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
70 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.

OriginalspracheEnglisch
ZeitschriftJournal of the American Academy of Dermatology
Jahrgang88
Ausgabenummer1
Seiten (von - bis)29-39
Seitenumfang11
ISSN0190-9622
DOIs
PublikationsstatusVeröffentlicht - 01.2023

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

  • 205-19 Dermatologie

Zitieren