Specific Biomarkers of Immune-mediated Hepatitis Secondary to Immune Checkpoint
Identify specific blood biomarkers for hepatitis induced by immune checkpoint inhibitors in comparison to idiopathic autoimmune hepatitis.
• Patient \> 18 years old
• Patient treated with immune checkpoint inhibitors (ICI) alone or in combination
• Patient suffering from Hepatitis secondary to immune checkpoint inhibitors (ICI) grade 3 or 4 Common Terminology Criteria For Adverse Events (CTCAE)\*
• Treatment with corticosteroids or Ursodeoxycholic acid (UDCA) not started, or started less than 30 days ago
⁃ Grade 3 or 4 hepatitis: increase in transaminases and/or alkaline phosphatases ≥ 5 x Upper Limit of Normal (ULN) or total bilirubin ≥ 3
• Patient \> 18 years old
• Patient suffering from Primary Biliary Cholangitis (PBC)\* or Autoimmune Hepatitis (AIH)\*\* or Primary Sclerosing Cholangitis (PSC) \*\*\*
‣ Primary Biliary Cholangitis (PBC)\* diagnosis :
‣ Association of at least 2 of the following 3 criteria :
• Cholestasis (PAL \> 1.5N, Gamma GT \> 3N) chronic (\> 6 months) without ultrasound abnormality of the bile ducts.
• M2 type anti-mitochondria Ab \> 1/40th
• Characteristic histological lesions (non-suppurative destructive cholangitis) or compatible (portal inflammation, granulomas, ductular proliferation, ductopenia, cholestasis).
• \*\* AIH diagnosis : ALT \> 5 N / Ig G \> 1.5 - 2 N or anti-smooth muscle ≥ 1/80 / Interface hepatitis of marked intensity The Hepactic Activity Index (HAI) score makes it possible to confirm the diagnosis when all the diagnostic criteria are not met.
• \*\*\* PSC diagnosis: presence of chronic cholestasis (alkaline phosphatase \> 1.5 N or GGT \> 3 N) and typical abnormalities of the bile ducts on cholangio-MRI (Magnetic Resonance Imaging), and in the absence of cause of secondary sclerosing cholangitis
• Treatment with corticosteroids or Ursodeoxycholic acid (UDCA) not initiated, or started less than 30 days ago