P201 Bezafibrate as second line treatment in patients with primary biliary cholangitis: a real world experience
Bibliographic record
Abstract
Introduction Failure to improve alkaline phosphatase (ALP) with treatment with Ursodeoxycholic acid (UDCA) is associated with reduced transplant-free survival in primary biliary cholangitis (PBC). Bezafibrate (BZ), as second line treatment, has been shown to be effective in improving ALP in patients with PBC in a recent randomised controlled trial1 but ‘real world’ data is limited. Aim and Method The aim of this study was to retrospectively assess the effectiveness of BZ as second line treatment in patients intolerant of, or non-responsive to UDCA in a single tertiary referral centre. ALP was recorded at six and twelve months of treatment and compared to baseline. Biochemical response was defined by the Toronto criteria of ALP less than 1.67 times the upper limit of normal. Results are expressed as median (range). Results 36 patients were identified as treated with BZ. Eight have been excluded as lost to follow-up (n=1) or had been taking BZ less than six months (n=7). Of the remaining 28 (5 UDCA intolerant, 23 UCDA incomplete response), 23 were female, median age was 54 (32–85) at the start of treatment and 11 patients (40%) had cirrhosis. Three (10.7%) patients stopped treatment due to intolerance (deteriorating renal function n=1; cramps n=1 and gastrointestinal symptoms n=1). The latter were both also intolerant to UDCA. In the remaining 25, ALP fell from 279 (125–782) to 154 (74 – 415) at six months, with 76% achieving biochemical response by Toronto criteria. 16 patients have completed 12 months of treatment, with 12 patients (75%) achieving biochemical response. ALP fell from 281 (125 – 720) to 138.5 (90–326) at 12 months. 7 (44%) patients normalised ALP. 20 patients were asked about pruritis before and after treatment. 6 patients (30%) reported no itch either before or after treatment, 2 (10%) reported no change in severity and 12 patients (60%) reported improvement in pruritis. Conclusion We have found that BZ is an effective second-line treatment, with 75% of those who tolerated it achieving biochemical response at 12 months. It was well tolerated and was also associated with improvement in pruritus in the majority of patients. Further research is required to assess the long-term outcome in these patients. Reference Corpechot C, et al. A Placebo-Controlled Trial of Bezafibrate in PBC. NEJM 2018;378;23:2171–81.
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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) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 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".