Bibliographic record
Abstract
Background: Damoctocog alfa pegol (BAY 94-9027, Jivi ® ) and rurioctocog alfa pegol (BAX 855, Adynovi ® ) are PEGylated, extended half-life, recombinant factor VIII (FVIII) products, indicated for use in patients ≥ 12 years of age with haemophilia A. Here, we present results from the first head-to-head comparative pharmacokinetic (PK) study of damoctocog alfa pegol and rurioctocog alfa pegol in adult patients with severe haemophilia A. Methods: In this single-centre, open-label, crossover study (ClinicalTrials.govidentifier: NCT04015492), previously FVIIItreated patients (≥150 exposure days) aged 18-65, with severe haemophilia A (FVIII < 1 IU/dL) were randomized to receive a single infusion of damoctocog alfa pegol followed by rurioctocog alfa pegol (50 IU/kg each, nominal potency), or vice versa, with ≥ 7-day wash-out between doses.Serial PK samples were collected and PK parameters were estimated.Population PK models were developed to simulate times to 1, 5 and 10 IU/dL FVIII.Results: Patients (N = 18; mean age, 34.2 years) received actual administered doses of 54.3 IU/kg damoctocog alfa pegol and 61.4 IU/ kg rurioctocog alfa pegol.The geometric mean [%CV] AUC(0-t last ) was numerically higher for damoctocog alfa pegol (2311 IU•h/dL [44.0%]) versus rurioctocog alfa pegol (2150 IU•h/dL [39.6%]) for ~10% lower actual dose of damoctocog alfa pegol versus rurioctocog alfa pegol.Damoctocog alfa pegol had a superior PK profile based on actual dosing, vs rurioctocog alfa pegol, with improvement in most patients: 22% increase in AUC norm (95%CI 1.11-1.33,P = 0.0004), 18% slower clearance (95%CI 0.75-0.90,P = 0.0004) and longer halflife (17.0 h vs 16.0 h, respectively, P = 0.0064, Table).Based on a
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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 | 0.014 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.003 | 0.003 |
| Science and technology studies | 0.002 | 0.001 |
| Scholarly communication | 0.008 | 0.004 |
| Open science | 0.002 | 0.004 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.854 | 0.763 |
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; the direct Gemma label and the distilled Codex classifier agree on what is shown here.
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".