Adelaide Hebert,1 Evan A Rieder,2 Emmy Graber3 Hilary Baldwin,4 Julie C. Harper,5 Linda Stein Gold,6 Leon Kircik,7 Andrew F. Alexis,8 James Del Rosso,9 Siva Narayanan,10 Volker Koscielny,11 Ismail Kasujee,11 Richard G. Fried12 1UTHealth McGovern Medical School, Houston, TX; 2New York University Grossman School of Medicine, New York, NY; 3The Dermatology Institute of Boston and Northeastern University, Boston, MA; 4Acne Treatment and Research Center, Brooklyn, NY; 5The Dermatology and Skin Care Center of Birmingham, Birmingham, AL; 6Henry Ford Health System, Bloomfield, MI; 7Icahn School of Medicine, Mount Sinai, New York, NY; 8Weill Cornell Medical College, New York, NY; 9JDR Dermatology Research/Thomas Dermatology, Las Vegas, NV; 10Avant Health LLC, Bethesda, MD; 11Almirall SA, Barcelona, Spain; 12Yardley Dermatology Associates, Yardley, PA. Objective: Evaluate patient self-perceived AV symptoms and impact of AV on emotional/social functioning and ADL, among pediatric patients with AV in community practices across the U.S. Methods: Single-arm, prospective cohort study (PROSES) 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 (no burden/impact) – 4 (most burden/impact)); 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) for EPQ items at baseline for pediatric age strata (Grp1: age 9-11yrs, Grp2: age 12-17yrs) was analyzed. Results: A total of 101 pediatric patients with AV were included in the analysis. At baseline, patients reported moderate AV burden in most domains, as depicted by signs domain scores of Grp1: 2.00, Grp2: 1.92; emotional impact subdomain scores of Grp1: 2.00, Grp2: 2.02; social impact subdomain scores of Grp1: 1.13, Grp2: 0.77. From EPQ items, proportion of patients reporting score=2/3/4 (moderate to severe burden) within age strata at baseline were: patients’ mood/anger (EPQ1)- Grp1: 25.00%, Grp2: 41.24%; worries about AV worsening (EPQ2)- Grp1: 50.00%, Grp2: 74.23%; thinking about acne (EPQ3)- Grp1: 50.00%, Grp2: 75.26%; level of acne worries (EPQ4)- Grp1: 50.00%, Grp2: 64.95%; patients’ social media/’selfie’ activity (EPQ5)- Grp1: 50.00%, Grp2: 37.11%; impact on real-life plans (EPQ6)- Grp1: 25.00%, Grp2: 27.84%; efforts to hide AV (EPQ7)- Grp1: 75.00%, Grp2: 63.92%; picked-on/judged due to AV (EPQ8)- Grp1: 25.00%, Grp2: 26.80%; ability to reach future goals (EPQ9)- Grp1: 25.00%, Grp2: 16.49%; parent understanding of AV concerns (EPQ10)- Grp1: 75.00%, Grp2: 82.47%; sleep impact (EPQ11)- Grp1: 50.00%, Grp2: 20.62%. Conclusion: Moderate to severe AV burden and psychosocial impact was observed in this prospective cohort of pediatric patients with AV in the U.S. Emotional impact and social impact of AV were more pronounced across the pediatric age groups. SYNOPSIS CONCLUSIONS • Moderate to severe AV burden and psychosocial impact was observed in this prospective cohort of pediatric patients with AV in the U.S., at the beginning of PROSES study. • Emotional impact and social impact of AV were more pronounced across the pediatric age groups. 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)); 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 for pediatric age strata (Grp1: age 9-11yrs, Grp2: age 12-17yrs) were analyzed, as observed. OBJECTIVE • Evaluate patient self-perceived AV symptoms and impact of AV on emotional/social functioning and ADL, among pediatric patients with AV in community practices across the U.S. Majority of pediatric patients reported moderate to severe AV burden in several areas associated with emotional and physical functioning, and ADL, across the age groups Note: Survey responses for pediatric patients 9 - 11 years old (N=4), were from caregivers of these patients. Survey responses for pediatric patients 12-17 years (N=97) were from patients themselves. Moderate to severe (high) burden/impact refers to a score of 2/3/4 for the EPQ items, as follows: • EPQ1, EP3, EPQ5, EPQ6. EPQ7, EPQ8, EPQ11: Some of the time (2), most of the time (3), all of the time (4) • EPQ2, EPQ4, EPQ9: Somewhat (2), moderately (3), extremely (4) • EPQ10: Somewhat (2), quite a bit (3), very much (4) RESULTS • 101 pediatric patients with data at week-12 were included in the final analyses. Table 2: ASIS Domain Scores at Baseline Depicting Moderate to Severe AV Burden ASIS Domain Group 1: 9 - 11 years (N=4) Group 2 12 – 17 years (N=97) Signs 2.00 1.92 Impact 1.78 1.70 Emotional Impact 2.00 2.02 Social Impact 1.13 0.77 RESULTS Table 1: Pediatric Patient Demographics Demographic Group N=101 Age, mean years 14.84 Gender, % Male 49.17 Female 50.86 Race, % White 79.31 Other 11.21 Black / African American 6.90 Asian 5.17 Prefer not to answer 3.45 Native Hawaiian / Pacific Islander 1.72 American Indian / Alaskan 1.72 Hispanic, Latino, or of Spanish Origin, % 31.03 Academic Accomplishments, % Pre-K – 5th grade 3.45 6th grade – 8th grade 19.83 9th grade – 12th grade 73.26 High school Diploma / Degree / Vocational School 2.59 Freshmen in College 0.86 U.S Region (home location), % Northeast 2.97 Midwest 24.75 West 11.88 South 60.40 ACNE SYMPTOMS AND IMPACT OF ACNE ON SOCIAL FUNCTIONING, EMOTIONAL FUNCTIONING, AND ACTIVITIES OF DAILY LIVING (ADL) AMONG PEDIATRIC PATIENTS WITH MODERATE TO SEVERE NON-NODULAR ACNE VULGARIS (AV) IN COMMUNITY PRACTICES ACROSS THE U.S: A PROSES STUDY ANALYSIS 25.00% 41.24% 0.0% 100.0% Moderate/Severe Burden P ro po rt io n of p at ie nt s EPQ1: Over the past 7 days, how often has your acne made you feel angry (mad/sad)? 9-11 yrs 12-17 years 50.00% 74.23% 0.0% 100.0% Moderate/Severe Burden P ro po rt io n of p at ie nt s EPQ2: How worried are you about how long your acne will last and how bad it will get? 9-11 yrs 12-17 yrs 50.00% 75.26% 0.0% 100.0% Moderate/Severe Burden P ro po rt io n of p at ie nt s EPQ3: How often do you think about your acne? 9-11 yrs 12-17 yrs 50.00% 64.95% 0.0% 100.0% Moderate/Severe Burden P ro po rt io n of p at ie nt s EPQ4: Over the past 7 days, how worried have you been about your acne? 9-11 yrs 12-17 yrs EPQ domain: Emotional Functioning 50.00% 37.11% 0.0% 100.0% Moderate/Severe Burden P ro po rt io n of p at ie nt s EPQ5: How often do you change, edit, or filter your social media photo or selfie because of your acne? 9-11 yrs 12-17 yrs 25.00% 27.84% 0.0% 100.0% Moderate/Severe Burden P ro po rt io n of p at ie nt s EPQ6: How often does acne impact your “in real life” plans? 9-11 yrs 12-17 yrs 75.00% 63.92% 0.0% 100.0% Moderate/Severe Burden P ro po rt io n of p at ie nt s EPQ7: How often are you doing something to hide your acne? 9-11 yrs 12-17 yrs EPQ domain: Social Functioning 25.00% 26.80% 0.0% 100.0% Moderate/Severe Burden P ro po rt io n of p at ie nt s EPQ8: How often do you feel picked on or judged because of your acne 9-11 yrs 12-17 yrs 25.00% 16.49% 0.0% 100.0% Moderate/Severe Burden P ro po rt io n of p at ie nt s EPQ9: How concerned are you that your acne will affect your ability to reach your future goals (in school or work) and be the best you can be? 9-11 yrs 12-17 yrs 75.00% 82.47% 0.0% 100.0% Moderate/High Burden P ro po rt io n of p at ie nt s EPQ10: Do you feel that your parents understand your acne-related concerns? 9-11 yrs 12-17 yrs 50.00% 20.62% 0.0% 100.0% Moderate/Severe Burden P ro po rt io n of p at ie nt s EPQ11: Over the past 7 days, how often has worrying about or discomfort (itching/hurting) from acne affected your sleep? 9-11 yrs 12-17 yrs EPQ domain: Activities of Daily Living