Pharmacogenetic Observational Study Evaluating the Influence of Genetic Variants and Cardiometabolic Risk Factors on 10-Year Survival of Biologic Therapies in Patients With Cutaneous Psoriasis With or Without Psoriatic Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Drug survival at 10 years
研究概览
简要总结
This retrospective observational study aims to evaluate the long-term survival of biologic therapies in adult patients with moderate-to-severe cutaneous psoriasis, with or without psoriatic arthritis, over a period of up to 10 years. The study investigates the influence of clinical, metabolic, and genetic factors, including SNPs and metabolic syndrome components, on treatment durability. Data were obtained from a single-centre cohort treated in routine clinical practice. This analysis seeks to identify predictors of therapeutic response and to explore pharmacogenetic profiles that may inform personalized treatment strategies.
详细描述
This retrospective observational cohort study investigates the influence of clinical, anthropometric, lifestyle, cardiometabolic, immunological, and genetic factors on the long-term effectiveness and durability of biologic therapies in patients with moderate-to-severe plaque psoriasis, with or without psoriatic arthritis.
The study includes adult patients diagnosed with plaque psoriasis who initiated treatment with a biologic agent between 2011 and 2021 at a tertiary academic dermatology center. All subjects were systematically assessed through standardized procedures, and follow-up data were collected over a period of up to 10 years. The primary endpoint is biologic drug survival (time to discontinuation), while secondary endpoints include treatment response (PGA), presence of psoriatic arthritis, nail psoriasis, and family history of psoriasis.
Clinical and biomarker data collected at baseline included:
Anthropometric variables: body mass index (BMI), waist circumference.
Lifestyle indicators: Mediterranean diet adherence (MEDAS), physical activity frequency, smoking and alcohol habits, and perceived stress scale.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years) diagnosed with moderate-to-severe cutaneous psoriasis.
- •Initiation of treatment with a biologic agent between 2010 and
- •Minimum follow-up of 12 months or until drug discontinuation.
- •Availability of clinical and treatment data at baseline.
- •Availability of at least one blood sample for biomarker/genetic analysis.
- •Informed consent obtained for biobanking and genetic analyses.
排除标准
- •Diagnosis of other chronic inflammatory skin diseases (e.g., atopic dermatitis, lupus).
- •Concomitant participation in interventional clinical trials at baseline.
- •Patients with incomplete treatment history or missing survival data.
- •Systemic immunosuppressive therapy (e.g., cyclosporine, methotrexate) without biologics during the study period.
研究组 & 干预措施
Psoriasis Cohort - Observational Follow-up
Adult patients with a confirmed diagnosis of plaque psoriasis, with or without psoriatic arthritis, who initiated biologic therapy between 2010 and 2020 at tertiary dermatology clinics in Spain. Participants were followed retrospectively for up to 10 years to assess treatment survival, safety, and disease outcomes. The study explores the influence of genetic variants (450 SNPs across 65 genes), cardiometabolic comorbidities, lifestyle factors, and circulating biomarkers (adipokines, cytokines, microparticles) on treatment durability and response. No interventions were assigned by protocol.
干预措施: Biologic therapy for psoriasis (Drug)
结局指标
主要结局
Drug survival at 10 years
时间窗: Up to 10 years from treatment start
Time from initiation of the biologic treatment to discontinuation for any cause (inefficacy, adverse events, remission, patient decision, etc.).
次要结局
- Predictors of biologic drug discontinuation in patients with psoriasis(Up to 10 years from treatment initiation)
- Association between baseline soluble immune biomarkers and biologic drug survival(Up to 10 years from treatment initiation)
- Genetic variants associated with baseline soluble immune biomarker levels(Baseline (pre-treatment))
- Mediation of genetic effects on biologic survival by soluble immune biomarkers(From baseline to 10 years)
- Incidence of new-onset psoriatic arthritis (PsA) during follow-up(From baseline to 10 years)
- Predictors of new-onset psoriatic arthritis during biologic treatment(From baseline to 10 years)
- Incidence and type of adverse events during biologic treatment(From baseline to 10 years)
- Predictors of adverse events during biologic treatment(From baseline to 10 years)
研究者
Juan Ruano Ruiz
Principal Investigator, IMIBIC-HURS, Córdoba, Spain
Maimónides Biomedical Research Institute of Córdoba