Abstract：
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.
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.
摘要：
背景：患者报告的结果（PRO）正在成为寻常痤疮（AV）疾病影响评估的基本组成部分，补充临床医生报告的结果。在现实世界中，使用sarecycline的AV患者的PRO上没有数据。
方法：单臂，纳入9岁被诊断为中度或重度非结节性房室综合征的患者的前瞻性队列研究作为临床实践中常规护理的一部分(N=30).患者接受口服sareccine（60毫克，100毫克，或150毫克）持续12周，作为日常护理的一部分。主要终点是12周时患者（12岁）和护理人员（9-11岁患者）的痤疮症状和影响量表（ASIS）反应以及相对于基线的变化（CFB）。研究者’sAV严重程度和不良事件（AE）的全球评估（IGA）也被记录。
结果：共有253名房室综合征患者完成了研究（成人：60.1%，女性：77.6%）。在第12周，ASIS平均得分显着下降（P＆lt;.0001）：体征（平均CFB＆plusmn；标准偏差[SD]：＆ndash;0.8＆plusmn;0.7），影响(–1.0±1.0)，情绪影响(–1.2±1.1)，和社会影响（0.6±1.1）。患者和护理人员报告AV严重程度（P＆lt;.0001）显着降低。IGA成功率为58.9%，医师对治疗结果的满意度为88.1%。在研究期间，共有31名（10.3%）患者报告了≥1不良事件。
结论：接受口服抗生素治疗12周的中度至重度房室综合征患者的房室综合征相关症状和社会心理负担显著改善。J药物Dermatol.2024；23：1（增刊1）：s12-18。
方法：单臂，纳入9岁被诊断为中度或重度非结节性房室综合征的患者的前瞻性队列研究作为临床实践中常规护理的一部分(N=30).患者接受口服sareccine（60毫克，100毫克，或150毫克）持续12周，作为日常护理的一部分。主要终点是12周时患者（12岁）和护理人员（9-11岁患者）的痤疮症状和影响量表（ASIS）反应以及相对于基线的变化（CFB）。研究者’sAV严重程度和不良事件（AE）的全球评估（IGA）也被记录。
结果：共有253名房室综合征患者完成了研究（成人：60.1%，女性：77.6%）。在第12周，ASIS平均得分显着下降（P＆lt;.0001）：体征（平均CFB＆plusmn；标准偏差[SD]：＆ndash;0.8＆plusmn;0.7），影响(–1.0±1.0)，情绪影响(–1.2±1.1)，和社会影响（0.6±1.1）。患者和护理人员报告AV严重程度（P＆lt;.0001）显着降低。IGA成功率为58.9%，医师对治疗结果的满意度为88.1%。在研究期间，共有31名（10.3%）患者报告了≥1不良事件。
结论：接受口服抗生素治疗12周的中度至重度房室综合征患者的房室综合征相关症状和社会心理负担显著改善。J药物Dermatol.2024；23：1（增刊1）：s12-18。
