National Registry of Patients With Psoriatic Disease Receiving Interleukin-23 Inhibitor Therapy Within the Costa Rican Social Security System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Clinical Effectiveness of Interleukin-23 Inhibitors in Psoriatic Disease
研究概览
简要总结
The goal of this observational registry study is to evaluate the real-world effectiveness and safety of IL-23 inhibitors in patients with psoriatic disease (psoriasis and/or psoriatic arthritis) treated in Costa Rica. The main questions it aims to answer are:
- Do IL-23 inhibitors (guselkumab or risankizumab) improve disease severity and quality of life in patients with psoriatic disease in routine clinical practice?
- What is the safety profile and treatment persistence of IL-23 inhibitors in this population?
- Patients receiving IL-23 inhibitors as part of their usual medical care will be followed longitudinally using standardized clinical measures (e.g., PASI, DLQI, DAPSA/BASDAI) and adverse-event reporting through a national registry.
详细描述
Psoriatic disease, including psoriasis and psoriatic arthritis, is a chronic inflammatory condition with substantial clinical and functional impact. Although IL-23 inhibitors such as guselkumab and risankizumab have shown high efficacy and favorable safety in international trials, real-world evidence in Latin America-and particularly Costa Rica-is limited. Differences in comorbidities, population genetics, access to therapy, and health-system factors may influence treatment response and safety outcomes.
This national observational registry is designed to generate standardized real-world data on patients with psoriatic disease treated with IL-23 inhibitors within the Costa Rican public health system. The registry will collect demographic and clinical characteristics, dermatologic and rheumatologic disease activity scores, treatment patterns, persistence, and adverse events over time. The resulting evidence will support clinical decision-making, optimize therapeutic strategies, and inform national health policy regarding biologic therapies for psoriatic disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of psoriatic disease, including psoriasis (any clinical variant) and/or psoriatic arthritis based on rheumatologic criteria.
- •Receiving IL-23 inhibitor therapy (guselkumab or risankizumab).
- •Treated within participating Costa Rican public health centers.
- •Availability of sufficient clinical records to complete registry data (history, follow-up, labs).
- •Age ≥12 years, any sex.
排除标准
- •None specified (all patients meeting inclusion criteria are eligible).
结局指标
主要结局
Clinical Effectiveness of Interleukin-23 Inhibitors in Psoriatic Disease
时间窗: 5 years
Proportion of patients achieving: 1. Psoriasis Area and Severity Index 75, 90, and 100 response 2. Dermatology Life Quality Index score of 0 or 1 3. Disease Activity in Psoriatic Arthritis.
Safety of Interleukin-23 Inhibitors
时间窗: 5 years
Incidence rate of adverse events and serious adverse events, including: * Serious infections * Hospitalizations * New malignancy * Thrombotic events * Injection-site reactions * Treatment discontinuation due to adverse events
次要结局
- Change in Psoriasis Severity(5 years)
- Treatment Persistence(5 years)
- Laboratory Safety Parameters(5 years)
- Factors Associated With Clinical Response(5 years)
- Articular Disease Activity(5 years)
研究者
Daniel Barquero Orias
Principal Investigator
Caja Costarricense de Seguro Social