Table 4.

Recommended data for proper assessement of a suspected case of drug-induced autoimmune-like hepatitis.

	Basic assessment criteria
Demographics	• Age, sex, weight, BMI, ethnicity
Clinical data	• Comorbid conditions, autoimmune disorders, underlying liver disease (e.g. steatosis) • Toxic habits: alcohol, tobacco, illicit drugs, over the counter drugs • Type of liver injury (aminotransferases, bilirubin, alkaline phosphatase) • Signs and symptoms: jaundice, hypersensitivity features (rash, peripheral eosinophilia, lymphopenia), encephalopathy, ascites, hospitalisation
Drug exposure history	• Take a thorough pharmacological history with exposure to drugs/vaccines/herbal remedies with doses and start-stop dates • Excluded exposure to immune-checkpoint inhibitors
Temporal relationship*	• Treatment duration, days • Latency, days
Meet criteria definition for DILI	•  ALT exceeding 5x ULN • ALP exceeding 2x ULN • ALT exceeding 3x ULN and bilirubin exceeding 2x ULN
Exclusion of alternative diagnoses#	• Viral hepatitis A, B, C, and E, biliary obstruction, AIH, alcohol-related hepatitis, ischaemic hepatitis, malignancy
Biochemical parameters¶	• Liver profile at onset, on remission, when worsening, relapse (ALT, AST, ALP, total bilirubin, INR) • Autoantibodies: ANA, ASMA with pattern on kidney tissue, Anti-LKM1, anti-SLA/LP • IgG levels
Histological features	Date. Description of the following features recommended: • Pattern of injury (portal or lobular based hepatitis) • Degree of necroinflammatory changes and fibrosis according to Ishak’s grading and staging system85 • Plasma cell infiltration or clusters. • Documentation of other histological features of significance: hepatocellular or canalicular cholestasis, chronic cholestasis changes, eosinophils, confluent necrosis, steatosis, vascular injury) • Exclusion of other diseases (e.g., steatohepatitis, cholangiopathy) • Overall assessment based on the revised AIH scoring system, simplified criteria, and histological criteria3
HLA data	• Specific HLA for given drugs and general AIH-related HLA
Severity**	• As recommended for DILI • nR-based Hy’s law
Treatment	• Steroid Therapy (when initiated) • Other immunosuppressant needed • Still on immunosuppressant
Outcome	• Remission achieved • Worsening of the disease • Relapse • Liver-related death • Liver transplant
Follow-up	•  2–4 weeks, 1–3-6–12-18–24 months after diagnosis and once a year thereafter for 5 years
Causality assessment tools	• The RUCAM/CIOMS and its recently improved version RECAM. • The revised and the simplified AIH scoring systems issued by the International Autoimmune Hepatitis Group

AIH, autoimmune hepatitis; ALP, alkaline phosphatase; ALT, alanine aminotransferase; ANA, anti-nuclear antibody; anti-LKM1, anti-liver-kidney microsomal type 1 antibody; anti-SLA/LP, anti-soluble liver antigen/liver pancreas antigen; ASMA, anti-smooth muscle/anti-actin antibody; DILI, drug-induced liver injury; INR, international normalised ratio; RUCAM/CIOMS, Roussel Uclaf Causality Assessment Method/Council of International Organization of Medical Sciences; ULN, upper limit of normal.

^*Between drug exposure and injury onset and improvement.

^#Imaging studies needed.

^¶Measured at different times of follow-up.

^**As recommended by Aithal et al.⁸⁵