REAL-WORLD EFFECTIVENESS OF RITLECITINIB IN ALOPECIA AREATA PATIENTS IN THE US: A RETROSPECTIVE ANALYSIS USING EHR AND CLAIMS DATA
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Pfizer
- 入组人数
- 7,500
- 主要终点
- Patient Outcome Measure: Counts and proportions of study participants in each SALT score category
研究概览
简要总结
This study will use US electronic health records (EHR) linked to US healthcare claims data to describe the baseline demographic and clinical characteristics of AA patients prescribed ritlecitinib; assess its real-world effectiveness based on dermatologist-recorded outcomes; and evaluate ritlecitinib treatment patterns and concomitant use of SOC (Standard of care) medications among patients aged 12 years and older.
Data Management All study data exist as structured data by the time of study. ModMed structured EHR data will be delivered to HealthVerity. HealthVerity will then normalize the data to comply with HealthVerity's HIPAA Certification and Expert Determination. HealthVerity will then deliver the transformed ModMed data to the sponsor's de-identified environment. HealthVerity also will deliver structured claims data to the sponsor's de-identified environment. The sponsor will then link the claims data with the transformed ModMed data. The sponsor will conduct data analyses using SAS (SAS Institute, Cary, NC, US) or R (The R Foundation for Statistical Computing, Vienna, Austria). Versions of packages will be documented to assure reproducibility. Analyses will extract data according to all details in the study design, e.g., inclusion and exclusion criteria.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- •1. ≥1 ritlecitinib prescription fill after 23 June 2023; the date of the first prescription fill is the index date, provided criterion 2 below is satisfied.
- •≥1 ModMed AA diagnosis on or within 365 days before the index date, identified using diagnosis-related variables (defined in the SAP) as well as any of the following ICD-10-CM codes:
- •L63.0: alopecia (capitis) totalis
- •L63.1: alopecia universalis
- •L63.2: ophiasis
- •L63.8: other alopecia areata
- •L63.9: alopecia areata, unspecified 1.
- •Age ≥12 years on the index date.
排除标准
- •Patients meeting any of the following criteria will not be included in the study:
- •1. ≥ 2 of the same diagnoses in the data source of other types of alopecia or diseases that can cause hair loss (e.g., androgenetic alopecia, traction and scarring alopecia, telogen effluvium) in the 365 days before the index date.
研究组 & 干预措施
Ritlecitinib Arm
All included participants must have: a physician-confirmed AA diagnosis, a ritlecitinib prescription fill (the first of which must occur after the date of an AA diagnosis; this first prescription fill date serves as the index date), and be at least 12 years old on the index date. Participants will be followed from the index date until the earliest of: the end of continuous health plan enrollment (defined as the day before a gap of ≥ 45 days in enrollment), or the date of the last available data in the linked dataset. The index date must occur after 23 June 2023.
干预措施: ritlecitinib (Drug)
结局指标
主要结局
Patient Outcome Measure: Counts and proportions of study participants in each SALT score category
时间窗: Baseline
Overall and for each stratifying variable.
Patient Outcome Measure: Change and mean percentage change in SALT scores from baseline
时间窗: Week 24; week 48; week 72; week 96; week 120; week 144
Overall and for each stratifying variable.
Patient Outcome Measure: Percentage of patients with SALT scores >20 at baseline who first achieve SALT scores of ≤20,
时间窗: Week 24; week 48; week 72; week 96; week 120; week 144
Patient Outcome Measure: Percentage of patients with SALT scores >20 at baseline who first achieve SALT scores of ≤10,
时间窗: Week 24; week 48; week 72; week 96; week 120; week 144
Patient Outcome Measure: Percentage of patients with SALT scores >20 at baseline who first achieve SALT scores of ≤5,
时间窗: Week 24; week 48; week 72; week 96; week 120; week 144
Patient Outcome Measure: Percentage of patients with SALT scores >20 at baseline who first achieve SALT scores of 0,
时间窗: Week 24; week 48; week 72; week 96; week 120; week 144
次要结局
- Patient clinical characteristics and outcome: Physician assessment(Baseline through 144 weeks)
- Patient demographics and characteristics: race(Baseline)
- Patient demographics and characteristics: age at index date(Baseline)
- Patient demographics and characteristics: sex(Baseline)
- Patient demographics and characteristics: ethnicity(Baseline)
- Patient pre-index clinical characteristic: AA duration of disease(Baseline)
- Patient clinical characteristic: AA body locations(Baseline)
- Patient clinical characteristics: progressors(Baseline)
- Patient clinical characteristics: comorbidities(Baseline)
- Patient clinical characteristics: JAKi exposure(Baseline)
- Patient clinical characteristics: Standard of care treatments(Baseline through 144 weeks)
- Patient Outcome Measure: Ritlecitinib persistence(Week 24; week 48; week 72; week 96; week 120; week 144)
- Patient Outcome Measure: Ritlecitinib adherence(Week 24; week 48; week 72; week 96; week 120; week 144)
- Patient Outcome Measure: Augmenting ritlecitinib with concomitant treatment(Week 24; week 48; week 72; week 96; week 120; week 144)
- Patient Outcome Measure: Treatment switching(Week 24; week 48; week 72; week 96; week 120; week 144)