PMID- 38306152 OWN - NLM STAT- MEDLINE DCOM- 20240205 LR - 20240206 IS - 1545-9616 (Print) IS - 1545-9616 (Linking) VI - 23 IP - 2 DP - 2024 Feb 1 TI - INDIVIDUAL ARTICLE: Sarecycline Improves Acne Severity, Symptoms, and Psychosocial Burden in Non-nodular Acne Vulgaris: PROSES Study. PG - SF405634s12-SF405634s18 LID - 10.36849/JDD.SF405634 [doi] AB - BACKGROUND: Patient-reported outcomes (PROs) are emerging as a fundamental component of disease impact assessment in acne vulgaris (AV), complementing clinician-reported outcomes. No data is available on PROs for patients with AV using sarecycline in real-world settings. METHODS: A single-arm, prospective cohort study that included patients ≥9 years old diagnosed with moderate or severe non-nodular AV was implemented as part of routine care in clinical practices (N=30). Patients received oral sarecycline (60 mg, 100 mg, or 150 mg) for 12 weeks, as part of usual care. The primary endpoint was Acne Symptom and Impact Scale (ASIS) responses from patients (≥12 years) and caregivers (for patients 9-11 years) at week 12 and change from baseline (CFB). Investigator’s Global Assessment (IGA) of AV severity and adverse events (AEs) were also recorded. RESULTS: A total of 253 patients with AV completed the study (adults: 60.1%, females: 77.6%). ASIS mean scores significantly decreased (P <.0001) at week 12 for: signs (mean CFB ± standard deviation [SD]: –0.8 ± 0.7), impact (–1.0 ± 1.0), emotional impact (–1.2 ± 1.1), and social impact (0.6 ± 1.1). Significant reductions in AV severity (P <.0001) were reported by patients and caregivers. The IGA success rate was 58.9% and physician satisfaction with treatment outcomes was 88.1%. A total of 31 (10.3%) patients reported ≥1 AE during the study. CONCLUSIONS: Patients with moderate-to-severe AV receiving acne management with an oral antibiotic for 12 weeks experienced a significant improvement in AV-related symptoms and psychosocial burden. J Drugs Dermatol. 2024;23:1(Suppl 1):s12-18. FAU - Baldwin, Hilary E AU - Baldwin HE FAU - Graber, Emmy AU - Graber E FAU - Harper, Julie C AU - Harper JC FAU - Alexis, Andrew F AU - Alexis AF FAU - Stein Gold, Linda AU - Stein Gold L FAU - Kircik, Leon AU - Kircik L FAU - Del Rosso, James AU - Del Rosso J FAU - Hebert, Adelaide A AU - Hebert AA FAU - Rieder, Evan A AU - Rieder EA FAU - Fried, Richard G AU - Fried RG FAU - Narayanan, Siva AU - Narayanan S FAU - Koscielny, Volker AU - Koscielny V FAU - Kasujee, Ismail AU - Kasujee I LA - eng PT - Journal Article PL - United States TA - J Drugs Dermatol JT - Journal of drugs in dermatology : JDD JID - 101160020 RN - 94O110CX2E (sarecycline) RN - 0 (Immunoglobulin A) RN - 0 (Tetracyclines) SB - IM MH - Adult MH - Female MH - Humans MH - Child MH - Male MH - Prospective Studies MH - Severity of Illness Index MH - *Acne Vulgaris/diagnosis/drug therapy MH - Treatment Outcome MH - Immunoglobulin A/therapeutic use MH - *Tetracyclines EDAT- 2024/02/02 12:44 MHDA- 2024/02/05 06:43 CRDT- 2024/02/02 11:45 PHST- 2024/02/05 06:43 [medline] PHST- 2024/02/02 12:44 [pubmed] PHST- 2024/02/02 11:45 [entrez] AID - S1545961624SSF405634s12X [pii] AID - 10.36849/JDD.SF405634 [doi] PST - ppublish SO - J Drugs Dermatol. 2024 Feb 1;23(2):SF405634s12-SF405634s18. doi: 10.36849/JDD.SF405634.