Deucravacitinib in plaque psoriasis: Four‐year safety and efficacy results from the Phase 3 <scp>POETYK PSO</scp>‐1, <scp>PSO</scp>‐2 and long‐term extension trials
Bibliographic record
Abstract
BACKGROUND: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, is approved in multiple countries for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. OBJECTIVES: To evaluate the safety and efficacy of deucravacitinib through 4 years in the Phase 3 POETYK PSO-1, PSO-2 and long-term extension (LTE) trials in psoriasis. METHODS: PSO-1 and PSO-2 (parent trials) randomized patients 1:2:1 to oral placebo, deucravacitinib 6 mg once daily (QD) or apremilast 30 mg twice daily. At 52 weeks, patients enrolled in the LTE trial received open-label deucravacitinib 6 mg QD. Safety was evaluated in patients who received ≥1 dose of deucravacitinib at any time. Clinical and patient-reported outcomes (PASI, PGA and DLQI) were analysed in patients who received continuous deucravacitinib from Day 1 of the parent trials and enrolled in the LTE trial. RESULTS: In total, 1519 patients received ≥1 dose of deucravacitinib, with cumulative exposure of 4392.8 person-years (PY) through the data cut-off of 1 November 2023. Exposure-adjusted incidence rates (EAIRs)/100 PY of noted safety measures were comparable or decreased from the 1-year to 4-year cumulative period, respectively, for adverse events (AEs) (229.23, 131.68), serious AEs (including COVID-19) (5.68, 5.01), deaths (0.20, 0.25), discontinuation due to AEs (4.38, 2.20), herpes zoster (0.81, 0.55), malignancies (1.02, 0.89), major adverse cardiovascular events (0.30, 0.32) and venous thromboembolism (0.20, 0.07). In patients who received continuous deucravacitinib (n = 513), clinical and patient-reported outcome rates were well maintained from 1 year through 4 years (e.g. PASI 90, 1 year, 45.6% [95% CI, 41.3%-50.0%], 4 years, 47.5% [42.6%-52.4%]; DLQI 0/1, 1 year, 51.5% [47.1%-55.9%], 4 years, 49.4% [44.4%-54.4%]). CONCLUSIONS: Deucravacitinib demonstrated a consistent safety profile and durable efficacy through 4 years of treatment in patients with moderate to severe plaque psoriasis.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.006 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".