Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial

April W. Armstrong; Melinda Gooderham; Richard B. Warren; Kim A. Papp; Bruce Strober; Diamant Thaçi; Akimichi Morita; Jacek C. Szepietowski; Shinichi Imafuku; Elizabeth Colston; John Throup; Sudeep Kundu; Steve Schoenfeld; Misti Linaberry; Subhashis Banerjee; Andrew Blauvelt

doi:10.1016/j.jaad.2022.07.002

Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial

April W. Armstrong^*, Melinda Gooderham, Richard B. Warren, Kim A. Papp, Bruce Strober, Diamant Thaçi, Akimichi Morita, Jacek C. Szepietowski, Shinichi Imafuku, Elizabeth Colston, John Throup, Sudeep Kundu, Steve Schoenfeld, Misti Linaberry, Subhashis Banerjee, Andrew Blauvelt

^*Korrespondierende/r Autor/-in für diese Arbeit

Institut für Entzündungsmedizin

317 Zitate (Scopus)

Abstract

Background: Effective, well-tolerated oral psoriasis treatments are needed. Objective: To compare the efficacy and safety of deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, versus placebo and apremilast in adults with moderate to severe plaque psoriasis. Methods: Participants were randomized 2:1:1 to deucravacitinib 6 mg every day (n = 332), placebo (n = 166), or apremilast 30 mg twice a day (n = 168) in the 52-week, double-blinded, phase 3 POETYK PSO-1 trial (NCT03624127). Coprimary end points included response rates for ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI 75) and static Physician's Global Assessment score of 0 or 1 (sPGA 0/1) with deucravacitinib versus placebo at week 16. Results: At week 16, response rates were significantly higher with deucravacitinib versus placebo or apremilast for PASI 75 (194 [58.4%] vs 21 [12.7%] vs 59 [35.1%]; P < .0001) and sPGA 0/1 (178 [53.6%] vs 12 [7.2%] vs 54 [32.1%]; P < .0001). Efficacy improved beyond week 16 and was maintained through week 52. Adverse event rates with deucravacitinib were similar to those with placebo and apremilast. Limitations: One-year duration, limited racial diversity. Conclusion: Deucravacitinib was superior to placebo and apremilast across multiple efficacy end points and was well tolerated in moderate to severe plaque psoriasis.

Originalsprache	Englisch
Zeitschrift	Journal of the American Academy of Dermatology
Jahrgang	88
Ausgabenummer	1
Seiten (von - bis)	29-39
Seitenumfang	11
ISSN	0190-9622
DOIs	https://doi.org/10.1016/j.jaad.2022.07.002
Publikationsstatus	Veröffentlicht - 01.2023

Fördermittel

Funding sources: This clinical trial was sponsored by Bristol Myers Squibb . Funding sources: This clinical trial was sponsored by Bristol Myers Squibb.The authors thank the patients and their families, the study site staff, and study site investigators for their participation. This clinical trial was sponsored by Bristol Myers Squibb. Writing and editorial assistance was provided by Lisa Feder, PhD, of Peloton Advantage, LLC, an OPEN Health company, Parsippany, NJ, USA, funded by Bristol Myers Squibb. Richard B. Warren, MD, is supported by the NIHR Manchester Biomedical Research Centre. The authors acknowledge Jonghyeon Kim, PhD, who was employed by Bristol Myers Squibb at the time the study was conducted, for his statistical assistance, as well as Marianne Peluso, Phenique Blacks, and Laura Aubrey for their assistance in trial coordination. The authors thank the patients and their families, the study site staff, and study site investigators for their participation. This clinical trial was sponsored by Bristol Myers Squibb . Writing and editorial assistance was provided by Lisa Feder, PhD, of Peloton Advantage, LLC, an OPEN Health company, Parsippany, NJ, USA, funded by Bristol Myers Squibb . Richard B. Warren, MD, is supported by the NIHR Manchester Biomedical Research Centre . The authors acknowledge Jonghyeon Kim, PhD, who was employed by Bristol Myers Squibb at the time the study was conducted, for his statistical assistance, as well as Marianne Peluso, Phenique Blacks, and Laura Aubrey for their assistance in trial coordination.

UN SDGs

Dieser Output leistet einen Beitrag zu folgendem(n) Ziel(en) für nachhaltige Entwicklung

SDG 3 – Gesundheit und Wohlergehen

Strategische Forschungsbereiche und Zentren

Forschungsschwerpunkt: Infektion und Entzündung - Zentrum für Infektions- und Entzündungsforschung Lübeck (ZIEL)
Zentren: Center for Research on Inflammation of the Skin (CRIS)

DFG-Fachsystematik

2.22-19 Dermatologie

Dokumente

10.1016/j.jaad.2022.07.002

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Armstrong, A. W., Gooderham, M., Warren, R. B., Papp, K. A., Strober, B., Thaçi, D., Morita, A., Szepietowski, J. C., Imafuku, S., Colston, E., Throup, J., Kundu, S., Schoenfeld, S., Linaberry, M., Banerjee, S., & Blauvelt, A. (2023). Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial. Journal of the American Academy of Dermatology, 88(1), 29-39. https://doi.org/10.1016/j.jaad.2022.07.002

@article{20024dd04f6547a0a0d9ed11fd4e7109,

title = "Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial",

abstract = "Background: Effective, well-tolerated oral psoriasis treatments are needed. Objective: To compare the efficacy and safety of deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, versus placebo and apremilast in adults with moderate to severe plaque psoriasis. Methods: Participants were randomized 2:1:1 to deucravacitinib 6 mg every day (n = 332), placebo (n = 166), or apremilast 30 mg twice a day (n = 168) in the 52-week, double-blinded, phase 3 POETYK PSO-1 trial (NCT03624127). Coprimary end points included response rates for ≥75\% reduction from baseline in Psoriasis Area and Severity Index (PASI 75) and static Physician's Global Assessment score of 0 or 1 (sPGA 0/1) with deucravacitinib versus placebo at week 16. Results: At week 16, response rates were significantly higher with deucravacitinib versus placebo or apremilast for PASI 75 (194 [58.4\%] vs 21 [12.7\%] vs 59 [35.1\%]; P < .0001) and sPGA 0/1 (178 [53.6\%] vs 12 [7.2\%] vs 54 [32.1\%]; P < .0001). Efficacy improved beyond week 16 and was maintained through week 52. Adverse event rates with deucravacitinib were similar to those with placebo and apremilast. Limitations: One-year duration, limited racial diversity. Conclusion: Deucravacitinib was superior to placebo and apremilast across multiple efficacy end points and was well tolerated in moderate to severe plaque psoriasis.",

author = "Armstrong, \{April W.\} and Melinda Gooderham and Warren, \{Richard B.\} and Papp, \{Kim A.\} and Bruce Strober and Diamant Tha{\c c}i and Akimichi Morita and Szepietowski, \{Jacek C.\} and Shinichi Imafuku and Elizabeth Colston and John Throup and Sudeep Kundu and Steve Schoenfeld and Misti Linaberry and Subhashis Banerjee and Andrew Blauvelt",

note = "Publisher Copyright: {\textcopyright} 2022 American Academy of Dermatology, Inc.",

year = "2023",

month = jan,

doi = "10.1016/j.jaad.2022.07.002",

language = "English",

volume = "88",

pages = "29--39",

journal = "Journal of the American Academy of Dermatology",

issn = "0190-9622",

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number = "1",

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Armstrong, AW, Gooderham, M, Warren, RB, Papp, KA, Strober, B, Thaçi, D, Morita, A, Szepietowski, JC, Imafuku, S, Colston, E, Throup, J, Kundu, S, Schoenfeld, S, Linaberry, M, Banerjee, S & Blauvelt, A 2023, 'Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial', Journal of the American Academy of Dermatology, Jg. 88, Nr. 1, S. 29-39. https://doi.org/10.1016/j.jaad.2022.07.002

Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial. / Armstrong, April W.; Gooderham, Melinda; Warren, Richard B. et al.
in: Journal of the American Academy of Dermatology, Jahrgang 88, Nr. 1, 01.2023, S. 29-39.

Publikation: Beiträge in Fachzeitschriften › Zeitschriftenaufsätze › Forschung › Begutachtung

TY - JOUR

T1 - Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis

T2 - Efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial

AU - Armstrong, April W.

AU - Gooderham, Melinda

AU - Warren, Richard B.

AU - Papp, Kim A.

AU - Strober, Bruce

AU - Thaçi, Diamant

AU - Morita, Akimichi

AU - Szepietowski, Jacek C.

AU - Imafuku, Shinichi

AU - Colston, Elizabeth

AU - Throup, John

AU - Kundu, Sudeep

AU - Schoenfeld, Steve

AU - Linaberry, Misti

AU - Banerjee, Subhashis

AU - Blauvelt, Andrew

PY - 2023/1

Y1 - 2023/1

N2 - Background: Effective, well-tolerated oral psoriasis treatments are needed. Objective: To compare the efficacy and safety of deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, versus placebo and apremilast in adults with moderate to severe plaque psoriasis. Methods: Participants were randomized 2:1:1 to deucravacitinib 6 mg every day (n = 332), placebo (n = 166), or apremilast 30 mg twice a day (n = 168) in the 52-week, double-blinded, phase 3 POETYK PSO-1 trial (NCT03624127). Coprimary end points included response rates for ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI 75) and static Physician's Global Assessment score of 0 or 1 (sPGA 0/1) with deucravacitinib versus placebo at week 16. Results: At week 16, response rates were significantly higher with deucravacitinib versus placebo or apremilast for PASI 75 (194 [58.4%] vs 21 [12.7%] vs 59 [35.1%]; P < .0001) and sPGA 0/1 (178 [53.6%] vs 12 [7.2%] vs 54 [32.1%]; P < .0001). Efficacy improved beyond week 16 and was maintained through week 52. Adverse event rates with deucravacitinib were similar to those with placebo and apremilast. Limitations: One-year duration, limited racial diversity. Conclusion: Deucravacitinib was superior to placebo and apremilast across multiple efficacy end points and was well tolerated in moderate to severe plaque psoriasis.

AB - Background: Effective, well-tolerated oral psoriasis treatments are needed. Objective: To compare the efficacy and safety of deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, versus placebo and apremilast in adults with moderate to severe plaque psoriasis. Methods: Participants were randomized 2:1:1 to deucravacitinib 6 mg every day (n = 332), placebo (n = 166), or apremilast 30 mg twice a day (n = 168) in the 52-week, double-blinded, phase 3 POETYK PSO-1 trial (NCT03624127). Coprimary end points included response rates for ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI 75) and static Physician's Global Assessment score of 0 or 1 (sPGA 0/1) with deucravacitinib versus placebo at week 16. Results: At week 16, response rates were significantly higher with deucravacitinib versus placebo or apremilast for PASI 75 (194 [58.4%] vs 21 [12.7%] vs 59 [35.1%]; P < .0001) and sPGA 0/1 (178 [53.6%] vs 12 [7.2%] vs 54 [32.1%]; P < .0001). Efficacy improved beyond week 16 and was maintained through week 52. Adverse event rates with deucravacitinib were similar to those with placebo and apremilast. Limitations: One-year duration, limited racial diversity. Conclusion: Deucravacitinib was superior to placebo and apremilast across multiple efficacy end points and was well tolerated in moderate to severe plaque psoriasis.

UR - https://www.scopus.com/pages/publications/85135861634

U2 - 10.1016/j.jaad.2022.07.002

DO - 10.1016/j.jaad.2022.07.002

M3 - Journal articles

C2 - 35820547

AN - SCOPUS:85135861634

SN - 0190-9622

VL - 88

SP - 29

EP - 39

JO - Journal of the American Academy of Dermatology

JF - Journal of the American Academy of Dermatology

IS - 1

ER -

Armstrong AW, Gooderham M, Warren RB, Papp KA, Strober B, Thaçi D et al. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial. Journal of the American Academy of Dermatology. 2023 Jan;88(1):29-39. doi: 10.1016/j.jaad.2022.07.002