Secukinumab (Cosentyx®) Effectiveness in Axial Spondyloarthritis and Psoriatic Arthritis Patients Using Artificial Intelligence (SpAINET): Spanish Multicenter, Retrospective, Real World Evidence Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 758
- 试验地点
- 1
- 主要终点
- Proportion of patients achieving disease control status at 6 months (±3 months) of secukinumab treatment
研究概览
简要总结
This was a multicenter, retrospective, and non-interventional study using secondary data captured in the Electronic Health Records (EHRs). The extraction of the data captured in the EHRs was performed with EHRead® by SAVANA, an innovating data-driven system based on Natural Language Processing (NLP) and big data analytics. Data was extracted and analyzed at Index Date, Follow Up, or as specified for each variable.
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
- •Aged ≥ 18 years.
- •Diagnosed with axSpA or PsA.
- •Had received or are receiving bDMARD, independently of the line of treatment, from January 2018 to data collection.
- •Had at least 3 months follow up from first bDMARD administration.
- •Patients with EHRs.
排除标准
- •Receiving bDMARD within a clinical trial from January 2018 to data collection.
研究组 & 干预措施
Axial Spondyloarthritis Patients
Patients with Axial Spondyloarthritis
干预措施: secukinumab (Drug)
Psoriatic Arthritis Patients
Patients with Psoriatic Arthritis
干预措施: secukinumab (Drug)
结局指标
主要结局
Proportion of patients achieving disease control status at 6 months (±3 months) of secukinumab treatment
时间窗: month 6
Disease control was defined as: For Axial Spondyloarthritis (axSpA) population: Bath Ankylosing Spondylitis Functional Index (BASDAI) score \< 4. If BASDAI was not available, Ankylosing Spondylitis Disease Activity Score (ASDAS) \< 2.1 was used. For Psoriatic Arthritis (PsA) population: Disease Activity in PSoriatic Arthritis (DAPSA) score \< 14. If DAPSA was not available, Disease activity score 28 (DAS-28) \< 3.2 was used.
次要结局
未报告次要终点