Excellent Long-Term Survival in Patients With Primary Biliary Cirrhosis and Biochemical Response to Ursodeoxycholic Acid
Open accessAbstract
Background & aims Because the efficacy of UDCA on long-term outcome of primary biliary cirrhosis (PBC) has not been completely elucidated, we have assessed the course and survival of patients with PBC treated with UDCA and compared with the survival predicted by the Mayo model and the estimated survival of a standardized population.Methods (One hundred ninety-two patients [181 women] with PBC treated with UDCA [15 mg/kg per day] for 1.5-14 years.) Response to treatment was defined by an alkaline phosphatase decrease greater than 40% of baseline values or normal levels after 1 year of treatment. The predicted survival was obtained by the Mayo model and the estimated survival was taken from the standardized matched Spanish population.Results Seventeen patients died or fulfilled criteria for liver transplantation (8.9%). The observed survival was higher than that predicted by the Mayo model and lower than that of the control population (P < .001). One hundred seventeen patients (61%) responded to treatment. The survival of responders was significantly higher than that predicted by the Mayo model and similar to that estimated for the control population (P = .15). By contrast, the survival of patients without biochemical response was lower than that estimated for the Spanish population (P < .001) although higher than that predicted by the Mayo model.Conclusions Biochemical response to UDCA after 1 year is associated with a similar survival to the matched control population, clearly supporting the favorable effects of this treatment in PBC. The suboptimal survival of nonresponders identifies the group for further treatments.
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Response to UDCA is variable, and incomplete response is associated with increased risk of death from PBC or need for liver transplantation.
“Response to UDCA is variable, and incomplete response is associated with increased risk of death from PBC or need for liver transplantation.11–18”
From The British Society of Gastroenterology/UK-PBC primary biliary cholangitis treatment and management guidelines (2018) · cites this paper as [13]
The Discussion reports that response to UDCA varies and that lack of biochemical response after one year predicts poorer survival free of liver transplantation. However, the Results define the outcome using deaths from any cause, including nonhepatic disease; they do not separately establish an increased risk of death specifically from PBC. (LLM, conf=0.83)
Experimental — accuracy not yet measuredEven when receiving UDCA, PBC can remain progressive with risk of liver-related complications and death.
“Even when patients are receiving UDCA treatment, PBC can remain a progressive disease, with a risk of liver-related complications and death [61][62][63].”
From EASL Clinical Practice Guidelines: The diagnosis and management of patients with primary biliary cholangitis. (2017) · cites this paper as [62]
Some studies with extended follow-up have shown improved survival with UDCA.
“Some studies with extended follow-up have also shown improved survival.(59,62,63)”
From Primary Biliary Cholangitis: 2018 Practice Guidance from the American Association for the Study of Liver Diseases (2019) · cites this paper as [59]
A number of studies have shown benefit of UDCA in PBC, with individual studies demonstrating consistent evidence of improved liver biochemistries.
“A number of studies have shown the benefit of UDCA in this context.(58)(59)(60)(61)(62)(63) Individual studies have demonstrated consistent evidence of improved liver biochemistries.”
From Primary Biliary Cholangitis: 2018 Practice Guidance from the American Association for the Study of Liver Diseases (2019) · cites this paper as [59]
Experimental — accuracy not yet measuredA number of studies have shown benefit of UDCA in PBC, with individual studies demonstrating consistent evidence of improved liver biochemistries.
“A number of studies have shown the benefit of UDCA in this context.(58)(59)(60)(61)(62)(63) Individual studies have demonstrated consistent evidence of improved liver biochemistries.”
From Primary Biliary Cholangitis: 2018 Practice Guidance from the American Association for the Study of Liver Diseases (2019) · cites this paper as [60]
Patients with primary biliary cholangitis who have an inadequate response to ursodeoxycholic acid are at high risk for disease progression.
“Patients with primary biliary cholangitis who have an inadequate response to therapy with ursodeoxycholic acid are at high risk for disease progression.”
From A Placebo-Controlled Trial of Bezafibrate in Primary Biliary Cholangitis (2018) · cites this paper as [6]
Long-term survival remains limited in patients who have an incomplete biochemical response to ursodeoxycholic acid.
“However, long-term survival remains limited in patients who have an incomplete biochemical response.[6][7][8]”
From A Placebo-Controlled Trial of Bezafibrate in Primary Biliary Cholangitis (2018) · cites this paper as [6]
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- Authors
- Parés, A., Caballería, L., & Rodés, J.
- Affiliations
- Hospital Clínic de Barcelona (ES)
- Corresponding author
- Parés, Albert
- Venue
- Gastroenterology
- Publisher
- Elsevier BV
- Published
- 2006-03
- Volume
- 130
- Issue
- 3
- Pages
- 715-720
- ISSN
- 0016-5085 (ISSN-L)
- OpenAlex
- W2063975050
- Semantic Scholar
- c66e830056a5b7e39090f830c0112c4d7d541591
- Cited by
- 756
- References
- 26
- Citations by year
- 2026: 22 · 2025: 42 · 2024: 33 · 2023: 35 · 2022: 47 · 2021: 44 · 2020: 50 · 2019: 53 · 2018: 52 · 2017: 43 · 2016: 32 · 2015: 49 · 2014: 45 · 2013: 37 · 2012: 30
- FWCI
- 22.01
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Gastroenterology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Instituto de Salud Carlos III
- 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
- primary biliary cirrhosis, ursodeoxycholic acid, long-term survival, biochemical response, alkaline phosphatase, liver transplantation, treatment response
- MeSH terms
- Alkaline Phosphatase, Female, Humans, Liver Cirrhosis, Biliary, Male, Middle Aged, Ursodeoxycholic Acid, Survival Rate
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