PowerPoint Presentation Primary outcome: Modified sPGA-G response (score 0 [clear] or 1 [almost clear] with a ≥ 2-point reduction from baseline) to assess genital psoriasis severity at week 16 Presented at: Winter Clinical Dermatology Conference - Hawaii 2023; January 13–18, 2023; HI, USA © 2023 Amgen Inc. Efficacy and Safety of Apremilast in Patients With Genital Psoriasis: Results From the Phase 3, Randomized, Placebo-Controlled, Double-blind DISCREET Study Joseph F. Merola, MD, MMSc1; Lawrence Charles Parish, MD, MD (Hons)2; Lyn Guenther, MD3; Charles Lynde, MD4,5; Jean-Philippe Lacour, MD6; Petra Staubach, MD7; Sue Cheng, MD, PhD8; Shauna Jardon, PharmD8; Maria Paris, MD8; Mindy Chen, MS8; Kim Papp, MD, PhD9,10 What do we know? What did we do? What were our findings at week 16? Key takeaways Apremilast, the first oral treatment to be studied for genital psoriasis, significantly improved disease symptoms, including skin, itch, and QoL and was well-tolerated in patients who were inadequately controlled by or intolerant to medications applied to the skin For additional findings, scan the QR code 1Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA; 2Parish Dermatology, Philadelphia, PA, USA; 3Guenther Research Inc., London, ON, Canada; 4Lynde Institute for Dermatology, Markham, ON, Canada; 5Probity Medical Research, Markham, ON, Canada; 6CHU de Nice - Hôpital l'Archet, Nice, France; 7Department of Dermatology, University Medical Center, Mainz, Germany; 8Amgen Inc., Thousand Oaks, CA, USA; 9Probity Medical Research, Waterloo, ON, Canada; 10K Papp Clinical Research, Waterloo, ON, Canada Up to 63% of patients with psoriasis report genital psoriasis,1,2 which can lead to: • Itching • Discomfort • Impaired QoL • Negative impact on sexual health Patient population: • Genital psoriasis severity (modified sPGA-G) score ≥ 3 • Overall psoriasis severity (sPGA) score ≥ 3 • Nongenital plaque psoriasis on ≥ 1% of BSA • Intolerant to/or not controlled by medications applied to the skin for genital psoriasis Phase 3, multicenter study Week 36 1: 1 Fo llo w -u p Week 16 Placebo Apremilast Week 32 Apremilast Apremilast Week 0 143 patients 146 patients 289 patients randomized Key secondary outcomes: • sPGA response to assess overall psoriasis severity • GPI-NRS response to assess genital itch severity • Change from baseline in DLQI score to assess the impact of psoriasis on QoL at week 16 No new safety signals were identified, and adverse events were consistent with the known apremilast safety profile All outcomes at week 16 improved with apremilast vs placebo Apremilast, n = 143 70% male; mean age: 44 years Genital psoriasis duration: 11 years DLQI: 13.3 sPGA-G: 86% moderate; 14% severe Placebo, n = 146 70% male; mean age: 46 years Genital psoriasis duration: 12 years DLQI: 12.8 sPGA-G: 88% moderate; 12% severe Baseline characteristics were similar between treatment groups Apremilast, an oral immunomodulator, is approved in adults with psoriasis, psoriatic arthritis, and oral ulcers associated with Behçet’s disease References: 1. Ryan C, et al. J Am Acad Dermatol. 2015;72:978-983. 2. Meeuwis KAP, et al. J Dermatol Treat. 2018;29:754-760. Abbreviations: BSA, body surface area; DLQI, Dermatology Life Quality Index; GPI-NRS, Genital Psoriasis Itch Numeric Rating Scale; QoL, quality of life; sPGA, static Physician Global Assessment; sPGA-G, static Physician Global Assessment of Genitalia. Disclosures and Funding Statement: JFM: AbbVie, Amgen, Biogen, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharmaceuticals, and UCB – consultant and/or investigator. LCP: AbbVie, Alfasigma, Amgen, Amytrx, Eli Lilly, Bristol Myers Squibb, Fibrocell, Galderma, GlaxoSmithKline, Kiniksa, Olix, Oneness, Pfizer, Trevi, and UCB – investigator. LG: AbbVie, Amgen, Bausch Health, Bristol Myers Squibb, Celgene, Eli Lilly, Galderma, Janssen, LEO Pharma, Merck Frosst, Pfizer, Sun Pharmaceuticals, and UCB – consultant, investigator, and/or speaker. Amgen, Bausch, Eli Lilly, Janssen, LEO Pharma, Pfizer, and Sun Pharmaceuticals – speaker, consultant, and grant/research support. AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Galderma, Merck Frosst, and UCB Pharma – grant/research support. CL: AbbVie, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Sun Pharma, and Valeant – principal investigator/consultant. J-PL: AbbVie, Amgen, Boehringer Ingelheim, Dermira, Janssen, LEO Pharma, and Pfizer – grants and personal fees. Celgene, Galderma, Eli Lilly, Novartis and Sanofi – grant/research support. PS: AbbVie, ALLERGIKA, Almirall Hermal, Amgen, Beiersdorf, BioCryst, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, CSL Behring, Eli Lilly, Galderma, Hexal, Janssen, Klinge, LEO Pharma, LETI Pharma, L´Oreal, Neubourg, Novartis, Octapharma, Pfizer, Pflüger, Pharming, Regeneron, Shire, Takeda, Regeneron, Sanofi Genzyme, and UCB Pharma – grants. SC, SJ, MP, and MC: Amgen Inc. – employees and stockholders. KP: AbbVie, Actelion, Amgen, Astellas Pharma US, Boehringer Ingelheim, Bausch Health, Celgene Corporation, Dermira, Dow Pharmaceuticals, Eli Lilly, Frontier, Galderma, Janssen, Kyowa Hakko Kirin Pharma, LEO Pharma, MedImmune, Merck & Co., Inc., Novartis, Pfizer, Regeneron, Roche Laboratories, Sanofi Genzyme, Takeda Pharmaceuticals, UCB, and Valeant – honoraria, grants, and/or research funding as a speaker, investigator, advisory board member, data safety monitoring board member, and/or consultant; PSLOAR, PURE – steering committee member. This study was funded by Amgen Inc. Writing support was funded by Amgen Inc. and provided by Archana Patkar, PhD, of Cactus Life Sciences (part of Cactus Communications) and Dawn Nicewarner, PhD, CMPP, employee of and stockholder in Amgen Inc.. What was our aim? To evaluate the benefit, safety, tolerability, and effect on health-related QoL of apremilast in patients with moderate to severe genital psoriasis after 16 weeks of treatment in the DISCREET study (NCT03777436) Limited treatment options are available for patients with moderate to severe genital psoriasis 3x 2x 2x 2x Genital psoriasis severity (sPGA-G response rate) Overall psoriasis severity (sPGA response rate) Genital itch (GPI-NRS response rate) QoL (reduction in DLQI score from baseline) 38.7% vs 19.1% 21.5% vs 7.2% 46.0% vs 19.6% –5.3 vs –2.6 Apremilast Placebovs Slide Number 1