P29 Second line treatment for primary biliary cholangitis( PBC) with obeticholic acid – A real world data from Wales
<h3></h3> 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.
Authors
- J. Nagaraj
- David Samuel (ORCID: https://orcid.org/0000-0001-6850-4932)
- Thiriloganathan Mathialahan
- Andrew D. Yeoman (ORCID: https://orcid.org/0000-0002-0739-3332)
- Irfan Ullah (ORCID: https://orcid.org/0000-0001-6992-6723)
- Areeb Khan
- Ian Rees
- Bradley Arms-Williams (ORCID: https://orcid.org/0000-0002-7178-2519)
- Brijesh Srivastava
- Rishab Avasarala
Institutions
- Wrexham Maelor Hospital (GB)
- Newport Hospital (US)
- Swansea University (GB)
- Prince Philip Hospital (GB)
- Pontydysgu (GB)
- Cardiff University (GB)
Publication Details
- Published
- 2024-10-01
- DOI
- https://doi.org/10.1136/gutjnl-2024-basl.38
- Primary Topic
- Liver Diseases and Immunity
- Type
- article
- Field-Weighted Citation Impact
- 0.00