Efficacy and safety of tildrakizumab for the treatment of moderate-to-severe plaque psoriasis of the scalp: Week 52 results from a phase 3b, randomized, double-blind, placebo-controlled trial
Bibliographic record
Abstract
BACKGROUND: In the primary analysis of a phase 3b, randomized, double-blind, placebo-controlled study in patients with moderate-to-severe plaque psoriasis affecting the scalp (NCT03897088), tildrakizumab, an anti-interleukin-23 p19 antibody, met the primary efficacy endpoint at week 16. OBJECTIVE: To evaluate maintenance of tildrakizumab efficacy and safety for the treatment of scalp psoriasis from the week 52 full analysis. METHODS: Patients randomized to tildrakizumab continued receiving tildrakizumab 100 mg every 12 weeks; patients randomized to placebo (analyzed separately) switched to tildrakizumab 100 mg at week 16. Efficacy endpoints included Investigator Global Assessment modified 2011 (scalp) score of 0 or 1 with ≥2-grade improvement and ≥90% improvement in Psoriasis Scalp Severity Index score from baseline. Safety was assessed from adverse events. RESULTS: In patients originally randomized to tildrakizumab versus placebo, Investigator Global Assessment modified 2011 (scalp) and ≥90% improvement in Psoriasis Scalp Severity Index score response rates, respectively, improved from 49.4% versus 7.3% and 60.7% versus 4.9% at week 16 to 62.9% versus 56.1% and 65.2% versus 57.3% at week 52; >80% of week 16 responders to tildrakizumab maintained response. No treatment-related serious adverse events occurred. LIMITATIONS: Results were obtained under controlled clinical conditions. CONCLUSION: Efficacy and safety of tildrakizumab for the treatment of scalp psoriasis are sustained long-term.
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.007 | 0.001 |
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".