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阿达木单抗治疗韩国中重度银屑病患者的真实世界疗效(RAPSODI研究)。

Real-World Outcomes of Adalimumab Treatment for Moderate and Severe Psoriasis in Korean Patients (RAPSODI Study).

作者信息

Kim Dong Hyun, Son Sang Wook, Jeong Ki-Heon, Ahn Jiyoung, Lee Eun-So, Kim Il-Hwan, Lee Un Ha, Park Hai-Jin, Ko Joo Yeon, Kim Byung-Soo, Kim Jin Ju, Rashid Javed, Kim Kwang Joong

机构信息

Department of Dermatology, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Korea.

Department of Dermatology, Korea University Ansan Hospital, Ansan, Korea.

出版信息

Ann Dermatol. 2023 Apr;35(2):107-115. doi: 10.5021/ad.22.041.

Abstract

BACKGROUND

Psoriasis imposes a significant treatment burden on patients, particularly impacting well-being and quality of life (QoL). The psychosocial impact of psoriasis treatments remains unexplored in most patient populations.

OBJECTIVE

To assess the impact of adalimumab on health-related QoL (HRQoL) in Korean patients with psoriasis.

METHODS

This 24-week, multicenter, observational study, assessed HRQoL in Korean patients treated with adalimumab in a real-world setting. Patient-reported outcomes (PROs) including European Quality of Life-5 Dimension scale (EQ-5D), EQ-5D VAS, SF-36, and DLQI were evaluated at week 16 and 24, versus baseline. Patient satisfaction was assessed using TSQM.

RESULTS

Among 97 enrolled patients, 77 were assessed for treatment effectiveness. Most patients were male (52, 67.5%) and mean age was 45.4 years. Median baseline body surface area and Psoriasis Area and Severity Index (PASI) scores were 15.00 (range 4.0080.00) and 12.40 (range 2.7039.40), respectively. Statistically significant improvements in all PROs were observed between baseline and week 24. Mean EQ-5D score improved from 0.88 (standard deviation [SD], 0.14) at baseline to 0.91 (SD, 0.17) at week 24 (=0.0067). The number of patients with changes in PASI 75, 90, or 100 from baseline to week 16 and 24 were 65 (84.4%), 17 (22.1%), and 1 (1.3%); and 64 (83.1%), 21 (27.3%), and 2 (2.6%), respectively. Overall treatment satisfaction was reported, including effectiveness and convenience. No unexpected safety findings were noted.

CONCLUSION

Adalimumab improved QoL and was well-tolerated in Korean patients with moderate to severe psoriasis, as demonstrated in a real-world setting. Clinical trial registration number (clinicaltrials.gov: NCT03099083).

摘要

背景

银屑病给患者带来了巨大的治疗负担,尤其对幸福感和生活质量(QoL)产生影响。在大多数患者群体中,银屑病治疗的社会心理影响仍未得到探索。

目的

评估阿达木单抗对韩国银屑病患者健康相关生活质量(HRQoL)的影响。

方法

这项为期24周的多中心观察性研究,在现实环境中评估了接受阿达木单抗治疗的韩国患者的HRQoL。在第16周和第24周,与基线相比,评估了患者报告的结局(PROs),包括欧洲五维健康量表(EQ-5D)、EQ-5D视觉模拟量表(VAS)、简明健康状况调查量表(SF-36)和皮肤病生活质量指数(DLQI)。使用治疗满意度问卷(TSQM)评估患者满意度。

结果

在97名入组患者中,77名患者接受了治疗效果评估。大多数患者为男性(52名,67.5%),平均年龄为45.4岁。基线时的中位体表面积和银屑病面积和严重程度指数(PASI)评分分别为15.00(范围4.0080.00)和12.40(范围2.7039.40)。在基线和第24周之间,所有PROs均观察到具有统计学意义的改善。平均EQ-5D评分从基线时的0.88(标准差[SD],0.14)提高到第24周时的0.91(SD,0.17)(P=0.0067)。从基线到第16周和第24周,PASI改善75%、90%或100%的患者人数分别为65名(84.4%)、17名(22.1%)和1名(1.3%);以及64名(83.1%)、21名(27.3%)和2名(2.6%)。报告了总体治疗满意度,包括有效性和便利性。未发现意外的安全性结果。

结论

在现实环境中,阿达木单抗改善了韩国中重度银屑病患者的生活质量,且耐受性良好。临床试验注册号(clinicaltrials.gov:NCT03099083)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c06e/10112372/06f1634b8ff1/ad-35-107-g001.jpg

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