The findings of this study confirmed the substantial disease burden and psychological distress of AV and indicated a significant effect of sarecycline in relieving them. Twelve weeks of sarecycline treatment not only improved patients’ acne signs but also significantly reduced psychological comorbidities by increasing patient confidence, self-acceptance, and self-appreciation. Patients’ self-assessments revealed improved appearance and clear/almost clear skin, implying treatment satisfaction. Clinicians reported a significant decrease in AV severity as measured by IGA success at week 12 and were satisfied with the treatment outcomes for the majority of patients.
Study results also showed that a treatment regimen including sarecycline in real-world clinical practice resulted in a two-fold higher IGA success rate than those reported in Phase III clinical trials.26 There also was close agreement between the clinician-reported IGA success (58.9%) and patients’ global assessment of AV severity as clear/almost clear (59.3%). The safety profile for sarecycline reported here was consistent with previous studies,20 and no AE was reported in ≥2% of patients. The high compliance rate further supports the efficacy and tolerability of sarecycline.
To our knowledge, this is the first real-world study that evaluated an oral antibiotic in pediatric and adult patients with moderate-to-severe non-nodular AV in routine clinical practice using a PRO along with conventional efficacy and safety assessments. Study results also showed that administering a validated PRO instrument, the ASIS questionnaire, accurately assessed the severity of AV signs and impacts in both pediatric and adult patients. All of these assessments support the use of sarecycline in this broad patient population. Additional multi-center real-world studies that incorporate PROs in routine clinical practice may further enhance understanding of how other acne treatments influence patients’ psychological well-being.
Study Limitations
Sarecycline was administered as a part of real-world clinical practice and investigators could add other AV medications, as per usual care. This could have influenced all study outcomes. In addition, results were potentially subject to recall bias, reporting bias, selection bias, and other biases commonly seen in real-world and open-label studies. Approaches such as standardized study inclusion/exclusion criteria, consecutive sampling, and geographically diverse dermatology clinics, having varied experience with oral antibiotics were employed to minimize these biases. An LOCF imputation method was employed for missing data at weeks 4 and 8, but there was no missing data for the analysis population at week 12.
CONCLUSIONS
AV patient management involving sarecycline was effective and well-tolerated, with low rates of AEs in patients with moderate-to-severe AV over a 12-week study period. In addition, treatment with this oral antibiotic demonstrated significant improvements in emotional and psychosocial impacts of AV at week 12 compared to baseline, as measured using the validated ASIS questionnaire. Patient self-reported ASIS responses correlated with physician assessments and the tool proved useful in demonstrating both disease burden and treatment effectiveness. Most of the patients experienced IGA success and clinicians expressed treatment satisfaction with the outcomes for the majority of their patients. PROSES study results reinforce that oral antibiotics, such as sarecycline, are an effective and safe treatment option for AV patients.
DISCLOSURES
Dr Graber reported receiving royalties from Wolters Kluwer Health and served as a consultant/advisor, research investigator and/or speaker for Almirall SA, Cutera, Digital Diagnostics, Hovione, Keratin Biosciences,
