背景:银屑病是一种慢性炎症性疾病,可以显着影响生活质量(QoL),无论皮肤受累的程度如何。Apremilast适用于治疗中度至重度银屑病。荷兰缺乏关于apremilast在临床实践中对患者报告结果的影响的真实世界数据。
方法:前瞻性,多中心观察性Apremilast在现实生活中的银屑病治疗(APRIL)研究纳入了在荷兰临床实践中接受apremilast的18岁以上中度至重度斑块型银屑病患者。患者随访12个月,评估时间为6个月和12个月。主要结果是6个月时的皮肤病学生活质量指数(DLQI)反应(评分比基线改善≤5分或≥5分)。次要患者报告的结果包括EQ-5D和皮肤特异性参数;探索性结果是患者受益指数(PBI)和工作效率和活动障碍(WPAI)。
结果:在纳入的155名患者中(2016年2月至2019年6月),153人接受apremilast;69(45%)和39(26%)在6个月和12个月继续治疗,分别。特殊区域的牛皮癣很常见(头皮,65%;钉,51%;掌足底,27%)。大多数患者(92%)之前曾接受过全身性抗银屑病治疗。在151名具有基线DLQI值的患者中,56(37%)在6个月时达到DLQI响应。在6个月和12个月时,平均(标准差)PBI评分分别为3.5(1.2)和3.8(1.1),分别。DLQI的改进,EQ-5D,WPAI评分和疾病体征和症状,包括痒和特殊区域,在6个月和12个月时观察到。不良事件与已知的安全性特征一致。
结论:在荷兰,接受apremilast长达12个月的中度至重度银屑病患者报告疾病相关QoL改善,皮肤受累,和患者报告的结果。这些数据增加了越来越多的证据,证明apremilast是牛皮癣的有效治疗方法,痒,和特殊区域(头皮和手掌)。
背景:ClinicalTrials.gov,NCT02652494。
BACKGROUND: Psoriasis is a chronic inflammatory condition that can significantly impact the quality of life (QoL), regardless of the level of skin involvement. Apremilast is indicated for the treatment of moderate to severe psoriasis. Real-world data regarding the impact of apremilast on patient-reported outcomes in clinical practice in the Netherlands is lacking.
METHODS: The prospective, multicenter observational Apremilast in Real-Life Psoriasis Treatment (APRIL) study enrolled patients ≥ 18 years old with moderate to severe plaque psoriasis receiving apremilast in clinical practice in the Netherlands. Patients were followed-up for 12 months, with assessments scheduled at 6 and 12 months. The primary outcome was Dermatology Life Quality Index (DLQI) response (score ≤ 5 or ≥ 5-point improvement from baseline) at 6 months. Secondary patient-reported outcomes included EQ-5D and skin-specific parameters; exploratory outcomes were Patient Benefit Index (PBI) and Work Productivity and Activity Impairment (WPAI).
RESULTS: Of the 155 patients enrolled (February 2016-June 2019), 153 received apremilast; 69 (45%) and 39 (26%) continued treatment at 6 and 12 months, respectively. Psoriasis in special areas was common (scalp, 65%; nail, 51%; palmoplantar, 27%). Most patients (92%) had received prior systemic antipsoriatic therapies. Of the 151 patients with a baseline DLQI value, 56 (37%) achieved DLQI response at 6 months. Mean (standard deviation) PBI scores were 3.5 (1.2) and 3.8 (1.1) at 6 and 12 months, respectively. Improvements in DLQI, EQ-5D, and WPAI scores and disease signs and symptoms, including itch and special areas, were observed at 6 and 12 months. Adverse events were consistent with the known safety profile.
CONCLUSIONS: In the Netherlands, patients with moderate to severe psoriasis receiving apremilast for up to 12 months reported improved disease-related QoL, skin involvement, and patient-reported outcomes. These data add to the growing body of evidence demonstrating apremilast is an effective treatment for psoriasis, itch, and special areas (scalp and palms).
BACKGROUND: ClinicalTrials.gov, NCT02652494.