Evidence map›Paper›PMID 38268101›Full record

Trial reportThe Journal of dermatology2024

Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in Japanese patients with moderate to severe plaque, erythrodermic, or generalized pustular psoriasis: Efficacy and safety results from an open-label, phase 3 trial.

Shinichi Imafuku, Yukari Okubo, Yayoi Tada, Mamitaro Ohtsuki, Elizabeth Colston, Andrew Napoli, Yanqiu Shao, Subhashis Banerjee, Akimichi Morita

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase III
In one paragraph

Trial report in The Journal of dermatology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03924427 (An Open-Label, Single-arm, Multi-Center, Phase 3 Study to Evaluate the Efficacy and Safety of BMS-986165 in Japanese Subjects With Moderate-to-Severe Psoriasis), which is not on this map. Cited by 23 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 3 pooled it
7.2field-weighted citation impact, top 2% of its field
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.

NCT03924427 phase3completednot on this map

An Open-Label, Single-arm, Multi-Center, Phase 3 Study to Evaluate the Efficacy and Safety of BMS-986165 in Japanese Subjects With Moderate-to-Severe Psoriasis

TypeinterventionalSponsorBristol-Myers SquibbRan2019 to 2021Enrolled74ConditionsPsoriasisArmsBMS-986165
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 3 syntheses or guidelines pooled it, 30 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Review
  9. Article
  10. The Role of TYK2 Inhibitors in the Pathogenesis and Treatment of Psoriasis.The Journal of clinical and aesthetic dermatology · 2026
    Review
  11. Article
  12. Article
  13. Article
  14. Review of Promising Off-Label Use of Deucravacitinib.International journal of molecular sciences · 2025
    Review
  15. Article
  16. Article
  17. Review
  18. Review
  19. Article
  20. Review
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

9 authors at 6 institutions in 2 countries.

Shinichi ImafukuDepartment of Dermatology, Fukuoka University Faculty of Medicine, Fukuoka, Japan.ORCID https://orcid.org/0000-0001-8568-4349
Yukari OkuboDepartment of Dermatology, Tokyo Medical University, Tokyo, Japan.ORCID https://orcid.org/0000-0002-9526-1259
Yayoi TadaDepartment of Dermatology, Teikyo University School of Medicine, Tokyo, Japan.
Mamitaro OhtsukiDepartment of Dermatology, Jichi Medical University, Tochigi, Japan.
Elizabeth ColstonBristol Myers Squibb, Princeton, New Jersey, USA.
Andrew NapoliBristol Myers Squibb, Princeton, New Jersey, USA.
Yanqiu ShaoBristol Myers Squibb, Princeton, New Jersey, USA.
Subhashis BanerjeeBristol Myers Squibb, Princeton, New Jersey, USA.
Akimichi MoritaDepartment of Geriatrics and Environmental Dermatology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.ORCID https://orcid.org/0000-0001-8372-3754
Bristol-Myers Squibb (United States) · USFukuoka University · JPJichi Medical University · JPNagoya City University · JPTeikyo University · JPTokyo Medical University · JP

Funding

Bristol Myers Squibb
6 · The paper itself

Abstract

Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in Japan for adult patients with plaque (PP), generalized pustular (GPP), and erythrodermic (EP) psoriasis who have had an inadequate response to conventional systemic therapies. This approval is based on results from the global phase 3 POETYK PSO-1 and PSO-2 trials in which deucravacitinib was associated with significantly improved efficacy outcomes compared with placebo in adults with moderate to severe plaque psoriasis, and results described here from POETYK PSO-4, an open-label, single-arm, phase 3 trial (NCT03924427), which evaluated the efficacy and safety of deucravacitinib 6 mg once daily in adult Japanese patients with PP, GPP, or EP. The coprimary endpoints were the proportion of patients achieving a ≥75% reduction from baseline in the Psoriasis Area and Severity Index (PASI 75) and a static Physician's Global Assessment score of 0 (clear) or 1 (almost clear) (sPGA 0/1) with at least a two-point improvement from baseline at week 16. Nonresponder imputation was used for missing data. Efficacy responses, adverse events (AEs), and serious AEs (SAEs) were recorded for up to 52 weeks. Seventy-four patients were treated (PP, n = 63; GPP, n = 3; EP, n = 8). At week 16, 76.2%, 66.7%, and 37.5% of patients with PP, GPP, and EP, respectively, had achieved PASI 75, and 82.5%, 0.0%, and 50.0% had achieved sPGA 0/1. Responses were overall maintained through week 52. AEs occurred in 74.6% of patients with PP, 100% of patients with GPP, and 87.5% of patients with EP. The most common AEs were nasopharyngitis and acne. Rates of SAEs and discontinuations were low. There were no deaths. Deucravacitinib was effective and well tolerated in Japanese patients with moderate to severe PP and in a limited number of patients with GPP or EP.

Indexed as

ExanthemaHeterocyclic CompoundsPsoriasisSkin Diseases, VesiculobullousAcute DiseaseAdultAntibodies, Monoclonal, HumanizedChronic DiseaseDouble-Blind MethodHumansJapanSeverity of Illness IndexTreatment OutcomeTYK2 KinaseAntibodies, Monoclonal, HumanizeddeucravacitinibHeterocyclic CompoundsTYK2 KinaseAsian populationclinical trialphase 3psoriasistyrosine kinase 2

Identifiers

PMID38268101
PMCPMC11483964
OpenAlexW4391227141

What OpenQuestion holds

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Registered trials

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.