Evidence map›Paper›PMID 40045918›Full record

Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2025

Deucravacitinib in plaque psoriasis: Four-year safety and efficacy results from the Phase 3 POETYK PSO-1, PSO-2 and long-term extension trials.

April W Armstrong, Mark Lebwohl, Richard B Warren, Howard Sofen, Akimichi Morita, Carle Paul, Kim A Papp, Matthew J Colombo, Julie Scotto, John Vaile and 7 more

Abstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed.

  1. Trial
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  5. The Role of TYK2 Inhibitors in the Pathogenesis and Treatment of Psoriasis.The Journal of clinical and aesthetic dermatology · 2026
    Review
  6. Review
  7. Review
  8. Review
  9. Psoriatic Arthritis: Developments in 2025.Mediterranean journal of rheumatology · 2026
    Review
  10. Review
  11. Review
  12. Article
  13. Article
  14. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

April W ArmstrongUniversity of California Los Angeles, Los Angeles, California, USA.ORCID https://orcid.org/0000-0003-0064-8707
Mark LebwohlIcahn School of Medicine at Mount Sinai, New York, New York, USA.
Richard B WarrenDermatology Centre, Northern Care Alliance NHS Foundation Trust, Manchester, UK.ORCID https://orcid.org/0000-0002-2918-6481
Howard SofenUniversity of California Los Angeles, Los Angeles, California, USA.ORCID https://orcid.org/0000-0001-7789-6915
Akimichi MoritaNagoya City University Graduate School of Medical Sciences, Nagoya, Japan.ORCID https://orcid.org/0000-0001-8372-3754
Carle PaulPaul Sabatier University and CHU Larrey, Toulouse, France.ORCID https://orcid.org/0000-0003-0165-5263
Kim A PappAlliance Clinical Trials and Probity Medical Research, Waterloo, and the University of Toronto, Toronto, Ontario, Canada.ORCID https://orcid.org/0000-0001-9557-3642
Matthew J ColomboBristol Myers Squibb, Princeton, New Jersey, USA.ORCID https://orcid.org/0009-0006-5653-381X
Julie ScottoBristol Myers Squibb, Princeton, New Jersey, USA.ORCID https://orcid.org/0009-0005-7910-1668
John VaileBristol Myers Squibb, Princeton, New Jersey, USA.
Joe ZhuoBristol Myers Squibb, Princeton, New Jersey, USA.
Eleni VritzaliBristol Myers Squibb, Princeton, New Jersey, USA.
Victoria BergerBristol Myers Squibb, Princeton, New Jersey, USA.
Georgene SchroederBristol Myers Squibb, Princeton, New Jersey, USA.
Subhashis BanerjeeBristol Myers Squibb, Princeton, New Jersey, USA.ORCID https://orcid.org/0009-0000-1365-5207
Diamant ThaçiInstitute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.ORCID https://orcid.org/0000-0001-8513-550X
Bruce StroberYale University School of Medicine, New Haven, and Central Connecticut Dermatology Research, Cromwell, Connecticut, USA.ORCID https://orcid.org/0000-0002-8394-2057

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDeucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, is approved in multiple countries for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.

objectivesTo evaluate the safety and efficacy of deucravacitinib through 4 years in the Phase 3 POETYK PSO-1, PSO-2 and long-term extension (LTE) trials in psoriasis.

methodsPSO-1 and PSO-2 (parent trials) randomized patients 1:2:1 to oral placebo, deucravacitinib 6 mg once daily (QD) or apremilast 30 mg twice daily. At 52 weeks, patients enrolled in the LTE trial received open-label deucravacitinib 6 mg QD. Safety was evaluated in patients who received ≥1 dose of deucravacitinib at any time. Clinical and patient-reported outcomes (PASI, PGA and DLQI) were analysed in patients who received continuous deucravacitinib from Day 1 of the parent trials and enrolled in the LTE trial.

resultsIn total, 1519 patients received ≥1 dose of deucravacitinib, with cumulative exposure of 4392.8 person-years (PY) through the data cut-off of 1 November 2023. Exposure-adjusted incidence rates (EAIRs)/100 PY of noted safety measures were comparable or decreased from the 1-year to 4-year cumulative period, respectively, for adverse events (AEs) (229.23, 131.68), serious AEs (including COVID-19) (5.68, 5.01), deaths (0.20, 0.25), discontinuation due to AEs (4.38, 2.20), herpes zoster (0.81, 0.55), malignancies (1.02, 0.89), major adverse cardiovascular events (0.30, 0.32) and venous thromboembolism (0.20, 0.07). In patients who received continuous deucravacitinib (n = 513), clinical and patient-reported outcome rates were well maintained from 1 year through 4 years (e.g. PASI 90, 1 year, 45.6% [95% CI, 41.3%-50.0%], 4 years, 47.5% [42.6%-52.4%]; DLQI 0/1, 1 year, 51.5% [47.1%-55.9%], 4 years, 49.4% [44.4%-54.4%]).

conclusionsDeucravacitinib demonstrated a consistent safety profile and durable efficacy through 4 years of treatment in patients with moderate to severe plaque psoriasis.

Indexed as

Protein Kinase InhibitorsPsoriasisQuinazolinonesAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedTreatment OutcomeProtein Kinase InhibitorsQuinazolinones

Identifiers

PMID40045918
PMCPMC12188513

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.