Incidence, clinical features and risk factors of tacrolimus induced idiosyncratic liver injury in renal transplant recipients: A nested case-control study

Rare data reported tacrolimus-induced liver injury (tac-DILI) in real world. We performed a nested case-control analysis of 1,010 renal transplant recipients. Recipients with tac-DILI were randomly matched at a ratio of 1:4 by the year of admission to the remaining recipients without tac-DILI to explore risk factors. The incidence of tac-DILI was 8.9% (95% CI = 7.2–10.7%). The most common type was cholestatic pattern (6.7%, 95% CI = 5.2–8.3%), followed by hepatocellular (1.6%, 95% CI = 0.8–2.4%) and mixed patterns (0.6%, 95% CI = 0.1–1.1%). 98.9% of recipients with tac-DILI have mild severity. The latency period were 42.0 (range, 21.5–99.8 days), 14.0 (range, 9.0–80.3 days), 16.0 (range, 11.5–24.5 days), and 49.0 days (range, 28.0–105.6 days) for total, hepatocellular, mixed, and cholestatic patterns, respectively. Baseline ALP level (OR = 1.015, 95% CI = 1.006–1.025, p = 0.002), age (OR = 0.971, 95% CI = 0.949–0.994 , p = 0.006), and body weight (OR = 0.960, 95% CI = 0.940–0.982, p < 0.001) were independent risk factors. In conclusion, cholestatic pattern represents the most frequent type of tac-DILI. Young age, low body weight and abnormal baseline ALP level were risk factors.