Bibliographic record
Abstract
Objectives: To report bimekizumab (BKZ) efficacy and safety to Week 52 from the phase 3 study BE OPTIMAL in biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve patients with psoriatic arthritis (PsA), with (+) or without (-) ongoing concomitant methotrexate (MTX).Methods: BE OPTIMAL (NCT03895203) comprised a 16-week double-blind placebo (PBO)-controlled period and a 36-week active treatment-blind period.Patients were randomized 3:2:1 to subcutaneous BKZ 160 mg every 4 weeks (Q4W):PBO: reference arm (adalimumab [ADA] 40 mg Q2W).From Week 16, PBO patients received BKZ 160 mg Q4W.Patients could not adjust their background medication during the 16-week PBO-controlled period.Efficacy and safety were evaluated by concomitant MTX use at baseline.Missing data were imputed using non-responder (discrete) or multiple (continuous) imputation.Results: 761/852 (89.3%) patients completed Week 52 (+ MTX: 454/497 [91.3%], -MTX: 307/355 [86.5%]).Baseline characteristics were generally similar + MTX vs -MTX: mean age 48.1 vs 49.4 years, BMI 29.1 vs 29.4 kg/m2, 5.7 vs 6.2 years since diagnosis, 47.3% vs 46.2% male, 49.5% vs 50.4% with psoriasis affecting ≥ 3% body surface area.To Week 52, the proportion of BKZ-randomized patients who achieved American College of Rheumatology (ACR)50, complete skin clearance (Psoriasis Area and Severity Index [PASI]100), and minimal disease activity (MDA) were similar regardless of baseline MTX use.Fewer patients receiving ADA -MTX achieved ACR50 or MDA at Week 52 compared to ADA + MTX.(Figure) Other Week 52 efficacy responses on BKZ were generally of a similar magnitude + MTX vs -MTX.To Week 52, patients with ≥ 1 treatment-emergent adverse event + MTX vs -MTX: PBO/BKZ, 124/158 (78.5%) vs 89/113 (78.8%);BKZ, 214/252 (84.9%) vs 150/179 (83.8%);ADA, 63/82 (76.8%) vs 50/58 (86.2%).Conclusion: BKZ treatment demonstrated consistent sustained clinical efficacy across disease manifestations to Week 52 in bDMARD-naïve patients with PsA, irrespective of concomitant MTX.BKZ was well tolerated in patients with PsA with or without MTX.
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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 | 0.001 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.002 | 0.000 |
| Scholarly communication | 0.005 | 0.002 |
| Open science | 0.002 | 0.003 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.900 | 0.791 |
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; the direct Gemma label and the distilled Codex classifier agree on what is shown here.
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".