Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, phase 3 Program fOr Evaluation of TYK2 inhibitor psoriasis second trial

Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, inhibits cytokine signaling in psoriasis pathogenesis. The objective of this study was to demonstrate deucravacitinib superiority versus placebo and apremilast in moderate to severe plaque psoriasis based on ≥75% reduction...

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Published in:Journal of the American Academy of Dermatology 2023-01, Vol.88 (1), p.40-51
Main Authors: Strober, Bruce, Thaçi, Diamant, Sofen, Howard, Kircik, Leon, Gordon, Kenneth B., Foley, Peter, Rich, Phoebe, Paul, Carle, Bagel, Jerry, Colston, Elizabeth, Throup, John, Kundu, Sudeep, Sekaran, Chitra, Linaberry, Misti, Banerjee, Subhashis, Papp, Kim A.
Format: Article
Language:English
Subjects:
Adult
Anti-Inflammatory Agents, Non-Steroidal - therapeutic use
apremilast
clinical trial
Dermatologic Agents - therapeutic use
deucravacitinib
Double-Blind Method
efficacy
Humans
phase 3
psoriasis
Psoriasis - chemically induced
Psoriasis - diagnosis
Psoriasis - drug therapy
Psoriasis Area and Severity Index
safety
Severity of Illness Index
skin diseases
static Physician's Global Assessment
Treatment Outcome
TYK2 Kinase - antagonists & inhibitors
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Summary:Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, inhibits cytokine signaling in psoriasis pathogenesis. The objective of this study was to demonstrate deucravacitinib superiority versus placebo and apremilast in moderate to severe plaque psoriasis based on ≥75% reduction from baseline in Psoriasis Area and Severity Index and a static Physician's Global Assessment score of 0 (clear) or 1 (almost clear) with a ≥2-point improvement from baseline at week 16. POETYK psoriasis second trial (NCT03611751), a 52-week, double-blinded, phase 3 trial, randomized patients 2:1:1 to deucravacitinib 6 mg every day (n = 511), placebo (n = 255), or apremilast 30 mg twice a day (n = 254). At week 16, significantly more deucravacitinib-treated patients versus placebo and apremilast patients achieved ≥75% reduction from baseline in Psoriasis Area and Severity Index (53.0% vs 9.4% and 39.8%; P 
ISSN:0190-9622
1097-6787
DOI:10.1016/j.jaad.2022.08.061