AB0890 Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 Inhibitor, in Moderate to Severe Plaque Psoriasis: 52-Week Efficacy Results From the Phase 3 POETYK PSO-1 and POETYK PSO-2 Trials

Background Tyrosine kinase 2 (TYK2) is an intracellular that mediates signaling of key cytokines (eg, interleukin [IL]-23 and Type I interferons) involved in the pathogenesis immune-mediated diseases including plaque psoriasis psoriatic arthritis (PsA). Deucravacitinib a novel, oral, selective, allosteric inhibitor TYK2 achieves high selectivity by uniquely binding to regulatory domain enzyme, rather than more conserved active domain. showed superior efficacy compared with placebo at 16 weeks Phase trial patients PsA ( NCT03881059 ). Results from 16-week, placebo-controlled periods two 52-week, 3 trials (POETYK PSO-1 POETYK PSO-2) previously deucravacitinib was significantly efficacious apremilast based on coprimary endpoints ≥75% reduction baseline Psoriasis Area Severity Index (PASI 75) static Physician’s Global Assessment (sPGA) score 0 or 1 (clear almost clear) Week 16. Objectives To evaluate over 52 PSO-2 trials. Methods NCT03624127 ) NCT03611751 were double-blinded randomised moderate severe (body surface area involvement ≥10%, PASI ≥12, sPGA ≥3) 2:1:1 6 mg once daily, placebo, 30 twice daily. Patients receiving switched both received continuously through 52. included withdrawal phase which originally who had achieved 75 response 24 rerandomised 1:1 deucravacitinib, whereas those did not achieve continued deucravacitinib. The proportions achieving 0/1 responses evaluated up Secondary this period 90, 100, percentage change PASI, (clear), Symptoms Signs Diary (PSSD) symptom score, Dermatology Life Quality (DLQI) (no impact patient’s life). A total 666 1020 PSO-2, respectively. Demographic disease characteristics balanced across treatment groups; mean age 46.6 years, duration 18.6 18.4% PsA, 34.8% used biologic therapy. 75, 100 maintained (Figure 1). Additionally, during (sPGA 0/1: 53.6% 52.7%; 0: 17.5% 23.5%, respectively). demonstrated (68.3% 53.8%, respectively) comparable observed continuous Day (65.1% 52.7%, In among deucravacitinib-treated continue treatment, majority 80.4% [119/148]; 0/1, 70.3% [83/118]). for PSSD DLQI consistent reported responses. Conclusion psoriasis. Clinical improved treatment. Acknowledgements This study sponsored Bristol Myers Squibb. Professional medical writing assistance provided Julianne Hatfield, PhD Peloton Advantage, LLC, OPEN Health company, Parsippany, NJ, USA, funded Disclosure Interests Richard B. Warren Consultant of: Consulting fees: AbbVie, Almirall, Amgen, Biogen, Boehringer Ingelheim, Celgene, DiCE, Eli Lilly, Janssen, Leo Pharma, Novartis, Pfizer, Sanofi, UCB, UNION., Grant/research support from: Research grants: UCB;, April Armstrong Grants personal Squibb, Novartis; Personal Ingelheim/Parexel, Dermavant, Genentech, GlaxoSmithKline, Menlo Therapeutics, Merck, Modernizing Medicine, Ortho Dermatologics, Regeneron, Sanofi Genzyme, Science 37, Sun Valeant; Grants: Dermira, Kyowa Hakko Kirin, outside submitted work., Melinda Gooderham Advisory board, principal investigator, lecture Arcutis, Galderma, Regeneron; Principal investigator consulting Akros Pharma Kirin; fees, investigator: Aslan, MedImmune, Roche Laboratories, UCB., Bruce Strober (honoraria): Arena, Aristea, Asana, Immunic Connect Biopharma, Equillium, Maruho, Meiji Seika Mindera, Ventyxbio, vTv Therapeutics; Speaker: Genzyme; Co-Scientific Director (consulting fee): CorEvitas’ Registry; Investigator: Cara, Registry, Novartis., Diamant Thaçi Speakers bureau: Biogen Idec, DS Galapagos, Janssen-Cilag, Roche-Posay, Samsung, Sandoz-Hexal, Shinichi Imafuku Eisai, Taiho, Tanabe Mitsubishi, Torii, Yakuhin; Daiichi Sankyo, Howard Sofen Pharma., Lynda Spelman Consultant, paid and/or speaker: Anacor, Ascend, Astellas, AstraZeneca, Blaze Bioscience, Botanix, Hexima, Mayne, Medimmune, Merck-Serono, Otsuka, Phosphagenics, Photon MD, Roche, Samumed, SHR, Trius, Zai Lab., Neil J Korman Principia, UCB; Genzyme., Grant support/principal Argenx, Chemocentryx, Menlo, Prothena, Rhizen, Syntimmune, Trevi, Xbiotech., Min Zheng Lilly China, Novartis Xian-Janssen., Elizabeth Colston Shareholder Employee John Throup Sudeep Kundu Renata Kisa Subhashis Banerjee Employees shareholders: Andrew Blauvelt Scientific advisor clinical Abcentra, Aligos, Athenex, EcoR1, Evommune, Forte, Incyte, Landos, Rapt, Vibliome.