POETYK PSO-2 (deucravacitinib vs. placebo)
Trial question
What is the role of deucravacitinib in patients with moderate-to-severe plaque psoriasis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
33.0% female
67.0% male
N = 766
766 patients (249 female, 517 male).
Inclusion criteria: adult patients with moderate-to-severe plaque psoriasis.
Key exclusion criteria: other forms of psoriasis; history of recent infection; prior exposure to deucravacitinib.
Interventions
N=511 deucravacitinib (at a dose of 6 mg daily).
N=255 placebo (matching placebo daily).
Primary outcome
≥ 75% reduction in Psoriasis Area and Severity Index at week 16
53%
9.4%
53.0 %
39.8 %
26.5 %
13.3 %
0.0 %
Deucravacitinib
Placebo
Significant
increase ▲
NNT = 2
Significant increase in ≥ 75% reduction in Psoriasis Area and Severity Index at week 16 (53% vs. 9.4%; AD 43.7%, 95% CI 38 to 49.3).
Secondary outcomes
Significant increase in static Physician's Global Assessment score of 0 or 1 at week 16 (49.5% vs. 8.6%; AD 40.9%, 95% CI 35.4 to 46.4).
Significant increase in ≥ 90% reduction in Psoriasis Area and Severity Index at week 16 (27% vs. 2.7%; AD 24.3%, 95% CI 19.9 to 28.7).
Significant increase in DLQI of 0 or 1 at week 16 (37.6% vs. 9.8%; AD 27.9%, 95% CI 22.2 to 33.7).
Safety outcomes
No significant difference in adverse events.
Conclusion
In adult patients with moderate-to-severe plaque psoriasis, deucravacitinib was superior to placebo with respect to ≥ 75% reduction in Psoriasis Area and Severity Index at week 16.
Reference
Bruce Strober, Diamant Thaçi, Howard Sofen et al. 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. J Am Acad Dermatol. 2023 Jan;88(1):40-51.
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