A Retrospective Multicenter Study for the Assessment of Effectiveness of Secukinumab as Assessed by Psoriasis Area and Severity Index With Subcutaneous Administration in Adult Patients With Moderate to Severe Plaque Psoriasis in Turkish Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 277
- 试验地点
- 1
- 主要终点
- Percentage of patients having absolute Psoriasis Area and Severity Index PASI≤3 at week 52
研究概览
简要总结
This study was a real-life study which was based on secondary data collection from the electronic or paper medical records from the Dermatology Clinics of the 14 University, Training & Research Hospitals in Turkey. Data were extracted between 02 September 2020 and 29 April 2021.
详细描述
The study was a retrospective, multicenter, cohort study which was based on data collection at week 4,16 and 52 of secukinumab treatment of moderate to severe plaque psoriasis.
The observational design of the study allowed data collection about secukinumab treatment patterns and clinical and demographic characteristics of plaque psoriasis patients treated with secukinumab for 52 weeks in Turkey. The adults included in the study were treated with secukinumab for 52 weeks. The adults with no available data of PASI scores at specific time points (4, 16 and 52 weeks) and no definite description of treatment cessation were excluded. The study population consisted of adults treated with secukinumab for 52 weeks and adults dropped out before 52 weeks with available data of PASI scores at 4, 16 and 52 weeks and definite description of treatment cessation.
Retrospective data collection from secondary sources (hospital medical records) allowed time and cost saving since description of patients' characteristics, analyses of outcomes of interest and their determinants could be made in a short period of time.
The study consisted of the following periods:
- The index date was the date of initiation of secukinumab
- The study (index) period was between 18 May 2018 to 31 May 2020
- The follow-up (post-index) period was 4,16 and 52 weeks post-index
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of psoriasis
- •Age ≥ 18 years at registry baseline.
- •Patients with a firm diagnosis of chronic plaque psoriasis for at least 6 months before enrollment
- •Secukinumab treatment should be initiated 52 weeks before data collection date
- •Moderate to severe plaque psoriasis with PASI score of ≥10 before initiating secukinumab.
排除标准
- •Patients diagnosed with others types of psoriasis (pustular psoriasis, erythrodermic psoriasis etc) are excluded.
- •Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA
结局指标
主要结局
Percentage of patients having absolute Psoriasis Area and Severity Index PASI≤3 at week 52
时间窗: at week 52
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). Assessment of the effectiveness of secukinumab in subjects with moderate to severe plaque psoriasis was performed based on the percentage of patients who had absolute PASI ≤3 at week 52 in Turkey.
次要结局
- Scalp psoriasis: percentage of patients experiencing scalp psoriasis(at week 52)
- Percentage of PASI 75 responder rates among very severe (PASI>20) patients prior the treatment(at week 52)
- Nail psoriasis: percentage of patients experiencing nail psoriasis, number of finger nails involved(at week 52)
- Palmoplantar psoriasis: percentage of patients experiencing palmoplantar psoriasis(at week 52)
- Percentage of patients experiencing a 75% reduction in PASI (PASI75) from baseline(at week 4)
- Percentage of patients experiencing a 75% reduction in PASI (PASI90) from baseline(at week 16)
- Percentage of PASI 90 responders at week 52 out of PASI 90 responders at week 16(at week 16 and week 52)
- Percentage of patients experiencing a 100% reduction in PASI (PASI100) from baseline(at week 52)
- Percentage of PASI 90 responders among biologic naive patients vs. biologic experienced patients(at week 52)
- Percentage of PASI 90 responder rates at week 52 among smokers vs. non-smokers(at week 52)
- Psoriatic arthritis: percentage of patients experiencing psoriatic arthritis(at week 52)
- Percentage of patients who discontinued secukinumab at 52 weeks period(at week 52)
- Time to discontinuation(at week 52)