Bimekizumab rates of oral candidiasis in patients with moderate to severe plaque psoriasis: Results from up to 4 years of five phase 3/3b studies
Bibliographic record
Abstract
Introduction: Bimekizumab (BKZ) selectively inhibits interleukin (IL)-17A and IL-17F. As IL-17A/F protect against oral candidiasis, understanding BKZ’s impact on oral candidiasis rates is important. We report long-term oral candidiasis rates in BKZ-treated patients with moderate to severe plaque psoriasis. Procedure: Final data were pooled from BE SURE (NCT03412747), BE VIVID (NCT03370133), BE READY (NCT03410992), their open-label extension (OLE), BE BRIGHT (NCT03598790; 4-year data), and BE RADIANT (NCT03536884; 3-year data). Patients received BKZ 320mg every 4 weeks (Q4W) or Q8W; all received Q8W from Week 64 (BE RADIANT)/OLE Week 48 (BE BRIGHT). Exposure-adjusted incidence rates/100 patient‑years (EAIR/100PY), recurrence and treatment of oral candidiasis treatment-emergent adverse events (TEAEs) are reported for patients who received ≥1 BKZ dose. Results: To Year 4 (N=2,186), Candida infection EAIR was 10.4/100PY. Most were oral candidiasis (8.9/100PY); 99.1% were mild/moderate (no serious cases). Eight patients discontinued the study due to oral candidiasis (one severe case; six recurrent cases). To Year 4, 78.8% had no oral candidiasis TEAEs. In patients with ≥1 oral candidiasis TEAE, most had one/two; 10.3% had one, 5.4% two, 2.1% three, 1.7% four and 1.8% had five or more. 71.1% of patients with oral candidiasis experienced their first occurrence within treatment Year 1. Most cases were treated with nystatin and/or fluconazole; median (interquartile range) antifungal therapy duration: 13.0 (7.0–26.0) days. Conclusion: To Year 4, ~80% of BKZ-treated patients did not experience oral candidiasis; in those who did, most had one/two events. >99% of events were mild/moderate; very few led to study discontinuation. Funding: These studies were funded by UCB. Medical writing support was provided by Costello Medical.
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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 | 0.016 | 0.005 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.004 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| 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".