Secukinumab Efficacy Without the Initial Loading Dose at Weeks 0, 1, 2, 3 and 4 in Patients With Chronic Plaque Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- PASI75
研究概览
简要总结
This was a retrospective, observational study. The objective of the study is investigate the efficacy and safety of secukinumab without the initial weekly loading dose in patients with chronic plaque psoriasis. Patients were stratified in two groups, those receiving secukinumab at the dose 300 mg every 4 weeks from the beginning (cases) and those who received the initial label, weekly loading dose (controls). Efficacy was evaluated by comparing the proportion of patients achieving PASI75 responses at week 16, 32 and 48 between cases and controls. Safety was evaluated by reporting every adverse events up to week 48.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Patients older than 18 years old
- •Patients with moderate to severe chronic plaque psoriasis treated with secukinumab with or without initial loading dose for at least 48 week
- •The criteria for receiving secukinumab were according to standard clinical practice.
排除标准
- •Patients younger than 18 years old
- •Patients with only psoriatic arthritis or with other forms of psoriasis than chronic plaque type (such as drug-induced psoriasis or guttate, erythrodermic, or pustular psoriasis)
- •Pregnant women and women during breastfeeding
研究组 & 干预措施
Cases
Cases received secukinumab at the dose 300 mg every 4 weeks from the beginning.
干预措施: Secukinumab (Drug)
Controls
Controls received secukinumab at the dose 300 mg with loading dose at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing.
干预措施: Secukinumab (Drug)
结局指标
主要结局
PASI75
时间窗: week 48
次要结局
- PASI90(week 48)
研究者
Paolo Gisondi
Professor
Universita di Verona