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

IF 1.5 4区 医学 Q3 DERMATOLOGY
Dong Hyun Kim, Sang Wook Son, Ki-Heon Jeong, Jiyoung Ahn, Eun-So Lee, Il-Hwan Kim, Un Ha Lee, Hai-Jin Park, Joo Yeon Ko, Byung-Soo Kim, Jin Ju Kim, Javed Rashid, Kwang Joong Kim
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引用次数: 0

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 4.00~80.00) and 12.40 (range 2.70~39.40), 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 (p=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).

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阿达木单抗治疗韩国中重度牛皮癣患者的真实世界结果(RAPSODI研究)。
背景:银屑病给患者带来了巨大的治疗负担,特别是影响了患者的健康和生活质量。牛皮癣治疗的社会心理影响在大多数患者群体中仍未被探索。目的:评价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评估了在现实环境中接受阿达木单抗治疗的韩国患者的HRQoL。患者报告的结果(PROs)包括欧洲生活质量5维度量表(EQ-5D)、EQ-5D VAS、SF-36和DLQI在第16周和第24周与基线相比进行评估。采用TSQM评估患者满意度。结果:在97例入组患者中,77例进行了治疗效果评估。患者以男性为主(52例,占67.5%),平均年龄45.4岁。基线体表面积和银屑病面积及严重程度指数(PASI)评分中位数分别为15.00(4.00~80.00)和12.40(2.70~39.40)。从基线到第24周,所有PROs均有统计学上的显著改善。平均EQ-5D评分从基线时的0.88(标准差[SD], 0.14)改善到第24周时的0.91(标准差[SD], 0.17) (p=0.0067)。从基线到第16周和第24周,PASI 75、90或100发生变化的患者数量分别为65(84.4%)、17(22.1%)和1 (1.3%);64例(83.1%),21例(27.3%),2例(2.6%)。报告了总体治疗满意度,包括有效性和便利性。没有意外的安全发现。结论:阿达木单抗改善了韩国中重度牛皮癣患者的生活质量,并具有良好的耐受性,这在现实世界中得到了证明。临床试验注册号(clinicaltrials.gov: NCT03099083)。
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来源期刊
Annals of Dermatology
Annals of Dermatology 医学-皮肤病学
CiteScore
1.60
自引率
6.20%
发文量
77
审稿时长
6-12 weeks
期刊介绍: Annals of Dermatology (Ann Dermatol) is the official peer-reviewed publication of the Korean Dermatological Association and the Korean Society for Investigative Dermatology. Since 1989, Ann Dermatol has contributed as a platform for communicating the latest research outcome and recent trend of dermatology in Korea and all over the world. Ann Dermatol seeks for ameliorated understanding of skin and skin-related disease for clinicians and researchers. Ann Dermatol deals with diverse skin-related topics from laboratory investigations to clinical outcomes and invites review articles, original articles, case reports, brief reports and items of correspondence. Ann Dermatol is interested in contributions from all countries in which good and advanced research is carried out. Ann Dermatol willingly recruits well-organized and significant manuscripts with proper scope throughout the world.
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