Abstract：
BACKGROUND: 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.
OBJECTIVE: To assess the efficacy and safety of apremilast 30 mg twice daily in patients with genital psoriasis.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: Lack of active-comparator.
CONCLUSIONS: 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.
OBJECTIVE: To assess the efficacy and safety of apremilast 30 mg twice daily in patients with genital psoriasis.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: Lack of active-comparator.
CONCLUSIONS: 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.
摘要：
背景：生殖器牛皮癣可能是污名化的，在牛皮癣患者中非常普遍，治疗选择有限。Apremilast是一种独特的口服免疫调节磷酸二酯酶4抑制剂，已被批准用于银屑病治疗。
目的：评估每日两次的阿普瑞司特30mg治疗生殖器银屑病的疗效和安全性。
方法：DISCREET，3期，安慰剂对照试验（NCT03777436），随机将中度至重度生殖器银屑病患者（根据受影响的体表面积<10％或≥10％进行分层）随机分为apremilast或安慰剂，为期16周，随后是一个永久的延长期。提供第16周的结果。
结果：患者被随机分为阿普瑞司特（n=143）或安慰剂（n=146）。在第16周，39.6%和19.5%的apremilast和安慰剂患者，分别,获得了生殖器反应的改良静态医师全球评估（PGA）（主要终点；评分为0/1，≥2分降低）；治疗差异显着（20.1％，P=0.0003)。生殖器体征和症状的改善，皮肤受累,并观察生活质量（QoL）。常见的治疗引起的不良事件是腹泻，头痛,恶心,还有鼻咽炎.
结论：缺乏活性比较剂。
结论：阿普雷米司表现出具有统计学和临床意义的生殖器PGA反应和体征的改善，症状,严重程度,和QoL在第一个随机分组中，生殖器银屑病患者口服全身治疗的对照研究。
目的：评估每日两次的阿普瑞司特30mg治疗生殖器银屑病的疗效和安全性。
方法：DISCREET，3期，安慰剂对照试验（NCT03777436），随机将中度至重度生殖器银屑病患者（根据受影响的体表面积<10％或≥10％进行分层）随机分为apremilast或安慰剂，为期16周，随后是一个永久的延长期。提供第16周的结果。
结果：患者被随机分为阿普瑞司特（n=143）或安慰剂（n=146）。在第16周，39.6%和19.5%的apremilast和安慰剂患者，分别,获得了生殖器反应的改良静态医师全球评估（PGA）（主要终点；评分为0/1，≥2分降低）；治疗差异显着（20.1％，P=0.0003)。生殖器体征和症状的改善，皮肤受累,并观察生活质量（QoL）。常见的治疗引起的不良事件是腹泻，头痛,恶心,还有鼻咽炎.
结论：缺乏活性比较剂。
结论：阿普雷米司表现出具有统计学和临床意义的生殖器PGA反应和体征的改善，症状,严重程度,和QoL在第一个随机分组中，生殖器银屑病患者口服全身治疗的对照研究。
