Third-line treatment agents in AIH [43, 47–80]

AgentN of studiesPatientsProposed doseComments
TAC820.1 mg/kg
Trough levels: 1–10 ng/mL

  • Best studied agent so far

  • Strict control of renal function is strongly recommended

Cyclosporine622 mg/kg per day
Trough levels: < 120 ng/mL

  • Limited data

  • Control of renal function is strongly recommended

Infliximab115 mg/kg on week 0, 2, 6 and every 4–8 weeks thereafter

  • Strict control for potential immune mediated liver injury and infections

Everolimus12Trough levels: 3–6 ng/mL

  • Limited data

Sirolimus21Trough levels: 10–20 ng/mL

  • Limited data increased risk of side effects

MTX1110 mg/week

  • High risk of DILI

Rituximab321,000 mg on days 0, 14 and repeat if necessary, according to liver biochemistry

  • In combination with 1st or 2nd line treatments

  • Surveillance of CD20 cells

  • Supplement of IgG if necessary

Belimumab2110 mg/kg at days 0 and 14 and every 28 days thereafter

  • In combination with 1st or 2nd line treatments

DILI: drug induced liver injury; MTX: methotrexate; TAC: tacrolimus; 0: naive/intolerance; 1: refractory; 2: both