INDIVIDUAL ARTICLE: Impact of Acne Vulgaris and Sarecycline on Social/Emotional Functioning and Daily Activities: PROSES Study

February 2024 | Volume 23 | Issue 2 | SF405634s5 | Copyright © February 2024


Published online January 31, 2024

Emmy Graber MD MBAa, Hilary E. Baldwin MDb, Richard G. Fried MD PhDc, Evan A. Rieder MDd, Adelaide A. Hebert MDe, James Del Rosso DOf, Leon Kircik MDg, Linda Stein Gold MDh, Julie C. Harper MDi, Andrew F. Alexis MDj, Siva Narayanan PhDk, Volker Koscielny MDl, Ismail Kasujee PhDl

aThe Dermatology Institute of Boston and Northeastern University, Boston, MA
bAcne Treatment and Research Center, Brooklyn, NY
cYardley Dermatology Associates, Yardley, PA; dPrivate Practice, New York, NY; eUT Health McGovern Medical School, Houston, TX;
fJDR Dermatology Research/Thomas Dermatology, Las Vegas, NV; gIcahn School of Medicine, Mount Sinai, New York, NY;
hHenry Ford Health System, Bloomfield, MI; iThe Dermatology and Skin Care Center of Birmingham, Birmingham, AL;
jWeill Cornell Medical College, New York, NY; kAvant Health LLC, Bethesda, MD; lAlmirall SA, Barcelona, Spain

Abstract
Background: Concise patient-reported outcome (PRO) instruments addressing the consequences of facial acne vulgaris (AV) on patients’ functioning and activities of daily living (ADL) are needed.
Methods: A 12-week, single-arm, prospective cohort study was conducted in patients ≥9 years old with moderate/severe non-nodular facial AV prescribed sarecycline as part of usual care. The primary endpoint included AV-specific patient- and caregiver-reported outcomes assessed with the expert panel questionnaire (EPQ, developed by 10 experts using a Delphi method) in patients (>12 years) and caregivers (for patients 9-11 years). Additional assessments included parental/caregiver perspectives on children’s AV.
Results: A total of 253 patients completed the study. Following 12-weeks of treatment, there were significant (P ≤.0001) changes from baseline in the proportion of patients responding that they never or rarely: felt angry (31.6%), worried about AV worsening (28.9%), had thoughts about AV (20.9%), had a certain level of worries about AV (38.7%), altered their social media/selfie activity (23.7%), had an impact on real-life plans due to AV (22.9%), made efforts to hide AV (21.3%), felt picked-on/judged due to AV (15.0%), were concerned about their ability to reach future goals due to AV (13.8%), or had sleep impacted due to AV (18.2%). No significant change from baseline was observed for parent/caregiver’s understanding of the child’s AV concerns, from both patient and parent/caregiver perspectives.
Conclusions: Over 12 weeks of AV management with oral sarecycline, patients reported significant reductions in AV-related effects on emotional/social functioning and ADL as measured by the EPQ, a simple PRO with potential for use in clinical practice.

J Drugs Dermatol. 2024;23:1(Suppl 1):s4-11.

INTRODUCTION

A cne vulgaris (AV) is a multifactorial inflammatory dermatosis of the pilosebaceous unit triggered by androgen-driven hyperseborrhea, follicular hyperkeratinization, hypercolonization of Cutibacterium acnes, and inflammation.1-3 It is the most common cutaneous disorder in the United States (US) and has an estimated global prevalence of 9.4%.4-8 Acne has significant morbidity associated with persistent scarring and psychosocial concerns that negatively affect quality of life (QoL), leading to low self-esteem and increased social and emotional anxiety.9-12 The psychosocial impact of AV is reported to be profound compared to other dermatologic diseases such as psoriasis and eczema.13 Patient-reported outcome (PRO) measures have become increasingly emphasized in clinical practice for determination of disease effects and its impact on patients’ and caregivers’ health-related QoL (HRQoL).14 Studies focused on these issues have shown that AV can adversely affect a patient’s mood, social/emotional functioning, activities of daily living (ADL), and general thoughts/worries about AV and their future goals.9,15,16 Patients and caregivers may also be concerned about side effects of treatment, particularly those associated with systemic therapies, such as broad-spectrum antibiotics.17-23 While several PROs have been developed for patients with acne, there remains a need for a targeted and concise list of questions for assessing the burden of AV.24 This study incorporated a new PRO, the expert panel questionnaire (EPQ), in a 12-week study of sarecycline, a narrow-spectrum tetracycline antibiotic, in patients with AV.

MATERIALS AND METHODS

Study Design
A 12-week single-arm prospective observational cohort study was carried out between March 2021 and May 2022 and enrolled 300 patients with AV who were administered sarecycline as part of usual care at one of 30 community US dermatology practices.

The study protocol was approved by the Advarra Institutional Review Board (SSU00149823 and SSU00150552). All participants provided written informed consent (assent, in the case of pediatric patients) prior to study initiation.
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