Main Article Content
PROSES, Acne, Acne Vulgaris, Sarecycline, Antibiotics, Pediatric, pediatric acne, Patient Reported Outcomes, PROs, Quality of Life, Emotional Functioning, Social Functioning, Activities of Daily Living, ADLs, ASIS, Expert Panel Questionnaire, EPQ
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 (mean age: 14.81yrs; age Grp1: 3.96%, age Grp2: 96.04%; female: 49.50%; white/Caucasian: 78.22%; Hispanic/Latino/Spanish origin: 30.69%). 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: 0.25, Grp2: 0.28. 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.