Real‐World Effectiveness of Obeticholic Acid in Patients with Primary Biliary Cholangitis
Open accessAbstract
Patients with primary biliary cholangitis (PBC) with incomplete response to ursodeoxycholic acid are at risk of disease progression and need additional therapy. Obeticholic acid (OCA) was approved in Canada in May 2017, but its effectiveness in a real‐world setting has not been described. We sought to describe our experience with OCA in a Canadian cohort. OCA‐naive patients treated at two Canadian centers were included. Clinical and biochemical data were collected at OCA initiation and during follow‐up. Primary outcomes were changes in serum alkaline phosphatase (ALP), gamma‐glutamyl transferase (GGT), and total bilirubin (TB) over the duration of therapy. Secondary outcomes were changes in alanine aminotransferase (ALT), aspartate aminotransferase (AST), immunoglobulin M (IgM), platelets, and albumin; and achievement of the primary endpoint of the original phase 3 study that led to OCA approval (A Placebo‐Controlled Trial of Obeticholic Acid in Primary Biliary Cholangitis [POISE]), dose reductions, discontinuations, and tolerability. Repeated‐measures models were used to assess changes in biochemistry over time. Sixty‐four patients were included; 4 carried a diagnosis of overlap with autoimmune hepatitis. Mean age was 54.6 years, median ALP was 250 U/L, TB was 13 µmol/L, platelet count was 225 × 10 9 /L, and 24% had liver stiffness measurements ≥16.9 kPa. There was a significant reduction in mean ALP of 55 U/L ( P < 0.001), GGT of 138 U/L ( P < 0.001), ALT of 11.9 U/L ( P < 0.001), AST of 5.7 U/L ( P < 0.05), and IgM of 0.70 g/L ( P < 0.001) over 12 months; TB remained stable ( P = 0.98). Forty‐four patients met POISE‐inclusion criteria, 39% (n = 17) of whom had 12‐month biochemical measurements. In this subset, 18% (n = 3/17) met the 12‐month POISE primary endpoint, but considering follow‐up to 19 months, 43% achieved this target (n = 9/21). Pruritus was the most commonly reported complaint. Conclusion : Use of OCA was associated with improvement in biochemical surrogates of outcome in PBC in a real‐world setting.
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Real-world data are gradually indicating an improvement in long-term prognosis with obeticholic acid.
“Regarding the long-term efficacy of obeticholic acid, real-world data are gradually indicating an improvement in long-term prognosis.[89][90][91][92][93]”
From Primary biliary cholangitis. (2024) · cites this paper as [89]
The Discussion reports real-world improvement in biochemical markers described as surrogates of outcome in patients with primary biliary cholangitis. It does not establish improved long-term prognosis: the Results report a median obeticholic-acid treatment duration of 13.1 months, and the 10-year transplant-free survival estimates describe risk at treatment initiation, not improvement after treatment. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn a Canadian cohort study of 64 patients treated with obeticholic acid, a significant reduction in liver enzymes was observed over 12 months.
“In a Canadian cohort study of 64 patients treated with obeticholic acid, a significant reduction in liver enzymes was observed over 12 months.”
From Primary biliary cholangitis. (2024) · cites this paper as [89]
Three (17.6%) of 17 patients with 12-month biochemical data met the 12-month POISE criteria in the Canadian cohort study.
“Three (17•6%) of 17 patients with 12-month biochemical data met the 12-month POISE criteria.89”
From Primary biliary cholangitis. (2024) · cites this paper as [89]
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- Authors
- Roberts, S. B., Ismail, M., Kanagalingam, G., Mason, A. L., Swain, M. G., Vincent, C., Yoshida, E. M., Tsien, C., Flemming, J. A., Janssen, H. L. A., Hirschfield, G. M., Hansen, B. E., Gulamhusein, A. F., & on behalf of the Canadian Network for Autoimmune Liver Disease
- Affiliations
- University Health Network (CA)
- University of Alberta (CA)
- University of Calgary (CA)
- Université de Montréal (CA)
- University of British Columbia (CA)
- University of Ottawa (CA)
- Queen's University (CA)
- Corresponding author
- Gulamhusein, Aliya F.
- ORCID
- Venue
- Hepatology Communications
- Published
- 2020-07-06
- Volume
- 4
- Issue
- 9
- Pages
- 1332-1345
- ISSN
- 2471-254X (ISSN-L)
- PMC
- PMC7471421
- OpenAlex
- W3040342452
- Cited by
- 58
- References
- 16
- Citations by year
- 2026: 3 · 2025: 17 · 2024: 9 · 2023: 5 · 2022: 14 · 2021: 8 · 2020: 2
- FWCI
- 4.26
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Hepatology Communications (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
- Health Sciences › Medicine › Surgery › Pediatric Hepatobiliary Diseases and Treatments
- Health Sciences › Medicine › Oncology › Drug Transport and Resistance Mechanisms
- Keywords
- obeticholic acid, primary biliary cirrhosis, real-world effectiveness, POISE trial, serum alkaline phosphatase, gamma-glutamyl transferase, total bilirubin, liver biochemistry, immunoglobulin M, treatment tolerability, Canadian patients
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