Deucravacitinib in Psoriasis Patients with a History of Malignancy: Follow-up after 4 Years of Deucravacitinib Treatment in the POETYK PSO Program
Bibliographic record
Abstract
Introduction: The global phase 3 POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) trials of deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, included psoriasis patients with a history of malignancy. This descriptive analysis evaluated malignancy events in deucravacitinib-treated patients with malignancy prior to enrolling in the POETYK PSO-1, PSO-2, and long-term extension (NCT04036435) trials. Methods: Patients in the pooled population who received ≥1 dose of deucravacitinib at any time over 4 years (data cutoff, November 1, 2023) were screened to identify those with a history of malignancy at baseline with no evidence of recurrence for >5 years prior to enrollment. Baseline patient demographics and clinical characteristics, type of prior malignancy, total deucravacitinib exposure, deucravacitinib treatment discontinuation, and occurrence of malignancy were evaluated for each patient with a history of malignancy. Results: Among 1519 deucravacitinib-treated patients, 19 had a history of malignancy (12 had a history of malignancy excluding nonmelanoma skin cancer [NMSC]; 7 had NMSC). Patients with a history of malignancy were older (mean age, 64.3 vs 46.6 years), had longer disease duration (mean, 36.2 vs 18.7 years), and had shorter deucravacitinib exposure (median, 814 vs 1298 days) compared with the total pooled population. Six of the 12 (50.0%) patients with a history of malignancy excluding NMSC discontinued treatment due to patient withdrawal (n=2), occurrence of malignancy (n=1), adverse events (n=1), lost to follow-up (n=1), or study site termination (n=1). Among the 12 patients with a history of malignancy excluding NMSC, there was 1 occurrence of malignancy. Conclusion: Malignancies were infrequently observed with deucravacitinib treatment in psoriasis patients with a history of malignancy. Analysis of larger patient populations over a longer duration of follow-up using real-world data will help to further characterize the safety of deucravacitinib in psoriasis patients with a history of malignancy.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| 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".