Lilly Immunology


Study was sponsored by Eli Lilly and Company, under license from Incyte CorporationWinter Clinical Dermatology Conference; Hawaii, USA; January 13-18, 2023

METHODS
Study Design, BRAVE-AA1 and BRAVE-AA2

DISCLOSURES
■ B. M. Piraccini has been an Investigator for, received honoraria and/or consulting fees from, and/or been a speaker for: Concert Pharmaceuticals, Eli Lilly and Company, ISDIN, and Pfizer; M. Ohyama has received advisory and/or lecture fees from: Eli Lilly Japan K.K., Janssen, Pfizer Japan, Rohto Pharmaceutical, and Taisho Pharmaceutical; and 

has received research grants from: Maruho, Shiseido, and Sun Pharma Japan; B. Craiglow has received honoraria and/or fees from: Eli Lilly and Company, Pfizer, Regeneron, and Sanofi Genzyme; A. Bewley has received honoraria and/or consulting fees from: AbbVie, Almirall, Eli Lilly and Company, Galderma, Janssen, LEO Pharma, Novartis, 

Sanofi, and UCB Pharma; Y. Ding, Y.-F. Chen, Y. Dutronc, E. Pierce, and F. Durand are employees and stockholders of: Eli Lilly and Company; A. Mostaghimi has been a consultant for: AbbVie, Concert Pharmaceuticals, Digital Diagnostics, Eli Lilly and Company, and Pfizer

■ Medical writing assistance was provided by Linda Donnini, PhD, of ProScribe – Envision Pharma Group, and was funded by Eli Lilly and Company

■ This study is previously presented at European Academy of Dermatology and Venereology - 31st Congress, 2022

Scalp Hair Regrowth Is Associated With Improvements in Health-Related Quality of Life and Psychological Symptoms 
in Patients With Severe Alopecia Areata: Results From Two Randomized Controlled Trials

Bianca Maria Piraccini,1 Manabu Ohyama,2 Brittany Craiglow,3 Anthony Bewley,4 Yuxin Ding,5 Yun-Fei Chen,5 Yves Dutronc,5 Evangeline Pierce,5 Frederick Durand,5 Arash Mostaghimi6

1University of Bologna, Bologna, Italy; 2Kyorin University Faculty of Medicine, Tokyo, Japan; 3Yale School of Medicine, New Haven, USA; 4The Royal London Hospital, London, UK; 5Eli Lilly and Company, Indianapolis, USA; 
6Brigham and Women’s Hospital, Harvard Medical School, Boston, USA

BACKGROUND
■ Alopecia areata (AA) is a common autoimmune disorder that results in hair loss1

– Hair loss can range in severity, from loss of hair in small localized patches on the scalp, 
to complete loss of hair on the scalp (alopecia totalis) and/or body (alopecia universalis)1

■ Severe AA is frequently associated with health-related quality of life (HRQoL) impairment 
and psychological burden2

■ However, the impact of hair regrowth on HRQoL and psychosocial burden has not been 
sufficiently investigated

OBJECTIVE
■ To evaluate the association between scalp hair regrowth and improvement of HRQoL and 

psychological burden in patients with severe AA using pooled data from the Phase 3, 
randomized, placebo-controlled trials, BRAVE-AA1 (NCT03570749) and BRAVE-AA2 
(NCT03899259)

CONCLUSIONS
■ Patients with severe AA who achieved scalp hair regrowth at Week 36 

experienced improvements in HRQoL and symptoms of anxiety and 
depression when compared with those who had no or minimal 
regrowth

– Higher benefit was observed in patients achieving a SALT ≤20 
response

– Improvements were also observed in the intermediate response 
group, but generally to a lesser extent than those in the SALT ≤20 
response group

■ These results support the clinical relevance of SALT ≤20, the primary 
endpoint for the baricitinib clinical program in severe AA

■ Longer treatment duration may be needed to assess the full impact on 
scalp hair regrowth, HRQoL, and symptoms of anxiety and depression

ABBREVIATIONS
AA=alopecia areata; B/AB=borderline/abnormal; BARI=baricitinib; HADS-A=Hospital Anxiety and Depression Scale–

Anxiety; HADS-D=Hospital Anxiety and Depression Scale–Depression; HRQoL=health-related quality of life; 

LSM=least squares mean; mLOCF=modified last observation carried forward; NRI=non-responder imputation; 

PBO=placebo; QD=once daily; SALT=Severity of Alopecia Tool; W=Week

KEY RESULTS

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REFERENCES
1. Pratt C, et al. Nat Rev Dis Primers. 2017;3:17011

2. Mostaghimi A, et al. Dermatol Ther (Heidelb). 2021;11:867-883.

3. Olsen EA, et al. J Am Acad Dermatol. 2004;51:440-447.

RESULTS

Patient Subgroups 
Note: Figure is not the full study design, but only the PBO-Controlled Period of both trials

Key Eligibility Criteria for BRAVE-AA1 and BRAVE-AA2

Inclusion
■ Age ≥18 years to ≤60 years (males) or ≤70 years (females)

■ Severe or very severe AA

– Hair loss encompassing ≥50% of the scalp, as measured by the Severity of Alopecia Tool (SALT)

■ Current episode of AA lasting >6 months to <8 yearsa

Exclusion
■ No spontaneous improvement in the 6 months before screening

■ Not primarily a “diffuse” type of AA

■ No concomitant treatments for AA allowedb

a Patients who had AA for ≥8 years could be enrolled if episodes of regrowth (spontaneous or due to under-treatment) had been observed on the affected areas over the past 8 years 
b Oral/topical minoxidil or finasteride were allowed if on stable dose for 12 months and bimatoprost ophthalmic solution was allowed if on stable dose for 8 weeks

SALT Score3

■ Assesses hair loss in each 
quadrant of the scalp 

■ The SALT score is a 
weighted sum of the percent 
of hair loss in the 4 
quadrants of the scalp, 
ranging from 0 to 100

■ Examples:

– SALT 0=no scalp hair 
loss​

– SALT 50=50% scalp 
hair loss​

– SALT 100=complete 
scalp hair loss

■ Patients were categorized into 3 groups according to scalp hair 
regrowth at Week 36:

1. SALT ≤20 Response (N=256):

Met the primary endpoint of SALT ≤20 (ie, ≥80% scalp hair 

coverage)

2. Intermediate Response (N=268): 

Did not meet the primary endpoint but achieved ≥30% 

improvement from baseline in SALT score at any post-

baseline visit up to Week 36 (SALT30)

3. No or Minimal Response (N=676): 

Did not achieve SALT30 at any post-baseline visit up to 

Week 36

Assessments

Skindex-16 adapted for AA: Assessed effects of AA on HRQoL over 3 
domains: 

■ Emotions, symptoms, and functioning

■ Each domain score ranged from 0 to 100, with higher scores indicating worse 
HRQoL

Hospital Anxiety and Depression Scale (HADS): Assessed levels 
of anxiety (HADS-A) and depression (HADS-D)a

■ Each domain score ranged from 0 to 21, with higher scores indicating greater 
anxiety or depression

■ Used to identify patients with borderline or abnormal severity scores at baseline 
(HADS-A ≥8 or HADS-D ≥8)

a Patients with significant uncontrolled neuropsychiatric disorder were not eligible for the study

Statistical Analyses
■ Data were pooled from the 3 arms (placebo, baricitinib 4-mg, and baricitinib 

2-mg) of BRAVE-AA1 and BRAVE-AA2 and analyzed independently of 
treatment allocation

■ Change from baseline in Skindex-16 domains, HADS-A, and HADS-D scores 
were analyzed 
using analysis of covariance with modified last observation carried forward 
imputation for missing data

– Data after permanent study drug discontinuation were censored and not 
carried forward

■ Percentage of patients who shifted from borderline or abnormal to normal 
HADS-A and HADS-D scores were analyzed using logistic regression with non-
responder imputation

Demographics and Baseline Characteristics, by Hair Regrowth Response Group

Response Categories According to Scalp Hair Regrowth at Week 36 for Pooled Treatment Arms

SALT ≤20 Response

(N=256)

Intermediate Response

(N=268)

No or Minimal Response

(N=676)

Age, years 37.4 (12.5) 37.3 (12.6) 37.7 (13.1)

Female, n (%) 166 (64.8) 149 (55.6) 413 (61.1)

Duration from onset of AA, years 9.0 (9.3) 11.5 (10.7) 13.6 (11.2)

Duration of current AA episode, years 3.0 (3.5) 3.5 (3.0) 4.4 (5.0)

SALT score 77.3 (18.9) 81.8 (18.3) 89.8 (16.1)

SALT category, n (%)

Severe (SALT 50-94) 179 (69.9) 157 (58.6) 225 (33.3)

Very severe (SALT 95-100) 77 (30.1) 111 (41.4) 450 (66.7)

Skindex-16 AA domain scorea

Symptoms 19.4 (20.2) 19.0 (20.9) 17.6 (19.9)

Emotions 70.3 (25.9) 68.3 (27.3) 67.0 (28.7)

Functioning 52.4 (30.9) 50.0 (32.6) 49.5 (32.2)

Patients with B/AB anxiety (HADS-A ≥8), n (%) 94 (36.7) 96 (35.8) 220 (32.5)

Patients with B/AB depression (HADS-D ≥8), n (%) 44 (17.2) 52 (19.4) 104 (15.4)

HADS-A scoreb 10.5 (2.7) 10.3 (2.3) 10.7 (2.8)

HADS-D scoreb 10.0 (1.9) 9.7 (2.0) 9.9 (2.0)

* p<0.05; ** p<0.01; *** p<0.001 vs. no or minimal response

Patients With a SALT ≤20 Response at Week 36 Were More Likely to Achieve Normal Anxiety 
and Depression Scores (HADS <8) 

* p<0.05; ** p<0.01 vs. no or 

minimal response in patients 

with borderline or abnormal 

severity scores at baseline 

(HADS-A ≥8 or HADS-D ≥8)

Greater Improvement (Decrease) in All Skindex-16 AA Domain Scores 
Was Observed in Patients With a SALT ≤20 Response at Week 36

Greater Improvement (Decrease) in Anxiety and Depression Scores Was 
Observed in Patients With a SALT ≤20 Response at Week 36

* p<0.05; vs. no or minimal response in patients with borderline or abnormal severity scores at baseline (HADS-A ≥8 or HADS-D ≥8)

Data are mean (standard deviation) unless stated otherwise
a In patients with baseline assessment of Skindex-16 adapted for AA
b In patients with baseline HADS-A ≥8 or HADS-D ≥8