Bimekizumab Efficacy in High-Impact Areas: Pooled 2-Year Analysis in Scalp, Nail, and Palmoplantar Psoriasis from Phase 3/3b Randomized Controlled Trials
Bibliographic record
Abstract
Psoriasis in high-impact areas, including the scalp, nails, palms, and soles, can disproportionately impair patient quality of life. Here, we evaluate the 2-year efficacy of bimekizumab treatment in patients with moderate to severe plaque psoriasis in post hoc analyses of five phase 3/3b trials. High-impact area efficacy data were pooled through 2 years across five phase 3/3b trials: BE VIVID, BE READY, BE SURE, their ongoing open-label extension (OLE) BE BRIGHT, and BE RADIANT (including its double-blinded treatment period and the first year of its OLE). Complete clearance of psoriasis in high-impact areas is reported over 2 years using the scalp Investigator’s Global Assessment (IGA), palmoplantar IGA, and modified Nail Psoriasis Severity Index (mNAPSI). Patients included in these analyses had baseline moderate to severe scalp or palmoplantar involvement (scalp or palmoplantar IGA score ≥ 3) or mNAPSI score > 10. A total of 1107 patients were randomized to bimekizumab and entered the OLEs. Subsets of 821 patients had scalp IGA ≥ 3 at baseline, 377 had mNAPSI > 10, and 193 had palmoplantar IGA ≥ 3. Complete scalp clearance in patients with baseline scalp IGA ≥ 3 randomized to bimekizumab was achieved rapidly, with high responses sustained from first (86.4%) to second year (85.9%). Nail clearance responses in patients with baseline mNAPSI > 10 increased from 63.4% to 68.5% from first to second year. Palmoplantar clearance in patients with baseline palmoplantar IGA ≥ 3 was sustained from first (88.3%) to second year (89.8%). Similar trends were seen in the 374 patients who received bimekizumab 320 mg every 4 weeks (Q4W)/every 8 weeks (Q8W) initial/maintenance dosing. In these analyses pooled across 2 years, bimekizumab showed sustained efficacy in psoriasis in high-impact areas. NCT03370133, NCT03410992, NCT03412747, NCT03598790, NCT03536884. Psoriasis in some body areas can have a bigger impact on the self-confidence and well-being of patients. These body areas, called high-impact areas, are often very visible or important for day-to-day activities. They include the scalp, fingernails, palms, and soles of the feet. People with psoriasis often find applying creams or ointments to these areas challenging. The treatment may also not be effective. Therefore, new medications that can clear psoriasis from these areas are needed by patients and physicians. Bimekizumab is a drug given by injection. We examined whether bimekizumab can clear psoriasis in high-impact areas over 2 years in five clinical trials. Psoriasis of the scalp, palms, and soles cleared quickly with bimekizumab. Most patients reported clear skin in these areas after 4 months, and skin remained clear for the rest of the 2-year period. After 2 years, 90% (18 in 20) of patients with psoriasis on their palms and soles saw it clear completely; 86% of patients (around 17 in 20) saw their scalp psoriasis completely cleared. Nail psoriasis took slightly longer to clear, because nails grow more slowly. Nevertheless, 63% of patients (around 13 in 20) had completely clear nails after 1 year and 69% of patients (around 14 in 20) had clear nails after 2 years. Bimekizumab can clear psoriasis in high-impact areas quickly, and this is maintained over the long-term. Bimekizumab can provide a lasting treatment option for areas of the body which are difficult to treat and have a big impact on patients’ lives.
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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 | 0.027 | 0.013 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.008 | 0.017 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 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".