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

  • J Am Acad Dermatol. 2023 Jan;88(1):29-39. doi: 10.1016/j.jaad.2022.07.002.
April W Armstrong  1 ,  Melinda Gooderham  2 ,  Richard B Warren  3 ,  Kim A Papp  4 ,  Bruce Strober  5 ,  Diamant Thaçi  6 ,  Akimichi Morita  7 ,  Jacek C Szepietowski  8 ,  Shinichi Imafuku  9 ,  Elizabeth Colston  10 ,  John Throup  10 ,  Sudeep Kundu  10 ,  Steve Schoenfeld  10 ,  Misti Linaberry  10 ,  Subhashis Banerjee  10 ,  Andrew Blauvelt  11
Affiliations
  • 1. Department of Dermatology, Keck School of Medicine, University of Southern California, Los Angeles, California. Electronic address: [email protected].
  • 2. SKiN Centre for Dermatology, Department of Dermatology at Queen's University, and Probity Medical Research, Peterborough, Ontario, Canada.
  • 3. Dermatology Centre at Salford Royal NHS Foundation Trust Hospital, NIHR Manchester Biomedical Research Centre at the University of Manchester, Manchester, United Kingdom.
  • 4. K Papp Clinical Research and Probity Medical Research, Waterloo, Ontario, Canada.
  • 5. Department of Dermatology, Yale University School of Medicine, New Haven, and Central Connecticut Dermatology Research, Cromwell, Connecticut.
  • 6. Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.
  • 7. Department of Geriatric and Environmental Dermatology, Nagoya City University Graduate School of Medical Sciences, Nagoya City, Aichi, Japan.
  • 8. Department of Dermatology, Venereology and Allergology, Wroclaw Medical University, Wrocław, Poland.
  • 9. Dermatology, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.
  • 10. Bristol Myers Squibb, Princeton, New Jersey.
  • 11. Oregon Medical Research Center, Portland, Oregon.
PMID: 35820547 DOI: 10.1016/j.jaad.2022.07.002
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.

Keywords
Psoriasis Area and Severity Index; apremilast; clinical trial; deucravacitinib; efficacy; phase 3; psoriasis; safety; skin diseases; static Physician's Global Assessment.
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