Bimekizumab Response Maintenance to 48 Weeks in Patients with Moderate to Severe Hidradenitis Suppurativa: Pooled Responder Analysis from the Phase 3, Double-Blind, Placebo-Controlled, Randomized Clinical Trials BE HEARD I and II
Bibliographic record
Abstract
OC: the denominator represents the number of patients with a non-missing lesion count assessment at the given week, and percentages are calculated accordingly.a Bimekizumab Q2W and Q4W treatment arms are pooled for the BKZ Total group. Synopsis• Hidradenitis suppurativa (HS) is a chronic, relapsing, and painful inflammatory skin disease associated with significant comorbidities and poor quality of life. 1 • However, treatment options are limited.2 • Bimekizumab (BKZ), a monoclonal immunoglobulin G1 antibody which selectively inhibits interleukin (IL)-17F in addition to IL-17A, has demonstrated efficacy in patients with moderate to severe HS. 2 • Here, we report maintenance of response through Week 48 for BE HEARD I and II.3,4 Objective To report maintenance of response over 48 weeks in patients with moderate to severe HS who achieved clinical responses after 16 weeks of BKZ treatment from the phase 3 BE HEARD I & II studies. Methods• Data were pooled from BE HEARD I & II.3,4 These randomized, double-blinded, placebo-(PBO-) controlled phase 3 studies were comprised of an initial (Weeks 0-16) and a maintenance (Weeks 16-48) treatment period (Figure 1).• Maintenance of response is reported respectively as a) the percentage of BKZ-treated patients who achieved 50/75/90% HS Clinical Response (HiSCR50/75/90) or b) an abscess and inflammatory nodule (AN) count of 0, 1, or 2 at both Week 16 and Week 48.• Data are reported as observed cases (OC) throughout; last observation carried forward (LOCF) data are provided in Table 2. Results Baseline Characteristics• Baseline demographics were comparable across treatment arms (Table 1). Week 48 Responders• Among Week 16 HiSCR50 responders, 88.5-89.6% of patients maintained this response through Week 48, across treatment regimens (Table 2; Figure 2).• Among Week 16 HiSCR75 responders, 80.9-88.3% of patients maintained this response through Week 48, across treatment regimens (Table 2; Figure 3).• Among Week 16 HiSCR90 responders, 65.2-69.2% of patients maintained this response through Week 48, across treatment regimens (Table 2; Figure 4).• Among patients with an AN count of 0, 1, or 2 at Week 16, 82.1%-88.0% of patients maintained this response through Week 48, across treatment regimens (Table 2; Figure 5). ConclusionsMaintenance of response among Week 16 responders was high across the primary endpoint (HiSCR50) and more stringent clinical outcome measures for BKZ-randomized patients.
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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 | 0.006 | 0.005 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.006 | 0.008 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.005 | 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".