Low Uveitis Rates in Patients with Axial Spondyloarthritis or Psoriatic Arthritis Treated with Bimekizumab: Long-Term Results from Phase 2B/3 Trials
Bibliographic record
Abstract
Objectives Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL17A. Here, we report long-term incidence of acute anterior uveitis (uveitis’) following BKZ treatment in patients (pts) with axial spondyloarthritis (axSpA) or psoriatic arthritis (PsA). Methods Safety data are reported for 2 pools, each comprising 3 phase 2b/3 studies and their open-label extensions, in pts with active axSpA (non-radiographic and radiographic axSpA) and active PsA, respectively. Uveitis events were identified using the preferred terms “autoimmune uveitis,” “iridocyclitis,” “iritis,” and “uveitis,” coded according to MedDRA v19.0; note that “acute anterior uveitis” was not a specific preferred term available in MedDRA v19.0. Uveitis rates and exposure-adjusted incidence rates (EAIR) per 100 pt-years (PY) for pts who received ≥1 BKZ 160 mg dose are reported (data cutoff: July 2023). Results Pts with axSpA (N=848) had a mean age (standard deviation [SD]) of 40.3 (11.9) years, and pts with PsA (N=1,409) had a mean age (SD) of 49.3 (12.4) years, with a mean time since diagnosis (SD) of 6.1 (7.8) and 7.0 (8.0) years, respectively. Of pts with axSpA, 130 (15.3%) had a history of uveitis; 21 (1.5%) pts with PsA had a history of uveitis. The majority of pts with axSpA were human leukocyte antigen (HLA)-B27 positive (717/848 [84.6%]). In pts with axSpA across the pooled phase 2b/3 axSpA trial data, BKZ exposure was 2,514 PY. Uveitis occurred in 31/848 (3.7%; EAIR [95% confidence interval; CI]: 1.3/100 PY [0.9, 1.8]) pts overall and in 18/130 (13.8%; 4.8/100 PY [2.8, 7.6]) pts with history of uveitis. In pts without a history of uveitis, 13/718 (1.8%; 0.6/100 PY [0.3, 1.1]) pts had uveitis events (Figure). All events were mild/moderate, 1 led to treatment discontinuation. Incidence of uveitis in pts with PsA was low across the pooled phase 2b/3 PsA trial data (total BKZ exposure: 3,656 PY); uveitis occurred in 3 (0.2%; 0.1/100 PY [0.0, 0.2]) pts overall; 1 had a history of uveitis. No uveitis events led to treatment discontinuation. Figure. Incidence of uveitis (EAIR/100 PY [95% CI]) in patients with axSpA stratified by history of uveitis Conclusion Across 2,514 PY in pts with axSpA and 3,656 PY in pts with PsA, the long-term incidence of uveitis in pts treated with BKZ remained low. Previously submitted to: ACR 2024.
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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 | 0.013 | 0.011 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.003 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.002 | 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".