P29 Second line treatment for primary biliary cholangitis( PBC) with obeticholic acid – A real world data from Wales
Bibliographic record
Abstract
Obeticholic acid (OCA) is indicated in patients with primary biliary cholangitis (PBC) that have failed or are intolerant to therapeutic dose of Ursodeoxycholic acid (UDCA).Optimal weight-based dosing of UDCA is essential before considering second-line treatment. We present real-world data of our experience with OCA treatment in Wales between Aug 2018– April 2024.A virtual MDT panel was set-up, compared with a spoke-hub model used elsewhere. Referral form is sent electronically to the MDT panel which consists of a hepatologist from each of the six health boards in Wales. Treatment is initiated and monitored by the referring clinician. Modified Toronto criteria (ALP < 1.67 x upper limit of normal (ULN)) is used to define biochemical response to OCA. Out of 111 referrals received, 99 were approved for OCA use. Median age at the time of referral was 55 years and 91% were females. 101 (91%) were on optimal UDCA dose, while 10 (9%) were intolerant to UDCA. Median ALP prior to commencing OCA was 490 (215–1037). 26/111 patients had cirrhosis( 23%).47% of patients had documented pruritus(n=52). 6 patients had severe pruritus of which 3 did not commence OCA while 2 patients were started on low dose. Out of 99 patients approved for OCA,11 patients did not start treatment due to fear of side effects, while in 11 patients OCA was stopped within median duration of 6 months due to adverse events( mostly pruritis).Complete follow-up data after 12 months of OCA treatment was available for 58/99 patients. Out of these,32 patients were on 5 mg OD OCA, 18 patients on 10 mg OD and 5 patients on 5 mg three times per week at 12 months period while for the remaining 3 patients, OCA dose was unknown. 30/58 (51%) patients achieved biochemical response with OCA. At 12 months, median ALP in the OCA responsive group was 185(91–249), and median ALP in the OCA non-responsive group was 436(280–1057). Response rate with OCA in Wales are similar to that reported in POISE trial.Use of second-line treatment with OCA is consistent and accessible across Wales, facilitated by our virtual MDT set-up. Patients remain under the care of their local clinician maintaining continuity of care. Overall, virtual monitoring of 12-month response after starting OCA can be challenging as it is reliant on receiving follow-up data from the referring clinician. Patients who fail to respond to OCA must be considered for other second line treatment options including Bezafibrate.
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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 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.004 | 0.001 |
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".