Okubo Yukari, Takahashi Hidetoshi, Hino Ryosuke, Endo Koki, Kikuchi Satoru, Ozeki Yasushi, Nakamura Taichi, Paris Maria, Abe Masatoshi
Tokyo Medical University, 6 Chome-7-1 Nishishinjuku, Shinjuku, Tokyo, 160-0023, Japan.
Takagi Dermatological Clinic, Hokkaido, Japan.
Dermatol Ther (Heidelb). 2022 Jun;12(6):1469-1480. doi: 10.1007/s13555-022-00747-5. Epub 2022 Jun 11.
Patients with mild-to-moderate plaque psoriasis often experience reduced quality of life and increased disease burden due to itch or involvement of psoriasis in special areas such as the scalp and nails. Systemic therapy may be used concurrently with topical therapy in patients with active disease not controlled by topical therapy alone. The objective of PROMINENT was to evaluate the efficacy and safety of apremilast in combination with topical therapy in patients with mild-to-moderate psoriasis in Japan.
PROMINENT, a phase 3b, open-label, single-arm study in Japan, enrolled adults ≥ 20 years of age with plaque psoriasis [static Physician Global Assessment (sPGA) 2 (mild) or 3 (moderate)] not adequately controlled by topical therapy. 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.
Of the 152 patients enrolled in the study, 136 completed week 32. The primary endpoint of sPGA response [score 0 (clear) or 1 (almost clear)] was achieved by 43.7% of patients at week 16, and 40.8% maintained response at week 32. Clinically meaningful improvements in skin, scalp, and nails were observed in > 40% of patients at weeks 16 and 32. Similarly, improvements in pruritus, quality of life, and treatment satisfaction were observed at week 16 and maintained at week 32. Common treatment-emergent adverse events through week 32 included gastrointestinal events, nasopharyngitis, and headache.
Apremilast in combination with topical therapy resulted in clinically meaningful and sustained efficacy in physician- and patient-reported outcomes at weeks 16 and 32 in Japanese patients with mild-to-moderate psoriasis. Tolerability was consistent with available prior safety data for apremilast.
ClinicalTrials.gov identifier, NCT03930186.
轻至中度斑块状银屑病患者常因瘙痒或银屑病累及头皮和指甲等特殊部位而生活质量下降，疾病负担增加。对于仅用局部治疗无法控制病情的活动性疾病患者，可同时采用全身治疗和局部治疗。PROMINENT研究的目的是评估阿普米司特联合局部治疗对日本轻至中度银屑病患者的疗效和安全性。
PROMINENT是一项在日本开展的3b期开放标签单臂研究，纳入年龄≥20岁、斑块状银屑病[静态医师整体评估（sPGA）为2（轻度）或3（中度）]且局部治疗控制不佳的成年人。患者在接受现有局部治疗的基础上，每日两次口服阿普米司特30mg，持续16周，医生可根据情况酌情减少局部治疗剂量，同时患者在第16至32周继续服用阿普米司特。
该研究共纳入152例患者，136例完成了第32周的治疗。第16周时，43.7%的患者达到sPGA反应的主要终点[评分为0（清除）或1（几乎清除）]，第32周时40.8%的患者维持了反应。在第16周和第32周时，超过40%的患者在皮肤、头皮和指甲方面有具有临床意义的改善。同样，在第16周时瘙痒、生活质量和治疗满意度有所改善，并在第32周时得以维持。至第32周常见的治疗中出现的不良事件包括胃肠道事件、鼻咽炎和头痛。
在日本轻至中度银屑病患者中，阿普米司特联合局部治疗在第16周和第32周时，在医生和患者报告的结局方面产生了具有临床意义的持续疗效。耐受性与阿普米司特先前可用的安全性数据一致。
ClinicalTrials.gov标识符，NCT03930186。
