Deucravacitinib in Plaque Psoriasis: Maintenance of Response Over 3 Years in the Phase 3 POETYK PSO-1 and PSO-2 Trials
Bibliographic record
Abstract
Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor for moderate-to-severe plaque psoriasis, was superior to placebo and apremilast in two global, 52-week, phase 3 trials and maintained long-term efficacy through 2 years with no new safety signals in an ongoing long-term extension (LTE) trial. We report clinical efficacy for up to 3 years (148 weeks) in a subset of patients from these trials. Materials: POETYK PSO-1 and PSO-2 randomized patients 1:2:1 to oral placebo, deucravacitinib 6 mg once daily (QD), or apremilast 30 mg twice daily. At Week 52, patients could enter the POETYK LTE and receive open-label deucravacitinib 6 mg QD. Deucravacitinib efficacy, as of June 15, 2022, was evaluated through Week 148 in patients from the pooled PSO-1/PSO-2 populations who received continuous deucravacitinib from Day 1, achieved ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI 75) at Week 16 (primary endpoint) or at Week 24 (peak response), and entered the LTE. Maintenance of response assessments included PASI 75, PASI 90, and sPGA 0/1 (static Physician Global Assessment of 0 [clear] or 1 [almost clear] with a ≥2-point improvement from baseline), which were reported using modified nonresponder imputation. Results: Of patients (N=513) who completed 52 weeks in the parent trials and received continuous deucravacitinib treatment from Day 1, 313 (61.4%) achieved PASI 75 at Week 16 and 336 (66.5%) achieved PASI 75 at Week 24. Among Week 16 PASI 75 responders, PASI 75, PASI 90, and sPGA 0/1 response rates were maintained from Week 52 (87.0%, 60.6%, and 70.8%, respectively) to Week 148 (84.5%, 60.0%, and 62.8%, respectively). Among Week 24 PASI 75 responders, PASI 75, PASI 90, and sPGA 0/1 response rates were maintained from Week 52 (90.2%, 61.6%, and 74.1%, respectively) to Week 148 (86.0%, 60.4%, and 64.5%, respectively). Conclusion: Clinical efficacy was maintained with continuous deucravacitinib treatment in most Week 16 and Week 24 PASI 75 responders from the parent trials through 148 weeks, supporting long-term effectiveness of once-daily oral deucravacitinib for moderate to severe plaque psoriasis.
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How this classification was reachedexpand
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 | 0.009 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| 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 itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, 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".