Deucravacitinib in Plaque Psoriasis: 3-Year Safety and Efficacy Results

April W. Armstrong¹, Mark Lebwohl², Richard B. Warren³, Howard Sofen⁴, Shinichi Imafuku⁵, Mamitaro Ohtsuki⁶, Lynda Spelman⁷, Thierry Passeron⁸, Kim A Papp⁹, Renata M. Kisa¹⁰, Victoria Berger¹⁰, Eleni Vritzali¹¹, Kim Hoyt¹⁰, Matthew J. Colombo¹⁰, Subhashis Banerjee¹⁰, Bruce Strober¹², Diamant Thaçi¹³ and Andrew Blauvelt¹⁴, ¹Keck School of Medicine of University of Southern California, Los Angeles, CA, ²Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, ³Dermatology Centre, Northern Care Alliance NHS Foundation Trust; NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom, ⁴University of California Los Angeles School of Medicine and Dermatology Research Associates, Los Angeles, CA, ⁵Fukuoka University Faculty of Medicine, Fukuoka, Japan, ⁶Jichi Medical University, Tochigi, Japan, ⁷Veracity Clinical Research, Brisbane, Australia, ⁸Université Côte d’Azur, University Hospital of Nice, Nice, France, ⁹Alliance Clinical Research and Probity Medical Research, Waterloo, and University of Toronto, Toronto, ON, Canada, ¹⁰Bristol Myers Squibb, Princeton, NJ, ¹¹Bristol Myers Squibb, Sissach, Switzerland, ¹²Yale University, New Haven, CT, ¹³Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany, ¹⁴Oregon Medical Research Center, Portland, OR

Meeting: ACR Convergence 2023

Keywords: Systemic lupus erythematosus (SLE)

Session Information

Date: Sunday, November 12, 2023

Title: (0252–0282) Miscellaneous Rheumatic & Inflammatory Diseases Poster I

Session Type: Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose: Deucravacitinib, a first-in-class, oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in multiple countries for the treatment of adults plaque psoriasis. Deucravacitinib was superior to placebo and apremilast in the global, 52-week, phase 3 POETYK PSO-1 (NCT03624127) and PSO-2 (NCT03611751) trials in plaque psoriasis and is currently being investigated in several immune-mediated diseases and has shown efficacy in phase 2 trials for SLE and PsA. Upon completion of the parent trials, patients could enroll in the POETYK long-term extension (LTE) trial (NCT04036435). In the present LTE analysis, we report safety and efficacy of deucravacitinib up to 3 years (week 148) through data cutoff (June 15, 2022).

Methods: PSO-1 and PSO-2 randomized patients 1:2:1 to oral placebo, deucravacitinib 6 mg once daily (QD), or apremilast twice daily. At week 52, POETYK PSO-1 and PSO-2 patients enrolled in the LTE trial received open-label deucravacitinib 6 mg once daily. Safety was evaluated in patients who received ≥ 1 dose of deucravacitinib via exposure-adjusted incidence rate (EAIR) per 100 person-years (PY). Efficacy outcomes included ≥ 75%/≥ 90% reduction from baseline in Psoriasis Area and Severity Index (PASI 75/90) and static Physician’s Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with a ≥ 2-point improvement from baseline. Efficacy was reported using modified nonresponder imputation (mNRI) in patients who received continuous deucravacitinib treatment from day 1 of the parent trial and were enrolled and treated in the LTE trial. As-observed results by treatment failure rule imputation were also analyzed.

Results: 1519 patients received ≥ 1 dose of deucravacitinib, with 513 patients receiving continuous deucravacitinib treatment from day 1 in PSO-1/PSO-2 and who were treated in the LTE trial. Cumulative exposure from parent trial randomization was 3294.3 PY for these safety analyses. EAIRs/100 PY were similar, or decreased, from the 2- to 3-year cumulative period, respectively, for adverse events (AEs) (154.4to 144.8), serious AEs (6.1 to 5.5), discontinuation due to AEs (2.8 to 2.4), herpes zoster (0.7 to 0.6), malignancies (0.9 to 0.9), major adverse cardiovascular events (0.4 to 0.3), venous thromboembolism (0.1 to 0.1), and deaths (0.4 to 0.3). Clinical response rates were maintained at week 148 by mNRI (PASI 75, 73.2% [95% CI, 68.7–77.8]; PASI 90, 48.1% [95% CI, 43.2–53.1]; sPGA 0/1, 54.1% [95% CI, 49.1–59.1]), with similar results regardless of data imputation methodology.

Conclusion: Deucravacitinib demonstrated a consistent safety profile through 3 years with no increases in AE or serious AE rates over time and no emergence of new or long-term safety signals. Efficacy was sustained through 3 years in patients treated continuously with deucravacitinib from day 1 in the parent trials. Since it is important to provide long-term safety for this new class of drugs, these findings provide additional support for deucravacitinib having a consistent safety profile and durable efficacy for up to 3 years of use in patients with plaque psoriasis.

Disclosures: A. Armstrong: AbbVie, 5, Almirall, 1, 6, Arcutis, 1, 6, Aslan Pharmaceuticals, 1, 1, 6, 6, Beiersdorf, 1, 6, Boehringer Ingelheim/Parexel, 12, Personal fees, Bristol-Myers Squibb(BMS), 5, Celgene, 12, Personal fees, Dermavant, 1, 6, 12, Personal fees, Dermira, 1, 5, 6, Eli Lilly, 5, EPI Health, 1, 6, Genentech, 12, Personal fees, GSK, 12, Personal fees, Incyte, 1, 6, Janssen, 5, Kyowa Kirin, 5, Leo Pharma, 5, Lilly, 1, 6, Menlo Therapeutics, 12, Personal fees, Merck, 12, Personal fees, Mindera Health, 1, 6, Modernizing Medicine, 12, Personal fees, Nimbus, 1, 6, Novartis, 5, Ortho Dermatologics, 12, Personal fees, Pfizer, 12, Personal fees, Regeneron, 12, Personal fees, Sanofi Genzyme, 12, Personal fees, Science 37, 12, Personal fees, Sun, 1, 6, Sun Pharma, 12, Personal fees, UCB, 5, Valeant, 12, Personal fees; M. Lebwohl: Mark Lebwohl is an employee of Mount Sinai and receives research funds fromAbbvie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Cara therapeutics,, 2; R. Warren: AbbVie, 2, 5, 6, Almirall, 2, 5, 6, Amgen, 2, 5, 6, Arena, 2, 6, Astellas, 2, 6, Avillion, 2, 6, Biogen, 2, 6, BMS, 2, 6, Boehringer Ingelheim, 2, 6, Celgene, 2, 5, DiCE, 6, Eli Lilly, 2, 5, 6, GSK, 2, 6, Janssen, 2, 5, 6, LEO Pharma, 2, 5, 6, Novartis, 2, 5, 6, Pfizer, 2, 5, 6, Sanofi, 2, 6, Sun Pharma, 6, UCB Pharma, 2, 5, 6, Union, 6; H. Sofen: AbbVie/Abbott, 5, Amgen, 5, Boehringer-Ingelheim, 5, Bristol-Myers Squibb(BMS), 1, 2, Eli Lilly, 5, UCB, 5; S. Imafuku: AbbVie, 5, Amgen (Celgene), 12, Personal fees, Boehringer Ingelheim, 12, Personal fees, Bristol Myers Squibb, 12, Personal fees, Daiichi Sankyo, 12, Personal fees, Eisai, 5, Eli Lilly, 12, Personal fees, GSK, 12, Personal fees, Janssen, 5, Kyowa Kirin, 5, Leo Pharma, 5, Maruho, 5, Novartis, 12, Personal fees, Sun Pharma, 5, Taiho Yakuhin, 5, Tanabe Mitsubishi, 5, Torii Yakuhin, 5, UCB, 12, Personal fees; M. Ohtsuki: AbbVie, 5, 6, Amgen, 5, 6, Boehringer-Ingelheim, 5, 6, Bristol Myers Squibb, 5, 6, Celgene, 5, 6, Eisai, 5, 6, Eli Lilly, 5, 6, Janssen, 5, 6, Kyowa Kirin, 5, 6, Leo Pharma, 5, 6, Maruho, 5, 6, Mitsubishi Tanabe Pharma, 5, 6, Nichi-Iko, 5, 6, Nippon Kayaku, 5, 6, Novartis, 5, 6, Pfizer, 5, 6, Sanofi, 5, 6, Sun Pharma, 5, 6, Taiho Pharmaceutical, 5, 6, Torii Pharmaceutical, 5, 6, UCB, 5, 6; L. Spelman: AbbVie, 1, 2, 6, Amgen, 2, 6, 12, Investigator, Anacor, 2, 6, 12, Investigator, Astellas, 2, 6, 12, Investigator, AstraZeneca, 2, 6, 12, Investigator, Blaze Bioscience, 2, 6, 12, Investigator, Boehringer-Ingelheim, 2, 6, 12, Investigator, Botanix, 2, 6, 12, Investigator, Bristol Myers Squibb, 2, 6, 12, Investigator, Celgene, 2, 6, 12, Investigator, Dermira, 2, 6, 12, Investigator, Eli Lilly, 2, 6, 12, Investigator, Galderma, 2, 6, 12, Investigator, Genentech, 2, 6, 12, Investigator, GSK, 2, 6, 12, Investigator, Hexima, 2, 6, 12, Investigator, Janssen, 2, 6, 12, Investigator, Leo Pharma, 2, 6, 12, Investigator, Mayne Pharma, 2, 6, 12, Investigator, MedImmune, 2, 6, 12, Investigator, Merck, 2, 6, 12, Investigator, Merck-Serono, 2, 6, 12, Investigator, Novartis, 2, 6, 12, Investigator, Otsuka, 2, 6, 12, Investigator, Pfizer, 2, 6, 12, Investigator, Phosphagenics, 2, 6, 12, Investigator, Photon MD, 2, 6, 12, Investigator, Regeneron, 2, 6, 12, Investigator, Roche, 2, 6, 12, Investigator, Samumed, 2, 6, 12, Investigator, Sanofi Genzyme, 2, 6, 12, Investigator, SHR Pharmacy, 2, 6, 12, Investigator, Sun Pharma ANZ, 2, 6, 12, Investigator, Trius, 2, 6, 12, Investigator, UCB, 2, 6, 12, Investigator, Zai Lab, 2, 6, 12, Investigator; T. Passeron: AbbVie/Abbott, 2, 6, Amgen, 6, Boehringer-Ingelheim, 6, Bristol-Myers Squibb(BMS), 1, 5, 6, Celgene, 6, Eli Lilly, 1, 6, Janssen, 1, 6, Novartis, 1, 6, Pfizer, 6, UCB, 1, 5, 6; K. Papp: AbbVie, 1, 2, 5, 6, Akros, 1, 2, 5, 6, Amgen, 1, 2, 5, 6, Anacor, 1, 2, 5, 6, Arcutis, 1, 2, 5, 6, Astellas, 1, 2, 5, 6, Bausch Health/Valeant, 1, 2, 5, 6, Baxalta, 1, 2, 5, 6, Boehringer-Ingelheim, 1, 2, 5, 6, Bristol-Myers Squibb, 1, 2, 5, 6, Can-Fite Biopharma, 1, 2, 5, 6, Celgene, 1, 2, 5, 6, Coherus, 1, 2, 5, 6, Dermira, 1, 2, 5, 6, Dow Pharma, 1, 2, 5, 6, Eli Lilly, 1, 2, 5, 6, Evelo, 1, 2, 5, 6, Forward Pharma, 5, Galapagos, 1, 2, 5, 6, Galderma, 1, 2, 5, 6, Genentech, 1, 2, 5, 6, Gilead, 1, 2, 5, 6, GlaxoSmithKlein, 1, 2, 5, 6, Janssen, 1, 2, 5, 6, Kyowa-Hakko Kirin, 1, 2, 5, 6, LEO Pharma, 1, 2, 5, 6, MedImmune, 1, 2, 5, 6, Meiji Seika Pharma, 1, 2, 5, 6, Merck-Serono, 1, 2, 5, 6, Mitsubishi Pharma, 1, 2, 5, 6, Moberg Pharma, 1, 2, 5, 6, MSD, 1, 2, 5, 6, Novartis, 1, 2, 5, 6, Pfizer, 1, 2, 5, 6, PRCL Research, 1, 2, 5, 6, Regeneron, 1, 2, 5, 6, Roche, 1, 2, 5, 6, Sanofi-Aventis/Genzyme, 1, 2, 5, 6, Sun Pharma, 1, 2, 5, 6, Takeda, 1, 2, 5, 6, UCB, 1, 2, 5, 6; R. Kisa: Bristol-Myers Squibb(BMS), 3, 12, Shareholder; V. Berger: Bristol-Myers Squibb(BMS), 3, 11; E. Vritzali: None; K. Hoyt: Bristol-Myers Squibb(BMS), 2; M. Colombo: Bristol-Myers Squibb(BMS), 3, 11; S. Banerjee: Bristol-Myers Squibb(BMS), 3, 11; B. Strober: AbbVie, 6, 6, Alamar, 6, Almirall, 6, Alumis, 6, Amgen, 6, Arcutis, 6, 6, Arena, 6, Aristea, 6, Asana, 6, Boehringer Ingelheim, 6, Bristol Myers Squibb, 12, Consultancy honoraria, Connect Biopharma, 6, 11, CorEvitas, 6, CorEvitas Psoriasis Registry, 12, Scientific Co-Director (consulting fee), 12, Investigator, Dermavant, 6, 6, Dermira, 12, Investigator, Eli Lilly, 6, 6, Evelo Biosciences, 6, Immunic Therapeutics, 6, Incyte, 6, Janssen, 6, 6, Journal of Psoriasis and Psoriatic Arthritis, 6, Leo, 6, Maruho, 6, Meiji Seika Pharma, 6, Mindera Health, 6, 11, Novartis, 6, Pfizer, 6, Protagonist, 6, Regeneron, 6, 6, Sanofi-Genzyme, 6, 6, Sun Pharma, 6, UCB Pharma, 6, Union Therapeutics, 6, Ventyxbio, 6, vTv Therapeutics, 6; D. Thaçi: AbbVie, 1, 2, 5, 12, Investigator, Almirall, 1, 2, 12, Investigator, Amgen, 1, 2, 12, Investigator, Boehringer-Ingelheim, 1, 2, 12, Investigator, Bristol-Myers Squibb(BMS), 1, 2, 12, Investigator, Celltrion, 1, 2, 12, Investigator, Eli Lilly, 1, 2, 12, Investigator, Galapagos, 1, 2, 12, Investigator, Galderma, 1, 2, 5, 12, Investigator, Janssen-Cilag, 1, 2, 12, Investigator, LEO Pharma, 1, 2, 5, 12, Investigator, Novartis, 1, 2, 5, 12, Investigator, Pfizer, 1, 2, 12, Investigator, Regeneron, 1, 2, 12, Investigator, Samsung, 1, 2, 12, Investigator, Sandoz, 1, 2, 12, Investigator, Sanofi, 1, 2, 12, Investigator, Target-Solution, 1, 2, 12, Investigator, UCB, 1, 2, 12, Investigator; A. Blauvelt: AbbVie/Abbott, 5, 6, Abcentra, 6, Acelyrin, 12, Clinical study investigator, Aclaris, 6, Affibody, 6, Aligos, 6, Allakos, 12, Clinical study investigator, Almirall, 6, Alumis, 6, Amgen, 5, 6, Anaptysbio, 6, Apogee, 6, Arcutis, 5, 6, Arena, 6, Aslan, 6, Athenex, 5, 6, 12, Clinical study investigator, Bluefin, 6, Boehringer-Ingelheim, 5, 6, Bristol-Myers Squibb(BMS), 5, 6, Cara Therapeutics, 6, Concert, 12, Clinical study investigator, CTI Biopharma, 6, Dermavant, 5, 6, EcoR1, 6, Eli Lilly, 5, 6, Escient, 6, Evelo, 6, Evommune, 6, Forte, 6, Galderma, 5, 6, Highlightll Pharma, 6, Incyte, 5, 6, InnoventBio, 6, Janssen, 5, 6, Landos, 6, Leo, 5, 6, Merck/MSD, 5, 6, Novartis, 5, 6, Pfizer, 5, 6, Rani, 6, Rapt, 6, Regeneron, 5, 6, Sanofi Genzyme, 6, Spherix Global Insights, 6, Sun Pharma, 5, 6, TLL Pharmaceutical, 6, TrialSpark, 6, UCB, 5, 5, 6, 6, Union, 6, Ventyx, 6, Vibliome, 6, Xencor, 6.

To cite this abstract in AMA style:

Armstrong A, Lebwohl M, Warren R, Sofen H, Imafuku S, Ohtsuki M, Spelman L, Passeron T, Papp K, Kisa R, Berger V, Vritzali E, Hoyt K, Colombo M, Banerjee S, Strober B, Thaçi D, Blauvelt A. Deucravacitinib in Plaque Psoriasis: 3-Year Safety and Efficacy Results [abstract]. Arthritis Rheumatol. 2023; 75 (suppl 9). https://acrabstracts.org/abstract/deucravacitinib-in-plaque-psoriasis-3-year-safety-and-efficacy-results/. Accessed .

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