INTERNAL USE 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. Leyden JJ, Sniukiene V, Berk D, Kaoukhov A. J Drugs Dermatol. 2018 Mar 1;17(3):333-338 5. Moore A, Green LJ, Bruce S, et al. J Drugs Dermatol. 2018 Sep 1;17(9):987-996. Sponsored by Almirall, S.A. REFERENCES Emmy Graber,1 Hilary Baldwin,2 Andrew F. Alexis,3 James Del Rosso,4 Richard G. Fried,5 Julie C. Harper,6 Adelaide Hebert,7 Leon Kircik,8 Evan A Rieder,9 Linda Stein Gold,10 Siva Narayanan,11 Volker Koscielny,12 Ismail Kasujee12 1The Dermatology Institute of Boston and Northeastern University, Boston, MA; 2Acne Treatment and Research Center, Brooklyn, NY; 3Weill Cornell Medical College, New York, NY; 4JDR Dermatology Research/Thomas Dermatology, Las Vegas, NV; 5Yardley Dermatology Associates, Yardley, PA; 6The Dermatology and Skin Care Center of Birmingham, Birmingham, AL; 7UTHealth McGovern Medical School, Houston, TX; 8Icahn School of Medicine, Mount Sinai, New York, NY; 9New York University Grossman School of Medicine, New York, NY; 10Henry Ford Health System, Bloomfield, MI; 11Avant Health LLC, Bethesda, MD; 12Almirall SA, Barcelona, Spain. CLINICIAN SATISFACTION WITH TREATMENT OUTCOMES AMONG PATIENTS WITH MODERATE TO SEVERE NON-NODULAR ACNE VULGARIS (AV) ADMINISTERED SARECYCLINE IN COMMUNITY PRACTICES ACROSS THE U.S IN PROSES STUDY: ANALYSIS BY CONCOMITANT MEDICATION USE • Acne Vulgaris (AV), 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 patient functioning, emotions, and overall QoL. 2,3 • Recommended treatment for moderate to severe inflammatory AV are oral antibiotics. However, currently used tetracyclines like doxycycline and minocycline impose negative effects by disrupting the gastrointestinal microbiome thereby, making it challenging for patients to comply with therapy. 4 • 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.5 • Limited data are available on clinician satisfaction with AV treatment outcomes in general, and no such data is available corresponding to patients using sarecycline as monotherapy or in combination with other Av treatments, in the real-world. • Clinician satisfaction with sarecycline treatment outcomes (at individual patient-level) could complement clinical assessment of treatment effectiveness and could portray a full picture of value of AV treatments in the real-world. BACKGROUND CONCLUSIONS • Within the study cohort administered sarecycline, a narrow-spectrum, tetracycline- derived antibiotic, for 12 weeks, for majority of patients, clinicians were very satisfied/satisfied with sarecycline treatment outcomes at week-12, and clinician satisfaction was similar among patients on sarecycline monotherapy and those on concomitant AV medications. METHODS • A single-arm, prospective cohort study (PROSES) was conducted with moderate-to-severe non-nodular AV 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. • Patients and clinicians completed surveys and clinical assessments at baseline and weeks 4, 8 & 12. • Clinician satisfaction with sarecycline treatment outcomes was assessed at week-12, on a five-point adjectival response scale (1 (very dissatisfied)-5 (very satisfied)). • Proportion of patients for whom clinicians reported very satisfied/satisfied was analyzed at week-12, as observed, for the overall study cohort, as well as stratified by the use of any concomitant AV medication during the study (Yes vs. No (monotherapy)). OBJECTIVE The objective of this analysis was to evaluate clinician satisfaction with treatment outcomes, stratified by the use or non-use of concomitant acne medications, among AV patients administered sarecycline in community practices across the U.S. RESULTS Table 1: Patient Baseline Characteristics N=253 Age Group, % Pediatric (<18 yrs) 39.92 Adult (≥18 yrs) 60.08 Age Group, Mean yrs Pediatric (<18 yrs) 14.81 Adult (≥18 yrs) 26.63 Gender, % Male 33.60 Female 66.40 Race,% White 66.80 Other 15.81 Black/African American 9.88 Asian 5.93 Prefer not to answer 3.16 American Indian or Alaskan 0.79 Native Hawaiian/Pacific Islander 0.40 Ethnicity,% (Hispanic, Latino or of Spanish Origin) Yes 33.99 No 66.01 Baseline IGA, % Moderate 86.56 Severe 13.44 88.98% 87.30% 11.02% 12.70% 0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 90.00% 100.00% Sarecycline Combination Therapy (N=127) Sarecycline Monotherapy (N=126) P ro po rti on o f P at ie nt s Figure 2: Regardless of Concomitant Medication Use, for Majority of Patients, Clinicians Were “Very Satisfied / Satisfied” with Sarecycline Outcomes at Week-12 Very Satisfied/Satisfied Other N=253 Note: 0.00% of clinicians rated “very dissatisfied” with sarecycline at week-12. • A total of 253 AV patients completed the study surveys at week-12 and included in the analyses. • Proportion of patients with moderate/severe facial acne (per IGA scores) at baseline was 100%. At week-12, patients with moderate/severe acne significantly reduced to 11.10% (p<0.0001). • For the overall cohort, for 88.14% of patients, clinicians were ‘very satisfied/satisfied’ with sarecycline treatment outcomes, at week-12 (Figure 1). 0.00% 5.14% 6.72% 37.55% 50.59% 0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% Very Dissastified Dissatisfied Neutral Sastisfied Very Satisfied P ro po rti on o f P at ie nt s Figure 1: For Majority of Patients, Clinicians Were “Very Satisfied / Satisfied” with Sarecycline Outcomes at Week-12 88.14% N=253 Table 2: Concomitant Medication Use N=253 Has not used any acne medication, % 49.80 Topical medication, % Topical retinoids 24.51 Salicylic acid 1.19 Benzoyl peroxide 5.93 Topical antibiotics 13.44 Topical Dapsone 5.14 Azelaic acid 2.77 Topical Clascoterone 0.79 Other* 17.00 Oral Medication^, % 4.74 *11.07% were on adapalene/benzoyl peroxide; ^4.35% were on spironolactone.