ointment 2% (Eucrisa™) is a novel, anti-inflammatory inhibitor of phosphodiesterase 4 (PDE4) that is available in the USA for the topical treatment of mild to moderate atopic dermatitis in patients aged ≥ 2 years. In two short-term (28 days), identically designed, multicentre, phase III studies in this patient population, topical therapy with crisaborole ointment 2% reduced disease severity and pruritus severity compared with vehicle, with the effect established early and sustained over the course of treatment. Improvements in the other signs of atopic dermatitis (erythema, exudation, excoriation, induration/papulation, and lichenification) were also seen. Crisaborole ointment 2% was generally well tolerated in the short-term studies, with its favorable safety profile maintained over the longer term (up to 52 weeks) in a multicentre, extension study. Most treatment-emergent adverse events (TEAEs) were of mild to moderate severity and considered unrelated to the study medication. Moreover, the incidence of application-site pain following short- and longer-term topical therapy with crisaborole ointment 2% was low. In conclusion, crisaborole ointment 2% is an effective and generally well tolerated new topical option for the management of mild to moderate atopic dermatitis in patients aged ≥ 2 years, with the potential to effectively treat this patient population over the longer term without the safety concerns associated with other current topical anti-inflammatory agents.

摘要

2% 克立硼罗软膏(Eucrisa™)是一种新型的磷酸二酯酶 4(PDE4)抑制剂,具有抗炎作用,已在美国获批用于治疗 2 岁及以上患者的轻至中度特应性皮炎。在两项针对该患者人群的短期(28 天)、设计相同、多中心的 III 期研究中,与赋形剂相比,2%克立硼罗软膏的局部治疗可降低疾病严重程度和瘙痒严重程度,其疗效在早期确立并在治疗过程中持续。其他特应性皮炎的体征(红斑、渗出、抓挠、硬结/肿胀和苔藓样变)也有所改善。在短期研究中,2%克立硼罗软膏通常具有良好的耐受性,在一项多中心扩展研究中,其长期(长达 52 周)安全性状况也保持良好。大多数治疗中出现的不良事件(TEAE)为轻至中度严重程度,被认为与研究药物无关。此外,在接受短期和长期 2%克立硼罗软膏局部治疗后,应用部位疼痛的发生率较低。总之,2%克立硼罗软膏是一种有效且通常具有良好耐受性的新型局部治疗选择,可用于治疗 2 岁及以上轻至中度特应性皮炎患者,具有在较长时间内有效治疗该患者人群的潜力,且不会出现与其他当前局部抗炎药物相关的安全性问题。

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