Emmy Graber,1 Hilary Baldwin,2 Andrew F. Alexis,3 James Del Rosso,4 Richard G. Fried,5 Julie C. Harper,6 Adelaide Hebert,7 Leon Kircik,8 Evan A Rieder,9 Linda Stein Gold,10 
Siva Narayanan,11 Volker Koscielny,12 Ismail Kasujee12

1The Dermatology Institute of Boston and Northeastern University, Boston, MA; 2Acne Treatment and Research Center, Brooklyn, NY; 3Weill Cornell Medical College, New York, NY; 4JDR Dermatology Research/Thomas Dermatology, Las 
Vegas, NV; 5Yardley Dermatology Associates, Yardley, PA; 6The Dermatology and Skin Care Center of Birmingham, Birmingham, AL; 7UTHealth McGovern Medical School, Houston, TX;  8Icahn School of Medicine, Mount Sinai, New York, 

NY; 9New York University Grossman School of Medicine, New York, NY; 10Henry Ford Health System, Bloomfield, MI; 11Avant Health LLC, Bethesda, MD; 12Almirall SA, Barcelona, Spain. 

Objective: Evaluate patient self-perceived AV symptoms and impact 
of AV on emotional/social functioning and ADL, among AV patients in 
community practices across the U.S. Methods: Single-arm, 
prospective cohort study (PROSES: NCT04820673) was conducted 
with moderate-to-severe non-nodular AV patients >9yrs who were 
prescribed sarecycline in real-world U.S community practices. 
Validated ASIS questionnaire (with Signs and Impact (emotional & 
social) domains) and an Expert Panel Questionnaire (EPQ; 
emotional functioning (items 1-4), social functioning (items 5-7), and 
ADL (items 8-11)) were completed by patients (>12yrs) and 
caregivers (for patients 9-11yrs) at baseline and week-12. All items 
were scored on five-point adjectival response scale (score: 0 
(never/not at all) – 4 (all the time/very much/extremely)); a higher 
ASIS domain score indicate severe symptoms or negative impact of 
AV. ASIS domain scores and proportion of patients reporting 
score=2/3/4 (moderate to high burden/impact or parent 
understanding (EPQ10)) for EPQ items at baseline were analyzed. 
Results: A total of 253 AV patients completed the study (pediatric: 
39.92%; female: 66.40%; moderate AV: 86.56%; severe AV: 
13.44%). At baseline, patients reported moderate AV burden in most 
domains, as depicted by the following domain score: signs: 1.96, 
impact: 2.06, emotional impact subdomain: 2.43; social impact 
subdomain: 0.98. From EPQ items, proportion of patients reporting 
score=2/3/4 (moderate to severe burden) at baseline were: patients’ 
mood/anger (EPQ1) – 56.13%; worries about AV worsening (EPQ2) 
– 79.45%; thinking about acne (EPQ3) – 84.19%; level of acne 
worries (EPQ4) – 72.73; patients’ social media/’selfie’ activity (EPQ5) 
– 51.38%; impact on real-life plans (EPQ6) – 44.66%; efforts to hide 
AV (EPQ7) – 72.73%; picked-on/judged due to AV (EPQ8) –
26.88%; ability to reach future goals (EPQ9) – 27.27%; sleep impact 
(EPQ11) – 27.67%; parent understanding of AV concerns (for 
patients<18yrs; EPQ10) – 84.16%. Conclusion: Moderate to severe 
AV burden/impact was observed in this prospective cohort of AV 
patients in the U.S. Emotional impact and social impact of AV were 
especially more pronounced among the AV population.

SYNOPSIS

CONCLUSIONS
• Moderate to severe AV burden/impact was observed at 

study entry, in this prospective cohort of AV patients in the 
U.S. Emotional impact and social impact of AV were 
especially more pronounced among the AV population.

METHODS
• Single-arm, prospective cohort study (PROSES: NCT04820673) 

was conducted with moderate-to-severe non-nodular AV patients ≥ 
9yrs who were prescribed sarecycline in real-world U.S community 
practices. 

• A total of 300 subjects were enrolled from 30 community practices 
across the U.S.

• Validated ASIS questionnaire (with Signs and Impact (emotional & 
social) domains) and an Expert Panel Questionnaire (EPQ; 
emotional functioning (items 1-4), social functioning (items 5-7), 
and ADL (items 8-11)) were completed by patients (>12yrs) and 
caregivers (for patients 9-11yrs) at baseline and week-12. 
• ASIS items are scored on a five-point adjectival response scale 

(score 0-4); higher scores indicate severe symptoms or 
negative impact of Acne. 

• EPQ items (1-9 & 11) were scored on five-point adjectival 
response scale (score: 0 (no burden/impact) – 4 (most 
burden/impact)); a higher EPQ score indicate severe symptoms 
or negative impact of AV. 

• EPQ item 10 was scored on five-point adjectival response scale 
(score: 0 (not at all) – 4 (very much), this question only asked to 
the pediatric/caregiver subgroup; higher score indicate better 
understanding.

• ASIS domain scores and proportion of patients reporting 
score=2/3/4 (moderate to high burden/impact) for individual EPQ 
items at baseline were evaluated, as observed. 

OBJECTIVE
• Evaluate patient self-perceived AV symptoms and impact of AV on 

emotional/social functioning and ADL, among AV patients in 
community practices across the U.S. 

Majority of patients reported moderate to severe AV burden in several areas associated with 
emotional and physical functioning, and ADL

Note: N=253
*Only asked for pediatric patient/caregiver subgroup (N=101).

Table 3: ASIS Domain Scores at Baseline Depicting 
Moderate to Severe AV Burden

ASIS Domain Domain Scores at Baseline (N=253)

Signs 1.96

Impact 2.06

Emotional Impact 2.43

Social Impact 0.98

RESULTS

ACNE SYMPTOMS AND IMPACT OF ACNE ON SOCIAL FUNCTIONING, EMOTIONAL FUNCTIONING, AND ACTIVITIES OF DAILY LIVING (ADL) AMONG 
PATIENTS WITH MODERATE TO SEVERE NON-NODULAR ACNE VULGARIS (AV) IN COMMUNITY PRACTICES ACROSS THE U.S: AN ANALYSIS OF 

PROSES STUDY COHORT

56.13%

72.73%
79.45% 84.19%

43.87%

27.27%
20.55% 15.81%

0%

20%

40%

60%

80%

100%

EPQ1:
Patients' mood/anger

EPQ4:
Level of acne worries

EPQ2:
Worries about AV worsening

EPQ3:
Thinking about acne

P
ro

po
rt

io
n 

of
 p

at
ie

nt
s 

Reporting 0/1: Never/ Rarely Reporting 0/1: Not at all/ Slightly

Reporting 2/3/4: Some/ Most/ All of the time Reporting 2/3/4: Somewhat/ Moderately/ Extremely

EPQ Domain: Emotional Functioning

EPQ Domain: Social Functioning

EPQ Domain: Activities of Daily Living

51.38%
44.66%

72.73%

48.62%
55.34%

27.27%

0%

20%

40%

60%

80%

100%

EPQ5:
Patients’ social media/’selfie’ activity 

EPQ6:
Impact on real-life plans

EPQ7:
Efforts to hide AV

P
ro

po
rt

io
n 

of
 p

at
ie

nt
s

Reporting 0/1: Never/ Rarely Reporting 2/3/4: Some/ Most/ All of the time

26.88% 27.67% 27.27%

84.16%

73.12% 72.33% 72.73%

20.55%

0%

20%

40%

60%

80%

100%

EPQ8:
Picked-on/judged due to AV

EPQ11:
Sleep impact

EPQ9:
Ability to reach future goals

EPQ10*:
Parent understanding of AV

concerns

P
ro

po
rt

io
n 

of
 p

at
ie

nt
s 

Reporting 0/1: Never/ Rarely
Reporting 2/3/4: Some/Most/All of the time

■ Reporting 0/1: Not at all/ A little
■ Reporting 2/3/4: Somewhat/ 

Quite a bit / Very much

■ Reporting 0/1: Not at all/ 
Slightly

■ Reporting 2/3/4: Somewhat/ 
Moderately/ Extremely

Table 1: Baseline Patient Characteristics

N=253

Age Group, %
Pediatric (<18 yrs) 39.92

Adult (≥18 yrs) 60.08

Age Group, Mean
Pediatric (<18 yrs) 14.81

Adult (≥18 yrs) 26.63

Gender, %
Male 33.60

Female 66.40

Race,%

White 66.80

Other 15.81

Black/African American 9.88

Asian 5.93

Prefer not to answer 3.16

American Indian or 
Alaskan

0.79

Native 
Hawaiian/Pacific 

Islander
0.40

Ethnicity,%
(Hispanic, Latino or 
of Spanish Origin) 

Yes 33.99

No 66.01

Baseline IGA, %
Moderate 86.56

Severe 13.44

Table 2: Site Characteristics

N=30
Current workplace, %

Private, office-based practice 100.00
Hospital-based practice 0.00

Total number of board-certified 
dermatologists in the clinic/practice, Mean

3.10

Number of patients with AV managed by the 
clinic in a given month, Mean

86.90

Number of years practicing dermatology, 
Mean

19.30