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August 19, 2025Open Access

Clinical significance of anti-mitochondrial antibodies and PBC-specific anti-nuclear antibodies in evaluating atypical primary biliary cholangitis with normal alkaline phosphatase levels

SLShasha LiQingdao University KZKai ZhangNanjing University of Chinese Medicine HLHongli LiuPhysikalisch-Technische Bundesanstalt

Key Points

Over 50% of patients with positive PBC-specific antibodies and normal alkaline phosphatase levels were diagnosed with primary biliary cholangitis.
The PBC diagnosis rate was highest at 82.1% in patients with specific antibody profiles and positive markers.
Assessment of patients included analysis of immunoglobulin M levels, revealing a significant correlation with PBC diagnosis.
Multivariate analysis highlights the importance of liver biopsy in diagnosing PBC when other liver disease etiologies are excluded.

Abstract

Abstract Objectives The clinical implications of positive anti-mitochondrial antibodies (AMAs) and/or primary biliary cholangitis (PBC)-specific anti-nuclear antibodies (ANAs) in patients with normal alkaline phosphatase (ALP) remain uncertain. Methods Patients at The Second Hospital of Nanjing with positive AMAs/PBC-ANAs and normal ALP levels from January 2016 to July 2024 were categorized into three groups based on autoantibody profiles: AMA/AMA-M2 + gp210/sp100 + , AMA/AMA-M2 + gp210/sp100 − , and AMA/AMA-M2 − gp210/sp100 + . The study compared PBC diagnostic rates, clinical symptoms, laboratory results, and pathology across these groups. Results A total of 53.3 % (88/165) of the patients showed cholangitis activity diagnosed of PBC. The PBC diagnosis rate in the three groups was 82.1 % (23/28), 48.4 % (46/95), and 45.2 % (19/42) respectively. Multivariate analysis indicated a significant association between the absence of liver disease-related etiology (p<0.001), baseline serum immunoglobulin M (IgM) exceeding 0.796 times the upper limit of normal (ULN) (p<0.001), and the diagnosis of PBC as determined by liver biopsy. In the three groups of non-PBC patients, the major pathological injury patterns were minor nonspecific reactive changes (40.0 %/28.6 %/39.1 %), inflammation (40.0 %/24.5 %/47.8 %), and fatty changes (20 %/20.4 %/4.3 %). The diagnosis included viral hepatitis, autoimmune hepatitis, fatty liver disease, vascular liver disorders, drug-induced liver injury, congenital hepatic fibrosis, and porphyria. Conclusions Over 50 % of patients with positive PBC-specific antibodies and normal ALP have PBC. Liver biopsy is recommended when AMAs and/or PBC-specific ANAs are positive, especially when baseline serum IgM exceeds 0.796 × ULN, and when other etiologies related to liver disease are absent. The area under the curve (AUC) for these three indicators reaches 0.84.

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