The Characteristics of Patients Treated With Secukinumab for Moderate to Severe Plaque Psoriasis in Real-world Practice in Thailand
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 163
- 试验地点
- 1
- 主要终点
- Duration of topical therapy
研究概览
简要总结
This study was a non-interventional, retrospective study collecting data from hospital medical records. Approximately 200 adult patients with moderate to severe plaque psoriasis who were treated with secukinumab from hospitals in Thailand that participated in this study were expected for data collection.
详细描述
The study was performed in 7 study sites in Thailand and planned to involve approximately 200 medical records.
At each study site, patients who were treated with secukinumab or had ever been treated with secukinumab for moderate to severe plaque psoriasis were included for screening by chronological order starting from the most recent date (April 2021) to September 2017. This was to include the most recent clinical practice in the study.
The data of patients diagnosed with moderate-to-severe chronic plaque-type psoriasis who received secukinumab in real clinical practice at least 1 dose were collected. The medical records were reviewed to collect the data from the date of the first diagnosis of psoriasis till the most recent dose of secukinumab.
The data of secukinumab use and clinical outcome (PASI score) were collected at 4 and 16 weeks after first dose initiation and at the most recent dose of secukinumab. The total number of secukinumab injections at the 3-time points were collected.
An index date was defined for each patient. The first secukinumab injection observed in the medical records was considered the index date for the exploratory endpoint.
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
- •Adult male or female aged ≥ 18 years at index date
- •Previous diagnosis of moderate to severe plaque psoriasis as hospital record with available baseline PASI at index date (date 0 to date -7 prior index date)
- •Initiated treatment with secukinumab for moderate to severe plaque psoriasis during September 2017-April 2021
排除标准
- •Patients diagnosed with other forms of psoriasis other than plaque-type
研究组 & 干预措施
Secukinumab
all patients with psoriasis who received secukinumab
干预措施: Secukinumab (Drug)
结局指标
主要结局
Duration of topical therapy
时间窗: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
To describe the PSO treatment history
Age
时间窗: Baseline
Age information was reported.
Date of first symptom of psoriasis (PSO) / year
时间窗: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
To describe the PSO treatment history
Date of psoriasis diagnosis / year
时间窗: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
To describe the PSO treatment history
BMI
时间窗: During 3 months pre-baseline
BMI information was reported.
Co-morbidities
时间窗: During 12 months pre-baseline
* Crohn's Disease * Diabetes Mellitus * Dyslipidemia * Hypertension * Inflammatory Bowel Disease * Latent Tuberculosis * Psoriatic Arthritis (PsA)
Duration of psoriasis diagnosis
时间窗: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
To describe the PSO treatment history
Date of first biologic agent/year
时间窗: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
To describe the PSO treatment history
Weight
时间窗: During 3 months pre-baseline
Weight information was reported.
Disease Life Quality Index (DLQI) score
时间窗: During 4 weeks pre-baseline
The Dermatology Life Quality Index (DLQI) is a simple, self-administered and user-friendly validated questionnaire. The DLQI is designed to measure the health-related quality of life of adult patients suffering from a skin disease. The DLQI is a validated, 10-question, self-reported questionnaire to evaluate the patient's perception of the impact of psoriasis on quality of life. The DLQI was rated on a 4-point scale (0 = not at all to 3 = very much). The highest possible total score for the DLQI is 30 and higher scores indicate more severe impact on quality of life.
Date of first systemic treatment/ year
时间窗: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
To describe the PSO treatment history
Treatment pattern with secukinumab
时间窗: Baseline
Secukinumab therapy
Psoriasis Area and Sensitivity Index (PASI) score
时间窗: During 4 weeks pre-baseline
Psoriasis Area and Severity Index (PASI) is the most widely used tool for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease).
Number of patients with Reimbursement scheme
时间窗: Baseline
Reimbursement scheme information was reported.
Height
时间窗: During 3 months pre-baseline
Height information was reported.
Date of PsA diagnosis/year
时间窗: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
To describe the PSO treatment history
Gender
时间窗: Baseline
Gender information was reported.
Percentage of Body Surface Area (BSA) involvement
时间窗: During 4 weeks pre-baseline
Percentage of Body Surface Area (BSA) involvement was reported.
Duration of PsA diagnosis
时间窗: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
To describe the PSO treatment history
Medication use concomitant to index secukinumab prescription
时间窗: Baseline
Secukinumab therapy
Treatment duration since the first dosing till the most recent dosing
时间窗: Baseline
Secukinumab therapy
History of topical therapy
时间窗: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
To describe the PSO treatment history
History of systemic therapy
时间窗: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
To describe the PSO treatment history
Duration of biologic therapy
时间窗: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
To describe the PSO treatment history
History of biologic therapy
时间窗: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
To describe the PSO treatment history
Duration since the discontinuation of the latest biological agents
时间窗: Baseline
Secukinumab therapy
Duration of systemic therapy
时间窗: Approximately 2 years pre-baseline (PSO diagnosed date to index date, where index date is defined as date of initiation of treatment)
To describe the PSO treatment history
Number of patients with baseline PSO treatment
时间窗: During 12 months pre-baseline
Topical Therapies * Topical corticosteroid * Coal tar * Salicylic acid * Vitamin D analogues * Anthralin * Calcineurin inhibitors * Others Oral systemic therapies * Methotrexate * Acitretin * Retinoid * Cyclosporine * Azathioprine * Hydroxyurea * Leflunomide * Sulfasalazine * Others Biologic therapy * Infliximab * Etanercept * Ustekinumab * Brodalumab * Guselkumab * Ixekizumab * Others
次要结局
未报告次要终点