PMID- 38268101
OWN - NLM
STAT- MEDLINE
DCOM- 20240305
LR  - 20240305
IS  - 1346-8138 (Electronic)
IS  - 0385-2407 (Linking)
VI  - 51
IP  - 3
DP  - 2024 Mar
TI  - 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.
PG  - 365-379
LID - 10.1111/1346-8138.17074 [doi]
AB  - 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.
CI  - (c) 2024 The Authors. The Journal of Dermatology published by John Wiley & Sons 
      Australia, Ltd on behalf of Japanese Dermatological Association.
FAU - Imafuku, Shinichi
AU  - Imafuku S
AUID- ORCID: 0000-0001-8568-4349
AD  - Department of Dermatology, Fukuoka University Faculty of Medicine, Fukuoka, 
      Japan.
FAU - Okubo, Yukari
AU  - Okubo Y
AUID- ORCID: 0000-0002-9526-1259
AD  - Department of Dermatology, Tokyo Medical University, Tokyo, Japan.
FAU - Tada, Yayoi
AU  - Tada Y
AD  - Department of Dermatology, Teikyo University School of Medicine, Tokyo, Japan.
FAU - Ohtsuki, Mamitaro
AU  - Ohtsuki M
AD  - Department of Dermatology, Jichi Medical University, Tochigi, Japan.
FAU - Colston, Elizabeth
AU  - Colston E
AD  - Bristol Myers Squibb, Princeton, New Jersey, USA.
FAU - Napoli, Andrew
AU  - Napoli A
AD  - Bristol Myers Squibb, Princeton, New Jersey, USA.
FAU - Shao, Yanqiu
AU  - Shao Y
AD  - Bristol Myers Squibb, Princeton, New Jersey, USA.
FAU - Banerjee, Subhashis
AU  - Banerjee S
AD  - Bristol Myers Squibb, Princeton, New Jersey, USA.
FAU - Morita, Akimichi
AU  - Morita A
AUID- ORCID: 0000-0001-8372-3754
AD  - Department of Geriatrics and Environmental Dermatology, Nagoya City University 
      Graduate School of Medical Sciences, Nagoya, Japan.
LA  - eng
GR  - Bristol Myers Squibb/
PT  - Clinical Trial, Phase III
PT  - Journal Article
DEP - 20240124
PL  - England
TA  - J Dermatol
JT  - The Journal of dermatology
JID - 7600545
RN  - EC 2.7.10.2 (TYK2 Kinase)
RN  - N0A21N6RAU (deucravacitinib)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Heterocyclic Compounds)
SB  - IM
MH  - Adult
MH  - Humans
MH  - Japan
MH  - TYK2 Kinase/therapeutic use
MH  - Antibodies, Monoclonal, Humanized/therapeutic use
MH  - Treatment Outcome
MH  - Severity of Illness Index
MH  - *Psoriasis/drug therapy/chemically induced
MH  - Chronic Disease
MH  - Acute Disease
MH  - *Exanthema/drug therapy
MH  - *Skin Diseases, Vesiculobullous/drug therapy
MH  - Double-Blind Method
MH  - *Heterocyclic Compounds
OTO - NOTNLM
OT  - Asian population
OT  - clinical trial
OT  - phase 3
OT  - psoriasis
OT  - tyrosine kinase 2
EDAT- 2024/01/25 06:43
MHDA- 2024/03/05 06:45
CRDT- 2024/01/25 00:13
PHST- 2023/11/01 00:00 [revised]
PHST- 2023/04/27 00:00 [received]
PHST- 2023/11/25 00:00 [accepted]
PHST- 2024/03/05 06:45 [medline]
PHST- 2024/01/25 06:43 [pubmed]
PHST- 2024/01/25 00:13 [entrez]
AID - 10.1111/1346-8138.17074 [doi]
PST - ppublish
SO  - J Dermatol. 2024 Mar;51(3):365-379. doi: 10.1111/1346-8138.17074. Epub 2024 Jan 
      24.