Therapeutic Drug Monitoring of Adalimumab in Psoriasis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 5
- 主要终点
- 75% improvement in clinical response
研究概览
简要总结
The main goal of this study is to determine optimal cut-off values of adalimumab trough levels corresponding to good clinical response. Determination of these values is necessary to compose a therapeutic algorithm, in which the dosing schedule can be adjusted according to serum trough levels of adalimumab and AAA (anti-adalimumab antibodies). A secondary objective of this study is to further detect and quantify AAA and to correlate them with adalimumab and clinical response in a real life setting cohort of psoriatic patients.
详细描述
In a multicenter cross-sectional study, 73 adult patients treated with adalimumab (40 mg) every other week for at least 24 weeks are assessed for psoriasis disease severity through measurement of the Psoriasis Area and Severity Index (PASI) before adalimumab treatment start, and prior to sampling. Patients who interrupted their treatment schedule during the 24 weeks prior to blood sampling are excluded. Samples of patients who were treated with adalimumab for any other inflammatory disease and later developed psoriasis are also excluded. Percentage of PASI improvement compared to baseline (∆PASI) represents clinical response. Patients are classified as nonresponders (∆PASI<50), moderate responders (∆PASI 50-75) or good responders (∆PASI 75-100).Serum is collected for adalimumab trough level and anti-drug antibody determination (Sanquin, The Netherlands). By receiver-operator characteristics (ROC) analysis, a cut-off value of adalimumab trough level can be determined to distinguish insufficient from adequate responders.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •minimum age 18 years old
- •chronic plaque psoriasis
- •adalimumab (40mg) subcutaneously every other week
- •at least 24 weeks of adalimumab treatment
排除标准
- •interruption of treatment schedule during 24 weeks prior to sampling
- •adalimumab for other inflammatory disease and later developed psoriasis
结局指标
主要结局
75% improvement in clinical response
时间窗: at least 24 weeks of treatment duration
Minimum of 75 % PASI improvement compared to baseline (∆PASI 75) represents 75% improvement in clinical response.
次要结局
- anti-adalimumab antibody formation(at least 24 weeks of treatment)