塞库单抗治疗希腊中重度斑块状银屑病患者的实际经验:SERENA 研究的三年中期结果

IF 3.7 4区 医学 Q1 DERMATOLOGY Dermatologic Therapy Pub Date : 2024-09-18 DOI:10.1155/2024/6530352
Dimitrios Ioannides, Dimitrios Rigopoulos, Markos Papakonstantis, Vasiliki Chasapi, Panagiotis Deligiannis, Panagiotis Rigatos, Ioanna Lefaki, Evangelia Papadavid, Eteoklis Pokas, Spyridon Tsilifis, Angeliki-Viktoria Roussaki-Schulze, Ioannis Barkis, Elisabeth Lazaridou, Christina Fotiadou, Chrysa Zisimou, Panagiotis Kallidis, Vasileios Chatzakis, Chrysa Oikonomou, Xenia Madia
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引用次数: 0

摘要

SERENA是一项正在进行中的欧洲非干预性纵向研究,旨在评估经赛库单抗治疗的活动性中重度斑块状银屑病、银屑病关节炎和强直性脊柱炎患者的保留率、有效性、安全性和生活质量(QoL)。本文介绍了希腊银屑病患者的三年中期治疗结果。根据批准的标签,同意接受secukinumab治疗≥16周的成人患者被纳入其中。在登记的 292 名患者中,对 290 名符合条件的患者(平均年龄 48.4 岁,71.7% 为男性)进行了分析。开始治疗时,65.9%的患者对生物制剂一无所知,牛皮癣面积严重程度指数(PASI)平均总分为29.0分。入组时,平均治疗时间约为 1.0 年。入组后1/2/3年的治疗保留率分别为94.4%/87.3%/85.9%;停药的主要原因是疗效不佳和不良事件(AEs)(分别占停药的43.6%和28.2%)。入组时,PASI平均分为4.0分,61.3%的患者PASI≤3分,71.7%的患者医生总体评估(PGA)得分为0/1分,59.5%的患者皮肤科生活质量指数(DLQI)得分为0/1分,而欧洲生活质量视觉模拟量表(EQ-VAS)平均分为82.0分。入组后1/2/3年,PASI平均分为1.9/1.6/1.0,86.6/89.4/90.0%的患者PASI≤3,89.5/94.8/97.5%的患者PGA为0/1,71.1/75.9/81.8%的患者DLQI为0/1,EQ-VAS平均分为85.7/90.0/92.0。在入组患者中,7.2%的患者出现了与赛库单抗相关的AEs,而特别关注的AEs(念珠菌感染、恶性肿瘤和主要不良心血管事件)报告人数均少于2例。这些结果表明,secukinumab在希腊人群中的持久性很高,在入组后长达三年的时间里,临床和生活质量参数都得到了持续改善,而且安全性良好。
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Real-World Experience of Secukinumab Treatment in Patients with Moderate-to-Severe Plaque Psoriasis in Greece: 3-Year Interim Results of the SERENA Study

SERENA is an ongoing European noninterventional longitudinal study evaluating retention, effectiveness, safety, and quality of life (QoL) in secukinumab-treated patients with active moderate-to-severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis. Herein, 3-year interim results among patients with psoriasis enrolled in Greece are presented. Consented adults receiving secukinumab according to the approved label for ≥16 weeks were included. Of 292 patients enrolled, 290 eligible patients (mean age 48.4 years, 71.7% male) were analyzed. At treatment initiation, 65.9% of patients were biologic-naïve and mean total Psoriasis Area Severity Index (PASI) score was 29.0. At enrolment, mean treatment duration was approximately 1.0 year. The treatment retention rate at 1/2/3 years after enrolment was 94.4/87.3/85.9%; main reasons for discontinuation were lack of effectiveness and adverse events (AEs) (43.6% and 28.2% of discontinuations, respectively). At enrolment, the mean PASI score was 4.0, 61.3% of patients had PASI ≤ 3, 71.7% had Physician’s Global Assessment (PGA) score 0/1, 59.5% had Dermatology Life Quality Index (DLQI) score 0/1, while the mean EuroQoL Visual Analogue Scale (EQ-VAS) score was 82.0. At 1/2/3 years postenrolment, the mean PASI score was 1.9/1.6/1.0, 86.6/89.4/90.0% had PASI ≤ 3, 89.5/94.8/97.5% had PGA 0/1, 71.1/75.9/81.8% had DLQI 0/1, and mean EQ-VAS score was 85.7/90.0/92.0. Of enrolled patients, 7.2% experienced secukinumab-related AEs, while special interest AEs (candida infections, malignancy, and major adverse cardiovascular events) were reported in ≤2 patients, each. These results demonstrate high secukinumab persistence in the Greek population up to three years after study enrolment, accompanied by sustained improvements in both clinical and QoL parameters and a favorable safety profile.

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来源期刊
Dermatologic Therapy
Dermatologic Therapy 医学-皮肤病学
CiteScore
7.00
自引率
8.30%
发文量
711
审稿时长
3 months
期刊介绍: Dermatologic Therapy has been created to fill an important void in the dermatologic literature: the lack of a readily available source of up-to-date information on the treatment of specific cutaneous diseases and the practical application of specific treatment modalities. Each issue of the journal consists of a series of scholarly review articles written by leaders in dermatology in which they describe, in very specific terms, how they treat particular cutaneous diseases and how they use specific therapeutic agents. The information contained in each issue is so practical and detailed that the reader should be able to directly apply various treatment approaches to daily clinical situations. Because of the specific and practical nature of this publication, Dermatologic Therapy not only serves as a readily available resource for the day-to-day treatment of patients, but also as an evolving therapeutic textbook for the treatment of dermatologic diseases.
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