The items were clustered into 3 domains for AV impact: emotional functioning (4-items), social functioning (3-items), and ADL (4-items). These items were complementary to the validated Acne Symptom and Impact Scale (ASIS) that the panel had chosen for use in the PROSES study.26,27 The panelists proposed 6 additional questions for caregivers, including 3 questions (items 4, 9, and 10) from the main instrument, 1 question adapted from the ASIS questionnaire on current AV status, and 2 questions regarding concerns about antibiotics and antibiotic resistance. The total set of questions was reviewed and modified by the expert panel to provide a final questionnaire on which there was 100% agreement among experts for all items (Figure 1). In the main 11-item EPQ, items 1-9 and 11 were scored on a 5-point adjectival response scale (score: 0 [no burden/impact] – 4 [most burden/impact]); item-10 was scored on a 5-point scale (score: 0 [not at all] – 4 [very much]). The 6 additional questions were also scored on a 5-point scale (score 0-4). The EPQ was aligned with prior research evaluating issues impacting patients with AV.15,16 The panel formulated the questions to be more relevant to the current social environment and addressed issues including bullying, embarrassment, social media manipulation, and perception of physical imperfection due to AV.
Statistical Analysis
All patients who received ≥1 dose of sarecycline and had ≥1 question answered at week 12 were included in the analyses. All continuous variables are presented as mean, standard deviation (SD), and number of patients; categorical variables are presented as counts and percentages. Discrete variables were analyzed using Chi-square tests. Statistical differences in continuous measures were assessed using paired t-tests. Items from the EPQ were analyzed individually. All statistical analyses were conducted using SAS statistical software and P ≤.05 was considered statistically significant.
RESULTS
Patients and Caregivers
A total of 253 patients received sarecycline throughout the study as part of usual care and had valid non-missing data at week 12. The baseline demographic characteristics for adult patients, pediatric patients, and caregivers are summarized in Table 1. The mean age was 26.6 years for adult patients (60.1%) and 14.8 years for pediatric patients (39.9%). The final cohort was predominantly female (66.4%) and White/Caucasian (68.4%). At baseline, most patients had moderate AV (86.6%) and the rest had severe AV (13.4%).
Concerns about Antibiotic Use and Resistance
The majority of adults were not at all/slightly concerned about antibiotic use for AV (79.6%) and antibiotic resistance (72.4%). Similarly, most caregivers were not at all or slightly concerned about antibiotic use for AV (68.3%) and antibiotic resistance (65.3%) (Figure 2).
Disease Burden at Baseline
Most of the patients with AV experienced high disease burden at baseline, with the emotional/social impact of AV more affected, as evidenced by the proportion of patients reporting “all/most/some of the time” on individual issues measured by EPQ items: 56.1% reported mood/anger issues, 79.4% worried about AV worsening, 84.2% were thinking about AV, 72.7% had some level of AV worries, 51.4% of patients often edited social media photo/selfie, 44.7% reported impact on real-life plans, 72.7% made efforts to hide AV, 26.9% reported being picked-on/
