FULL SUPPLEMENT: Looking Beyond the Skin, Examining the Patient and Clinician Reported Outcomes and Effects of Acne Vulgaris and Sarecycline Treatment

February 2024 | Volume 23 | Issue 2 | SF405634s1 | Copyright © February 2024


Published online January 28, 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 or older 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.
In this supplement:

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

Read the article here.


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

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. 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.

Read the article here.


Assessing the Impact of Acne and Its Treatment on Disease Burden and Quality of Life
It is well established that acne vulgaris (AV) is associated with high patient burden and an associated adverse impact on quality of life (QoL), and it is also recommended that patient-reported outcome measures (PROs) be employed for assessment of health-related QoL in both clinical studies and routine practice. Quality of life assessment is frequently included in registration studies of new acne treatments, but less often in real-world studies. Thus, there is an important unmet need to address the burden of acne and the effects of treatment in the real-world using well-designed PROs.

Read the article here.
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