Deucravacitinib Long-term Efficacy Through 4 Years in Week 16 Placebo Crossover Patients in the Phase 3 POETYK PSO-1, PSO-2, and LTE Program

Mark Lebwohl¹, Richard Warren², Shinichi Imafuku³, Jerry Bagel⁴, April W. Armstrong⁵, Thierry Passeron⁶, Subhashis Banerjee⁷, Renata M. Kisa⁸, Matthew J. Colombo⁷, Thomas Scharnitz⁸, Kim Hoyt⁸, Diamant Thaçi⁹ and Andrew Blauvelt¹⁰, ¹Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, ²Dermatology Centre, Northern Care Alliance NHS Foundation Trust and NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom, ³Fukuoka University Hospital Faculty of Medicine, Fukuoka, Japan, ⁴Psoriasis Treatment Center of New Jersey, East Windsor, ⁵University of California Los Angeles, Los Angeles, ⁶Université Côte d’Azur, University Hospital of Nice, Nice, France, ⁷Bristol Myers Squibb, Princeton, NJ, ⁸Bristol Myers Squibb, Princeton, ⁹Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Schleswig-Holstein, Germany, ¹⁰Oregon Medical Research Center, Portland, OR

Meeting: ACR Convergence 2024

Keywords: clinical trial, Cutaneous, Outcome measures, Randomized Trial, skin

Session Information

Date: Saturday, November 16, 2024

Title: Miscellaneous Rheumatic & Inflammatory Diseases Poster I

Session Type: Poster Session A

Session Time: 10:30AM-12:30PM

Background/Purpose: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US, EU, and other countries for treatment of adults with moderate to severe plaque psoriasis. Deucravacitinib was efficacious and well tolerated in 2 global, 52-week, phase 3 POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) parent trials and through 2 additional years in the POETYK long-term extension (LTE) (NCT04036435) trial in patients treated with deucravacitinib from day 1 of PSO-1/PSO-2. Here, long-term efficacy was assessed through 4 years in patients who crossed over from placebo to deucravacitinib at week 16 in PSO-1 or PSO-2 and entered the LTE trial.

Methods: PSO-1 and PSO-2 randomized patients 1:2:1 to oral placebo, deucravacitinib 6 mg once daily, or apremilast 30 mg twice daily. At week 16, patients randomized to placebo crossed over to deucravacitinib. At week 52, patients could enroll in the LTE and receive open-label deucravacitinib. Efficacy was evaluated in patients who crossed over from placebo to deucravacitinib at week 16 of the parent trial and received continuous deucravacitinib through 4 years (week 208; data cutoff, November 1, 2023). Outcomes included ≥ 75%/≥ 90% reduction from baseline in Psoriasis Area and Severity Index (PASI 75/90) and static Physician Global Assessment score of 0 (clear) or 1 (almost clear) (sPGA 0/1). Efficacy is reported using modified nonresponder imputation (mNRI) in patients who reached the week 208 assessment or discontinued before week 208.

Results: Of 421 patients originally randomized to placebo, 348 crossed over to deucravacitinib at week 16; 298 completed the parent trials and entered the LTE, with 291 meeting mNRI criteria. Efficacy response rates improved from week 16 on placebo (PASI 75, 12.0% [95% CI, 8.5%-16.3%]; PASI 90, 3.4% [1.7%-6.2%]; sPGA 0/1, 10.0% [6.8%-14.0%]) through week 52 on deucravacitinib (PASI 75, 75.2% [70.2%-80.2%]; PASI 90, 47.4% [41.6%-53.1%]; sPGA 0/1, 60.1% [54.5%-65.7%]). Response rates were maintained well through week 208 (PASI 75, 75.6% [70.0%-81.2%]; PASI 90, 46.6% [40.4%-52.7%]; sPGA 0/1, 55.1% [48.8%-61.4%]).

Conclusion: These findings support the long-term efficacy profile of once-daily oral deucravacitinib for treatment of patients with moderate to severe plaque psoriasis.

Disclosures: M. Lebwohl: AbbVie, 5, Almirall, 2, AltruBio Inc., 2, Amgen, 5, AnaptysBio, 2, Arcutis, 2, 5, AstraZeneca, 2, Avotres, 2, 5, Boehringer Ingelheim, 2, 5, Brickell Biotech, 2, Bristol Myers Squibb, 2, Cara Therapeutics, 5, Castle Biosciences, 2, Celltrion, 2, CorEvitas, 2, Dermavant Sciences, 2, 5, Eli Lilly, 5, EPI, 2, Evommune Inc., 2, Facilitation of International Dermatology Education, 2, Forte Biosciences, 2, Foundation for Research and Education in Dermatology, 2, Galderma, 2, Genentech, 2, Incyte, 2, 5, Inozyme, 5, Janssen, 5, LEO Pharma, 2, LLC, 5, Meiji Seika Pharma, 2, Mindera, 2, Mount Sinai, 3, Ortho Dermatologics, 5, Pfizer, 2, Sanofi-Regeneron, 5, Seanergy, 2, Strata, 2, Trevi, 2, UCB Pharma, 5, Verrica, 2; R. Warren: AbbVie, 2, 5, 6, Almirall, 2, 5, 6, Amgen, 2, 5, Arena, 2, Astellas, 2, Avillion, 2, Biogen, 2, Boehringer Ingelheim, 2, Bristol Myers Squibb, 2, 6, Celgene, 2, 5, Dice Therapeutics, 2, Eli Lilly, 2, 5, 6, Galderma, 6, GSK, 2, Janssen, 2, 5, 6, LEO Pharma, 2, 5, Meiji Pharma, 2, Novartis, 2, 5, 6, Pfizer, 2, 5, RAPT Therapeutics, 2, Sanofi, 2, UCB Pharma, 2, 5, Union, 2; S. Imafuku: AbbVie, 5, 12, Personal fees, Alexion Pharma, 5, 12, Personal fees, Amgen, 5, 12, Personal fees, Boehringer Ingelheim, 5, 12, Personal fees, Bristol Myers Squibb, 5, 12, Personal fees, Daiichi Sankyo, 5, 12, Personal fees, Eisai, 5, 12, Personal fees, GSK, 5, 12, Personal fees, Janssen, 5, 12, Personal fees, Kaken, 5, 12, Personal fees, Kyowa Kirin, 5, 12, Personal fees, Leo Pharma, 5, 12, Personal fees, Lilly, 5, 12, Personal fees, Maruho, 5, 12, Personal fees, Novartis, 5, 12, Personal fees, Sun Pharma, 5, 12, Personal fees, Taiho Yakuhin, 5, 12, Personal fees, Torii Yakuhin, 5, 12, Personal fees, UCB, 5, 12, Personal fees; J. Bagel: AbbVie, 2, 5, 6, Amgen, 2, 5, Arcutis, 5, Boehringer Ingelheim, 5, Bristol Myers Squibb, 5, Celgene, 5, 6, CorEvitas Psoriasis Registry, 5, Dermavant, 5, Dermira/UCB, 5, Glenmark, 5, Janssen Biotech, 2, 5, 6, Kadmon, 5, Leo Pharma, 5, Lilly, 2, 5, 6, Lycera, 5, Menlo Therapeutics, 5, Novartis, 2, 5, 6, Pfizer, 5, Regeneron, 5, Sun Pharma, 2, 5, Taro, 5, Valeant, 2, 5; A. Armstrong: AbbVie, 1, 6, 12, Research Investigator, Almirall, 1, 6, 12, Research Investigator, Arcutis, 1, 6, 12, Research Investigator, Aslan, 1, 6, 12, Research Investigator, Beiersdorf, 1, 6, 12, Research Investigator, Boehringer Ingelheim, 1, 6, 12, Research Investigator, Bristol Myers Squibb, 1, 6, 12, Research Investigator, Dermavant, 1, 6, 12, Research Investigator, Dermira, 1, 6, 12, Research Investigator, EPI Health, 1, 6, 12, Research Investigator, Incyte, 1, 6, 12, Research Investigator, Janssen, 1, 6, 12, Research Investigator, Leo Pharma, 1, 6, 12, Research Investigator, Lilly, 1, 6, 12, Research Investigator, Mindera Health, 1, 6, 12, Research Investigator, Nimbus, 1, 6, 12, Research Investigator, Novartis, 1, 6, 12, Research Investigator, Ortho Dermatologics, 1, 6, 12, Research Investigator, Pfizer, 1, 6, 12, Research Investigator, Regeneron, 1, 6, 12, Research Investigator, Sanofi, 1, 6, 12, Research Investigator, Sun Pharma, 1, 6, 12, Research Investigator, UCB, 1, 6, 12, Research Investigator; T. Passeron: AbbVie, 1, 2, Almirall, 1, 2, Amgen, 1, 2, Boehringer Ingelheim, 1, 2, Bristol Myers Squibb, 1, 2, Celgene, 1, 2, Galderma, 1, 2, Incyte, 1, 2, Janssen, 1, 2, Leo Pharma, 1, 2, Lilly, 1, 2, Novartis, 1, 2, Pfizer, 1, 2, Sanofi Genzyme, 1, 2, Sun Pharma, 1, 2, UCB, 1, 2; S. Banerjee: Bristol Myers Squibb, 3, 8; R. Kisa: Bristol Myers Squibb, 3, 8; M. Colombo: Bristol Myers Squibb, 3, 8; T. Scharnitz: Bristol Myers Squibb, 3, 8; K. Hoyt: Bristol Myers Squibb, 12, ConsultantBristol Myers Squibb via Syneos Health; 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, 1, 2, 12, Investigator, Celltrion, 1, 2, 12, Investigator, Eli Lilly, 1, 2, 12, Investigator, Galapagos, 1, 2, 12, Investigator, Galderma, 1, 2, 12, Investigator, Janssen-Cilag, 1, 2, 12, Investigator, Kyowa Kirin, 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 Pharma, 1, 2, 12, Investigator; A. Blauvelt: AbbVie, 1, 12, Clinical Study Investigator, Abcentra, 1, Acelyrin, 12, Clinical Study Investigator, Aclaris, 1, Affibody, 1, Aligos, 1, Allakos, 12, Clinical Study Investigator, Almirall, 1, 12, Clinical Study Investigator, Alumis, 1, 12, Clinical Study Investigator, Amgen, 1, 12, Clinical Study Investigator, Apogee, 1, Arcutis, 1, 12, Clinical Study Investigator, Arena, 1, Aslan, 1, Athenex, 1, 12, Clinical Study Investigator, Bluefin Biomedicine, 1, Boehringer Ingelheim, 1, 12, Clinical Study Investigator, Bristol Myers Squibb, 1, 12, Clinical Study Investigator, Cara Therapeutics, 1, Celldex, 1, Concert, 12, Clinical Study Investigator, CTI BioPharma, 1, Dermavant, 1, 12, Clinical Study Investigator, DermBiont, 12, Clinical Study Investigator, EcoR1, 1, Eli Lilly, 1, 6, 12, Clinical Study Investigator, Escient, 1, Evelo Biosciences, 1, 12, Clinical Study Investigator, Evommune, 1, 12, Clinical Study Investigator, Forte Biosciences, 1, Galderma, 1, 12, Clinical Study Investigator, HighlightII Pharma, 1, Incyte, 1, 12, Clinical Study Investigator, InnoventBio, 1, Janssen, 1, 12, Clinical Study Investigator, Landos, 1, LEO Pharma, 1, 12, Clinical Study Investigator, Lipidio, 1, 11, 12, Clinical study investigator, Merck, 1, 12, Clinical Study Investigator, Microbion, 1, Monte Rosa, 1, Nektar, 1, Novartis, 1, 12, Clinical Study Investigator, Oruka, 11, Overtone Therapeutics, 1, Paragon, 1, Pfizer, 1, 12, Clinical Study Investigator, Q32 Bio, 1, Rani, 1, Rapt, 1, Regeneron, 1, 12, Clinical Study Investigator, Sanofi, 12, Clinical Study Investigator, Sanofi Genzyme, 1, Spherix Global Insights, 1, Sun Pharma, 1, 12, Clinical Study Investigator, Takeda, 1, 12, Clinical Study Investigator, TLL Pharmaceutical, 1, TrialSpark, 1, UCB, 1, 6, 12, Clinical Study Investigator, Union, 1, Ventyx, 1, 12, Clinical Study Investigator, Vibliome, 1, Xencor, 1.

To cite this abstract in AMA style:

Lebwohl M, Warren R, Imafuku S, Bagel J, Armstrong A, Passeron T, Banerjee S, Kisa R, Colombo M, Scharnitz T, Hoyt K, Thaçi D, Blauvelt A. Deucravacitinib Long-term Efficacy Through 4 Years in Week 16 Placebo Crossover Patients in the Phase 3 POETYK PSO-1, PSO-2, and LTE Program [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/deucravacitinib-long-term-efficacy-through-4-years-in-week-16-placebo-crossover-patients-in-the-phase-3-poetyk-pso-1-pso-2-and-lte-program/. Accessed .

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