Table 2 Recruitment eligibility criteria for each cohort
Cohorts | DILI n = 30 (2 visits) | Other acute liver injury (non-DILI) n = 13 (2 visits) | Chronic liver disease (ARLD/NAFLD) n = 20 (1 visit) | Rheumatoid arthritis and/or psoriasis n = 100 (1 visit) | Healthy volunteers (HV) n = 120 (1 visit) |
|---|---|---|---|---|---|
Inclusion criteria | Age ≥ 18 | Age ≥ 18 | Age ≥ 18 | Age ≥ 18 | Age ≥ 18 |
Exposure to potential causal agent | Exposure to potential causal agent | Clinical diagnosis of ARLD/NAFLD | Diagnosed with rheumatoid arthritis or psoriasis for ≥ 2 years | BMI ≤ 32 | |
Meets one of the following analytical thresholds at enrolment (visit 1) | Meets one of the following analytical thresholds at enrolment (visit 1) | ARLD: current > 112 g alcohol per week or past sustained alcohol excess clinically suggested as contributing to disease | Eligible for methotrexate treatment | Normal liver enzymes | |
○ ALT ≥ 5 × ULN | ○ ALT ≥ 5 × ULN | ||||
○ ALP ≥ 2 × ULN | ○ ALP ≥ 2 × ULN | ||||
○ ALT ≥ 3 × ULN + TBL > 2 × ULN | ○ ALT ≥ 3 × ULN + TBL > 2 × ULN | ||||
Diagnosis of acute DILI by panel | Diagnosis of non-DILI acute liver injury by panel | NAFLD:≤ 112 g alcohol per week | Either treated with methotrexate for past 6 months or unexposed to methotrexate in past 24 months | ||
Exclusion criteria | Clear diagnosis of alternative acute liver condition (e.g. acute viral or autoimmune hepatitis unrelated to the drug) | Relapse of previously diagnosed chronic liver injury | Diagnosis of other liver disease | Diagnosis of liver disease other than ARLD/NAFLD | Diagnosis of liver disease |
Suspicion of acute cause of liver injury (e.g. viral hepatitis, autoimmune hepatitis, DILI) | Other significant dermatological or rheumatological condition | Transient Elastography CAP score of ≥ 260 dB/m |