Impact of acne on social functioning, emotional functioning, and activities of daily living (ADL) among patients with moderateto- severe non-nodular acne vulgaris (AV) administered sarecycline in real-world community practices across the US (PROSES Study)

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Conference Proceeding

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Publication Title

The Journal of clinical and aesthetic dermatology


Background: Understanding of AV impact on patient Health-related quality of life (HRQoL) is still evolving.

Objective: The key objective of this analysis was to evaluate patientperceived impact of AV on emotional/social functioning and ADL through a novel Expert Panel Questionnaire (EPQ), among AV patients administered sarecycline, an oral narrow-spectrum, tetracycline-derived antibiotic, in real-world community practices across the US.

Methods: A single-arm, prospective cohort study (PROSES) was conducted with moderate-to-severe non-nodular AV patients aged 9 years or older who were prescribed sarecycline. Primary endpoint included 11-item EPQ responses (completed by patients (>12years) and caregivers (for patients 9-11 yrs) at Week 12 and corresponding change from baseline (CFB)). All items were scored on a five-point adjectival response scale (score=0/1 (never/rarely, not at all/slightly/a little), score=2 (some of the time, somewhat), and score=3/4 (most of the time/all of the time, moderately/ extremely, quite a bit/very much). The EPQs related to AV impact on emotional functioning (EPQ 1-4), social functioning (EPQ 5-7), and ADL (EPQ 8-11) were formulated based on dermatology expert panel consensus using modified Delphi method. CFB in proportion of patients reporting score=0/1 (no/least impact) for EPQ items at Week-12 were analyzed.

Results: A total of 253 AV patients completed the study (adults: 60.08%; pediatric: 39.92%; female: 66.40%). CFB in patients reporting score=0/1 (no/least impact) for each EPQ item increased statistically significantly (p<0.0001) except for EPQ10. In emotional functioning domain, CFB=31.62 percent for EPQ1 on patients' mood/anger; CFB= 28.85 percent, 20.95 percent, 38.74 percent respectively for EPQ2, EPQ3, EPQ4 on hopelessness/worries about skin. In social functioning domain, CFB=23.72 percent for EPQ5 on patients' social media/selfie activity, CFB=22.93 percent for EPQ6 on impact on real-life plans, and CFB=21.34 percent for EPQ7 on efforts to hide AV. In ADL domain, CFB=15.02 percent for EPQ8 on picked-on/judged due to AV, CFB=13.83 percent for EPQ9 on ability to reach future goals, and CFB=0.99 percent for EPQ10 on parent understanding of AV concerns (for patients<18yrs), and CFB=18.18 percent for EPQ11 on sleep impact.

Conclusion: Patients reporting no/least AV burden in emotional functioning, social functioning, and ADL significantly increased in patients with moderate-to-severe AV who were administered sarecycline for 12 weeks.





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