A200 AN INTEGRATED ANALYSIS OF EFFICACY OF OBETICHOLIC ACID IN CANADIAN PATIENTS
Bibliographic record
Abstract
Obeticholic acid (OCA) is a potent FXR agonist investigated for the treatment of primary biliary cholangitis (PBC) in 3 randomized, double-blind (DB), placebo (PBO)-controlled trials ± UDCA. This analysis pools data from all 3 trials to investigate the efficacy and safety of OCA in patients treated in Canada. Key Entry Criteria: ALP 1.5 to 10x ULN and conjugated bilirubin ≤2x ULN (Phase 2 trials, DB phase=3 months); ALP ≥1.67x ULN or total bilirubin >ULN but <2x ULN (Phase 3 trial, DB phase=12 months). Data were pooled and assessed at the end of DB treatment (EOT) for each trial. Patients receiving 5 or 10 mg OCA were pooled into a single group: ≤10 mg OCA. Baseline (BL) biochemistry values were elevated in the ≤10 mg OCA group compared to the PBO group (Table 1). In patients receiving concomitant UDCA, there were significant reductions in ALP, ALT, and GGT at EOT compared to PBO. Total bilirubin and AST were reduced but not significant. Efficacy was similar in patients receiving OCA monotherapy. Pruritus was the most common adverse event, which occurred in 32% of PBO patients and 61% of patients receiving ≤10 mg OCA. Reductions in markers of cholestasis and hepatic damage with OCA treatment in Canadian patients were generally comparable to the global OCA treated population. Improvements in many of these markers have been associated with improved long-term outcomes in PBC. None
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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 | 0.006 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.003 |
| Bibliometrics | 0.002 | 0.006 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.006 | 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".