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

^*Corresponding author for this work

Institute of Inflammation Medicine

333 Citations (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.

Original language	English
Journal	Journal of the American Academy of Dermatology
Volume	88
Issue number	1
Pages (from-to)	29-39
Number of pages	11
ISSN	0190-9622
DOIs	https://doi.org/10.1016/j.jaad.2022.07.002
Publication status	Published - 01.2023

Funding

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

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Research Areas and Centers

Academic Focus: Center for Infection and Inflammation Research (ZIEL)
Centers: Center for Research on Inflammation of the Skin (CRIS)

DFG Research Classification Scheme

2.22-19 Dermatology

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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",

publisher = "Elsevier Inc.",

number = "1",

}

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, vol. 88, no. 1, pp. 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, Vol. 88, No. 1, 01.2023, p. 29-39.

Research output: Journal Articles › Journal articles › Research › peer-review

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

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

Funding

UN SDGs

Research Areas and Centers

DFG Research Classification Scheme

Access to Document

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