Table 1.
Characteristics of patients with immune checkpoint-induced liver injury.
| Value, N = 117 | |
|---|---|
| Age at diagnosis (years), median (range) | 63 (23–89) |
| Sex, n (%) | |
| Female | 54 (46.2) |
| Male | 63 (53.8) |
| Medical history, n (%) | |
| Chronic alcohol consumption | 9 (11) |
| IgG-4 mesenteric panniculitis | 1 (0.9) |
| Diabetes | 18 (15.5) |
| Liver transplant | 1 (0.9) |
| Pre-existing liver disease, n (%) | |
| Liver metastasis | 14 (11.9) |
| Cirrhosis | 5 (4.3) |
| Chronic viral hepatitis | 3 (2.6) |
| Cancer, n (%) | |
| Melanoma | 49 (41.9) |
| Lung | 32 (27.3) |
| Renal | 16 13.7) |
| Urothelial | 6 (5.1) |
| Cutaneous and oral squamous cell carcinoma | 7 (5.9) |
| Gastrointestinal | 3 (2.6) |
| Hepatocellular carcinoma | 2 (1.7) |
| Haematological malignancies | 1 (0.9) |
| Pancreatic adenocarcinoma | 1 (0.9) |
| Cancer stage, n (%) | |
| Stage I–II | 23 (19.6) |
| Stage III | 13 (11.1) |
| Stage IV | 43 (36.8) |
| Unknown | 38 (32.5) |
| Baseline hepatic biochemistries (×ULN), median (range) | |
| ALT | 1 (1–5) |
| AST | 1 (1–3) |
| ALP | 1 (1–3.6) |
| GGT | 1 (1–4) |
| Total bilirubin | 1 (1–1.6) |
| Checkpoint inhibitor, n (%) | |
| Anti-PD-1 | 62 (53) |
| Anti-PDL-1 | 8 (6.8) |
| Anti-CTLA-4 | 4 (3.4) |
| Anti-PD-1 + anti-CTLA-4 | 42 (35.9) |
| Anti-PD-1 + anti-LAG-3 | 1 (0.9) |
| RUCAM, n (%) | |
| Possible (4–5) | 7 (6) |
| Probable (6–8) | 71 (60.7) |
| Highly probable (≥9) | 39 (33.3) |
| Severity (CTCAE), n (%) | |
| Grade 1 | 4 (3.4) |
| Grade 2 | 17 (14.5) |
| Grade 3 | 73 (62.4) |
| Grade 4 | 23 (19.7) |
| Grade 5 | 0 |
| DILIN severity score, n (%) | |
| Mild | 72 (61.5) |
| Moderate | 45 (38.5) |
| Severe | 0 |
Continuous values are provided as median and IQR.
ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; CTCAE, Common Terminology Criteria for Adverse Events; CTLA-4, cytotoxic T-lymphocyte-associated protein-4; DILIN, Drug-Induced Liver Injury Network; GGT, gamma-glutamyl-transferase; LAG-3, lymphocyte-activation gene 3; PD-1, programmed cell death-1; PDL-1, programmed cell death ligand-1; RUCAM, Roussel Uclaf Causality Assessment Method; ULN, upper limit normal.