Alopecia Areata
Conditions
Brief summary
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.
Interventions
DRUGritlecitinib
As provided in real world practice
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient demographics and characteristics: race | Baseline | number of AA patients prescribed ritlecitinib in the real-world in the US |
| Patient demographics and characteristics: age at index date | Baseline | Number of percentages of patients by age at index date |
| Patient demographics and characteristics: sex | Baseline | Number of percentages of patients by sex |
| Patient demographics and characteristics: ethnicity | Baseline | Number of percentages of patients by ethnicity |
| Patient pre-index clinical characteristic: AA duration of disease | Baseline | — |
| Patient clinical characteristic: AA body locations | Baseline | — |
| Patient clinical characteristics and outcome: Physician assessment | Baseline through 144 weeks | — |
| Patient clinical characteristics: progressors | Baseline | Among those with a PA assessment in the 45 days before index, yes = those with an assessment consistent with worsening AA; no = those with an assessment consistent with a stable or improving AA assessment. |
| Patient clinical characteristics: comorbidities | Baseline | — |
| Patient clinical characteristics: JAKi exposure | Baseline | Any prescribed JAKi inhibitor before index date. |
| Patient clinical characteristics: Standard of care treatments | Baseline through 144 weeks | Pre-index and concomitant standard of care treatments other than ritlecitinib |
| Patient Outcome Measure: Ritlecitinib persistence | Week 24; week 48; week 72; week 96; week 120; week 144 | Among those with ≥ 183 days of continuous enrollment post-index date. Continuous: number of ritlecitinib days' supply (will be reported as months where 30.4 days = 1 month; months range = \~0.5 to \~36) up to the earliest of: a gap of 90+ days in ritlecitinib days' supply; end of continuous enrollment (a gap in enrollment lasting ≥ 45 days); last day of data availability. |
| Patient Outcome Measure: Ritlecitinib adherence | Week 24; week 48; week 72; week 96; week 120; week 144 | Among those with ≥ 183 days of continuous enrollment post-index date. |
| Patient Outcome Measure: Augmenting ritlecitinib with concomitant treatment | Week 24; week 48; week 72; week 96; week 120; week 144 | Among those with ≥ 183 days of continuous enrollment post-index date. Binary for each SOC treatment class in each follow-up window: yes/no. |
| Patient Outcome Measure: Treatment switching | Week 24; week 48; week 72; week 96; week 120; week 144 | Among those with ≥ 183 days of continuous enrollment post-index date. Binary for each SOC treatment class, and for the JAKi treatment class, in each follow-up window: yes/no. |
Contacts
CONTACTPfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed