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阿普米拉斯在现实世界中治疗患者的特征与结局:APPRECIATE研究结果

Characteristics and outcomes of patients treated with apremilast in the real world: results from the APPRECIATE study.

作者信息

Augustin M, Kleyn C E, Conrad C, Sator P G, Ståhle M, Eyerich K, Radtke M A, Bundy C, Mellars L, Greggio C, Cordey M, Koscielny V, Griffiths C E M

机构信息

Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

The Dermatology Centre, The University of Manchester, NIHR Manchester Biomedical Research Centre, Manchester, UK.

出版信息

J Eur Acad Dermatol Venereol. 2021 Jan;35(1):123-134. doi: 10.1111/jdv.16431. Epub 2020 Jul 30.

Abstract

BACKGROUND

APPRECIATE is a multinational, observational, retrospective, cross-sectional study in patients treated for psoriasis with apremilast, an oral phosphodiesterase 4 inhibitor.

OBJECTIVES

To describe the characteristics of patients with psoriasis treated with apremilast in the clinical setting, to evaluate real-world outcomes of psoriasis treatment with apremilast and to better understand the perspectives of patients and physicians on treatment outcomes.

METHODS

In six European countries, patients with chronic plaque psoriasis treated in clinical practice who could be contacted 6 (±1) months after apremilast initiation were enrolled. Patient characteristics, Dermatology Life Quality Index (DLQI) and Psoriasis Area and Severity Index (PASI) were obtained from medical records when available. Outcomes were evaluated using patient/physician questionnaires.

RESULTS

In 480 patients at treatment initiation, mean [median; 95% confidence interval (CI)] PASI and DLQI scores were 12.5 (10.7; 11.6-13.4) and 13.4 (13.0; 11.4-14.2), respectively. At 6 (±1) months, 72.3% of patients (n = 347) continued apremilast treatment [discontinuations: lack of efficacy (13.5%), safety (11.7%), other (2.5%)]. In patients continuing treatment, 48.6% achieved a ≥75% reduction in PASI score; mean (95% CI) DLQI score was 5.7 (4.5-6.9), and mean (SD) Patient Benefit Index score was 2.8 (1.2). Physicians perceived clinical improvement in 75.6% of patients. Physicians' perspective on overall success of apremilast in meeting expectations correlated with patients' perception of treatment benefit (r = 0.691). Most commonly reported adverse events (>5% of patients) were diarrhoea, nausea and headache.

CONCLUSIONS

Patients in APPRECIATE reported high disease burden despite more moderate skin involvement than those who enrolled in clinical trials of apremilast. Findings from APPRECIATE demonstrate the real-world value of apremilast for psoriasis treatment, as 7 of 10 patients continued therapy and showed notable improvement in disease severity and quality of life 6 (±1) months after apremilast initiation.

摘要

背景

APPRECIATE是一项针对接受阿普米拉斯(一种口服磷酸二酯酶4抑制剂)治疗的银屑病患者的跨国、观察性、回顾性横断面研究。

目的

描述临床环境中接受阿普米拉斯治疗的银屑病患者的特征,评估阿普米拉斯治疗银屑病的实际疗效,并更好地了解患者和医生对治疗效果的看法。

方法

在6个欧洲国家,纳入临床实践中接受治疗的慢性斑块状银屑病患者,这些患者在开始使用阿普米拉斯6(±1)个月后可以被联系到。如有可能,从医疗记录中获取患者特征、皮肤病生活质量指数(DLQI)和银屑病面积和严重程度指数(PASI)。使用患者/医生问卷评估疗效。

结果

在480例治疗开始时的患者中,平均[中位数;95%置信区间(CI)]PASI和DLQI评分分别为12.5(10.7;11.6 - 13.4)和13.4(13.0;11.4 - 14.2)。在6(±1)个月时,72.3%的患者(n = 347)继续使用阿普米拉斯治疗[停药原因:缺乏疗效(13.5%)、安全性(11.7%)、其他(2.5%)]。在继续治疗的患者中,48.6%的患者PASI评分降低≥75%;平均(95%CI)DLQI评分为5.7(4.5 - 6.9),平均(标准差)患者受益指数评分为2.8(1.2)。医生认为75.6%的患者有临床改善。医生对阿普米拉斯总体成功达到预期的看法与患者对治疗益处的看法相关(r = 0.691)。最常报告的不良事件(>5%的患者)是腹泻、恶心和头痛。

结论

APPRECIATE研究中的患者尽管皮肤受累程度比参加阿普米拉斯临床试验的患者轻,但疾病负担仍然很高。APPRECIATE研究结果证明了阿普米拉斯在银屑病治疗中的实际价值,因为10名患者中有7名在开始使用阿普米拉斯6(±1)个月后继续治疗,并且疾病严重程度和生活质量有显著改善。

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