Mohammed Ibrahim Fatani, Abdulaziz Madani, Fahad Alzuriqan, Abdullah Albadri, Ahmed Aljedai, Hajer Almudaiheem, Maysa Tariq Eshmawi
{"title":"瑞善单抗治疗牛皮癣的有效性和安全性：来自沙特阿拉伯牛皮癣登记处（PSORSA）的综合分析。","authors":"Mohammed Ibrahim Fatani, Abdulaziz Madani, Fahad Alzuriqan, Abdullah Albadri, Ahmed Aljedai, Hajer Almudaiheem, Maysa Tariq Eshmawi","doi":"10.1007/s13555-025-01493-0","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Psoriasis is a chronic immune-mediated skin condition that has a substantial impact on patients' quality of life. The Saudi Arabia Psoriasis Registry (PSORSA) was established to address long-term real-world data (RWD) on systemic and biologic therapies in the region. This observational cohort study provides a comprehensive analysis of baseline disease characteristics, comorbidities, and treatment efficacy among patients enrolled in PSORSA, with an emphasis on risankizumab.</p><p><strong>Methods: </strong>Data were sourced from a governmental online database covering multiple healthcare centers. Patients eligible for biologics were followed at baseline and at weeks 16, 28, 40, and 52 to evaluate disease severity, quality of life, and adherence. Statistical analyses were conducted using Jamovi and R. Descriptive statistics were performed for categorical and continuous variables. p-Values < 0.05 were considered significant.</p><p><strong>Results: </strong>The study cohort included 313 patients. Plaque psoriasis was the most prevalent clinical type (93.9%). An analysis of treatment history revealed that 39.6% of patients had prior therapy exposure, and all patients received risankizumab as a biologic therapy. At baseline, the mean Psoriasis Area and Severity Index (PASI) score was 25.49. By week 52, it had decreased to 0.358, indicating complete clearance. PASI scores showed a steady and substantial reduction over time, with an 88% reduction at week 16, 96% at week 28, 97.5% at week 40, and 98.5% by week 52, demonstrating a strong and sustained treatment effect (p < 0.001). Additionally, risankizumab exhibited a favorable drug survival profile, with many patients maintaining treatment beyond 122 weeks.</p><p><strong>Conclusion: </strong>This study represents the first real-world assessment of risankizumab for moderate-to-severe psoriasis in Saudi Arabia. The findings demonstrate that risankizumab is an effective and well-tolerated treatment for moderate-to-severe psoriasis in this Saudi Arabian cohort. However, future studies should explore long-term safety outcomes and the comparative effectiveness of risankizumab and emerging biologics in diverse patient populations.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.5000,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Real-World Effectiveness and Safety of Risankizumab in Psoriasis: A Comprehensive Analysis from the Saudi Arabia Psoriasis Registry (PSORSA).\",\"authors\":\"Mohammed Ibrahim Fatani, Abdulaziz Madani, Fahad Alzuriqan, Abdullah Albadri, Ahmed Aljedai, Hajer Almudaiheem, Maysa Tariq Eshmawi\",\"doi\":\"10.1007/s13555-025-01493-0\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Psoriasis is a chronic immune-mediated skin condition that has a substantial impact on patients' quality of life. The Saudi Arabia Psoriasis Registry (PSORSA) was established to address long-term real-world data (RWD) on systemic and biologic therapies in the region. This observational cohort study provides a comprehensive analysis of baseline disease characteristics, comorbidities, and treatment efficacy among patients enrolled in PSORSA, with an emphasis on risankizumab.</p><p><strong>Methods: </strong>Data were sourced from a governmental online database covering multiple healthcare centers. Patients eligible for biologics were followed at baseline and at weeks 16, 28, 40, and 52 to evaluate disease severity, quality of life, and adherence. Statistical analyses were conducted using Jamovi and R. Descriptive statistics were performed for categorical and continuous variables. p-Values < 0.05 were considered significant.</p><p><strong>Results: </strong>The study cohort included 313 patients. Plaque psoriasis was the most prevalent clinical type (93.9%). An analysis of treatment history revealed that 39.6% of patients had prior therapy exposure, and all patients received risankizumab as a biologic therapy. At baseline, the mean Psoriasis Area and Severity Index (PASI) score was 25.49. By week 52, it had decreased to 0.358, indicating complete clearance. PASI scores showed a steady and substantial reduction over time, with an 88% reduction at week 16, 96% at week 28, 97.5% at week 40, and 98.5% by week 52, demonstrating a strong and sustained treatment effect (p < 0.001). Additionally, risankizumab exhibited a favorable drug survival profile, with many patients maintaining treatment beyond 122 weeks.</p><p><strong>Conclusion: </strong>This study represents the first real-world assessment of risankizumab for moderate-to-severe psoriasis in Saudi Arabia. The findings demonstrate that risankizumab is an effective and well-tolerated treatment for moderate-to-severe psoriasis in this Saudi Arabian cohort. However, future studies should explore long-term safety outcomes and the comparative effectiveness of risankizumab and emerging biologics in diverse patient populations.</p>\",\"PeriodicalId\":11186,\"journal\":{\"name\":\"Dermatology and Therapy\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.5000,\"publicationDate\":\"2025-07-25\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Dermatology and Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s13555-025-01493-0\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"DERMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Dermatology and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s13555-025-01493-0","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"DERMATOLOGY","Score":null,"Total":0}
Real-World Effectiveness and Safety of Risankizumab in Psoriasis: A Comprehensive Analysis from the Saudi Arabia Psoriasis Registry (PSORSA).
Introduction: Psoriasis is a chronic immune-mediated skin condition that has a substantial impact on patients' quality of life. The Saudi Arabia Psoriasis Registry (PSORSA) was established to address long-term real-world data (RWD) on systemic and biologic therapies in the region. This observational cohort study provides a comprehensive analysis of baseline disease characteristics, comorbidities, and treatment efficacy among patients enrolled in PSORSA, with an emphasis on risankizumab.
Methods: Data were sourced from a governmental online database covering multiple healthcare centers. Patients eligible for biologics were followed at baseline and at weeks 16, 28, 40, and 52 to evaluate disease severity, quality of life, and adherence. Statistical analyses were conducted using Jamovi and R. Descriptive statistics were performed for categorical and continuous variables. p-Values < 0.05 were considered significant.
Results: The study cohort included 313 patients. Plaque psoriasis was the most prevalent clinical type (93.9%). An analysis of treatment history revealed that 39.6% of patients had prior therapy exposure, and all patients received risankizumab as a biologic therapy. At baseline, the mean Psoriasis Area and Severity Index (PASI) score was 25.49. By week 52, it had decreased to 0.358, indicating complete clearance. PASI scores showed a steady and substantial reduction over time, with an 88% reduction at week 16, 96% at week 28, 97.5% at week 40, and 98.5% by week 52, demonstrating a strong and sustained treatment effect (p < 0.001). Additionally, risankizumab exhibited a favorable drug survival profile, with many patients maintaining treatment beyond 122 weeks.
Conclusion: This study represents the first real-world assessment of risankizumab for moderate-to-severe psoriasis in Saudi Arabia. The findings demonstrate that risankizumab is an effective and well-tolerated treatment for moderate-to-severe psoriasis in this Saudi Arabian cohort. However, future studies should explore long-term safety outcomes and the comparative effectiveness of risankizumab and emerging biologics in diverse patient populations.
期刊介绍：
Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged.
Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
