他氟康唑治疗难治性甲癣病例：III期受试者的事后评估

Tavaborole in Difficult-to-Treat Onychomycosis Cases: A Post-hoc Assessment of Phase III Subjects.

作者信息

Aly Raza, Gupta Aditya K, Winter Tate, Zane Lee T, Vlahovic Tracey

出版信息

J Drugs Dermatol. 2017 Oct 1;16(10):1016-1021.

Abstract

Toenail onychomycosis is a chronic fungal infection that often requires prolonged treatment in order to effectively manage pathogenic organisms and obtain a clear nail. Traditionally, certain clinical features of onychomycosis, including the presence of substantial lateral disease, focal fungal masses, yellow/brown streaks, and extensive nail involvement (ie, >50%), indicate a poor treatment prognosis and have proven difficult-to-treat with oral or traditional topical therapies. Owing to the novel features of topical tavaborole, we sought to understand the potential utility of tavaborole in difficult-to-treat onychomycosis. A blinded, post-hoc assessment of Phase III trials was conducted, focusing on initial presentation, midpoint assessment (24 weeks), and final outcomes (52 weeks) in subjects identified as having difficult-to-treat onychomycosis and treated for 48 weeks with once-daily application of either tavaborole 5% solution or vehicle. Our post-hoc analysis identified 84 difficult-to-treat cases (tavaborole 5%; n=60; vehicle, n=24) in subjects with toenail onychomycosis due to Trichophyton rubrum or Trichophyton mentagrophytes. No subjects identified as difficult-to-treat and treated with vehicle achieved a complete cure, while 6 subjects treated with tavaborole 5% attained a completely clear nail and negative mycology. Similarly, 7 subjects treated with tavaborole 5% solution achieved an almost complete cure (≤10% involvement and negative mycology) while 1 subject on vehicle achieved an almost complete cure. We present a case series of 4 patients, of varying age and difficult-to-treat clinical features, which responded positively to tavaborole 5% solution. Three of the subjects achieved complete cure after being treated with tavaborole 5%, with one additional subject (an 88-year-old female) achieving an almost complete clear nail by treatment end. The outcomes presented here may not be reflective of patients that may present with these clinical characteristics. Additional investigations would be useful in order to assess the value of topical tavaborole 5% solution in difficult-to-treat clinical presentations of onychomycosis.

J Drugs Dermatol. 2017;16(10):1016-1021.

摘要

趾甲甲癣是一种慢性真菌感染，通常需要长期治疗，以有效控制病原体并使指甲恢复正常。传统上，甲癣的某些临床特征，包括严重的侧方病变、局灶性真菌团块、黄色/棕色条纹以及广泛的指甲受累（即>50%），提示治疗预后不良，并且已证明口服或传统外用疗法难以治愈。由于外用他扎罗汀的新特性，我们试图了解他扎罗汀在难治性甲癣中的潜在效用。我们对III期试验进行了一项盲法事后评估，重点关注被确定为难治性甲癣并每日一次应用5%他扎罗汀溶液或赋形剂治疗48周的受试者的初始表现、中期评估（24周）和最终结果（52周）。我们的事后分析在由红色毛癣菌或须癣毛癣菌引起的趾甲甲癣受试者中确定了84例难治性病例（5%他扎罗汀；n = 60；赋形剂，n = 24）。没有被确定为难治性且接受赋形剂治疗的受试者实现完全治愈，而6例接受5%他扎罗汀治疗的受试者指甲完全恢复正常且真菌学检查呈阴性。同样，7例接受5%他扎罗汀溶液治疗的受试者实现了几乎完全治愈（受累≤10%且真菌学检查呈阴性），而1例接受赋形剂治疗的受试者实现了几乎完全治愈。我们展示了一个包含4例患者的病例系列，这些患者年龄各异且具有难治性临床特征，他们对5%他扎罗汀溶液反应良好。3例受试者在接受5%他扎罗汀治疗后实现了完全治愈，另外1例受试者（一名88岁女性）在治疗结束时指甲几乎完全恢复正常。此处呈现的结果可能并不反映具有这些临床特征的所有患者情况。进行更多研究将有助于评估5%外用他扎罗汀溶液在难治性甲癣临床表现中的价值。

《药物皮肤病学杂志》。2017年；16(10):1016 - 1021。