INDIVIDUAL ARTICLE: Sarecycline Improves Acne Severity, Symptoms, and Psychosocial Burden in Non-nodular Acne Vulgaris: PROSES Study

February 2024 | Volume 23 | Issue 2 | SF405634s12 | Copyright © February 2024


Published online January 31, 2024

Hilary E. Baldwin MDa, Emmy Graber MD MBAb, Julie C. Harper MDc, Andrew F. Alexis MDd, Linda Stein Gold MDe, Leon Kircik MDf, James Del Rosso DOg, Adelaide A. Hebert MDh, Evan A. Rieder MDi, Richard G. Fried MD PhDj, Siva Narayanan PhDk, Volker Koscielny MDl, Ismail Kasujee PhDl

aAcne Treatment and Research Center, Brooklyn, NY
bThe Dermatology Institute of Boston and Northeastern University, Boston, MA
cThe Dermatology and Skin Care Center of Birmingham, Birmingham, AL; dWeill Cornell Medical College, New York, NY
eHenry Ford Health System, Bloomfield, MI; fIcahn School of Medicine, Mount Sinai, New York, NY
gJDR Dermatology Research/Thomas Dermatology, Las Vegas, NV; hUTHealth McGovern Medical School, Houston, TX
iPrivate Practice, New York, NY; jYardley Dermatology Associates, Yardley, PA; kAvant Health LLC, Bethesda, MD; lAlmirall SA, Barcelona, Spain

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.

INTRODUCTION

Acne vulgaris (AV) is a complex, inflammatory, cutaneous disorder of the pilosebaceous unit that affects 9.4% of the global population,1,2 ranking it as the eighth most prevalent disease in the world.3 AV can persist into adulthood with 85% of impacted individuals being adolescents and young adults,4 and it has a higher prevalence among adult women than their male counterparts.5 More than 5.1 million Americans sought medical treatment for AV in 2013 with direct costs estimated to exceed 3 billion dollars.6 The condition is chronic, has a high potential for relapse and long-term sequelae, and its physical appearance contributes to the emotional and psychosocial burden of disease, impaired quality of life (QoL), low self-image,7 poor self-esteem, and increased social and emotional anxiety.8,9 Psychosocial impact on patients with AV is reported to be greater than that attributed to other dermatologic conditions (psoriasis and eczema)10 and equivalent to that for other debilitating conditions such as asthma, epilepsy, diabetes, or arthritis.11,12 Antibiotics have been a standard of care in treating AV for >5 decades.13,14 Oral antibiotics are recommended by the American Academy of Dermatology for the treatment of moderate and severe AV, and oral tetracyclines are used frequently for this condition. However, prolonged and repetitive use of broad-spectrum antibiotics, such as doxycycline and minocycline, have been associated with the development of antimicrobial resistance.15-19

Sarecycline is the first narrow-spectrum tetracycline-derived antibiotic approved by the US Food and Drug Administration (US FDA) for the treatment of inflammatory lesions of non-nodular moderate-to-severe AV, and it has a low potential to induce bacterial resistance.20-23 Two identically designed, pivotal, double-blind, randomized, placebo-controlled clinical trials demonstrated sarecycline to be efficacious and well-tolerated with a favorable safety profile.20 These studies assessed patient-reported outcomes (PROs) with the Skindex-16, and demon