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西班牙常规临床实践中接受阿普米拉斯治疗患者的特征及结局:APPRECIATE研究结果

Characterization and Outcomes in Patients Treated With Apremilast in Routine Clinical Practice in Spain: Results From the APPRECIATE Study.

作者信息

Herranz P, Trasobares L, Mateu A, Martínez E, Ruiz-Villaverde R, Baniandrés O, Mataix Díaz J, Jiménez-Gómez N, Serra M, Ruiz Genao D P, Rivera N, Tercedor-Sánchez J, Garcia C, Cordey M, Herrera-Acosta E

机构信息

Hospital Universitario La Paz, Madrid, España.

Hospital Universitario Príncipe de Asturias, Madrid, España.

出版信息

Actas Dermosifiliogr (Engl Ed). 2021 May 27. doi: 10.1016/j.ad.2021.05.010.

Abstract

BACKGROUND AND OBJECTIVES

It is necessary to expand the knowledge in the use of apremilast in clinical practice. The APPRECIATE study (NCT02740218) aims to describe the characteristics of patients with psoriasis treated with apremilast, to evaluate their perspectives and those of dermatologists, as well as the outcomes obtained in clinical practice in Spain.

METHODS

Observational, retrospective, cross-sectional, multicenter study of patients with chronic plaque psoriasis who could be contacted 6 (±1) months after apremilast initiation. The data were obtained from medical records and questionnaires from patients and physicians.

RESULTS

A total of 80 patients were evaluated; at apremilast onset, they showed mean (standard deviation, SD) Psoriasis Area and Severity Index (PASI) = 8.3 (5.3), mean (SD) Dermatology Life Quality Index (DLQI) = 8.9 (6.6). At six months, 58.8% (n=47) of patients continued apremilast treatment (discontinuations due to lack of efficacy [16.3%], safety/tolerability [20.0%]). In patients continuing treatment, PASI75 was achieved by 36.7% of patients; mean (95% CI) DLQI score was 2.2 (0.7-3.6) and mean (SD) Patient Benefit Index score was 2.8 (0.8). Compliance with physicians' expectations was correlated with benefits reported by patients (r=0.636). Adverse events were reported by 56.3% of patients (the most common were diarrhoea and nausea).

CONCLUSIONS

Patients receiving apremilast for 6 months in Spanish clinical practice, reported substantial improvements in their quality of life (mean DLQI reduced by more than 6 points) and disease severity (PASI75 achieved by over one-third of patients), despite less skin involvement than patients who enrolled in clinical trials.

摘要

背景与目的

有必要在临床实践中拓展阿普米拉斯使用方面的知识。APPRECIATE研究(NCT02740218)旨在描述接受阿普米拉斯治疗的银屑病患者的特征,评估他们以及皮肤科医生的观点,还有在西班牙临床实践中获得的结果。

方法

对慢性斑块状银屑病患者进行观察性、回顾性、横断面、多中心研究,在阿普米拉斯开始治疗6(±1)个月后能够联系到这些患者。数据来自患者和医生的病历及问卷。

结果

共评估了80例患者;在开始使用阿普米拉斯时,他们的银屑病面积和严重程度指数(PASI)平均(标准差,SD)为8.3(5.3),皮肤病生活质量指数(DLQI)平均(SD)为8.9(6.6)。6个月时,58.8%(n = 47)的患者继续接受阿普米拉斯治疗(因疗效不佳停药[16.3%],因安全性/耐受性停药[20.0%])。在继续治疗的患者中,36.7%的患者达到了PASI75;平均(95%置信区间)DLQI评分为2.2(0.7 - 3.6),患者获益指数平均(SD)评分为2.8(0.8)。患者对医生期望的依从性与患者报告的获益相关(r = 0.636)。56.3%的患者报告了不良事件(最常见的是腹泻和恶心)。

结论

在西班牙临床实践中接受阿普米拉斯治疗6个月的患者报告称,他们的生活质量有显著改善(平均DLQI降低超过6分),疾病严重程度也有所改善(超过三分之一的患者达到PASI75),尽管皮肤受累程度低于参加临床试验的患者。

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