Use of Oral Sarecycline as Monotherapy and in Combination With Topical Treatments in Patients With Acne: A Post-Hoc Analysis of Results From the Patient Reported Outcomes for Sarecycline Effectiveness and Safety (PROSES), a Single-Arm Prospective Cohort Study
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Keywords
Acne, Sarecycline, IGA Success, Combination Therapy
Abstract
Background The American Academy of Dermatology (AAD) recommends oral sarecycline, a narrow-spectrum antibiotic, for treatment of patients with moderate-to-severe acne vulgaris (AV). While these guidelines also suggest that systemic antibiotics should be administered with benzoyl peroxide and/or other topical therapies, limited data is available on the efficacy and safety of combination therapy vs administration of an oral antibiotic alone.
Methods PROSES, a single-arm, prospective, observational cohort study was carried out at 30 community dermatology practices in the United States (US) between March 2021 and May 2022. Patients (N=300) ≥9 years old, with a confirmed diagnosis of facial non-nodular moderate-to-severe AV, were included and received oral sarecycline (60 mg, 100 mg, or 150 mg) as part of usual care per clinician’s judgment. Appropriate sarecycline dosages were determined based on clinical judgment per US Food and Drug Administration prescribing guidelines. In this real-world study, there were no restrictions on the use of concomitant medications. Efficacy was assessed by Investigators’ Global Assessment (IGA) with acne severity rated as 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe, at baseline and week 12. Data were evaluated with nonparametric statistics (sign-rank and Fisher’s Exact tests).
Results Results for 121 evaluable patients who received no concomitant medications and 124 patients who received at least one topical agent indicated no significant difference between groups for acne severity at baseline (P=0.913) or week 12 (P=0.807). The percentages of patients in the monotherapy and combination treatment groups who achieved IGA of clear or almost clear at 12 weeks were 61.2% vs 57.2%, respectively (P=0.6033). The use of sarecycline alone or with each of the topical therapies assessed significantly decreased acne severity
References
2. Baldwin HE, Graber E, Harper JC, et al. Sarecycline Improves Acne Severity, Symptoms, and Psychosocial Burden in Non-nodular Acne Vulgaris: PROSES Study. J Drugs Dermatol. 2024;23(2):SF405634s12-SF405634s18.
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