Factors associated with response to therapy and outcome of patients with primary biliary cirrhosis with features of autoimmune hepatitis
Open accessAbstract
Background & aims For patients with primary biliary cirrhosis (PBC) with features of autoimmune hepatitis (AIH), treatment with ursodeoxycholic acid (UDCA) alone or in combination with immunosuppression is controversial. Little is known about the factors associated with initial response to therapy or outcome. We performed a retrospective analysis of treatment strategies and factors associated with outcomes of patients with PBC-AIH.Methods We analyzed data from 88 patients who were diagnosed with PBC-AIH according to Paris criteria, from 7 centers in 5 countries. First-line therapies included UDCA alone (n = 30) or a combination of UDCA and immunosuppression (n = 58).Results Of patients who received UDCA alone as the first-line therapy, 37% did not respond to treatment. Severe interface hepatitis was independently associated with lack of response to treatment (P = .024; odds ratio, 0.05; 95% confidence interval, 0.004-0.68). The combination of UDCA and immunosuppression was effective in 73% of patients who had not been previously treated or had not responded to UDCA. The presence of advanced fibrosis was associated with lack of response to the combination of UDCA and immunosuppression (P = .003; odds ratio, 0.13; 95% confidence interval, 0.03-0.48). Second-line immunosuppressive agents (cyclosporine, tacrolimus, and mycophenolate mofetil) led to biochemical remission in 54% of patients who did not respond to initial immunosuppression. Liver transplants were given to 4 patients with PBC-AIH. Five patients died during follow-up (3 from liver-related causes).Conclusions In a retrospective study of a large cohort of patients with PBC-AIH, UDCA alone did not produce a biochemical response in most patients with severe interface hepatitis; these patients require additional therapy with immunosuppression. Second-line immunosuppressive agents are effective in controlling disease activity in patients who do not respond to conventional immunosuppression.
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Severe interface hepatitis is the most reliable marker of hepatitis activity.
“Severe interface hepatitis, as the most reliable marker of hepatitis activity, mandates immunosuppression [175]”
From EASL Clinical Practice Guidelines: The diagnosis and management of patients with primary biliary cholangitis. (2017) · cites this paper as [175]
The Discussion (page unavailable) says patients with severe interface hepatitis required additional immunosuppression in this PBC-AIH study. The results also identify it as an independent predictor of nonresponse to UDCA alone, but the paper does not establish that it is the most reliable marker of hepatitis activity. (LLM, conf=0.85)
Experimental — accuracy not yet measuredPBC-AIH overlap patients may respond to less intense immunosuppression and have higher rates of successful withdrawal than AIH-only patients.
“It has been suggested that these patients respond to less intense immunosuppressive treatment and have higher rates of successful withdrawal of immunosuppression than patients with AIH only [175,176].”
From EASL Clinical Practice Guidelines: The diagnosis and management of patients with primary biliary cholangitis. (2017) · cites this paper as [175]
The Discussion (page not provided) says patients with moderate interface hepatitis may respond to UDCA alone, without immunosuppression, and reports no relapse in 15 of 20 patients after immunosuppression withdrawal. These findings support the possibility of less intensive treatment and successful withdrawal in some PBC-AIH patients, but the paper does not compare either outcome with AIH-only patients. (LLM, conf=0.86)
Experimental — accuracy not yet measuredPBC patients who meet the Paris criteria for AIH at presentation or during follow-up may benefit from additional immunosuppression in the short and medium term.
“The available data suggest that patients who fulfil the Paris criteria for the diagnosis of AIH either at presentation or during the course of their PBC may benefit from additional immunosuppression in the short-and medium-term [160,162,175,176].”
From EASL Clinical Practice Guidelines: The diagnosis and management of patients with primary biliary cholangitis. (2017) · cites this paper as [175]
Patient Selection and Diagnosis states that all participants met the Paris criteria. The Abstract reports that adding immunosuppression was effective for some patients, particularly those with severe interface hepatitis or inadequate response to UDCA. The paper does not establish that this benefit applies specifically both to patients meeting the criteria at presentation and to those who first meet them during PBC follow-up. (LLM, conf=0.82)
Experimental — accuracy not yet measuredCombined corticosteroid and azathioprine treatment has been used in PBC-AIH overlap with high response rates.
“This combined treatment regime has been used in patients with PBC and features of AIH with high response rates [160,161,175,180].”
From EASL Clinical Practice Guidelines: The diagnosis and management of patients with primary biliary cholangitis. (2017) · cites this paper as [175]
The Study Design says patients with PBC-AIH received UDCA plus prednisone, either alone or with azathioprine. The Abstract reports a 73% response rate for UDCA plus immunosuppression, but does not give a separate response rate for patients receiving both prednisone and azathioprine. (LLM, conf=0.84)
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Popova, E. N., Некрасова, Т. П., Львовна, Т. Е., Lebedeva, M. V., Пономарев, А. Б., Дмитриевич, Б. В., Ponomareva, L. A., Бурневич, Э. З., Бондаренко, И. Б., & Лопаткина, Т. Н. (2017) · Russian Journal of Evidence-Based Gastroenterology · doi:10.17116/dokgastro20176351-59
Making Sense of Overlap and Crossover Syndromes
Chazouillères, O. (2020) · doi:10.1002/9781119532637.ch15
Primary Biliary Cholangitis: Autoimmune Hepatitis Overlap Syndrome
Cazzagon, N., & Chazouillères, O. (2020) · Springer eBooks · doi:10.1007/978-3-030-51709-0_24
Le syndrome de chevauchement - Cholangite biliaire primitive/hépatite auto-immune
Hanslik, B. (2019) · HEGEL - HEpato-GastroEntérologie Libérale · doi:10.3917/heg.094.0358
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Diagnosis and Treatment of Autoimmune Hepatitis-Primary Biliary Cholangitis Overlap Syndrome
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Neue Standards in der Behandlung der primären biliären Cholangitis
Vögelin, M., & Kremer, A. E. (2025) · Schweizer Gastroenterologie · doi:10.1007/s43472-025-00173-w
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AISF practice guidance on the treatment of primary biliary cholangitis: A 2026 update
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- Authors
- Ozaslan, E., Efe, C., Heurgué–Berlot, A., Kav, T., Masi, C., Purnak, T., Muratori, L., Ustündag, Y., Bresson–Hadni, S., Thiéfin, G., Schiano, T. D., Wahlin, S., & Muratori, P.
- Affiliations
- Hacettepe University (TR)
- Centre Hospitalier Universitaire de Reims (FR)
- University of Bologna (IT)
- Mount Sinai Hospital (US)
- Corresponding author
- Efe, Cumali
- Venue
- Clinical Gastroenterology and Hepatology
- Publisher
- Elsevier BV
- Published
- 2014-05
- Volume
- 12
- Issue
- 5
- Pages
- 863-869
- ISSN
- 1542-3565 (ISSN-L)
- OpenAlex
- W2008708698
- Semantic Scholar
- bb872586d018aabcce616758d6d87453ed72c157
- Cited by
- 79
- References
- 18
- Citations by year
- 2026: 3 · 2025: 6 · 2024: 9 · 2023: 6 · 2022: 4 · 2021: 6 · 2020: 7 · 2019: 5 · 2018: 8 · 2017: 8 · 2016: 4 · 2015: 11 · 2014: 1 · 2013: 1
- FWCI
- 3.53
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Clinical Gastroenterology and Hepatology (publishedVersion)
- PubMed (publishedVersion)
- HAL (submittedVersion)
- Zonguldak Bülent Ecevit University Institutional Repository (submittedVersion, cc-by-nc-nd)
- Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion)
- Topics
- Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
- Health Sciences › Medicine › Surgery › Pediatric Hepatobiliary Diseases and Treatments
- Health Sciences › Medicine › Rheumatology › IgG4-Related and Inflammatory Diseases
- Keywords
- primary biliary cirrhosis, autoimmune hepatitis, ursodeoxycholic acid, immunosuppression, treatment response, interface hepatitis, liver fibrosis, cyclosporine, tacrolimus, mycophenolate mofetil, biochemical remission, liver transplantation
- MeSH terms
- Adolescent, Adult, Aged, Aged, 80 and over, Cholagogues and Choleretics, Female, Humans, Immunosuppressive Agents, Liver Cirrhosis, Biliary, Male, Middle Aged, Retrospective Studies, Ursodeoxycholic Acid, Cohort Studies, Treatment Outcome, Hepatitis, Autoimmune, Young Adult
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