King B, et al. J Eur AcadDermatol Venereol. 2025. [In press, doi: 10.1111/jdv.20547] Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/)
Early responders
had SALT ≤20 at Week 24 and Months 12 and 24
Middle responders
had SALT ≤20 by Months 12 and 24
Late responders
had SALT ≤20 by Month 24
Partial responders
achieved 30% improvement that was maintained
Relapsers
achieved but did not maintain a 30% improvement
Non-responders
did not achieve 30% improvement
Study Design
This post hoc analysis includes pooled data from the pivotal, international, randomized, double-blind, placebo-controlled, dose-ranging ALLEGRO-2b/3 (NCT03732807) and the long-term, open-label, Phase 3 ALLEGRO-LT study (NCT04006457).1–3 Patients were aged ≥12 years and had ≥50% scalp hair loss, including AT and AU (defined as baseline SALT score 100 and were designated AT or AU by the investigator), with current episode of hair loss ≤10 years.1
The objective of the post hoc analysis was to evaluate individual SALT score trajectories and describe trajectories of clinical response over 24 months from treatment initiation in patients with AA who received ritlecitinib 50 mg, with the goal of describing long-term response patterns and associated baseline characteristics. Patients who received placebo and switched to ritlecitinib 50 mg were re-baselined to align time points across groups.1
The data cutoff date was February 28, 2022.
AA, alopecia areata; AT, alopecia totalis; AU, alopecia universalis; LT, long-term; SALT, Severity of Alopecia Tool.
1. King B, et al. J Eur Acad Dermatol Venereol. 2024. [Submitted manuscript]; 2. ClinicalTrials.gov. NCT03732807. https://clinicaltrials.gov/study/NCT03732807 [Last accessed September 2024]; 3. ClinicalTrials.gov. NCT04006457. https://clinicaltrials.gov/study/NCT04006457 [Last accessed September 2024].
This analysis includes 191 patients: 130 patients who received ritlecitinib 50 mg QD throughout ALLEGRO-2b/3 and ALLEGRO-LT, and 61 patients who received placebo for 24 weeks in ALLEGRO-2b/3 before switching to ritlecitinib 50 mg QD.
Baseline Demographic and Disease Characteristics by Sex
| Female (n=107) |
Male (n=84) |
|
|---|---|---|
| Age, mean (SD), years | 36.2 (15.1) | 29.4 (12.5) |
| 12‒17 years, n (%) | 12 (11.2) | 15 (17.9) |
| ≥18 years, n (%) | 95 (88.8) | 69 (82.1) |
| Race, n (%) | ||
| White | 70 (65.4) | 53 (63.1) |
| Other | 37 (34.6) | 31 (36.9) |
| BMI, mean (SD), kg/m2 | 24.4 (5.2) | 25.5 (6.4) |
| Type of AA, n (%) | ||
| ATa | 13 (12.1) | 24 (28.6) |
| AUa | 20 (18.7) | 21 (25.0) |
| Other | 74 (69.2) | 39 (46.4) |
| Baseline SALT score, mean (SD) | 87.8 (15.5) | 94.8 (11.0) |
| Abnormal EBA score at baseline,b n (%) | 80 (74.8) | 74 (88.1) |
| Abnormal ELA score at baseline,b n (%) | 69 (64.5) | 70 (83.3) |
| Duration of AA since diagnosis, mean (SD), years | 11.4 (12.3) | 7.8 (7.2) |
| Duration of current AA episode, mean (SD), years | 2.9 (2.6) | 3.8 (2.9) |
| Duration of significant (≥50%) scalp hair loss, mean (SD), years | 2.5 (2.6) | 3.1 (2.7) |
| Prior pharmacological treatment for AA, n (%) | 83 (77.6) | 62 (73.8) |
| Comorbid conditions, n (%) | ||
| Asthma | 13 (12.1) | 9 (10.7) |
| Autoimmune thyroiditis | 10 (9.3) | 1 (1.2) |
| Atopic dermatitis | 20 (18.7) | 11 (13.1) |
| Allergic rhinitis | 14 (13.1) | 6 (7.1) |
aParticipants 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; AT, alopecia totalis; AU, alopecia universalis; BMI, body mass index; EBA, eyebrow assessment; ELA, eyelash assessment; LT, long-term; QD, once daily; SALT, Severity of Alopecia Tool; SD, standard deviation.
King B, et al. J Eur Acad Dermatol Venereol . 2024. [Submitted manuscript].
This analysis is not without limitations.1 Response pattern definitions in this analysis diverge from the clinical endpoint assessments conducted in ALLEGRO-2b/3, and because the analyses in this study are of as-observed data, the proportions of responders cannot be directly compared with those published previously.1,2 Additionally, the small patient numbers in certain response groups may limit the interpretation of these results.1 The ALLEGRO-LT study is ongoing and will provide additional data on long-term response patterns in patients with AA treated with ritlecitinib.1 The full safety profile of ritlecitinib across the Phase 2 and 3 studies of the ALLEGRO clinical program has been reported previously and supports the chronic use of ritlecitinib in patients aged ≥12 years with AA.1,3
AA, alopecia areata; LT, long-term.
1. King B, et al. J Eur Acad Dermatol Venereol. 2024. [Submitted manuscript]; 2. King B, et al. Lancet. 2023;401:1518–29; 3. King B, et al. Am J Clin Dermatol. 2024;25:299–314.
SALT 0 = no scalp hair loss; SALT 100 = full scalp hair loss.
aBold colored lines indicate the median SALT score trajectory. Trajectories that do not extend to Month 24 reflect patients who had not reached this time point at the data cutoff (February 2022) or who were discontinued from the study. Data are as observed.
bThe current analysis includes data from (1) patients from the ALLEGRO-2b/3 study and who rolled over to the currently ongoing ALLEGRO-LT study, and (2) patients who were newly enrolled in the ALLEGRO-LT study. All patients received ritlecitinib 50 mg QD.
AA, alopecia areata; LT, long-term; QD, once daily; SALT, Severity of Alopecia Tool.