PMID- 38226713
OWN - NLM
STAT- MEDLINE
DCOM- 20240419
LR  - 20240419
IS  - 1365-2133 (Electronic)
IS  - 0007-0963 (Linking)
VI  - 190
IP  - 5
DP  - 2024 Apr 17
TI  - Deucravacitinib in plaque psoriasis: 2-year safety and efficacy results from the 
      phase III POETYK trials.
PG  - 668-679
LID - 10.1093/bjd/ljae014 [doi]
AB  - BACKGROUND: In the phase III POETYK PSO-1 and PSO-2 trials, deucravacitinib, an 
      oral selective allosteric tyrosine kinase 2 inhibitor, was well tolerated and 
      efficacious over 1 year in patients with psoriasis. OBJECTIVE: To evaluate 
      deucravacitinib safety and efficacy over 2 years in patients participating in the 
      phase III trials. METHODS: In the POETYK long-term extension (LTE), an ongoing 
      phase IIIb open-label trial, adults with moderate-to-severe plaque psoriasis who 
      completed PSO-1 or PSO-2 receive deucravacitinib 6 mg once daily. Safety was 
      assessed via adverse events (AEs) and laboratory parameter abnormalities. 
      Efficacy endpoints, including >/= 75% reduction from baseline Psoriasis Area and 
      Severity Index score (PASI 75) and static Physician's Global Assessment (sPGA) 
      score of 0/1 (clear/almost clear), were evaluated in patients originally 
      randomized to deucravacitinib, patients who crossed over from placebo at week 16 
      and patients who achieved PASI 75 at week 24 (peak efficacy). RESULTS: At data 
      cutoff (1 October 2021), 1519 patients had received at least one dose of 
      deucravacitinib; 79.0% and 39.9% had >/= 52 weeks and >/= 104 weeks of total 
      deucravacitinib exposure, respectively. Exposure-adjusted incidence rates (EAIRs) 
      per 100 person-years were similar at 1 year and 2 years for any AEs (229.2 vs. 
      154.4, respectively), serious AEs (5.7 vs. 6.1), discontinuations (4.4 vs. 2.8), 
      deaths (0.2 vs. 0.4), serious infections (1.7 vs. 2.6), herpes zoster (0.9 vs. 
      0.8), major adverse cardiovascular events (0.3 vs. 0.4), venous thromboembolic 
      events (0.2 vs. 0.1) and malignancies (1.0 vs. 0.9). EAIRs for COVID-19 
      infections were higher at 2 years than at 1 year (5.1 vs. 0.5) owing to the peak 
      of the global COVID-19 pandemic occurring during the LTE. No clinically 
      meaningful changes from baseline or trends were observed over 2 years in 
      haematological, chemistry or lipid parameters. Clinical responses were maintained 
      in patients who received continuous deu-cravacitinib treatment from baseline 
      [PASI 75: week 52, 72.4%; week 112, 79.7%; sPGA 0/1: week 52, 57.9%; week 112, 
      61.1% (as observed)]. Responses at week 52 were also maintained in placebo 
      crossovers and in week-24 PASI-75 responders. CONCLUSIONS: Deucravacitinib 
      maintained efficacy and demonstrated consistent safety with no new safety signals 
      observed through 2 years.
CI  - (c) The Author(s) 2024. Published by Oxford University Press on behalf of British 
      Association of Dermatologists.
FAU - Lebwohl, Mark
AU  - Lebwohl M
AUID- ORCID: 0000-0002-4705-5303
AD  - Icahn School of Medicine at Mount Sinai, New York, NY, USA.
FAU - Warren, Richard B
AU  - Warren RB
AUID- ORCID: 0000-0002-2918-6481
AD  - Dermatology Centre, Northern Care Alliance NHS Foundation Trust, Manchester, UK.
AD  - NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation 
      Trust, Manchester Academic Health Science Centre, Manchester, UK.
FAU - Sofen, Howard
AU  - Sofen H
AD  - University of California Los Angeles, David Geffen School of Medicine, Los 
      Angeles, CA, USA.
FAU - Imafuku, Shinichi
AU  - Imafuku S
AD  - Fukuoka University Hospital, Fukuoka, Japan.
FAU - Paul, Carle
AU  - Paul C
AUID- ORCID: 0000-0003-0165-5263
AD  - Toulouse University and CHU, Toulouse, France.
FAU - Szepietowski, Jacek C
AU  - Szepietowski JC
AUID- ORCID: 0000-0003-0766-6342
AD  - Wroclaw Medical University, Wroclaw, Poland.
FAU - Spelman, Lynda
AU  - Spelman L
AD  - Veracity Clinical Research, Brisbane, QLD, Australia.
FAU - Passeron, Thierry
AU  - Passeron T
AD  - Universite Cote d'Azur, University Hospital of Nice, Nice, France.
FAU - Vritzali, Eleni
AU  - Vritzali E
AD  - Bristol Myers Squibb, Princeton, NJ, USA.
FAU - Napoli, Andrew
AU  - Napoli A
AD  - Bristol Myers Squibb, Princeton, NJ, USA.
FAU - Kisa, Renata M
AU  - Kisa RM
AD  - Bristol Myers Squibb, Princeton, NJ, USA.
FAU - Buck, Alex
AU  - Buck A
AD  - Cytel Inc, Waltham, MA, USA.
FAU - Banerjee, Subhashis
AU  - Banerjee S
AD  - Bristol Myers Squibb, Princeton, NJ, USA.
FAU - Thaci, Diamant
AU  - Thaci D
AUID- ORCID: 0000-0001-8513-550X
AD  - Institute and Comprehensive Center for Inflammation Medicine, University of 
      Lubeck, Lubeck, Germany.
FAU - Blauvelt, Andrew
AU  - Blauvelt A
AD  - Oregon Medical Research Center, Portland, OR, USA.
LA  - eng
GR  - Bristol Myers Squibb/
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - England
TA  - Br J Dermatol
JT  - The British journal of dermatology
JID - 0004041
RN  - N0A21N6RAU (deucravacitinib)
RN  - 0 (Heterocyclic Compounds)
SB  - IM
CIN - Br J Dermatol. 2024 Feb 26;:. PMID: 38407434
MH  - Adult
MH  - Humans
MH  - *Pandemics
MH  - Severity of Illness Index
MH  - *Psoriasis/drug therapy
MH  - Treatment Outcome
MH  - Double-Blind Method
MH  - *Heterocyclic Compounds
OAB - Psoriasis is a chronic inflammatory skin condition. Many available treatments for 
      psoriasis are injected, but can be inadequate in terms of effectiveness, and/or 
      cause serious side-effects. Deucravacitinib is a recently approved oral medicine 
      that interferes with an enzyme involved in inflammation called 'tyrosine kinase 
      2' (TYK2). Deucravacitinib has been shown to improve psoriatic patches and 
      symptoms (such as itching) through 1 year in two global clinical trials in adults 
      with moderate-to-severe plaque psoriasis (POETYK PSO-1 and PSO-2). This study was 
      an analysis of the safety and efficacy of deu-cravacitinib for up to 2 years. To 
      do this, the researchers used data from approximately 1500 people who completed 
      both trials and continued into an ongoing, long-term extension trial (POETYK 
      LTE). Overall, there were no new side-effects, and the number, type and severity 
      of side-effects, as well as the number of patients who stopped treatment because 
      of these side-effects, remained low. The most frequent side-effects included 
      common cold symptoms and COVID-19. Rates of shingles and serious side-effects 
      were comparable to rates reported in the real world. Improvements in psoriasis 
      symptoms seen at 1 year were maintained for up to 2 years in patients receiving 
      deucravacitinib treatment from the start of PSO-1 or PSO-2, or who crossed over 
      from placebo to deucravacitinib at 4 months. Long-term treatment with 
      deucravacitinib improved psoriasis symptoms and resulted in mostly mild 
      side-effects. The study findings suggest that deucravacitinib could be a 
      well-tolerated and effective treatment for people with psoriasis.
OABL- eng
COIS- Conflicts of interest M.L. has received research funds on behalf of Mount Sinai 
      from: AbbVie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Cara Therapeutics, 
      Dermavant Sciences, Eli Lilly, Incyte, Inozyme, Janssen Research & Development, 
      LLC, Ortho Dermatologics, Pfizer, Sanofi-Regeneron, and UCB, Inc., and is a 
      consultant for Almirall, AltruBio Inc., AnaptysBio, Apogee, Arcutis, Inc., 
      AstraZeneca, Atomwise, Avotres Therapeutics, Brickell Biotech, Boehringer 
      Ingelheim, Bristol Myers Squibb, Castle Biosciences, Celltrion, CorEvitas, 
      Dermavant Sciences, EPI, Evommune, Inc., Facilitation of International 
      Dermatology Education, Forte Biosciences, Foundation for Research and Education 
      in Dermatology, Galderma, Genentech, Incyte, LEO Pharma, Meiji Seika Pharma, 
      Mindera, Pfizer, Sanofi-Regeneron, Seanergy, Strata, Takeda, Trevi, and Verrica. 
      R.B.W. has received research grants from AbbVie, Almirall, Amgen, Celgene, Eli 
      Lilly, Janssen, LEO Pharma, Novartis, Pfizer and UCB, and has received consulting 
      fees from AbbVie, Almirall, Amgen, Biogen, Boehringer Ingelheim, Celgene, DICE 
      Therapeutics, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi, UCB and 
      Union Therapeutics. H.S. has been a clinical investigator for AbbVie, Amgen, 
      Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Janssen, LEO Pharma, 
      Novartis and Sun Pharma. S.I. has received grants and personal fees from AbbVie, 
      Eisai, GlaxoSmithKline, Janssen, Kyowa Kirin, LEO Pharma, Maruho, Sun Pharma, 
      Taiho Yakuhin, Tanabe Mitsubishi and Torii Yakuhin, and has received personal 
      fees from Amgen (Celgene), Boehringer Ingelheim, Bristol Myers Squibb, Daiichi 
      Sankyo, Eli Lilly, Novartis, and UCB. C.P. has received grants from and served as 
      a consultant for AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers 
      Squibb, Celgene, Eli Lilly, Janssen, LEO Pharma, Merck, Mylan, Novartis, Pfizer, 
      Sandoz, and UCB. J.C.S. has served on an advisory board and served as a 
      consultant for AbbVie, LEO Pharma, Novartis, Pierre-Fabre, Sanofi Genzyme, and 
      Trevi; has served as a speaker for AbbVie, Eli Lilly, Janssen-Cilag, LEO Pharma, 
      Novartis and Sanofi Genzyme; and has been an investigator for AbbVie, Amgen, 
      Bristol Myers Squibb, Galapagos, Galderma, Incyte, InfraRX, Janssen-Cilag, Manlo 
      Therapeutics, Merck, Novartis, Pfizer, Regeneron, Trevi, and UCB. L.S. has served 
      as a consultant, paid investigator, and/or speaker for AbbVie, Amgen, Anacor, 
      Ascend, Astellas, AstraZeneca, Blaze Bioscience, Boehringer Ingelheim, Botanix, 
      Bristol Myers Squibb, Celgene, Dermira, Eli Lilly, Galderma, Genentech, 
      GlaxoSmithKline, Hexima, Janssen, LEO Pharma, Mayne Pharma, MedImmune, Merck, 
      Merck-Serono, Novartis, Otsuka, Pfizer, Phosphagenics, Photon MD, Regeneron, 
      Roche, Samumed, Sanofi Genzyme, Sun Pharma ANZ, Trius, UCB and Zai Lab. T.P. has 
      served on an advisory board for and received consulting fees from AbbVie, 
      Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, 
      Galderma, Incyte, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi Genzyme, Sun 
      Pharma and UCB. E.V., A.N., R.M.K. and S.B. are employees of and shareholders in 
      Bristol Myers Squibb. A.B. is a consultant for Bristol Myers Squibb through 
      functional service provider Cytel. D.T. has received research support from and 
      has been a principal investigator (clinical trials) for AbbVie, Almirall, Amgen, 
      Biogen Idec, Boehringer Ingelheim, Eli Lilly, Galderma, GlaxoSmithKline, 
      Janssen-Cilag, LEO Pharma, Merck Sharp & Dohme, Novartis, Pfizer, Regeneron, 
      Roche, Sandoz-Hexal, Sanofi and UCB; has served as a consultant for AbbVie, 
      Almirall, Galapagos, LEO Pharma, Novartis, Pfizer, and UCB; has been a lecturer 
      for AbbVie, Almirall, Amgen, Janssen, Eli Lilly, Leo Pharma, Merck Sharp & Dohme, 
      Novartis, Pfizer, Roche-Posay, Sandoz-Hexal, Sanofi, Target-Solution and UCB; and 
      has served on a scientific advisory board for AbbVie, Amgen, Eli Lilly, 
      Janssen-Cilag, LEO Pharma, Morphosis, Merck Sharp & Dohme, Novartis, Pfizer, 
      Sanofi and UCB. A.B. has served as a speaker (received honoraria) for AbbVie, 
      Bristol Myers Squibb, Eli Lilly and Company, Pfizer, Regeneron and Sanofi; served 
      as a scientific adviser (received 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, Eli Lilly and Company, 
      Escient, Evelo, Evommune, Forte, Galderma, HighlightII Pharma, Incyte, 
      InnoventBio, Janssen, Landos, LEO, Lipidio, Merck, Monte Rosa Therapeutics, 
      Nektar, Novartis, Overtone Therapeutics, Pfizer, Rani, Rapt, Regeneron, Sanofi 
      Genzyme, Spherix Global Insights, Sun Pharma, Takeda, TLL Pharmaceutical, 
      TrialSpark, UCB Pharma, Union, Ventyx, Vibliome and Xencor; and has acted as a 
      clinical study investigator (institution has received clinical study funds) for 
      AbbVie, Acelyrin, Allakos, Almirall, Alumis, Amgen, Arcutis, Athenex, Boehringer 
      Ingelheim, Bristol Myers Squibb, Concert, Dermavant, Eli Lilly and Company, 
      Evelo, Evommune, Galderma, Incyte, Janssen, LEO Pharma, Merck, Novartis, Pfizer, 
      Regeneron, Sanofi, Sun Pharma, UCB Pharma and Ventyx.
EDAT- 2024/01/16 13:42
MHDA- 2024/04/19 06:43
CRDT- 2024/01/16 08:33
PHST- 2023/11/03 00:00 [received]
PHST- 2024/01/05 00:00 [accepted]
PHST- 2024/04/19 06:43 [medline]
PHST- 2024/01/16 13:42 [pubmed]
PHST- 2024/01/16 08:33 [entrez]
AID - 7558435 [pii]
AID - 10.1093/bjd/ljae014 [doi]
PST - ppublish
SO  - Br J Dermatol. 2024 Apr 17;190(5):668-679. doi: 10.1093/bjd/ljae014.