Characteristics, Treatment Patterns, and Treatment Satisfaction Among Psoriasis Patients Treated With Cosentyx (Secukinumab)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17,743
- 试验地点
- 1
- 主要终点
- Treatment satisfaction level at 6 months post-index
研究概览
简要总结
This was a retrospective cohort study utilizing data from Modernizing Medicine Data Services' (MMDS) electronic medical records (EMR)-based dermatology database to evaluate secukinumab patient characteristics, treatment patterns, and outcomes.
详细描述
This was a retrospective cohort study utilizing data from Modernizing Medicine Data Services' (MMDS) electronic medical records (EMR)-based dermatology database to evaluate secukinumab patient characteristics, treatment patterns, and outcomes. Psoriasis (PsO) patients initiating secukinumab were identified and indexed to the first secukinumab use using the most recent data at study initiation (data period: March 1, 2018 to August 31, 2019) and with a subsequent data refresh (data period: March 1, 2017 - July 31, 2020).
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
- •≥1 orders/administrations for secukinumab within the index window (March 1, 2018 to August 31,2019 for the base analysis; March 1, 2018 to January 31, 2020 for the refresh analysis). The date of the first order or administration was be the index date
- •Patients in the MMDS database with a diagnosis of PsO on or prior to the 1st secukinumab order/administration
- •≥18 years of age as of the index date
- •To ensure capturing continuous patient activities in the EMR dataset, patients must have at least one more visit (any visit regardless of diagnosis) in addition to the index visit within the first 6 months after secukinumab initiation
- •Patients must have at least one visit (any visit regardless of diagnosis) within the 12 months pre-index period
排除标准
- •Evidence of secukinumab use in the 12-month pre-index period
- •Data quality issues (missing age, gender, prescription order information)
研究组 & 干预措施
Overall cohort: Secukinumab
Included all the patients treated with secukinumab
干预措施: Secukinumab (Drug)
Bio-naive
Included PsO patients initiating treatment with secukinumab. Bio-naïve was defined as no observed treatment (i.e., injection, prescription or patient reported history) with any of the following biologic drugs of interest anytime pre-index: secukinumab, certolizumab, etanercept, adalimumab, infliximab, golimumab, ustekinumab, ixekizumab, brodalumab, abatacept, and guselkumab and risankizumab during all available history
干预措施: Secukinumab (Drug)
Bio-experienced
Included PsO patients initiating treatment with secukinumab. Patients had pre-index use of one or more of the biologic drugs of interest during all available history
干预措施: Secukinumab (Drug)
Systemic-naive
Included PsO patients initiating treatment with secukinumab. Systemic-naïve was defined as no observed treatment (i.e., injection, prescription or patient reported history) with any of the biologic treatments or with any of the following systemic (i.e., oral or injectable - no topical forms) drugs of interest pre-index: methotrexate, corticosteroids, acitretin or apremilast.
干预措施: Secukinumab (Drug)
Systemic-experienced
Included PsO patients initiating treatment with secukinumab. Systemic-experienced patients had pre-index use of one or more of the systemic drugs of interest.
干预措施: Secukinumab (Drug)
结局指标
主要结局
Treatment satisfaction level at 6 months post-index
时间窗: 6 months after initiating treatment with secukinumab (The date of the first order or administration was the index date; index period: March 1, 2018 - January 31, 2020)
Patient reported satisfaction with treatment effectiveness was captured on a 5-point scale - "I believe this treatment is effective in clearing my skin of psoriasis." (1 = strongly agree, 2 = somewhat agree, 3 = Neither agree nor disagree, 4 = Somewhat disagree, 5 = Strongly disagree; n, %) in the EMR data system. For this analysis, the responses were classified into three groups: 1. Satisfied with treatment effectiveness (1 = strongly agree, 2 = somewhat agree) 2. Dissatisfied with treatment effectiveness ( 4 = Somewhat disagree, 5 = Strongly disagree) 3. Neither satisfied nor dissatisfied with treatment effectiveness (3 = Neither agree nor disagree)
Treatment satisfaction level at Baseline
时间窗: Baseline
Patient reported satisfaction with treatment effectiveness was captured on a 5-point scale - "I believe this treatment is effective in clearing my skin of psoriasis." (1 = strongly agree, 2 = somewhat agree, 3 = Neither agree nor disagree, 4 = Somewhat disagree, 5 = Strongly disagree; n, %) in the EMR data system. For this analysis, the responses were classified into three groups: 1. Satisfied with treatment effectiveness (1 = strongly agree, 2 = somewhat agree) 2. Dissatisfied with treatment effectiveness ( 4 = Somewhat disagree, 5 = Strongly disagree) 3. Neither satisfied nor dissatisfied with treatment effectiveness (3 = Neither agree nor disagree)
次要结局
- Number of patients at various regions(Baseline (March 1, 2017 - March 1, 2018))
- Weight(Baseline (March 1, 2017 - March 1, 2018))
- Number of patients at Index year(Study Period: March 1, 2017 - July 31, 2020)
- Comorbidities of interest(Baseline (March 1, 2017 - March 1, 2018))
- Age(Baseline (March 1, 2017 - March 1, 2018))
- Gender(Baseline (March 1, 2017 - March 1, 2018))
- Number of patients with plaque psoriasis subtype(Baseline (March 1, 2017 - March 1, 2018))
- Number of patients with different race(Baseline (March 1, 2017 - March 1, 2018))
- Number of patients with Plaque location(Baseline (March 1, 2017 - March 1, 2018))
- Physician global assessment (PGA)(Baseline and 6 months post index including index date (The date of the first order or administration was the index date; index period: March 1, 2018 - January 31, 2020))
- Total body surface area (TBSA)(Baseline and 6 months post index including index date (The date of the first order or administration was the index date; index period: March 1, 2018 - January 31, 2020))
- Psoriasis-related therapy(6 months post index including index date (The date of the first order or administration was the index date; index period: March 1, 2018 - January 31, 2020))