Low Risk of Serious Infections and Infections of Interest in Psoriasis Patients Treated with Guselkumab (GUS) for up to 5 Years in VOYAGE (VOY) 1&2 Phase 3 Trials
Bibliographic record
Abstract
Treatment of psoriasis with immunomodulatory biologics may increase the risk for certain types of infections (eg, candidiasis, herpes zoster) 1-3 • Guselkumab (GUS), a monoclonal antibody targeting the p19 subunit of interleukin-23, is approved for the treatment of moderate to severe psoriasis and active psoriatic arthritis• VOYAGE 1 and 2 were randomized, double-blinded, placebo (PBO)-and active-comparator-controlled Phase 3 studies that demonstrated the long-term efficacy and safety of GUS in patients (pts) with moderate to severe psoriasis 4,5ɤ Infection rates were low and comparable across groups during the PBO-and active-comparator periods of these studies 4,5 † As determined by diagnosis and location; search criteria included MedDRA preferred terms of fungal balanitis, genital infection fungal, vulvovaginal mycotic infection, oral fungal infection, tongue fungal infection, oropharyngitis fungal, and fungal esophagitis.Only preferred terms matching these search criteria were included in this analysis.
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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) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| 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 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 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".