Abstract
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.
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