A prospective surveillance study of factor VIII inhibitor development in the Canadian haemophilia A population following the switch to a recombinant factor VIII product formulated with sucrose
Bibliographic record
Abstract
The introduction of new factor concentrates has, at times, resulted in an increase in inhibitor development; hence large systematic surveys of inhibitor development are necessary whenever new products are introduced. This study presents the results of a surveillance study conducted by the Inhibitor Subcommittee of the Association of Hemophilia Clinic Directors of Canada that evaluated inhibitor development in patients with haemophilia A following the switch to a second generation recombinant FVIII product (rFVIII-FS; Kogenate((R)) Bayer). Four hundred and sixty haemophilia A paediatric and adults patients from 17 Canadian Comprehensive Hemophilia Care Centers were enrolled in the study. Of these, 274 patients had evaluable data. Blood samples collected at baseline (prior to the switch to rFVIII-FS), and at 12 and 24 months following conversion were tested for inhibitors by the Nijmegen-modified Bethesda assay. Four subjects had positive inhibitor titres at baseline, with values ranging from 3.3 to 160 BU. Of the 274 patients who had baseline samples collected, 225 had postswitch samples collected at 12 months and 189 subjects had samples collected at 24 months. Only patients with positive baseline inhibitor titres (n = 4) had positive inhibitor titres at either the 12- or 24-month postswitch time points; therefore no de novo inhibitors developed over the 2-year evaluation period in this patient population. The results of this surveillance study suggest that the altered formulation of this recombinant FVIII concentrate was not associated with an increased incidence of inhibitor formation.
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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 | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.001 | 0.003 |
| Science and technology studies | 0.002 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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".