Bimekizumab Maintained Efficacy Responses in Patients with Active Psoriatic Arthritis: Up to 2-Year Results from Two Phase 3 Studies
Bibliographic record
Abstract
Objectives To report the proportion of Week (Wk) 16 responders maintaining their response in joint, skin, and composite efficacy outcomes up to 2 years in bimekizumab (BKZ)-treated patients (pts) with psoriatic arthritis (PsA). Methods Two phase 3 studies assessed subcutaneous BKZ 160 mg every 4 wks in pts with PsA: BE OPTIMAL (biologic DMARD [bDMARD]-naïve; NCT03895203 ) and BE COMPLETE (TNF inhibitor inadequate response/intolerance [TNFi-IR]; NCT03896581 ); both were placebocontrolled to Wk16. BE OPTIMAL Wk52 and BE COMPLETE Wk16 completers were eligible for BE VITAL (open-label extension; NCT04009499 ). Efficacy data are reported for pts randomized to BKZ at baseline (BL); safety data are reported for all BKZ-treated pts. Maintenance of response is reported as the proportion of Wk16 responders who were responders at Wk104/100 (BE OPTIMAL/BE COMPLETE). Efficacy outcomes include ACR20/50/70, Psoriasis Area and Severity Index (PASI)75/90/100, Minimal/Very Low Disease Activity (MDA/VLDA), and Disease Activity Index for PsA (DAPSA) remission or low disease activity responses (REM ≤4; REM+LDA ≤14); these are reported here to Wk104 in BE OPTIMAL and Wk100 in BE COMPLETE. Data are reported as observed case or using non-responder or worst category imputation. Exposure-adjusted incidence rates per 100 pt-years (EAIR/100 PY) are reported to Wk104 for both bDMARD-naïve and TNFi-IR pts. Results Of BKZ-randomized pts, 359/431 (83.3%) bDMARD-naïve and 215/267 (80.5%) TNFi-IR pts completed Wk104/100. High proportions of pts achieving ACR50, PASI100, and MDA at Wk16 maintained responses at Wk104/100 (Table). At Wk16, 189 (43.9%) bDMARD-naïve and 115 (43.1%) TNFi-IR pts achieved ACR50; of those, 150 (79.4%) bDMARD-naïve and 87 (75.7%) TNFi-IR pts maintained response at Wk104/100. Similarly, for pts with BL psoriasis affecting ≥3% body surface area, 103/217 (47.5%) bDMARD-naïve and 103/176 (58.5%) TNFi-IR pts achieved PASI100 at Wk16; of those, 73 (70.9%) bDMARD-naïve and 83 (80.6%) TNFi-IR pts maintained response at Wk104/100. MDA was achieved by 194 (45.0%) bDMARD-naïve and 117 (43.8%) TNFi-IR pts at Wk16; of those, 147 (75.8%) bDMARD-naïve and 87 (74.4%) TNFi-IR pts maintained response at Wk104/100. Similar results were observed for other joints, skin, and composite efficacy outcomes at Wk104/100 (Table). To Wk104, the EAIR/100 PY for BKZ-treated pts with ≥1 treatment-emergent adverse event was 179.9 in bDMARD-naïve and 100.3 in TNFi-IR pts. Table. Maintenance of response at Week 104/100 in Week 16 responders for joint, skin, and composite efficacy outcomes (NRI, WCI, OC) Conclusion BKZ demonstrated robust maintenance of response at 2 years in both bDMARD-naïve and TNFi-IR pts with PsA who responded to BKZ treatment at Wk16. The safety profile was consistent with previous reports.[1,2] Previously submitted to: ACR 2024. [1.] Ritchlin CT. Ann Rheum Dis 2023;82:1404-14. [2.] Coates LC. RMD Open 2024;10:e003855.
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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 | 0.012 | 0.006 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.004 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.002 | 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".