Abe Masatoshi, Okubo Yukari, Takahashi Hidetoshi, Endo Koki, Chaudhari Siddharth, Deignan Cynthia, Amouzadeh Hamid, Hino Ryosuke
Sapporo Skin Clinic, Chuo-ku Minami 3 Jo Nishi 2-1-1 H&B Plaza Building 5F, Sapporo, Japan.
Tokyo Medical University, Tokyo, Japan.
Dermatol Ther (Heidelb). 2024 Jun;14(6):1587-1597. doi: 10.1007/s13555-024-01179-z. Epub 2024 May 27.
Psoriasis involvement in special areas (e.g., scalp or nails) is associated with a great disease burden yet it is often inadequately treated with topical treatments. The efficacy and tolerability of apremilast plus existing topical therapy in Japanese patients with mild to moderate plaque psoriasis were demonstrated in PROMINENT, a phase 3b, multicenter, open-label, single-arm study. We evaluated the efficacy of apremilast across disease severities and special areas involved in these patients.
In PROMINENT, patients received apremilast 30 mg twice daily for 16 weeks in addition to their existing topical therapy, with the option of topical therapy reduction at the discretion of their physician while continuing apremilast treatment from Weeks 16 to 32. We performed a post hoc analysis, assessing apremilast efficacy and safety in Japanese patients stratified by baseline static Physician Global Assessment (sPGA) score (2 [mild] or 3 [moderate]) and special area involvement.
Of patients with baseline sPGA = 2 and sPGA = 3, 62.7% and 30.7%, respectively, achieved sPGA score 0 or 1 at Week 32. At Week 32, improvements in skin, nail, scalp, and quality of life assessments were observed regardless of baseline sPGA score. Improvements in these endpoints at Week 32 were also observed in patients with special area (scalp or nail) involvement (n = 134). Incidence of adverse events was similar between patients with baseline sPGA = 2 and sPGA = 3.
Apremilast in combination with topical therapy may be a beneficial treatment for Japanese patients, who have limited systemic treatment options for mild to moderate psoriasis or psoriasis in special areas.
NCT03930186.
银屑病累及特殊部位（如头皮或指甲）会带来巨大的疾病负担，但局部治疗往往效果不佳。在一项3b期、多中心、开放标签、单臂研究PROMINENT中，已证实阿普米拉斯联合现有局部治疗对日本轻至中度斑块状银屑病患者的疗效和耐受性。我们评估了阿普米拉斯在这些患者不同疾病严重程度和受累特殊部位的疗效。
在PROMINENT研究中，患者除接受现有局部治疗外，还每日两次服用30毫克阿普米拉斯，持续16周，医生可根据情况酌情减少局部治疗，同时患者在第16至32周继续服用阿普米拉斯。我们进行了一项事后分析，评估按基线静态医师整体评估（sPGA）评分（2[轻度]或3[中度]）和特殊部位受累情况分层的日本患者中阿普米拉斯的疗效和安全性。
基线sPGA评分为2和3的患者中，分别有62.7%和30.7%在第32周时达到sPGA评分0或1。在第32周时，无论基线sPGA评分如何，皮肤、指甲、头皮和生活质量评估均有改善。在有特殊部位（头皮或指甲）受累的患者（n = 134）中，第32周时这些终点指标也有改善。基线sPGA评分为2和3的患者不良事件发生率相似。
对于日本轻至中度银屑病或特殊部位银屑病全身治疗选择有限的患者，阿普米拉斯联合局部治疗可能是一种有益的治疗方法。
NCT03930186。
