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Clinical Trial
. 2025 Jan 1;161(1):56-66.
doi: 10.1001/jamadermatol.2024.4688.

Safety and Efficacy of Deucravacitinib in Moderate to Severe Plaque Psoriasis for Up to 3 Years: An Open-Label Extension of Randomized Clinical Trials

April W Armstrong  1 , Mark Lebwohl  2 , Richard B Warren  3   4 , Howard Sofen  1   5 , Shinichi Imafuku  6 , Mamitaro Ohtsuki  7 , Lynda Spelman  8 , Thierry Passeron  9 , Kim A Papp  10 , Renata M Kisa  11 , John Vaile  12 , Victoria Berger  13 , Eleni Vritzali  14 , Kim Hoyt  15 , Matthew J Colombo  11 , Julie Scotto  16 , Subhashis Banerjee  17 , Bruce Strober  18 , Diamant Thaçi  19 , Andrew Blauvelt  20
Affiliations
Clinical Trial

Safety and Efficacy of Deucravacitinib in Moderate to Severe Plaque Psoriasis for Up to 3 Years: An Open-Label Extension of Randomized Clinical Trials

April W Armstrong et al. JAMA Dermatol. .

Abstract

Importance: Safe and effective long-term treatments for moderate to severe plaque psoriasis are needed.

Objective: To evaluate the long-term safety and efficacy of deucravacitinib through 3 years (week 148) in the randomized POETYK PSO-1, PSO-2, and nonrandomized long-term extension (LTE) trials.

Design, setting, and participants: PSO-1/PSO-2 were global, 52-week, randomized, double-blinded phase 3 trials in patients with moderate to severe plaque psoriasis. After completing 52 weeks of treatment in PSO-1/PSO-2, patients could enroll in the prespecified, ongoing, nonrandomized LTE trial. The peak of the global COVID-19 pandemic coincided with the LTE trial. Patient enrollment in the LTE started August 12, 2019; safety and efficacy were assessed through June 15, 2022; and these data were analyzed through June 28, 2024.

Interventions: The PSO-1/PSO-2 trials randomized patients 1:2:1 to oral placebo, deucravacitinib, 6 mg once daily, or apremilast, 30 mg twice daily. Patients enrolling in the LTE trial received open-label deucravacitinib, 6 mg once daily.

Main outcomes and measures: Safety outcomes were evaluated in patients who received 1 or more doses of deucravacitinib. Efficacy outcomes included 75% or greater or 90% or greater reduction from baseline in Psoriasis Area and Severity Index (PASI 75/90) and static Physician Global Assessment scores of 0 (clear) or 1 (almost clear) (sPGA 0/1) and were assessed in patients who received deucravacitinib treatment from day 1 of the parent trials who continued in the LTE trial.

Results: Of 1519 patients who received 1 or more doses of deucravacitinib, 513 received continuous deucravacitinib treatment from day 1 and entered the LTE trial. Exposure-adjusted incidence rates (EAIRs) per 100 person-years were decreased or similar in the 1-year vs 3-year cumulative periods, respectively, for adverse events (AEs) (229.2 vs 144.8; 95% CI, 215.4-243.9 vs 137.1-153.0), serious AEs (5.7 vs 5.5; 95% CI, 4.4-7.4 vs 4.7-6.4), discontinuations due to AEs (4.4 vs 2.4; 95% CI, 3.3-5.9 vs 2.0-3.0), and deaths (0.2 vs 0.3; 95% CI, 0.1-0.8 vs 0.2-0.6). Incidence rates of the most common AEs (EAIR per 100 person-years ≥5) during the 1-year and 3-year cumulative periods, respectively, were nasopharyngitis (26.1 vs 11.4; 95% CI, 23.0-29.8 vs 10.2-12.7), COVID-19 (0.5 vs 8.0; 95% CI, 0.2-1.2 vs 7.1-9.1), and upper respiratory tract infection (13.4 vs 6.2; 95% CI, 11.3-16.0 vs 5.4-7.2). EAIRs for AEs of interest, including herpes zoster, major adverse cardiovascular events, and malignant diseases, remained low and were decreased or comparable between the 1-year and 3-year cumulative periods. Clinical response rates were maintained through 3 years.

Conclusions and relevance: The findings of this integrated analysis of the phase 3 POETYK PSO-1, PSO-2, and nonrandomized LTE trials demonstrate a consistent safety profile and durable clinical response of continuous treatment with deucravacitinib through 3 years of treatment in patients with psoriasis.

Trial registration: ClinicalTrials.gov Identifiers: NCT03624127, NCT03611751, and NCT04036435.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: Dr Armstrong reported serving as a research investigator, scientific advisor, and/or speaker for AbbVie, Almirall, Arcutis, Aslan Pharmaceuticals, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Dermira, EPI Health, Incyte, Janssen, Leo Pharma, Lilly, Mindera Health, Nimbus, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi, Sun Pharma, and UCB. Dr Lebwohl reported receiving research funds on behalf of Mount Sinai from AbbVie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Cara Therapeutics, Dermavant, Incyte, Janssen, Lilly, Ortho Dermatologics, Regeneron, and UCB, and serving as a consultant for Almirall, AltruBio, AnaptysBio, Arcutis, Avotres, Boehringer Ingelheim, Brickell Biotech, Bristol Myers Squibb, Castle Biosciences, Celltrion, CorEvitas Psoriasis Registry, Dermavant, EPI Health, Evommune, Forte Biosciences, Galderma, Genentech, Incyte, Leo Pharma, Meiji Seika Pharma, Mindera Health, Pfizer, Seanergy, Strata, Trevi, and Verrica. Prof Warren reported receiving research grants from AbbVie, Almirall, Amgen/Celgene, Janssen, Leo Pharma, Lilly, Novartis, Pfizer, and UCB, and consulting fees from AbbVie, Almirall, Amgen/Celgene, Astellas, Boehringer Ingelheim, Dice Therapeutics, GSK, Janssen, Leo Pharma, Lilly, Novartis, Pfizer, Sanofi, UCB, and UNION Therapeutics. Dr Sofen reported serving as a clinical investigator for AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Janssen, Leo Pharma, Lilly, Novartis, and Sun Pharma. Dr Imafuku reported receiving grants and personal fees from AbbVie, Eisai, Janssen, Kyowa Kirin, Leo Pharma, Maruho, Sun Pharma, Taiho Yakuhin, Tanabe Mitsubishi, and Torii Yakuhin, and personal fees from Amgen/Celgene, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, GSK, Lilly, Novartis, and UCB. Dr Ohtsuki reported receiving honoraria and/or research grants from AbbVie, Amgen/Celgene, Boehringer Ingelheim, Bristol Myers Squibb, Eisai, Janssen, Kyowa Kirin, Leo Pharma, Lilly, Maruho, Mitsubishi Tanabe Pharma, Nichi-Iko, Nippon Kayaku, Novartis, Pfizer, Sanofi, Sun Pharma, Taiho Pharmaceutical, Torii Pharmaceutical, and UCB. Dr Spelman reported serving as a consultant, paid investigator, and/or speaker for AbbVie, Amgen, Anacor, Anaptys Bio, Ascend, Astellas, AstraZeneca, Blaze Bioscience, Boehringer Ingelheim, Botanix, Bristol Myers Squibb, Celgene, Connect Biopharma, Dermira, Enkang Pharmaceuticals, Equillium Inc, Evelo Biosciences, Galderma, Genentech, Genesis Care, GlaxoSmithKline, Hexima, Incyte, InflaRx GmbH, Invion, Janssen, Kiniksa Pharmaceuticals, Kobio Labs, Leo Pharma, LG Chem, Lilly, Lipidio Pharma, Mayne Pharma, MedImmune, Merck, Merck-Serono, Nektar Therapeutics, Novartis, Olix Therapeutics, Otsuka, Pfizer, Phosphagenics, Photon MD, Principia, Regeneron, Ribon, Samumed, Sanofi Genzyme, SHR Pharmacy, Sun Pharma ANZ, Takeda Pharmaceuticals, UCB, and Zai Lab. Dr Passeron reported receiving advisory board and consulting fees from AbbVie, Almirall, Amgen/Celgene, Boehringer Ingelheim, Bristol Myers Squibb, Galderma, Incyte, Janssen, Leo Pharma, Lilly, Novartis, Pfizer, Sanofi Genzyme, Sun Pharma, UCB, and Vyne Therapeutics. Dr Papp reported serving as a consultant for AbbVie, Acelyrin, Akros, Amgen/Celgene, Aralez, Arcutis, Avillion, Bausch Health/Valeant, Boehringer Ingelheim, Bristol Myers Squibb, Can-Fite BioPharma, Celltrion, Coherus, Dermavant, Dermira, Dice Therapeutics, Dow Pharma, Evelo, Forbion, Galderma, Incyte, Janssen, Kyowa Hakko Kirin, Leo Pharma, Lilly, Meiji Seika Pharma, Merck, Mitsubishi Pharma, Novartis, Pfizer, Regeneron, Reistone, Roche, Sanofi Genzyme, Sandoz, Sun Pharma, Takeda, UCB, vTv Therapeutics, and Xencor; serving on a speakers bureau for AbbVie, Amgen/Celgene, Bausch Health/Valeant, Galderma, Incyte, Janssen, Kyowa Hakko Kirin, Leo Pharma, Lilly, Merck, Novartis, Pfizer, and Sanofi Genzyme; receiving clinical research grants from AbbVie, Akros, Amgen/Celgene, Anacor, Arcutis, Avillion, Bausch Health/Valeant, Boehringer Ingelheim, Bristol Myers Squibb, Can-Fite BioPharma, Coherus, Dermavant, Dermira, Dice Therapeutics, Dow Pharma, Evelo Biosciences, Galderma, Gilead, GSK, Incyte, Janssen, Kyowa Hakko Kirin, Leo Pharma, Lilly, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Sun Pharma, Takeda, and UCB; receiving honoraria from AbbVie, Acelyrin, Akros, Amgen/Celgene, Aralez Pharmaceuticals, Bausch Health/Valeant, Boehringer Ingelheim, Celltrion, Coherus, Dermavant, Dice Therapeutics, Forbion, Galderma, Janssen, Kyowa Hakko Kirin, Leo Pharma, Lilly, Meiji Seika Pharma, Merck, Mitsubishi Pharma, Novartis, Pfizer, Reistone, Sanofi Genzyme, Sandoz, Sun Pharma, Takeda, UCB, vTv Therapeutics, and Xencor; serving as scientific officer for Akros, Anacor, Arcutis, Dice Therapeutics, and Kyowa Hakko Kirin; serving on steering committees for AbbVie, Amgen/Celgene, Bausch Health/Valeant, Boehringer Ingelheim, Janssen, Kyowa Hakko Kirin, Lilly, Merck, Novartis, Pfizer, Regeneron, Reistone, and Sanofi Genzyme; and serving on advisory boards for AbbVie, Amgen/Celgene, Bausch Health/Valeant, Boehringer Ingelheim, Bristol Myers Squibb, Dice Therapeutics, Dow Pharma, Galderma, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, and UCB. Dr Kisa, Dr Vaile, Dr Berger, Dr Vritzali, Dr Colombo, Ms Scotto, and Dr Banerjee reported being employees of and shareholders in Bristol Myers Squibb. Ms Hoyt reported serving as a consultant to Bristol Myers Squibb via Syneos Health. Dr Strober reported serving as a consultant (with honoraria) for AbbVie, Almirall, Amgen, Arcutis, Arena, Aristea, Asana, Boehringer Ingelheim, Bristol Myers Squibb, Connect Biopharma, Dermavant, Equillium Bio, GSK, Immunic Therapeutics, Janssen, Leo Pharma, Lilly, Maruho, Meiji Seika Pharma, Mindera Health, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, UCB, Ventyx Biosciences, and vTv Therapeutics; serving as a speaker for AbbVie, Janssen, Lilly, and Sanofi Genzyme; serving as co-scientific director (with consulting fee) for CorEvitas Psoriasis Registry; and serving as an investigator for AbbVie, Cara Therapeutics, CorEvitas Psoriasis Registry, Dermavant, Dermira, and Novartis. Dr Thaçi reported providing research support to and serving as a principal investigator (clinical trial funds to institution) for AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Galderma, Janssen-Cilag, Leo Pharma, Lilly, New Bridge, Novartis, Pfizer, Regeneron, Sanofi, Target RWE, and UCB; consulting fees from AbbVie, Almirall, Boehringer Ingelheim, Bristol Myers Squibb, Galápagos, Leo Pharma, Novartis, Pfizer, and UCB; serving as a lecturer for AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Janssen, Leo Pharma, Lilly, New Bridge, Novartis, Pfizer, Roche-Posay, Sanofi, and UCB; and serving on the scientific advisory board for AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Janssen-Cilag, Leo Pharma, Lilly, Novartis, Pfizer, Sanofi, and UCB. Dr Blauvelt reported serving as a speaker (with honoraria) for Lilly, Pfizer, and UCB; serving as a scientific adviser (with honoraria) for 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, Escient, Evelo Biosciences, Evommune, Forte Biosciences, Galderma, HighlightII Pharma, Incyte, InnoventBio, Janssen, Landos, Leo Pharma, Lilly, Lipidio, Merck, Microbion, Monte Rosa Therapeutics, Nektar, Novartis, Overtone Therapeutics, Paragon, Pfizer, Q32 Bio, Rani, Rapt, Regeneron, Sanofi Genzyme, Spherix Global Insights, Sun Pharma, Takeda, TLL Pharmaceutical, TrialSpark, UCB, UNION Therapeutics, Ventyx Biosciences, Vibliome, and Xencor; and serving as a clinical study investigator (clinical study funds received by institution) for AbbVie, Acelyrin, Allakos, Almirall, Alumis, Amgen, Arcutis, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Concert, Dermavant, DermBiont, Evelo Biosciences, Evommune, Galderma, Incyte, Janssen, Leo Pharma, Lilly, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, Takeda, UCB, and Ventyx Biosciences. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Patient Disposition as of June 15, 2022 (Week 148)
A, Safety population. B, Efficacy population (continuous deucravacitinib treatment from day 1). “Withdrawal by patient” and “other” were listed by patients for multiple reasons with no clear pattern and mostly related to personal reasons, relocation away from site, lack of satisfaction from treatment, or withdrawal of consent for undisclosed reasons. aThis represents the population of patients who received 1 or more doses of deucravacitinib in a parent study and/or the long-term extension (LTE) through the data cutoff date of June 15, 2022. Given the study designs, (1) some patients who discontinued while receiving placebo may have received deucravacitinib, 6 mg once daily, before they were assigned to placebo (withdrawal design; n = 17), (2) some of the patients may have been assigned to apremilast before they received deucravacitinib (n = 165), and (3) patients who discontinued treatment in the parent study were permitted to rollover if they had completed all study visits (n = 8). bParent study refers to POETYK PSO-1 or PSO-2. Reasons for discontinuation in the parent studies have previously been reported. cThis represents patients who received deucravacitinib in the LTE through the data cutoff date of June 15, 2022. dOne additional patient was recorded as completed treatment but was discontinued from the study on day 706 due to study termination at that site. ePatients include those with ongoing treatment as of June 15, 2022, who reached week 148. Week 148 is calculated based on duration of deucravacitinib treatment up to the data cutoff date of June 15, 2022.
Figure 2.
Figure 2.. Clinical Efficacy Outcomes Through 3 Years
LTE indicates long-term extension; mNRI, modified nonresponder imputation; PASI 75, 75% or greater reduction from baseline in Psoriasis Area and Severity Index; PASI 90, 90% or greater reduction from baseline in PASI; sPGA 0/1, static Physician Global Assessment score of 0 (clear) or 1 (almost clear) with a 2 or higher point improvement from baseline; TFR, treatment failure rules. aPASI 90 results were not estimable at weeks 1 and 2 using mNRI.
See this image and copyright information in PMC

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