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. Hudgens S, Harper JC, Daniels SR, et al. J Drugs Dermatol. 2015; 14(6):552-9. Sponsored by Almirall, S.A. REFERENCES Emmy Graber,1 Hilary Baldwin,2 Julie C. Harper,3 Linda Stein Gold,4 Ayman Grada,5 Andrew F. Alexis,6 Adelaide Hebert,7 Richard G. Fried,8 Evan A Rieder,9 James Del Rosso,10 Siva Narayanan,11 Volker Koscielny,12 Ismail Kasujee, 12 Leon Kircik13 1The Dermatology Institute of Boston and Northeastern University, Boston, MA; 2Acne Treatment and Research Center, Brooklyn, NY; 3The Dermatology and Skin Care Center of Birmingham, Birmingham, AL; 4Henry Ford Health System, Bloomfield, MI; 5Department of Dermatology, Case Western Reserve University School of Medicine, Cleveland, OH; 6Weill Cornell Medical College, New York, NY; 7UTHealth McGovern Medical School, Houston, TX; 8Yardley Dermatology Associates, Morrisville, PA; 9New York University Grossman School of Medicine, New York, NY; 10JDR Dermatology Research/Thomas Dermatology, Las Vegas, NV; 11Avant Health LLC, Bethesda, MD; 12Almirall SA, Barcelona, Spain; 13Icahn School of Medicine, Mount Sinai, New York, NY. PATIENT REPORTED OUTCOMES AND INVESTIGATOR GLOBAL ASSESSMENT OF ACNE VULGARIS AMONG PATIENTS WITH MODERATE TO SEVERE NON-NODULAR ACNE VULGARIS ADMINISTERED SARECYCLINE IN REAL-WORLD COMMUNITY PRACTICES ACROSS THE U.S. (PROSES STUDY) 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 (U.S).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 also been associated with considerable negative psychosocial impact, causing significant negative effects on self-image.5 • Sarecycline is a newer oral tetracycline class of 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 patient reported outcomes (PROs) and clinical effectiveness (in terms of Investigator Global Assessment (IGA) of acne) among patients in real-world setting is important to inform HCPs and Payers to aid their clinical and reimbursement decisions, respectively. BACKGROUND CONCLUSIONS • Patients with moderate to severe acne using sarecycline reported a statistically significant improvement in acne symptoms, and social/emotional impact, as measured by validated ASIS questionnaire. • Majority of acne patients had significant reduction in acne severity, and majority (58.9%) had IGA success at week-12. • Overwhelming majority of physicians (88.1%) were satisfied/very satisfied with sarecycline outcomes. • Assessing the impact of sarecycline treatment on acne patient outcomes, including patient QoL, in real-world community practice settings highlights the humanistic and clinical benefits associated this narrow-spectrum antibiotic treatment option. 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. • Primary outcome measures included validated Acne Symptom and Impact Scale (ASIS) questionnaire responses (from subjects (>12 years) and caregivers (for subjects 9-11 years) at week-12 and corresponding change from baseline (CFB). • ASIS is a 17-item validated instrument that asks patients about the signs and impact of acne on emotional and social wellbeing and is a viable tool to assess disease burden and treatment outcomes.7 • ASIS contains Signs domain (items 1-9) and Impact domain (emotional (items 10-15) & social (items 16-17)); all items are scored on a five-point adjectival response scale (score 0-4); higher scores indicate severe symptoms or negative impact of Acne. • Secondary outcome measure was physician-reported facial IGA collected on a five-point adjectival response scale (score 0 (clear) - 4 (severe)). IGA success was assessed as >2-grade improvement in IGA and a score 0 [clear] or 1 [almost clear] at week-12. • Last observation carried forward (LOCF) imputation was considered for imputing missing data for the calculation of IGA success: however, there was no missing data at week-12, within the analytic population. • Physician satisfaction with sarecycline outcome at individual patient- level was also assessed at week-12. OBJECTIVE • To evaluate PROs in terms of self-perceived acne signs and impact of acne on emotional/social functioning, and evaluate IGA success at Week- 12, among acne patients administered sarecycline, in community practices across the U.S. RESULTS • A total of 253 acne patients completed the study. • Pediatric (9-17 years): 39.92%; adults (>18 years): 60.08%. • Male: 33.60%; Female: 66.40%. • White: 68.39%; African-American: 9.88%; Asian: 7.11%. • A statistically significant increase in patients with clear or almost clear acne at week-12 (baseline: 0%, week-12: 58.90%; p<0.0001). Correspondingly, IGA success was observed in majority (58.90%) of acne patients at week-12. • A statistically significant reduction in patients with moderate/severe acne at week-12 (baseline: 100%, week-12: 11.10%; p<0.0001). RESULTSRESULTS N=253 for all items. In comparison to baseline: *p<0.0001; ^p<0.0001; **p=0.0006; ***p=0.0001; ^^ p=0.0101. ASIS - Signs Domain 44.3% 36.0% 19.8% 64.8%* 26.1% 9.1%** 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 A1: How oily is your face right now? 13.0% 34.4% 52.6% 63.6%* 22.1% 14.2%^ 0.0% 100.0% None/A few Some Quite a bit/a lot P ro po rti on o f p at ie nt s Baseline 12 weeks A2: How many pimples do you have on your face right now? 34.8% 26.5% 38.7% 57.7%* 21.0% 21.3%^ 0.0% 100.0% None/A few Some Quite a bit/a lot P ro po rti on o f p at ie nt s Baseline 12 weeks A3: How many acne scars (holes or indents) do you have on your face right now? 62.5% 21.3% 16.2% 83.0%* 11.5% *** 5.5% 0.0% 100.0% None/A few Some Quite a bit/ a lot P ro po rti on o f p at ie nt s Baseline 12 weeks A4: How many scabs from acne do you have on your face right now? 43.9% 25.3% 30.8% 66.8%* 18.2% 15.0%^ 0.0% 100.0% None/ A few Some Quite a bit/A lot P ro po rti on o f p at ie nt s Baseline 12 weeks A5: How many dark marks from acne do you have on your face right now? 38.3% 29.3% 32.4% 73.1%* 17.0% 9.9%^ 0.0% 100.0% None/ A few Some Quite a bit/ A lot P ro po rti on o f p at ie nt s Baseline 12 weeks A6: How many blackheads do you have on your face right now? 53.8% 26.9% 19.4% 85.4%* 10.3% 4.4%^ 0.0% 100.0% None/A few Some Quite a bit/ A lot P ro po rti on o f p at ie nt s Baseline 12 weeks A7: How many whiteheads do you have on your face right now? 31.2% 34.0% 34.8% 63.6%* 22.5% 13.8%^ 0.0% 100.0% None/A few Some Quite a bit/ A lot P ro po rti on o f p at ie nt s Baseline 12 weeks A8: How much redness do you have on your face right now? 4.7% 20.6% 74.7% 59.3%* 28.1% 12.7%^ 0.0% 100.0% Clear/ Almost Clear Mild Moderate/ Severe P ro po rti on o f p at ie nt s Baseline 12 weeks A9: Overall, how is the acne on your face right now? 2.4% 11.5% 86.2% 37.2%* 34.8% 28.1%^ 0.0% 100.0% Excellent/ Very Good Good Fair/Bad P ro po rti on o f p at ie nt s Baseline 12 weeks A10: Over the past 7 days, rate how your face looked because of your acne? 31.2% 34.0% 34.8% 70.8%* 24.5% 4.7%^ 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 A11: Over the past 7 days, how often did you feel sad because of the acne on your face? 28.9% 32.4% 38.7% 71.2%* 20.2% 8.7%^ 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 A12: Over the past 7 days, how often did you feel embarrassed because of the acne on your face? 23.3% 30.0% 46.6% 68.0%* 20.6% 11.5%^ 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 A13: Over the past 7 days, how often did you feel self- conscious because of the acne on your face? 12.7% 25.7% 61.7% 51.4%* 31.2% 17.4%^ 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 A14: Over the past 7 days, how often did you annoyed because of the acne on your face? 30.0% 30.4% 39.5% 65.6%* 23.7% 10.7%^ 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 A15: Over the past 7 days, how often did you feel not confident because of the acne on your face? 64.4% 18.6% 17.0% 89.3%* 7.1% 3.6%^ 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 A16: Over the past 7 days, how often did you choose not to be around other people? 77.5% 16.6% 5.9% 93.7%* 4.7% 1.6%^^ 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 A17: Over the past 7 days, how often did someone make bad comments about the acne on your face? ASIS - Impact domain: Emotional Impact Subscale ASIS - Impact domain: Social Impact Subscale 2.0 2.1 2.4 1.0 1.2 1.1 1.3 0.4 0.0 1.0 2.0 3.0 4.0 Signs Impact Emotional Subscale (Impact) Social Subscale (Impact) M ea n A S IS s co re Baseline Week 12 N= 253. Impact domain includes Emotional and Social impact subscales. CFB: Change from baseline to Week-12. *P <0.0001 Mean ASIS scores significantly decreased over the 12-week sarecycline treatment period CFB: - 0.77* CFB: - 1.01* CFB: - 1.15* CFB: - 0.60* 88.10% 6.70% 3.10% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Very Satisfied/Satisfied Neutral Dissatisfied/Very Dissatisfied N=253. For majority of acne patients, physicians were very satisfied or satisfied with sarecycline treatment outcomes at week-12 P ro po rti on o f p at ie nt s Acne severity (by IGA) decreased significantly over the 12-week sarecycline treatment period 0.00% 100.00% 58.90%* 11.10%* 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% IGA 0 or 1 IGA 3 or 4 Baseline Week 12 P ro po rti on o f p at ie nt s N=253. *P<0.0001. Patient’s individual acne signs and social/emotional impact significantly improved over the 12-week sarecycline treatment period