Utilization and Effectiveness of Ritlecitinib in a Real-World Population With Severe AA in the US
- Registration Number
- NCT07226531
- Lead Sponsor
- Pfizer
- Brief Summary
Alopecia areata (AA) is a chronic, relapsing T-cell mediated autoimmune disease characterized by nonscarring, typically patchy hair loss that affects people of all ages, races, and genders. In the United States (US), AA has an estimated point prevalence of 1.14% (Beningo et al., 2020). The three most common subtypes of AA are defined by the affected area:
* Patchy alopecia (PA), as seen in 90% of clinical diagnoses: hair loss occurring in one or more patches (ranging from coin-sized to large patches and even full scalp involvement) on the scalp or other parts of the body;
* Alopecia totalis (AT): loss of all or nearly all scalp hair;
* Alopecia universalis (AU): loss of all or nearly all scalp, face, and body hair Traditionally, a range of medications, including corticosteroids, immunotherapy, and minoxidil, are used to treat AA. However, few of these mainstay therapies are supported by robust clinical evidence, limiting the development of widely accepted clinical practice guidelines (Asfour et al., 2023). As a result of suboptimal effectiveness of traditional therapies, patients with AA, particularly those with extensive hair loss, have a persistent unmet medical need. Furthermore, the potential effects of AA on other subgroups, including patients with skin of color, remain undefined. As these subgroups have been historically underrepresented in clinical trials, an additional unmet medical need and evidence gap exists for these patients.
Recent clinical studies have demonstrated efficacy of novel treatments for AA, including ritlecitinib, a JAK3/TEC family kinase inhibitor developed and marketed by Pfizer (King et al., 2023). Ritlecitinib was approved by the US Food and Drug Administration (FDA) in June 2023 for the treatment of severe AA in adults and adolescents aged 12 years or older. Extensive information from clinical trials exists on the safety and efficacy of ritlecitinib, which, along with JAK inhibitors such as baricitinib and deuruxolitinib that are FDA approved for severe alopecia areas in adults 18 and over, have presented needed new therapeutic options for these patients. However, little is known about the clinical effectiveness of ritlecitinib in real-world clinical practice.
The objective of the current study is to evaluate patient characteristics, treatment patterns and related clinical outcomes of patients who initiated ritlecitinib to treat severe AA.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Alopecia areata (AA) patients treated with ritlecitinib Ritlecitinib -
- Primary Outcome Measures
Name Time Method Patient demographics characteristics: race Baseline Number of percentages of patients by race
Patient demographics characteristics: sex, age at initial AA diagnosis, geographic location of patient's treating dermatologist, insurance type "Baseline" or "Day 1" Number of percentages of patients by sex
Patient demographics characteristics: age at initial AA diagnosis "Baseline" or "Day 1" Number of percentages of patients by age at initial AA diagnosis
Patient demographics characteristics: geographic location of patient's treating dermatologist "Baseline" or "Day 1" Number of percentages of patients by geographic location of patient's treating dermatologist
Patient demographics characteristics: insurance type "Baseline" or "Day 1" Number of percentages of patients by insurance type
Patient clinical characteristics at initial AA diagnosis: AA disease activity "Baseline" or "Day 1" Number of percentages of Patient clinical characteristics at initial AA diagnosis: AA disease activity
Patient clinical characteristics at initial AA diagnosis: SALT score "Baseline" or "Day 1" Number of percentages of Patient clinical characteristics at initial AA diagnosis: SALT score
Patient clinical characteristics at initial AA diagnosis: dermatology life quality index (DLQI) score "Baseline" or "Day 1" Number of percentages of Patient clinical characteristics at initial AA diagnosis: dermatology life quality index (DLQI) score
Patient clinical characteristics at initial AA diagnosis: eyebrow involvement "Baseline" or "Day 1" Number of percentages of Patient clinical characteristics at initial AA diagnosis: eyebrow involvement
Patient clinical characteristics at initial AA diagnosis: eyelash involvement "Baseline" or "Day 1" Number of percentages of Patient clinical characteristics at initial AA diagnosis: eyelash involvement
Patient clinical characteristics at initial AA diagnosis: beard involvement "Baseline" or "Day 1" Number of percentages of Patient clinical characteristics at initial AA diagnosis: beard involvement
Patient clinical characteristics at initial AA diagnosis: AA involvement at other body locations "Baseline" or "Day 1" Number of percentages of Patient clinical characteristics at initial AA diagnosis: AA involvement at other body locations
Patient treatment history: Additional treatment classes received during ritlecitinib treatment, additional treatment classes received after discontinuation of ritlecitinib, duration of each treatment class "Day 1 through study completion, a minimum of 6-months follow-up" Characteristics of ritlecitinib treatment: Total duration of ritlecitinib exposure, reasons for ritlecitinib discontinuation (if ritlecitinib treatment stopped before last known clinic visit), "Day 1 through study completion, a minimum of 6-months follow-up" Real-world clinical outcomes of ritlecitinib treatment: AA disease activity "Day 1 through study completion, a minimum of 6-months follow-up" AA disease activity reported as active hair loss or inactive hair loss
Real-world clinical outcomes of ritlecitinib treatment: SALT score overall change from baseline "Day 1 through study completion, a minimum of 6-months follow-up" SALT score overall change from baseline (i.e., to last observed clinic visit), as well as change from baseline to predefined post-index time points (6-, 12-, 18-, and 24-months post-index, or other relevant timepoints based on actual distribution of data). Numeric and Categorical Data: no reduction from baseline, \>0%-≤25% SALT reduction, \>25%-≤50% SALT reduction, \>50%-≤75% SALT reduction, \>75% SALT reduction; Yes/No indicator for ≥30% SALT reduction; other categories/thresholds may also be applied.
Real-world clinical outcomes of ritlecitinib treatment: SALT score "Day 1 through study completion, a minimum of 6-months follow-up" Numeric data, with categorical values of \<50. 50-75, 75-100, and additional categories for ≥50 (to define severe AA) and 95-100 (to defined very severe AA); alternative categories may also be applied.
Real-world clinical outcomes of ritlecitinib treatment: landmark probabilities of achieving SALT ≤20 and ≤10 "Day 1 through study completion, a minimum of 6-months follow-up" Landmark probabilities of achieving SALT≤20 and SALT≤10 at 6-, 12-, 18-, and 24-months post-index date, or other relevant timepoints based on actual distribution of data.
Real-world clinical outcomes of ritlecitinib treatment: landmark probabilities of achieving a sustained SALT response "Day 1 through study completion, a minimum of 6-months follow-up" Landmark probabilities of achieving a sustained SALT response at 6-, 12-, 18-, and 24-months post-index date, or other relevant timepoints based on actual distribution of data
Real-world clinical outcomes of ritlecitinib treatment: landmark probabilities of achieving ≥30% SALT score reduction from baseline at 6-, 12-, 18-, and 24-months post-index date "Day 1 through study completion, a minimum of 6-months follow-up" Real-world clinical outcomes of ritlecitinib treatment: beard involvement "Day 1 through study completion, a minimum of 6-months follow-up" Categorical; none; minimal bear hair loss; moderate beard hair loss; severe beard hair loss; very severe or complete beard hair loss
Real-world clinical outcomes of ritlecitinib treatment: eyebrow and eyelash involvement "Day 1 through study completion, a minimum of 6-months follow-up" Categorical data with values of 0 (no involvement), 1 (minimal gaps), 2 (significant gaps), or 3 (complete loss)
Real-world clinical outcomes of ritlecitinib treatment: AA involvement at other body locations "Day 1 through study completion, a minimum of 6-months follow-up" Yes/no indicator for involvement at each of the following body sites: Extremities (arms, hands, legs, feet); Torso (chest, back, stomach); Pubic areas; Nasal hair; Nails
Real-world clinical outcomes of ritlecitinib treatment: DLQI score "Day 1 through study completion, a minimum of 6-months follow-up" Real-world clinical outcomes of ritlecitinib treatment: Patient report of feeling embarrassed or self-conscious because of AA "Day 1 through study completion, a minimum of 6-months follow-up" Yes; no; as documented by the physician at each clinic visit in the post-index date period
Real-world clinical outcomes of ritlecitinib treatment: DLQI score overall change from baseline "Day 1 through study completion, a minimum of 6-months follow-up" Real-world clinical outcomes of ritlecitinib treatment: patient report of AA affecting social or leisure activities "Day 1 through study completion, a minimum of 6-months follow-up" Yes; no; as documented by the physician at each clinic visit in the post-index date period
Real-world clinical outcomes of ritlecitinib treatment: mental health comorbidities present at last known clinic visit "Day 1 through study completion, a minimum of 6-months follow-up" Yes; No; indicators for presence of specific psychiatric disorders examined in a prior systematic literature review by Lee et al. (2019)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pfizer, Inc
🇺🇸New York, New York, United States
Pfizer, Inc🇺🇸New York, New York, United States