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P65 Real-world experience of seladelpar among patients with primary biliary cholangitis including patients switched from obeticholic acid

gutjnl · 2026-06-23 · canonical JSON source

21 visible annotations · policy: published · automated confidence ≥ 75.00%

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Introduction Primary biliary cholangitis (PBC) is a progressive autoimmune liver disease. Obeticholic acid (OCA) was recently withdrawn from the US creating a therapeutic gap. Seladelpar (SEL), approved in 2024 in the US for patients with PBC and an inadequate response or intolerance to ursodeoxycholic acid (UDCA), offers a new treatment option. This study aims to characterise the real-world experiences of patients switching from OCA to SEL vs adding on to UDCA or monotherapy use.Methods Patients with PBC who received ≥1 prescription and ≥30 days of supply for SEL were identified in the HealthVerity database with laboratory data from LabCorp and Quest. Baseline (BL) characteristics and laboratory values were assessed using the most recent tests during the 12 months preceding SEL initiation. SEL treatment duration was determined in patients who switched from OCA within 3 months of SEL (OCA-switch) or patients who started SEL as add on to UDCA or as monotherapy without use of UDCA, OCA, fenofibrate, or elafibranor for >3 months prior to SEL (SEL-2L), using all available data as of 13 Jun 2025. Biochemical response was assessed using the most recent available lab data. Safety labs were assessed based on the most recent tests available within 90 days prior to SEL initiation vs within 90 days after any SEL treatment.Results A total of 396 PBC patients initiated SEL including 130 OCA-switch and 266 SEL-2L patients. The 2 groups had comparable sex distribution (88% vs 91% female) and mean age (59 vs 58 years) at the time of SEL initiation. Cirrhosis was observed in 11.5% and 18.5% of OCA-switch and SEL-2L patients, respectively. In the OCA-switch group, mean duration of prior OCA treatment was 788 days; mean time between last OCA use and the initiation of SEL was 8 days. Mean duration of SEL treatment was 119 days in the OCA-switch group and 98 days in SEL-2L. In patients switching from OCA, mean alkaline phosphatase (ALP) decreased from 235 U/L at BL to 171 U/L. In the SEL-2L group, ALP decreased from 290 U/L at BL to 194 U/L. ALP <1.67 × upper limit of normal (ULN) was observed in 55% at BL and 83% post SEL in OCA-switch patients and, similarly, 53% at BL and 74% post SEL in SEL-2L patients. Safety labs within 90 days prior to SEL initiation vs after were generally similar between the groups. 93% of patients maintained continuous SEL treatment from initiation until the end of the observation period.Conclusions These real-world experiences suggest SEL may be an effective and safe alternative for patients switching from OCA and as a second-line therapy. Given the relatively short SEL observation period, further evaluation with extended follow-up is warranted.