Bimekizumab Efficacy and Safety Over 48 Weeks in US and Canadian Patients with Psoriasis who had a Treatment Interruption After 3 Years of Treatment: Results from BE RADIANT
Bibliographic record
Abstract
Patients with psoriasis treated with biologics frequently experience treatment interruptions; 1,2 therefore, it is important to assess recovery of response upon retreatment. ObjectiveTo report efficacy and safety of bimekizumab (BKZ) in patients from the US and Canada treated for 1 year following a treatment interruption during the BE RADIANT study. Methods • After 144 weeks of BE RADIANT (3 years; 48-week double-blinded period plus a 96-week open-label extension period [OLE]), 3 patients from the US and Canada could enter a second OLE (OLE2; 48 weeks); most had a treatment interruption before entering OLE2 (Figure 1).• Patients scoring ≤ 2 in the Investigator's Global Assessment (IGA) at OLE2 baseline received BKZ every 8 weeks (Q8W), and those scoring IGA ≥ 3 received BKZ Q4W for 16 weeks then Q8W thereafter (Q4W/Q8W).• The following efficacy outcomes are reported through OLE2, in patients who had a treatment interruption, using non-responder imputation (NRI) and observed cases (OC):-≥ 90%/100% improvement from baseline in Psoriasis Area and Severity Index (PASI 90/100); -IGA 0/1 (clear or almost clear); -Dermatology Life Quality Index (DLQI) 0/1 (no effect of skin disease on quality of life).4• Following a treatment interruption, the proportions of patients who had treatmentemergent adverse events (TEAEs) during OLE2 are reported, regardless of dosing regimen (BKZ Total).-Rates of TEAEs are also reported as exposure-adjusted incidence rates per 100 patient-years. Results Efficacy• Baseline characteristics at the start of BE RADIANT are shown in Table 1.• 66 patients had an IGA score of ≤ 2 at OLE2 entry and received BKZ Q8W, after a median (range) treatment interruption of 23 (6-51) weeks.-Among these patients, PASI 100 rates were high at Week 144 (74.2%; last visit before treatment interruption), decreased to OLE2 baseline (27.3%; after treatment interruption), regained to OLE2 Week 12 (69.7%; 3 months), and were maintained to OLE2 Week 48 (71.2%;Year 1; Figure 2A).-PASI 90, IGA 0/1, and DLQI 0/1 rates followed a similar trend (Figures 2B-D).• 59 patients had an IGA score ≥ 3 at OLE2 entry and received BKZ Q4W/Q8W, after a median treatment interruption of 28 (7-49) weeks.-Among these patients, PASI 100 rates were high at Week 144 (64.4%), decreased to OLE2 baseline (0%), regained after 3 months (64.4%), and were maintained to Year 1 (54.2%; Figure 2A).-PASI 90, IGA 0/1, and DLQI 0/1 rates followed a similar trend (Figures 2B-D). Safety• The proportions of patients who reported TEAEs and TEAEs of interest are shown in Table 2.• One death occurred in OLE2 (pneumonia on a background of metastatic cancer; patient had underlying risk factors).• The most common TEAEs were coronavirus infection (OLE2 started during the global COVID-19 pandemic), oral candidiasis, and nasopharyngitis.• Oral candidiasis events occurred in nine (7.2%) patients.No cases of oral candidiasis were serious, severe, or led to discontinuation. ConclusionsAfter bimekizumab retreatment following a treatment interruption, efficacy responses were regained and maintained through 1 year; bimekizumab was well-tolerated with no unexpected safety findings.
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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 | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| 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".