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.
Eligibility
Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria
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.
1.1. ≥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 1.2. Age ≥12 years on the index date. Exclusion Criteria
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.
Primary outcome measure(s)
Patient Outcome Measure: Counts and proportions of study participants in each SALT score category — Baseline Overall and for each stratifying variable.
Patient Outcome Measure: Change and mean percentage change in SALT scores from baseline — 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, — 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, — 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, — 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, — Week 24; week 48; week 72; week 96; week 120; week 144
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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