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

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