Effects of IL17/23 Inhibitors on Markers of Subclinical Atherosclerosis in Patients With Psoriasis: an Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- change of pulse wave velocity (PWV) from baseline to week 24 and 52
研究概览
简要总结
Data on the antiatherogenic effect of IL23 inhibitors are sparse. This study aimed to assess the impact of one-year treatment with an IL17 or IL23 inhibitor on arterial stiffness in patients with moderate-to-severe psoriasis.
This observational cohort study included patients with moderate-to-severe psoriasis treated with either an IL17 inhibitor or an IL23 inhibitor or a conventional systemic agent/apremilast (control group) for 52 weeks. The primary outcome was the evaluation of changes in carotid-femoral pulse wave velocity (PWV) and augmentation index normalized to 75 beats/min (AIx75) after 24 and 52 weeks. Secondary outcomes were the comparison of change in PWV and AIx75 between the study groups and the assessment of psoriasis disease severity scores and in ankle-brachial index (ABI).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate-to-severe psoriasis (Psoriasis Area Severity Index (PASI) score > 10 or Body Surface Area (BSA) >10 or Dermatology Life Quality Index (DLQI) >10)
- •Indication for treatment with an IL17 or an IL23 inhibitor based on disease characteristics and comorbidities
排除标准
- •Prior treatment with an IL17 or an IL23 inhibitor
- •Prior therapy with an TNFa-inhibitor for up to 3 months before entering the study
- •Chronic or severe acute infections, malignancy
- •Pregnancy or lactation
研究组 & 干预措施
Group 1
IL17 inhibitor
干预措施: interleukin 17 inhibitor (Drug)
Group 2
IL23 inhibitor
干预措施: interleukin-23 inhibitor (Drug)
Group 3
conventional systemic agent or apremilast
干预措施: conventional systemic agent or apremilast (Drug)
结局指标
主要结局
change of pulse wave velocity (PWV) from baseline to week 24 and 52
时间窗: from enrollment to the end of treatment at week 52
PWV can range from approximately 6.6 m/s in patients under 30 to 11.7 m/s in patients over 70 years of age; higher scores mean a worse outcome
change of augmentation index normalized to 75 beats/min (AIx75) from baseline to week 24 and 52
时间窗: from enrollment to the end of treatment at week 52
no single universally accepted normal range for an AIx@75; lower values indicate better arterial health, with values below 20-25% often considered optimal, and values above 30% associated with increased arterial stiffness and cardiovascular risk
次要结局
- comparison of change in PWV between the study groups(From enrollment to the end of treatment at 52 weeks)
- change in psoriasis area severity index (PASI)(From enrollment to the end of treatment at 52 weeks)
- change in ankle-brachial index (ABI)(From enrollment to the end of treatment at 52 weeks)
- comparison of change in AIx75 between the study groups(from enrollment to the end of treatment at 52 weeks)
- change in body surface area (BSA)(From enrollment to the end of treatment at 52 weeks)
- change in physician's global assessment (PGA)(From enrollment to the end of treatment at 52 weeks)
- change in dermatology life quality index (DLQI)(From enrollment to the end of treatment at 52 weeks)
研究者
Aikaterini Tsiogka
dermatologist, clinical research associate
National and Kapodistrian University of Athens