AB1374 DEUCRAVACITINIB IN PLAQUE PSORIASIS: MAINTENANCE OF RESPONSE OVER 3 YEARS (2024)

Abstract

Background: Deucravacitinib, a first-in-class, oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in multiple countries for the treatment of adults with 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 psoriasis. [1] Deucravacitinib is being investigated in several immune-mediated diseases and has shown efficacy vs placebo in phase 2 trials in systemic lupus erythematosus (SLE) (NCT03252587) and psoriatic arthritis (PsA) (NCT03881059). The POETYK long-term extension (LTE) trial (NCT04036435) showed that deucravacitinib maintained long-term efficacy through 2 years, with no new safety signals. [2]

Objectives: We report clinical efficacy up to 3 years (148 weeks) in the POETYK LTE trial in a subset of patients with plaque psoriasis who received continuous deucravacitinib from day 1 in the parent trials.

Methods: In POETYK PSO-1 and PSO-2, patients were randomized 1:2:1 to placebo, deucravacitinib 6 mg once daily (QD), or apremilast 30 mg twice daily. At week 52, patients could enter the POETYK LTE trial and receive open-label deucravacitinib 6 mg QD. Deucravacitinib efficacy through week 148 was evaluated in patients from pooled POETYK PSO-1 and PSO-2 populations; these patients received continuous deucravacitinib from day 1, achieved ≥ 75% reduction from baseline in Psoriasis Area and Severity Index score (PASI 75) at week 16 (primary endpoint) or week 24 (peak response), and were enrolled in the POETYK LTE trial. Maintenance of response was assessed through the data cutoff (June 15, 2022); responses assessed included PASI 75 and ≥ 90% reduction from baseline in PASI (PASI 90). A static Physician’s Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with a ≥ 2-point improvement from baseline was assessed.

Results: A total of 513 patients completed 52 weeks in the parent trials and received continuous deucravacitinib from day 1, including 313 patients (61.4%; 95% CI, 57.0–65.6) who achieved PASI 75 at week 16 and 336 patients (66.5%; 95% CI, 62.2–70.6) who achieved PASI 75 at week 24. Among these patients, PASI 75 response rates were maintained from weeks 52 to 148 (Table 1). PASI 90 response rates were maintained in > 50% of patients from the start of the POETYK LTE trial (Table 1). Response rates for sPGA score of 0/1 were maintained from weeks 52 to 148 (Table 1).

Conclusion: Clinical efficacy was maintained for up to 148 weeks with continuous deucravacitinib in most patients who were week 16 and week 24 PASI 75 responders in the parent trials and enrolled in the POETYK LTE trial. These findings further support the long-term use of once-daily oral deucravacitinib as an effective treatment for patients with psoriasis.

Acknowledgements: We would like to thank the patients and their families who made this study possible, as well as the clinical teams who participated. This study was sponsored by Bristol Myers Squibb. Professional medical writing assistance was provided by Regina Kelly, MA, of Peloton Advantage, LLC, an OPEN Health company, Parsippany, NJ, USA, and Angela R. Eder, PhD, of Nucleus Global, and funded by Bristol Myers Squibb.

Disclosure of Interests: Bruce Strober AbbVie, Eli Lilly, Janssen, and Sanofi Genzyme; Co-scientific director, AbbVie, Almirall, Amgen, Arcutis, Arena, Aristea, Asana, Boehringer Ingelheim, Bristol Myers Squibb, Connect Biopharma, Dermavant, Eli Lilly, Equillium, GSK, Immunic Therapeutics, Janssen, Leo Pharma, Maruho, Meiji Seika Pharma, Mindera Health, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, UCB, Ventyx Biosciences, and vTv Therapeutics; CorEvitas’ (Corrona) Psoriasis Registry, AbbVie, Cara, CorEvitas’ (Corrona) Psoriasis Registry, Dermavant, Dermira, and Novartis, Howard Sofen AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Janssen, Leo Pharma, Novartis, and Sun Pharma., Shinichi Imaf*cku AbbVie, Eisai, Janssen, Kyowa Kirin, Leo Pharma, Maruho, Sun Pharma, Taiho Yakuhin, Tanabe Mitsubishi, and Torii Yakuhin; Personal fees: Amgen (Celgene), Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Eli Lilly, GSK, Novartis, and UCB., Carle Paul AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Leo Pharma, Merck, Mylan, Novartis, Pfizer, Sandoz, and UCB, AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Leo Pharma, Merck, Mylan, Novartis, Pfizer, Sandoz, and UCB, Melinda Gooderham AbbVie, Amgen, Arcutis, Bausch Health, Boehringer Ingelheim International GmbH, Celgene, Eli Lilly, Janssen, Novartis, Sanofi Genzyme, Sun Pharma, UCB Galderma SA, Leo Pharma, Pfizer, and Regeneron, ASLAN, Akros Pharma and Kyowa Kirin, Asana BioSciences, Galderma SA, Leo Pharma, Pfizer, Regeneron, Aristea, AnaptysBio, Bristol Myers Squibb, Coherus Biosciences, GSK, Incyte, Dermira, Immunotherapeutics, MedImmune, Meiji Seika, Merck, MoonLake, Nimbus Therapeutics, Lynda Spelman AbbVie, Amgen, Anacor, Ascend, Astellas, AstraZeneca, Blaze Bioscience, Boehringer Ingelheim, Botanix, Bristol Myers Squibb, Celgene, Dermira, Eli Lilly, Galderma, Genentech, GSK, Hexima, Janssen, Leo Pharma, Mayne Pharma, MedImmune, Merck, Merck-Serono, Novartis, Otsuka, Pfizer, Phosphagenics, Photon MD, Regeneron, Roche, Samumed, Sanofi Genzyme, SHR Pharmacy, Sun Pharma ANZ, Trius, UCB, and Zai Lab, AbbVie, Amgen, Anacor, Ascend, Astellas, AstraZeneca, Blaze Bioscience, Boehringer Ingelheim, Botanix, Bristol Myers Squibb, Celgene, Dermira, Eli Lilly, Galderma, Genentech, GSK, Hexima, Janssen, Leo Pharma, Mayne Pharma, MedImmune, Merck, Merck-Serono, Novartis, Otsuka, Pfizer, Phosphagenics, Photon MD, Regeneron, Roche, Samumed, Sanofi Genzyme, SHR Pharmacy, Sun Pharma ANZ, Trius, UCB, and Zai Lab, Seong Jun Seo: None declared, Thierry Passeron AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Galderma, Incyte, Janssen, Leo Pharma, Novartis, Pfizer, Sanofi Genzyme, Sun Pharma, and UCB, Renata M Kisa Bristol Myers Squibb, Bristol Myers Squibb, Victoria Berger Bristol Myers Squibb, Bristol Myers Squibb, Eleni Vritzali Bristol Myers Squibb, Bristol Myers Squibb, Kim Hoyt Bristol Myers Squibb, Matthew J. Colombo Bristol Myers Squibb, Bristol Myers Squibb, Subhashis Banerjee Bristol Myers Squibb, Bristol Myers Squibb, Matthias Augustin AbbVie, Amgen, Janssen Biotech, Leo Pharma, Sun Pharma, UCB, AbbVie, Amgen, Boehringer Ingelheim, Janssen Biotech, Leo Pharma, Eli Lilly, Novartis, Sun Pharma, UCB, AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen Biotech, Leo Pharma, Merck, Novartis, Sun Pharma, UCB, Janssen Biotech, Sun Pharma, Linda Stein Gold AbbVie, Amgen, Arcutis, ASLAN, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Dermira, Eli Lilly, Galderma, Incyte, Janssen, Leo Pharma, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, and UCB, AbbVie, Amgen, Arcutis, ASLAN, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Dermira, Eli Lilly, Galderma, Incyte, Janssen, Leo Pharma, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, and UCB, Andrew Alexis Bristol Myers Squibb, Pfizer, Regeneron, and Sanofi-Genzyme; Royalties: Springer, Wiley-Blackwell, and Wolters Kluwer Health, AbbVie, Allergan, Almirall, Amgen, Arcutis, Bausch Health, Beiersdorf, Bristol Myers Squibb, Cara Therapeutics, Castle Biosciences, Cutera, Dermavant, Eli Lilly, EPI Health, Galderma, Incyte, Janssen, Leo Pharma, L’Oréal, Ortho, Pfizer, Sanofi-Regeneron, Swiss American, UCB, VisualDx, and Vyne, AbbVie, Almirall, Amgen, Arcutis, Bristol Myers Squibb, Cara Therapeutics, Castle Biosciences, Dermavant, Galderma, Leo Pharma, Novartis, Valeant (Bausch Health), and Vyne, Diamant Thaçi AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Janssen, Eli Lilly, Leo Pharma, Novartis, Pfizer, Roche-Posay, Sanofi, Target RWE, UCB, AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Janssen, Eli Lilly, Leo Pharma, Novartis, Pfizer, Roche-Posay, Sanofi, Target RWE, UCB, AbbVie, Almirall, Boehringer Ingelheim, Bristol Myers Squibb, Galapagos, Leo Pharma, Novartis, Pfizer, UCB, AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galderma, Janssen-Cilag, Leo Pharma, Novartis, Pfizer, Regeneron, Roche, Sandoz-Hexal, Sanofi, UCB, Andrew Blauvelt AbbVie, Abcentra, Aclaris, Affibody, Aligos, Almirall, Alumis, Amgen, AnaptysBio, Apogee, Arcutis, Arena, ASLAN, Athenex, Bluefin Biomedicine, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, CTI BioPharma, Dermavant, EcoR1, Eli Lilly, Escient, Evelo Biosciences, Evommune, Forte Biosciences, Galderma, Highlightll Pharma, Incyte, Innovent Bio, Janssen, Landos, Leo Pharma, Lipidio, Merck, Nektar, Novartis, Pfizer, Rani, Rapt, Regeneron, Sanofi Genzyme, Spherix Global Insights, Sun Pharma, Takeda, TLL Pharmaceutical, TrialSpark, UCB, Union, Ventyx Biosciences, Vibliome, and Xencor, AbbVie, Bristol Myers Squibb, Eli Lilly, Pfizer, Regeneron, and Sanofi, AbbVie, ACELYRIN, Allakos, Almirall, Alumis, Amgen, Arcutis, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Concert, Dermavant, Eli Lilly, Evelo Biosciences, Evommune, Galderma, Incyte, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, UCB, and Ventyx Biosciences, Mark Lebwohl Aditum Bio, Almirall, AltruBio, AnaptysBio, Arcutis, Aristea, Avotres, Boehringer Ingelheim, Brickell Biotech, Bristol Myers Squibb, Cara Therapeutics, Castle Biosciences, Celltrion, CorEvitas’ (Corrona) Psoriasis Registry, Dermavant, Dr. Reddy’s Laboratories, EPI Health, Evommune, Forte Biosciences, Helsinn Therapeutics, Hexima, Incyte, Leo Pharma, Meiji Seika Pharma, Mindera Health, Pfizer, Seanergy, Strata, Trevi, and Verrica, On behalf of Icahn School of Medicine at Mount Sinai: AbbVie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Cara Therapeutics, Dermavant, Eli Lilly, Incyte, Janssen, Ortho Dermatologics, Regeneron, and UCB.