EPQ domain: Activities of Daily Living Richard G. Fried,1 Evan A Rieder,2 Andrew F. Alexis,3 Hilary Baldwin,4 Emmy Graber,5 Julie C. Harper,6 Linda Stein Gold,7 Adelaide Hebert,8 James Del Rosso,9 Leon Kircik,10 Ayman Grada,11 Siva Narayanan,12 Volker Koscielny,13 Ismail Kasujee13 1Yardley Dermatology Associates, Morrisville, PA; 2New York University Grossman School of Medicine, New York, NY; 3The Dermatology Institute of Boston and Northeastern University, Boston, MA; 4Acne Treatment and Research Center, Brooklyn, NY; 5Grada Dermatology Research LLC, Chesterbrook, PA; 6The Dermatology and Skin Care Center of Birmingham, Birmingham, AL; 7Weill Cornell Medical College, New York, NY; 8Henry Ford Health System, Bloomfield, MI; 9UTHealth McGovern Medical School, Houston, TX; 10JDR Dermatology Research/Thomas Dermatology, Las Vegas, NV; 11Icahn School of Medicine, Mount Sinai, New York, NY; 12Almirall SA, Barcelona, Spain; 13Avant Health LLC, Bethesda, MD. Presented at Fall Clinical Dermatology Conference, 2022 – October 19-23, 2022 – Las Vegas, NV • Acne Vulgaris, hereinafter referred to as acne, affects up to 50 million Americans and is the most common skin condition in the United States (US). 1 • Acne has been shown to negatively affect QoL; resulting in low self- esteem and increased social and emotional anxiety. 2,3 • Patients with acne report more effects of their skin condition on their functioning, emotions, and symptoms than do patients with isolated benign skin lesions or those in the normative sample. 4 • Acne has been associated with considerable psychosocial impact, causing significant negative effects on self-image, leading to feelings of isolation and loneliness, and a significantly lower self-attitude, uselessness feeling, sense of pride and self-worth, and body satisfaction. 5 • Sarecycline is a newer oral tetracycline-derived, narrow spectrum antibiotic, a first line therapy treatment for moderate to severe acne patients. Sarecycline is a viable option for acne patients to reduce disease burden, due to its safety profile and efficacy demonstrated in two identical Phase-III randomized controlled trials. 6 • Assessing PROs among patients in real-world setting is important to inform HCPs and patients to aid optimal disease management. BACKGROUND 1. Bickers DR, Lim HW, Margolis D, et al. J Am Acad Dermatol. 2006; 55:490-500. 2. Timms RM. Psychol Health Med. 2013; 18(3):310–320. 3. Revol O, Milliez N, Gerard D. Br J Dermatol. 2015; 172(Suppl 1):52–58. 4. Lasek RJ, Chren MM. Arch Dermatol. 1998; 134: 454-8. 5. Gieler U et al. JEADV. 2015; 29 (Suppl. 4):12–14. 6. Moore A, Green LJ, Bruce S, et al. J Drugs Dermatol. 2018 Sep 1;17(9):987-996. 7. Seite S et al. Clin Cosmet Investig Dermatol. 2012; 5:123–128. 8. Lafrance, M., Carey, R. S. Body & Society. 2018; 24(1-2), 55-87. Sponsored by Almirall, S.A. REFERENCES CONCLUSIONS • Acne related burden was pronounced at baseline. • Over the 12-week study period, patients reporting no/least acne burden increased significantly, while those reporting most/highest burden decreased significantly in emotional functioning, social functioning, and ADL domains among patients with moderate to severe acne who were administered sarecycline for 12 weeks. METHODS • Single-arm, prospective cohort study (PROSES) was conducted with moderate to severe non-nodular acne patients >9 years who were prescribed sarecycline in real-world community practices in the US. • A total of 300 subjects were enrolled from 30 community practices across the U.S. • Study primary outcome measures included responses to EPQ items (completed by subjects (>12 years) and caregivers (for subjects 9-11 years) at Week-12 and corresponding change from baseline (CFB)). • A 10-person consensus panel of eight dermatologists with expertise in the treatment of acne, one dermatologist/clinical psychologist and one dermatologist/psychiatrist was virtually convened using a three-step modified Delphi method to establish consensus on 11-item EPQ that relate to how acne impacts the patient’s mood, social interactions, general thoughts/worries about acne and one’s future goals, and impact on daily activities, including sleep. These recommendations were aligned with literature depicting the issues impacting acne patients.7,8 • EPQ consisted of three domains: emotional functioning (EPQ items 1-4), social functioning (EPQ items 5-7), and ADL (EPQ items 8-11). • All EPQ items were scored on a five-point adjectival response scale (0: never, not at all; 1: slightly, rarely, a little; 2: some of the time, somewhat, 3: most of the time, moderately, quite a bit; 4: all of the time, extremely, very much). • CFB in EPQ items was analyzed by evaluating the change in proportion of patients reporting score=0/1 (no/least impact) for EPQ items at Week-12, in comparison to baseline. OBJECTIVE • To evaluate patient-perceived impact of AV on emotional functioning, social functioning and activities of daily living (ADL), using a novel Expert Panel Questionnaire (EPQ), among Acne patients administered sarecycline in real-world community practices across the U.S. Patient’s Emotional and Physical Functioning and ADL significantly improved over the 12-week sarecycline treatment period In comparison to baseline: *p<0.0001; ^p<0.0001; **p=0.0009; ^^p=0.0005; #p=0.0042. N=253 for all items, except for EPQ10 which corresponded to only caregivers of pediatric patients, with N=101. EPQ domain: Social Functioning RESULTS • 253 patients with data at week-12 were included in the final analyses. CFB in proportion of patients reporting (never/rarely, not at all/slightly/a little) for EPQ items significantly improved over the 12-week sarecycline treatment period EPQ CFB p-value EPQ1 31.6% p<0.0001 EPQ2 28.9% p<0.0001 EPQ3 20.9% p<0.0001 EPQ4 38.7% p<0.0001 EPQ5 23.7% p<0.0001 EPQ6 22.9% p<0.0001 EPQ7 21.3% p<0.0001 EPQ8 15.0% p=0.0001 EPQ9 13.8% p=0.0005 EPQ10 1.0% p=0.8491 EPQ11 18.2% p<0.0001 RESULTS Patient Demographics (N=253) Demographic Group Proportion of Patients Age Group Pediatric (<18 yrs) 39.9% Adult (>18 yrs) 60.1% Gender Male 33.6% Female 66.4% Race White 68.4% Other 15.4% Black/African American 9.9% Asian 7.1% Prefer not to answer 3.2% Native Hawaiian/Pacific Islander 1.2% American Indian /Alaskan 0.8% • Proportion of patients reporting no/least acne burden (i.e., EPQ item scores of 0/1: (never/rarely; not at all/slightly) statistically significantly (p<0.001) increased at week-12 across all measures, except EPQ10. • Proportion of patients reporting high acne burden (i.e., EPQ item scores of 3/4: most of the time/all of the time) statistically significantly (p<0.001) decreased at week-12 across all measures, except EPQ10. IMPACT OF ACNE ON SOCIAL FUNCTIONING, EMOTIONAL FUNCTIONING, AND ACTIVITIES OF DAILY LIVING AMONG PATIENTS WITH MODERATE TO SEVERE NON-NODULAR ACNE VULGARIS ADMINISTERED SARECYCLINE IN REAL-WORLD COMMUNITY PRACTICES ACROSS THE U.S. (PROSES STUDY) 43.9% 35.2% 21.0% 75.5%* 16.6% 7.9%^ 0.0% 100.0% Never/Rarely Some of the time Most /All of the time P ro po rti on o f p at ie nt s Baseline 12 weeks EPQ1: Over the past 7 days, how often has your acne made you feel angry (mad/sad)? 20.6% 22.9% 56.5% 49.4%* 22.1% 28.5%^ 0.0% 100.0% Not at all/ Slightly Somewhat Moderately/ Extremely P ro po rti on o f p at ie nt s Baseline 12 weeks EPQ2: How worried are you about how long your acne will last and how bad it will get? 15.8% 34.8% 49.4% 36.8%* 41.9% 21.3%^ 0.0% 100.0% Never/ Rarely Some of the time Most/ All of the time P ro po rti on o f p at ie nt s Baseline 12 weeks EPQ3: How often do you think about your acne? 27.3% 26.1% 46.6% 66.0%* 22.1% 11.9%^ 0.0% 100.0% Not at all/ Slightly Somewhat Moderately/ Extremely P ro po rti on o f p at ie nt s Baseline 12 weeks EPQ4: Over the past 7 days, how worried have you been about your acne? 48.6% 18.6% 32.8% 72.3%* 15.0% 12.7%^ 0.0% 100.0% Never/ Rarely Some of the time Most/ All of the time P ro po rti on o f p at ie nt s Baseline 12 weeks EPQ5: How often do you change, edit, or filter your social media photo or selfie because of your acne? 55.3% 26.1% 18.6% 78.3%* 15.8% 5.9%^ 0.0% 100.0% Never/ Rarely Some of the time Most / All of the time P ro po rti on o f p at ie nt s Baseline 12 weeks EPQ6: How often does acne impact your “in real life” plans? 27.3% 24.5% 48.2%48.6%* 21.0% 30.4%^ 0.0% 100.0% Never/Rarely Some of the time Most/All of the time P ro po rti on o f p at ie nt s Baseline 12 weeks EPQ7: How often are you doing something to hide your acne? 73.1% 16.2% 10.7% 88.1%* 8.7% 3.2%** 0.0% 100.0% Never/Rarely Some of the time Most/All of the time P ro po rti on o f p at ie nt s Baseline 12 weeks EPQ8: How often do you feel picked on or judged because of your acne? 72.7% 13.0% 14.2% 86.6%* 8.3% 5.1%^^ 0.0% 100.0% P ro po rti on o f p at ie nt s Baseline 12 weeks EPQ9: How concerned are you that your acne will affect your ability to reach your future goals (in school or work) and be the best you can be? 15.8% 25.7% 58.4% 16.8% 20.8% 62.4% 0.0% 100.0% Not at all/A little Somewhat Quite a bit/Very Much P ro po rti on o f p at ie nt s Baseline 12 weeks EPQ10: Do you feel that your parents understand your acne- related concerns? 72.3% 18.2% 9.5% 90.5%* 6.3% 3.2%# 0.0% 100.0% Never/Rarely Some of the time Most /All of the time P ro po rti on o f p at ie nt s Baseline 12 weeks EPQ11: Over the past 7 days, how often has worrying about or discomfort (itching/hurting) from acne affected your sleep? EPQ domain: Emotional Functioning