Impact of Secukinumab on Clinical and Patient Reported Outcomes in Patients With Psoriasis in a Real World Setting in the US (Bionaive Secukinumab Users NVS 521)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,518
- 试验地点
- 1
- 主要终点
- Gender
研究概览
简要总结
The study was conducted to describe the demographics, disease characteristics, disease severity, comorbidities and patient reported outcomes at baseline and follow-up periods among adult patients diagnosed with PsO in CorEvitas' PsO Registry under routine medical care initiating secukinumab (SEC).
详细描述
This is a retrospective analysis of a prospective observational cohort using CorEvitas' PsO registry of adult PsO patients. This study describes clinical and patient reported outcomes among adult patients initiating Secukinumab (SEC). Biologic experienced and naïve patients are examined separately. This study also describes changes in clinical and patient reported outcomes over time.
CorEvitas' Psoriasis Registry is a prospective, observational cohort of adult PsO patients starting systemic therapy, launched in April 2015 with sites in the US and Canada. Data collection occurs every ~6 months at routine dermatology visits. This study included US PsO patients who initiated secukinumab at or after enrollment and had a subsequent 6- and/or 12-month follow-up visit (Apr 2015 to Dec 2020).The index date is defined as the date of the first SEC initiation at or after enrollment.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must:
- •Have been diagnosed with PsO by a dermatologist.
- •Be at least 18 years of age.
- •Be willing and able to provide written informed consent for participation in the registry.
- •Have started on or switched to an eligible systemic PsO treatment at enrollment1 or within the previous 12 months of the date of enrollment.
排除标准
- •Patient is participating in or planning to participate in an interventional clinical trial with a nonmarketed or marketed investigational drug (i.e. phase I-IV drug trial).
研究组 & 干预措施
Secukinumab: Overall Cohort
Patients with Psoriasis who initiated Secukinumab
干预措施: Secukinumab (Drug)
结局指标
主要结局
Gender
时间窗: Baseline
Gender was reported to describe the sociodemographic characteristics of the patients.
Number of patients: Smoking history
时间窗: Baseline
Number of patients with Smoking history were reported to describe the sociodemographic characteristics of the patients.
Number of patients: Alcohol use history
时间窗: Baseline
Number of patients with Alcohol use history were reported to describe the sociodemographic characteristics of the patients.
Race
时间窗: Baseline
Race was reported to describe the sociodemographic characteristics of the patients.
Number of patients: CDC BMI categories
时间窗: Baseline
Number of patients with CDC BMI categories were reported to describe the sociodemographic characteristics of the patients.
Psoriatic arthritis duration
时间窗: Baseline
Psoriatic arthritis duration was reported to describe the Disease characteristics of the patients.
Number of patients: Any infection
时间窗: Baseline
Number of patients with any infection were reported to describe the disease characteristics of the patients.
Age
时间窗: Baseline
Age was reported to describe the sociodemographic characteristics of the patients.
Ethnicity
时间窗: Baseline
Ethnicity was reported to describe the sociodemographic characteristics of the patients.
Number of patients: Comorbid psoriatic arthritis (PsA)
时间窗: Baseline
Number of patients with Comorbid psoriatic arthritis (PsA) were reported to describe the disease characteristics of the patients.
Patient itch assessment (VAS: 0-100)
时间窗: Baseline
Patient itch assessment was reported to evaluate overall, how severe was the itch from psoriasis in the past week. The score ranged from 0 to 100, where negative change indicated that the score declined over time.
Patient fatigue assessment (VAS: 0-100)
时间窗: Baseline
Patient fatigue assessment was reported to evaluate overall, how severe was the fatigue from psoriasis in the past week. The score ranged from 0 to 100, where negative change indicated that the score declined over time.
Number of patients: Weight category
时间窗: Baseline
Number of patients with Weight category were reported to describe the sociodemographic characteristics of the patients.
Psoriasis duration
时间窗: Baseline
Psoriasis duration was reported to describe the Disease characteristics of the patients.
Number of patients: Morphology
时间窗: Baseline
Number of patients with Morphology were reported to describe the disease characteristics of the patients.
Number of patients: History of IBD
时间窗: Baseline
Number of patients with History of IBD were reported to describe the disease characteristics of the patients.
Body weight
时间窗: Baseline
Body weight was reported to describe the sociodemographic characteristics of the patients.
Number of patients: Insurance type
时间窗: Baseline
Number of patients with Insurance type were reported to describe the sociodemographic characteristics of the patients.
Number of patients: DLQI: Effect on life
时间窗: Baseline
The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Patient global assessment (PGA)
时间窗: Baseline
The PGA scoring system is based on response to treatment as measured by lesion erythema, induration, and scale, with score assignments that range from clear, almost clear, mild, moderate, to severe.
Patient health state today (EQ-5D VAS: 0-100)
时间窗: Baseline
Questions: Given questions in the following 5 dimensions: (a) mobility, (b) self-care, (c) usual activities, (d) pain/discomfort and (e) anxiety/depression. With each dimension scored in 3 levels: 1 = {(a)-(c) =No problems, (d)=No pain, (e)=Not anxious or depressed}; 2 = {(a)-(c) = Some problems, (d) = Moderate pain or discomfort, (e ) = Moderately anxious or depressed}; 3={(a) = Confined to bed, (b)-(c)= Unable to do, (d) = Extreme pain or discomfort, (e) = Extremely anxious or depressed} With each dimension scored in 5 levels: 1 = No problems, 2 = Slight problems, 3 = Moderate problems, 4 = Severe problems, 5 = Extreme problems.
BSA (% involvement)
时间窗: Baseline
BSA (% involvement) was reported to describe the PsO Specific Measures of the patients.
Number of patients: Investigator Global Assessment
时间窗: Baseline
Number of patients with Investigator Global Assessment were reported to describe the PsO Specific Measures of the patients.
Number of patients: PEST Score
时间窗: Baseline
Number of patients with PEST Score were reported to describe the PsO Specific Measures of the patients.
Number of patients: Primary reason for SEC initiation
时间窗: Baseline
Number of patients with Primary reason for SEC initiation
Number of patients: Self-care problems
时间窗: Baseline
Included the following: No problems, some problems, unable
PASI (Score: 0-72)
时间窗: Baseline
PASI (Score: 0-72) was reported to describe the PsO Specific Measures of the patients.
Number of patients: Provider region (US Census Bureau)
时间窗: Baseline
Number of patients with Provider region (US Census Bureau) were reported to describe the sociodemographic characteristics of the patients.
Age at onset of PsO symptoms
时间窗: Baseline
Age at onset of PsO symptoms was reported to describe the Disease characteristics of the patients.
Number of patients: History of comorbidities/toxicities
时间窗: Baseline
Number of patients with History of comorbidities/toxicities were reported to describe the disease characteristics of the patients.
Dermatology Life Quality Index (DLQI) (Score: 0-30)
时间窗: Baseline
The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Number of patients: Mobility problems
时间窗: Baseline
Included the following: No problems, some problems, confined to bed
Number of patients: Usual activities problems
时间窗: Baseline
Included the following: No problems
Number of patients: Work Productivity and Activity Impairment Questionnaire (WPAI) (0 to 100%)
时间窗: Baseline
Questions:1 = Currently employed? 2 = Hours missed due to psoriasis? 3 = Hours missed other reasons? 4 = Hours actually worked? 5 = Degree problem affected productivity while working (VAS (0 to 100) measurement)? 6 = Degree problem affected regular activities (VAS (0 to 100) measurement)? Scores: Multiply scores by 100 to express in percentages for reported categories: Percent work time missed due to problem: Q2/(Q2+Q4) Percent impairment while working due to problem: Q5/10 Percent overall work impairment due to problem: Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4)))x(Q5/10)\] Percent activity impairment due to problem: Q6/10
Number of patients: Therapies - Prior and Concomitant Drugs
时间窗: Baseline
Included the following: Unique prior biologic count Prior biologic exposures Unique prior non-biologic count Prior non-biologic exposures Nonbiologic naïve Current or prior topical use Concomitant non-biologic systemics
Number of patients: Some problems
时间窗: Baseline
Included the following: Unable
Number of patients: BSA categorical
时间窗: Baseline
Number of patients with BSA categorical were reported to describe the PsO Specific Measures of the patients.
Patient skin pain assessment (VAS: 0-100)
时间窗: Baseline
Patient skin pain assessment was reported to evaluate overall, how severe was the skin pain from psoriasis in the past week. The score ranged from 0 to 100, where negative change indicated that the score declined over time.
Number of patients: Pain or discomfort
时间窗: Baseline
Included the following: None, moderate and extreme
次要结局
- Change from baseline in DLQI (Score: 0-30)(Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020))
- Change from baseline in WPAI summary scores(Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020))
- Change from baseline in Patient global assessment(Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020))
- Change from baseline in Patient skin pain assessment (VAS: 0-100)(Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020))
- Change from baseline in PASI (Score: 0-72)(Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020))
- Change from baseline in Investigator Global Assessment (IGA)(Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020))
- Change from baseline in BSA (% involvement)(Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020))
- Change from baseline in Patient health state today (EQ-5D VAS: 0-100)(Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020))
- Change from baseline in Patient itch assessment (VAS: 0-100)(Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020))
- Change from baseline in Patient fatigue assessment (VAS: 0-100)(Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020))