Utilization and Effectiveness of Ritlecitinib in a Real-World Population With Severe AA in the US

RETROSPECTIVE COHORT STUDY TO ASSESS UTILIZATION AND EFFECTIVENESS OF RITLECITINIB IN A REAL-WORLD POPULATION WITH SEVERE ALOPECIA AREATA IN THE UNITED STATES

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: Ritlecitinib

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10001
      • Pfizer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will include patients with severe AA who initiated ritlecitinib (for treatment of severe AA) at least 6 months before the start of data collection. The study assumes that treatment with ritlecitinib was per label, as indicated for severe AA among patients at least 12 years of age. Data collection will be led by physicians (or their designated clinical assistants and staff, including nurse practitioners and physician assistants) recruited to the study who specialize in dermatology and are experienced in managing patients with AA.

Description

Inclusion criteria:

1. Confirmed diagnosis of severe AA (as determined by the treating physician)
2. Initiated ritlecitinib for severe AA between 01 July 2023 and 28 February 2025
3. At least 12 years of age at ritlecitinib initiation
4. Has at least one additional follow-up visit/consultation after ritlecitinib initiation in which scalp hair loss was assessed
5. Has a complete medical record regarding management or treatment of AA, covering the period initial AA diagnosis until their most recent follow-up/consultation

Exclusion criteria:

1. Ever diagnosed with other types of alopecia (i.e., e.g., chemotherapy-induced alopecia, androgenic alopecia [i.e., male pattern baldness], cicatricial alopecia [i.e., scarring alopecia], postpartum alopecia, or traction alopecia), other diseases (besides AA) that can cause hair loss, or other diseases that could interfere with assessment of hair loss/regrowth
2. No documentation in the medical record of percent of scalp hair loss
3. Participated in any clinical trial involving treatment with ritlecitinib, baricitinib, deuruxolitinib, delgocitinib, brepocitinib, or upadacitinib

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Alopecia areata (AA) patients treated with ritlecitinib	Drug: Ritlecitinib; As provided in real-world practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient demographics characteristics: race	Number of percentages of patients by race	Baseline
Patient demographics characteristics: sex, age at initial AA diagnosis, geographic location of patient's treating dermatologist, insurance type	Number of percentages of patients by sex	"Baseline" or "Day 1"
Patient demographics characteristics: age at initial AA diagnosis	Number of percentages of patients by age at initial AA diagnosis	"Baseline" or "Day 1"
Patient demographics characteristics: geographic location of patient's treating dermatologist	Number of percentages of patients by geographic location of patient's treating dermatologist	"Baseline" or "Day 1"
Patient demographics characteristics: insurance type	Number of percentages of patients by insurance type	"Baseline" or "Day 1"
Patient clinical characteristics at initial AA diagnosis: AA disease activity	Number of percentages of Patient clinical characteristics at initial AA diagnosis: AA disease activity	"Baseline" or "Day 1"
Patient clinical characteristics at initial AA diagnosis: SALT score	Number of percentages of Patient clinical characteristics at initial AA diagnosis: SALT score	"Baseline" or "Day 1"
Patient clinical characteristics at initial AA diagnosis: dermatology life quality index (DLQI) score	Number of percentages of Patient clinical characteristics at initial AA diagnosis: dermatology life quality index (DLQI) score	"Baseline" or "Day 1"
Patient clinical characteristics at initial AA diagnosis: eyebrow involvement	Number of percentages of Patient clinical characteristics at initial AA diagnosis: eyebrow involvement	"Baseline" or "Day 1"
Patient clinical characteristics at initial AA diagnosis: eyelash involvement	Number of percentages of Patient clinical characteristics at initial AA diagnosis: eyelash involvement	"Baseline" or "Day 1"
Patient clinical characteristics at initial AA diagnosis: beard involvement	Number of percentages of Patient clinical characteristics at initial AA diagnosis: beard involvement	"Baseline" or "Day 1"
Patient clinical characteristics at initial AA diagnosis: AA involvement at other body locations	Number of percentages of Patient clinical characteristics at initial AA diagnosis: AA involvement at other body locations	"Baseline" or "Day 1"
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	AA disease activity reported as active hair loss or inactive hair loss	"Day 1 through study completion, a minimum of 6-months follow-up"
Real-world clinical outcomes of ritlecitinib treatment: SALT score overall change from baseline	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.	"Day 1 through study completion, a minimum of 6-months follow-up"
Real-world clinical outcomes of ritlecitinib treatment: SALT score	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.	"Day 1 through study completion, a minimum of 6-months follow-up"
Real-world clinical outcomes of ritlecitinib treatment: landmark probabilities of achieving SALT ≤20 and ≤10	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.	"Day 1 through study completion, a minimum of 6-months follow-up"
Real-world clinical outcomes of ritlecitinib treatment: landmark probabilities of achieving a sustained SALT response	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	"Day 1 through study completion, a minimum of 6-months follow-up"
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	Categorical; none; minimal bear hair loss; moderate beard hair loss; severe beard hair loss; very severe or complete beard hair loss	"Day 1 through study completion, a minimum of 6-months follow-up"
Real-world clinical outcomes of ritlecitinib treatment: eyebrow and eyelash involvement	Categorical data with values of 0 (no involvement), 1 (minimal gaps), 2 (significant gaps), or 3 (complete loss)	"Day 1 through study completion, a minimum of 6-months follow-up"
Real-world clinical outcomes of ritlecitinib treatment: AA involvement at other body locations	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	"Day 1 through study completion, a minimum of 6-months follow-up"
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	Yes; no; as documented by the physician at each clinic visit in the post-index date period	"Day 1 through study completion, a minimum of 6-months follow-up"
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	Yes; no; as documented by the physician at each clinic visit in the post-index date period	"Day 1 through study completion, a minimum of 6-months follow-up"
Real-world clinical outcomes of ritlecitinib treatment: mental health comorbidities present at last known clinic visit	Yes; No; indicators for presence of specific psychiatric disorders examined in a prior systematic literature review by Lee et al. (2019)	"Day 1 through study completion, a minimum of 6-months follow-up"

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2025
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): May 29, 2026

Study Registration Dates

• First Submitted: September 22, 2025
• First Submitted That Met QC Criteria: November 5, 2025
• First Posted (Actual): November 10, 2025

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Alopecia; Hypotrichosis; Hair Diseases; Skin and Connective Tissue Diseases; Alopecia Areata
• Other Study ID Numbers: B7981121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.