P089 Real-world data for obeticholic acid treatment in Wales utilising a virtual MDT panel
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 dosing of UDCA dependent on weight is essential before considering second-line treatment. We present real-world data of our experience with OCA treatment in Wales between November 2017 – October 2020. A virtual MDT panel was set-up, compared with a spoke-hub model used elsewhere. Local consultants refer 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 70 referrals received, 56 were approved for OCA use. Median age at the time of referral was 59 and 89% were females (n = 50). 48 (86%) were on optimal UDCA dose, while 8 (14%) were intolerant to UDCA. Median ALP prior to commencing OCA was 405 (211–817). 19/56 patients had cirrhosis (18 Child-Pugh A and 1 Child-Pugh B). 27 patients referred had documented pruritus, two of whom had severe pruritus. In those with severe pruritus low dose OCA was started in one, and one did not commence OCA. The average time from approval to commencing OCA was 3 months. Patients with pruritus received standard pruritus treatment prior to commencing OCA. Complete follow-up data after 12 months of OCA treatment was available for 33/56 patients. 12/33 (36%) patients achieved biochemical response. At 12 months, median ALP in the OCA responsive group was 165 (104–249), and median ALP in the OCA non-responsive group was 398 (218–887). This compares with the POISE trial where 46% met Toronto response criteria.1 Use of second-line treatment with OCA is consistent and accessible across Wales, facilitated by our virtual MDT set-up, and was not adversely impacted by the COVID-19 pandemic. Patients do not need to travel to central hubs, and can remain under the care of their local hepatologist maintaining continuity of care and also promoting their involvement in decision making process. However, monitoring of 6- and 12-month response after starting OCA can be challenging as it is reliant on receiving follow-up data from the referring clinician. OCA dose must be adjusted based on the stage of liver disease and presence of pruritus. Reference Nevens F, et al. A placebo-controlled trial of obeticholic acid in primary biliary cholangitis. The New England Journal of Medicine 2016;375:631–643.
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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) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 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) | 0.007 | 0.002 |
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".