Safety and efficacy of envudeucitinib, a highly selective, oral allosteric TYK2 inhibitor, in patients with moderate-to-severe plaque psoriasis: Results from the 52-week open-label extension period of the phase 2 STRIDE study
Bibliographic record
Abstract
BACKGROUND: Envudeucitinib (ESK-001), a highly selective, oral tyrosine kinase 2 inhibitor, was well-tolerated and effective in patients with plaque psoriasis in the STRIDE study. OBJECTIVE: To assess long-term safety and efficacy of envudeucitinib throughout 52 weeks in the ongoing phase 2 open-label extension in patients who completed STRIDE. METHODS: Patients completing STRIDE were eligible to enroll in the long-term open-label extension study (NCT05739435) and received envudeucitinib 40-mg once or twice daily. RESULTS: In the open-label extension which enrolled 165 patients, envudeucitinib was generally well-tolerated, with an overall 3.7% study drug discontinuation rate due to adverse events, as well as no clinically concerning laboratory or electrocardiogram findings. After 52 weeks of treatment with envudeucitinib 40-mg twice daily, 78% of patients achieved Psoriasis Area and Severity Index (PASI)-75, 61% achieved PASI-90, 39% achieved PASI-100, and 39% achieved sPGA-0. Moreover, 62% showed continued improvement in PASI response over time versus STRIDE week 12. In addition, approximately 80% reported pruritus Numerical Rating Scale <4 and 61% achieved Dermatology Life Quality Index 0/1. LIMITATIONS: This was an open-label study with limited sample size and no control. CONCLUSION: Envudeucitinib 40-mg twice daily in adults with moderate-to-severe plaque psoriasis demonstrated increasing and durable improvements in skin clearance and pruritus and was well-tolerated throughout 52 weeks of treatment.
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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 | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 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".