Main Article Content
Acne, Symptoms, Impact, Social Functioning, Emotional Functioning, Activities of Daily Living, ADL, PROs, Patient Reported Outcomes, PROSES, Sarecycline, RWE, Real World Evidence, Disease Burden, Expert Panel Questionnaire, EPQ
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.