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阿普米司特治疗银屑病关节炎的长期疗效和安全性:关注皮肤表现及特殊人群。

Long-term efficacy and safety of apremilast in psoriatic arthritis: Focus on skin manifestations and special populations.

作者信息

Balato Anna, Campione Elena, Cirillo Teresa, Malara Giovanna, Trifirò Caterina, Bianchi Luca, Fabbrocini Gabriella

机构信息

Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.

Dermatology Unit, Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.

出版信息

Dermatol Ther. 2020 May;33(3):e13440. doi: 10.1111/dth.13440. Epub 2020 May 3.

Abstract

Few real-life studies evaluated long-term apremilast therapy in the variable spectrum of clinical-anamnestic features which can be found in psoriatic arthritis (PsA) patients. This real-life retrospective observational study aimed to assess long-term efficacy, safety, and tolerability of apremilast among patients with PsA and concomitant cutaneous psoriasis. A stratified analysis was performed on special populations, defined as (a) number (≤1 vs >2) of comorbidities, presence or absence of: (b) history of malignancy, and (c) previous exposure to biologics. Patients attending three Italian University and Hospital centers, who received at least one dose of apremilast and had at least one follow-up visit were included. Ninety-six patients with PsA were identified. Psoriasis Area and Severity Index (PASI), Body Surface Area, 28-joint Disease Activity Score, and Dermatology Life Quality Index scores improved during treatment, already at week 4, relative to baseline. More than 2 comorbidities, history of malignancy and previous biologic treatment negatively influenced PASI responses. At least one adverse event was experienced by 56/96 patients, and 11/56 events required drug withdrawal. In conclusion, this study confirm efficacy and safety of apremilast on joints and skin involvement of PsA, highlighting which patients could have less favorable treatment response.

摘要

很少有实际研究评估阿普米司特在银屑病关节炎(PsA)患者临床病史特征多样的情况下的长期治疗效果。这项实际的回顾性观察研究旨在评估阿普米司特在PsA合并皮肤银屑病患者中的长期疗效、安全性和耐受性。对特殊人群进行了分层分析,特殊人群定义为:(a)合并症数量(≤1个 vs >2个)、(b)是否有恶性肿瘤病史、(c)既往是否接触过生物制剂。纳入了在三个意大利大学和医院中心就诊、接受过至少一剂阿普米司特且至少有一次随访的患者。共确定了96例PsA患者。治疗期间,银屑病面积和严重程度指数(PASI)、体表面积、28关节疾病活动评分和皮肤病生活质量指数评分在第4周时相对于基线就有所改善。超过2种合并症、恶性肿瘤病史和既往生物治疗对PASI反应有负面影响。56/96例患者至少经历了一次不良事件,其中11/56例事件需要停药。总之,本研究证实了阿普米司特对PsA关节和皮肤受累的疗效和安全性,突出了哪些患者的治疗反应可能较差。

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