FIBRATES SEEM TO BE EQUALLY EFFECTIVE AS SECOND-LINE THERAPY IN PRIMARY BILIARY CHOLANGITIS, WITH BIOCHEMICAL RESPONSE PLATEAUING AT 6 MONTHS
Bibliographic record
Abstract
Approximately 40% of patients with primary biliary cholangitis (PBC) exhibit an incomplete biochemical response to ursodeoxycholic acid (UDCA) and require second-line therapy. Fibrates are widely available in Latin America and commonly used off-label in this setting. We aimed to evaluate clinical and biochemical outcomes in PBC patients with incomplete UDCA response treated with different fibrates. This ongoing, retrospective, multicenter cohort study (ALLATIN), sponsored by ALEH, includes PBC patients from several Latin American countries. For this analysis, only patients with incomplete response (based on biochemical criteria or physician judgment), who received fibrates, were included. Among 1,204 patients, 342 received fibrates; 263 (76.7%) were treated for incomplete UDCA response (93.2% female; mean age: 50 ± 11 years; 76.5% AMA-positive; 19.6% with cirrhosis). Bezafibrate, fenofibrate, and ciprofibrate were used in 72.2%, 7.2%, and 17.9% of cases. Median ALP before fibrates was 1.9xULN (IQR 1.4-3.0); median time from UDCA start to fibrate use was 30 months (IQR 13-69). At 6 months (n = 153), ALP normalization occurred in 42.5%, while 67.3% and 50.3% met Toronto and POISE criteria, respectively; 30.9% achieved deep response (normal ALP and bilirubin <0.6×ULN). At 12 months (n=150), rates remained stable. No differences were observed across fibrate types (p>0.4). Liver transplantation or death occurred in 24 patients (9.1%) over 87 months (IQR 44-135), associated with cirrhosis at diagnosis (OR 9.9; 95%CI 3.3-29.9; p<0.001) and response at 6 months by Toronto criteria (OR 0.31; 95%CI 0.1-0.9; p=0.035). Discontinuation occurred in 13.7%; adverse events included renal injury (n=1), myalgia (n=4), liver injury (n=4), and abdominal pain (n=4). Fibrates showed high efficacy regardless of agent used. Biochemical response plateaued by 6 months and predicted long-term outcomes. These findings support early assessment and a pragmatic approach to second-line therapy in PBC, independent of fibrate type.
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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 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| 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".