Merola Joseph F, Parish Lawrence Charles, Guenther Lyn, Lynde Charles, Lacour Jean-Philippe, Staubach Petra, Cheng Sue, Paris Maria, Picard Hernan, Deignan Cynthia, Jardon Shauna, Chen Mindy, Papp Kim A
Division of Rheumatology, Department of Dermatology and Department of Medicine and Associate Program Director, Combined Medicine-Dermatology Residency Program, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
President, Paddington Testing Company, Inc, Philadelphia, Pennsylvania.
J Am Acad Dermatol. 2024 Mar;90(3):485-493. doi: 10.1016/j.jaad.2023.10.020. Epub 2023 Oct 16.
Genital psoriasis can be stigmatizing, is highly prevalent among patients with psoriasis, and has limited treatment options. Apremilast is a unique oral immunomodulating phosphodiesterase 4 inhibitor approved for psoriasis treatment.
To assess the efficacy and safety of apremilast 30 mg twice daily in patients with genital psoriasis.
DISCREET, a phase 3, placebo-controlled trial (NCT03777436), randomized patients with moderate-to-severe genital psoriasis (stratified by affected body surface area <10% or ≥10%) to apremilast or placebo for a 16-week period, followed by an apremilast extension period. Week 16 results are presented.
Patients were randomized to apremilast (n = 143) or placebo (n = 146). At Week 16, 39.6% and 19.5% of apremilast and placebo patients, respectively, achieved a modified static Physician Global Assessment of Genitalia response (primary endpoint; score of 0/1, ≥2-point reduction); treatment difference was significant (20.1%, P = .0003). Improvements in genital signs and symptoms, skin involvement, and quality of life were observed. Common treatment-emergent adverse events were diarrhea, headache, nausea, and nasopharyngitis.
Lack of active-comparator.
Apremilast demonstrated statistically and clinically meaningful genital Physician Global Assessment responses and improvement of signs, symptoms, severity, and quality of life in this first randomized, controlled study of an oral systemic treatment in patients with genital psoriasis.
生殖器银屑病会带来污名化影响，在银屑病患者中非常普遍，且治疗选择有限。阿普米拉斯是一种获批用于治疗银屑病的独特口服免疫调节磷酸二酯酶4抑制剂。
评估每日两次服用30毫克阿普米拉斯治疗生殖器银屑病患者的疗效和安全性。
DISCREET是一项3期、安慰剂对照试验（NCT03777436），将中度至重度生殖器银屑病患者（按受累体表面积<10%或≥10%分层）随机分为阿普米拉斯组或安慰剂组，为期16周，随后进入阿普米拉斯延长期。本文展示第16周的结果。
患者被随机分为阿普米拉斯组（n = 143）或安慰剂组（n = 146）。在第16周时，阿普米拉斯组和安慰剂组分别有39.6%和19.5%的患者实现了改良静态医生对生殖器的整体评估反应（主要终点；评分为0/1，降低≥2分）；治疗差异具有显著性（20.1%，P = .0003）。观察到生殖器体征和症状、皮肤受累情况及生活质量有所改善。常见的治疗中出现的不良事件为腹泻、头痛、恶心和鼻咽炎。
缺乏活性对照药。
在这项针对生殖器银屑病患者口服全身治疗的首次随机对照研究中，阿普米拉斯在统计学和临床上均显示出有意义的生殖器医生整体评估反应，并改善了体征、症状、严重程度及生活质量。
