Bimekizumab Maintained Stringent Clinical Responses Over 2 Years in Patients with Axial Spondyloarthritis: Results from Two Phase 3 Studies
Bibliographic record
Abstract
Objectives To assess the maintenance of response to bimekizumab (BKZ) among patients (pts) across the full disease spectrum of axial spondyloarthritis (axSpA) over 2 years in the open-label extension (OLE) of BE MOBILE 1 and 2. Methods BE MOBILE 1 ( NCT03928704 ) and 2 ( NCT03928743 ) comprised a 16-week (wk) double-blind period followed by a 36-wk maintenance period in pts with non-radiographic (nr-) and radiographic (r-) axSpA, respectively.[1] Pts were randomized to receive subcutaneous BKZ 160 mg every 4 wks (Q4W) or placebo (PBO); from Wk16, all received BKZ. At Wk52, eligible pts could enter BE MOVING (OLE; NCT04436640 ). Proportions of pts achieving Assessment of SpondyloArthritis international Society ≥40% improvement (ASAS40), ASAS partial remission (PR), ASDAS low disease activity (LDA) and ASDAS inactive disease (ID) to Wk104 were assessed among BKZrandomized pts who achieved each respective outcome at Wk16, pooled across studies. Presented data use non-responder imputation (NRI), multiple imputation (MI) and worst category imputation (WCI; ASDAS only). Observed case (OC) data are also reported. Treatment-emergent adverse events (TEAEs) to Wk104 are reported for pts who received ≥1 BKZ dose, including pts who switched from PBO to BKZ at Wk16. Results Overall, 128 and 221 pts were randomized to BKZ in BE MOBILE 1 and 2, respectively (N=349). High proportions of Wk16 responders maintained their responses at Wk104 (Figure). At Wk16, 160 (45.8%) pts achieved ASAS40; this increased to 180 (51.6%) at Wk104 (NRI). Of Wk16 ASAS40 achievers, 85.7% maintained this response at Wk104 (MI). At Wk16, ASAS PR was achieved by 86 (24.6%) pts; this increased to 100 (28.7%) pts at Wk104 (NRI). Of Wk16 ASAS PR achievers, 76.8% also achieved this outcome at Wk104 (MI) (Figure). ASDAS LDA was achieved by 152 (43.6%) pts at Wk16; this increased to 172 (49.3%) at Wk104 (NRI). Of Wk16 ASDAS LDA achievers, 89.3% also achieved this outcome at Wk104 (MI). ASDAS ID was achieved by 58 (16.6%) pts at Wk16; this increased to 88 (25.2%) at Wk104 (NRI). Of Wk16 ASDAS ID achievers, 76.0% achieved this outcome at Wk104 (MI) (Figure). Through Wk104, 514/574 (89.5%; exposure-adjusted incidence rate per 100 pt-years [EAIR/100 PY]: 141.9) pts on BKZ had ≥1 TEAE; 72 (12.5%; EAIR/100 PY: 5.4) had serious TEAEs. 39 (6.8%; EAIR/100 PY: 2.8) pts discontinued BKZ due to TEAEs. Figure. Maintenance of ASAS40, ASAS PR, ASDAS LDA and ASDAS ID to Wk104 of BKZ 160 mg Q4W among Wkl6 ASAS40, ASAS PR, ASDAS LDA and ASDAS ID responders, respectively Conclusion BKZ maintained stringent clinical responses from Wk16 to Wk104 in axSpA. No new safety signals were observed. Previously submitted to: ACR 2024. [1.] Baraliakos X. Ann Rheum Dis 2024;83:199-213.
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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 | 0.008 | 0.006 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 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".