Distribution of SALT Scores with Ritlecitinib Treatment up to 24 months from the ALLEGRO Phase 2b/3 and Long-Term Phase 3 Clinical Studies in Alopecia Areata

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Ziad Reguiai
Leila Asfour
Delphine Staumont-Sallé
Ángela Hermosa-Gelbard
Andrea Sechi
Dalia Wajsbrot
Rahmat Adejumo
Deborah Woodworth
Alexandre Lejeune

Keywords

SALT scores, ritlecitinib, ALLEGRO, alopecia areata

Abstract

Background:
• Alopecia areata (AA) is an autoimmune disease that has an underlying immuno-inflammatory
pathogenesis and is characterized by non-scarring hair loss ranging from small patches to complete
scalp, face, and/or body hair loss1
• Ritlecitinib, an oral JAK3/TEC family kinase inhibitor, demonstrated efficacy and safety up to 48 weeks in
patients aged ≥12 years with AA in the ALLEGRO phase 2b/3 study (NCT03732807; “ALLEGRO-2b/3”)2
• The long-term efficacy of ritlecitinib in patients who rolled over from ALLEGRO-2b/3 to the ongoing
phase 3, open-label ALLEGRO-LT study (NCT04006457) has been reported in terms of the proportions of
patients with Severity of Alopecia Tool (SALT) scores of ≤20 and ≤10 (≤20% or ≤10% scalp without hair)
at Month 243
• However, the distribution of SALT scores in the overall population, including patients not reaching the
SALT score ≤20 and ≤10 thresholds, has not yet been described
OBJECTIVE
• This study describes changes in the distribution of SALT scores over 24 months of ritlecitinib treatment
in the overall population and in age and disease severity subgroups


Methods: 
Study design and patients
• Key inclusion criteria in ALLEGRO-2b/3:
- Age ≥12 years
- Diagnosis of AA with ≥50% scalp hair loss due to AA (including alopecia totalis [AT] and alopecia universalis [AU])
- Maximum duration of current episode of hair loss ≤10 years
• This analysis includes patients who received ritlecitinib 50 mg once daily (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 (Figure 1)
- Continuation criteria for adolescents (aged 12-17 years) in ALLEGRO-LT: ≥50% improvement from baseline in SALT score
by Month 3 for rollover patients from ALLEGRO-2b/3 and SALT score ≤20 by Month 6 in ALLEGRO-LT
Figure 1. Study design and patient population
Combined
ritlecitinib
50 mg group
(N=191)
ALLEGRO phase 2b/3 ALLEGRO-LT
Loading
(4 weeks)
Maintenance
(20 weeks)
Extension
(24 weeks)
Long-term study
(60 months)
Group A (n=131) 200 mg 50 mg 50 mg 50 mg
Group B (n=129) 200 mg 30 mg 30 mg 50 mg
Group C (n=130) 50 mg 50 mg 50 mg 50 mg
Group D (n=132) 30 mg 30 mg 30 mg 50 mg
Group E (n=61) 10 mg 10 mg 10 mg 50 mg
Group F (n=63) Placebo Placebo 200 mg 50 mg 50 mg
Group G* (n=61) Placebo Placebo 50 mg 50 mg
De novo group (n=447) 200 mg 50 mg
*Data while on placebo were not included in this analysis; data from patients in Groub G were rebaselined from the start of treatment with ritlecitinib.
Assessments and statistical analysis
• 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


Results:


The analysis included 191 patients (27 adolescents and 164 adults) (Table 1)
• At the time of data cutoff, 71 patients had discontinued; withdrawal by
patient (n=19), adverse events (n=18), and lack of efficacy (n=14) were the
most common reasons for discontinuation
• The distribution of participants by SALT score (as observed) at baseline, Month
12, and Month 24 are presented for the overall population (Figure 2)
(Interactive dynamic plot)
• Per the inclusion criteria, all participants had a SALT score of ≥50 at baseline;
136/191 patients (71.2%) had SALT >90
• Among patients who had a nonmissing SALT score, 56/178 (31.5%), 37/164
(22.6%), and 17/120 (14.2%) were in the SALT >90-100 category at Months 6,
12, and 24, respectively
• Reductions in the number of patients in the other SALT >50 categories were
observed from baseline through Month 24
• At Month 12, 56/164 (34.2%) and 18/164 (11.0%) patients were in the SALT
0-10 and >10-20 categories, respectively, with 61/120 (50.8%) and 12/120
(10.0%) patients in these categories at Month 24
• Among the patients with AT/AU at baseline, 18/69 (26.1%) and 6/69 (8.7%)
were in the SALT 0-10 and >10-20 categories, respectively, at Month 12; 25/47
(53.2%) and 3/47 (6.4%) were in these categories, respectively, at Month 24
(Figure 3) (Interactive dynamic plot)
• For the adolescent participants, 10/22 (45.5%) and 4/22 (18.2%) were in the
SALT 0-10 and >10-20 categories, respectively, at Month 12, and 11/14
(78.6%) and 0/14 (0%) were in these categories at Month 24 (Figure 4)


 Conclusions:
• Over 24 months, daily treatment with ritlecitinib 50 mg resulted in fewer patients in
the highest SALT score categories
• These data provide a comprehensive overview of patient response to ritlecitinib
treatment and enable us to understand treatment response and time frames while
on treatment with ritlecitinib


• This information can empower clinicians when counseling patients and managing
treatment expectations based on patient characteristics
• This study also shows that response to treatment improves over time, which
suggests that adequate time should be given when assessing treatment efficacy

References

Islam N, et al. Autoimmun Rev. 2015;14:81-89.

King B, et al. Lancet. 2023;401:1518-1529.

Piliang M, et al. Poster; presented at: Winter Clinical Dermatology Conference 2024, Maui, Hawaii. Poster P178.

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