Deucravacitinib in plaque psoriasis: Safety and efficacy through 3 years in Japanese patients in the phase 3 <scp>POETYK PSO</scp> ‐1, <scp>PSO</scp> ‐4, and <scp>LTE</scp> trials
Why this work is in the frame
A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.
Bibliographic record
Abstract
Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, was effective and well tolerated at a dose of 6 mg once daily through 1 year (52 weeks) in patients with moderate to severe plaque psoriasis in the phase 3 POETYK PSO-1 and POETYK PSO-4 trials. Patients completing PSO-1 or PSO-4 could enter the ongoing POETYK long-term extension trial and receive open-label deucravacitinib. Safety and efficacy were evaluated through 3 years (148 weeks; data cutoff date: June 15, 2022) in Japanese patients in these trials. Safety was assessed via adverse events (AEs). Efficacy endpoints, including ≥75% reduction from baseline in the Psoriasis Area and Severity Index (PASI 75) and static Physician Global Assessment (sPGA) score of 0/1 (clear/almost clear), were evaluated in patients receiving continuous deucravacitinib treatment from baseline in PSO-1 and PSO-4 and in PSO-1 patients crossing over from placebo to deucravacitinib at week 16. At data cutoff, 125 patients had received at least one deucravacitinib dose; 86.4% had >24 months and 27.2% had >36 months of total deucravacitinib exposure. Exposure-adjusted incidence rates per 100 person-years for AEs were: any AEs, 188.5; discontinuations attributable to AEs, 3.2; serious AEs, 7.4; serious infections, 1.3; herpes zoster events, 1.6; major adverse cardiovascular events, 0.6; venous thromboembolic events, 0; and malignancies, 1.0. Clinical responses (as observed) were maintained in PSO-1 patients receiving continuous deucravacitinib treatment from baseline (PASI 75: year 1, 88.9%; year 3, 87.5%; sPGA 0/1: year 1, 74.1%; year 3, 66.7%). Year 1 response rates were also maintained through year 3 in PSO-4 patients and in PSO-1 placebo crossovers. Response rates were also consistent using modified nonresponder imputation and treatment failure rules data imputation methodologies. These findings support the consistent safety profile and durable efficacy of deucravacitinib through 3 years in Japanese patients with psoriasis. ClinicalTrials.gov: NCT03624127; NCT03924427; NCT04036435.
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Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 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 it