Reprinted from Reguiai Z, et al. [submitted for publication] 2024. Creative Commons Attribution 4.0 International License
Study Design
This post hoc analysis includes patients who received ritlecitinib 50 mg QD (without a loading dose) in the ALLEGRO-2b/3 study and who subsequently continued in the ALLEGRO-LT study where they continued to receive ritlecitinib 50 mg QD. Continuation criteria for adolescents (aged 12–17 years) in ALLEGRO-LT required patients to have at least a 50% improvement from baseline in SALT score by Month 3 and SALT score ≤20 by Month 6 in ALLEGRO-LT. Patients who received placebo and switched to ritlecitinib 50 mg were re-baselined to align time points across groups.
This analysis describes SALT score distribution changes over 24 months of ritlecitinib treatment.
The distribution of patients according to SALT score (as observed) was assessed through Month 24 for the overall population and subgroups based on age (adults [≥18 years] vs adolescents [12–17 years]) and disease severity (patients with AT/AU vs those without AT/AU).
The data cutoff date was December 9, 2022.
AT, alopecia totalis; AU, alopecia universalis; LT, long-term; QD, once daily; SALT, Severity of Alopecia Tool.
Reguiai Z, et al. Presented at: EADV, September 25–28, 2024. Presentation P2139.
Baseline Characteristics
The analysis included 191 patients: 27 adolescents and 164 adults.
At the time of data cutoff, 71 patients had discontinued; withdrawal by patient (n=19), AEs (n=18), and lack of efficacy (n=14) were the most common reasons for discontinuation.
Baseline Demographic and Disease Characteristics in Patients Treated With Ritlecitinib 50 mg QD
| Ritlecitinib 50 mg QD (N=191) |
|
|---|---|
| Age, mean (SD), years | 33.2 (14.4) |
| 12–17 years, n (%) | 27 (14.1) |
| ≥18 years, n (%) | 164 (85.9) |
| Female, n (%) | 107 (56.0) |
| White, n (%) | 123 (64.4) |
| BMI, mean (SD), kg/m2 | 24.9 (5.8) |
| AT,a n (%) | 37 (19.4) |
| AU,a n (%) | 41 (21.5) |
| Mean baseline SALT score (SD) | 90.8 (14.1) |
| Baseline SALT score ≥50, n (%) | 191 (100) |
| Abnormal EBA score at baseline,b n (%) | 154 (80.6) |
| Abnormal ELA score at baseline,b n (%) | 139 (72.8) |
| Duration of AA since diagnosis, mean (SD), years | 9.8 (10.5) |
| Duration of current AA episode, mean (SD), years | 3.3 (2.8) |
| Duration of significant (<50%) scalp hair loss, mean (SD), years | 2.8 (2.7) |
| Prior pharmacological treatment for AA, n (%) | 145 (75.9) |
| Comorbid conditions, n (%) | |
| Asthma | 22 (11.5) |
| Autoimmune thyroiditis | 11 (5.8) |
| Atopic dermatitis | 31 (16.2) |
| Allergic rhinitis | 20 (10.5) |
aPatients in the AT and AU categories had a SALT score of 100 (complete scalp hair loss) at baseline and a clinical diagnosis of AT or AU by the investigator.
bPatients with abnormal EBA or ELA scores had a score of 0 to 2 (no eyebrows/eyelashes to moderate eyebrows/eyelashes).
AA, alopecia areata; AE, adverse event; AT, alopecia totalis; AU, alopecia universalis; BMI, body mass index; EBA, eyebrow assessment; ELA, eyelash assessment; QD, once daily; SALT, Severity of Alopecia Tool; SD, standard deviation.
Reguiai Z, et al. Presented at: EADV, September 25–28, 2024. Presentation P2139.
aThe current analysis includes patients who received ritlecitinib 50 mg QD without a loading dose in ALLEGRO-2b/3 and who subsequently rolled-over into ALLEGRO-LT where they continued to receive ritlecitinib 50 mg QD.
bThe AT/AU category is defined by a baseline SALT score of 100, and the non-AT/AU category is defined by a baseline SALT score of <100.
cAdolescents were aged 12–17 years at baseline.
AA, alopecia areata; AT, alopecia totalis; AU, alopecia universalis; LT, long-term; QD, once daily; SALT, Severity of Alopecia Tool.