Clinical Study

Clinical Features of Liver Injury Induced by Immune Checkpoint Inhibitors in Japanese Patients

Table 1

Comparison of patients with grade ≤2 liver injury and grade ≥3 liver injury induced by ICIs.

CharacteristicAll gradeGrade 1 or 2Grade 3 or 4 value

The number of patients56/343 (16.3%)45/56 (80.4%)11/56 (19.6%)
Median age, years63 (49–69)63.0 (50–70)58.0 (48.0–67.0)0.4327
Sex, male31 (63.6%)24/45 (53.3%)7/11 (63.6%)0.7373
Previous extrahepatic irAEs7/56 (12.5%)6/45 (13.3%)1/11 (9.1%)0.4749
Duration of ICIs until liver injury, days45.5 (21–94)56 (26–134)26 (20–56)0.1116
T-Bil (mg/dl)0.7 (0.4–1.0)0.6 (0.4–0.8)0.8 (0.5–1.3)0.0871
AST (IU/l)60 (39–136)46 (37–87)321 (101–1180)<0.001
ALT (IU/l)58 (47–129)53 (45–97)372 (228–780)<0.001
ALP (IU/l)471 (263–857)431 (242–783)811 (436–1453)0.0620
γGTP (IU/l)95.5 (47–276)79 (38–250)187 (90–630)0.0391
Hepatocellular type11/56 (19.6%)5/45 (11.1%)6/11 (54.5%)0.0041
Cholestatic or mixed type34/56 (60.7%)29/45 (64.4%)5/11 (45.5%)0.3101

ICIs: immune checkpoint inhibitors; irAEs: immune-related adverse events; T-Bil: total bilirubin; AST: aspartate aminotransferase; ALT: alanine aminotransferase; ALP: alkaline phosphatase; γGTP: gamma-glutamyltransferase.