IDDF2022-ABS-0120 Hepatocyte apoptosis fragment product cytokeratin-18 M30 and non-alcoholic steatohepatitis risk prediction: an international registry study

BackgroundLiver biopsy for the diagnosis of non-alcoholic steatohepatitis (NASH) is limited by its inherent invasiveness and sampling errors. Some studies have shown that cytokeratin-18 (CK-18) concentrations may be useful in predicting NASH, but results across studies have been inconsistent. The aim of this study was to identify the feasibility of CK-18 M30 concentrations as a non-invasive alternative to liver biopsy for diagnosing NASH.MethodsUsing an open online reporting form, individual data were collected from 15 registry centers on patients with biopsy-proven non-alcoholic fatty liver disease (NAFLD), and in all patients circulating CK-18 M30 levels were measured. These data included sex, age, ethnic, hypertension, diabetes, and serum alanine aminotransferase, but not personal health identifier. Individuals with NAFLD activity score (NAS) ≥ 5 including a score of ≥ 1 for each of steatosis, ballooning and lobular inflammation were diagnosed as having definite NASH; individuals with NAS ≤ 2 and no fibrosis were diagnosed as having non-alcoholic fatty liver (NAFL) (simple steatosis). (IDDF2022-ABS-0120 Table 1, IDDF2022-ABS-0120 Table 2).Abstract IDDF2022-ABS-0120 Table 1Main patient characteristics of the included cohorts Center Country Age range, (mean) years Number (%) Men, n (%) NASH, n (%) Ln CK-18 M30 (mean±SD) U/L Angers (France) France 21–79 (56.4) 199 (18.4) 104 (52.3) 175 (87.9) 5.75±0.752 Buenos Aires (Argentina) Argentina 18–78 (53.7) 75 (6.9) 23 (30.7) 56 (74.7) 5.66±0.408 Athens (Greece) Greece 19–72 (46.1) 42 (3.9) 22 (52.4) 17 (40.5) 5.48±0.608 Sydney (Australia) Australia 17–79 (47.8) 62 (5.7) 34 (54.8) 32 (51.6) 5.26±1.141 Mainz (Germany) Germany 25–61 (42.7) 7 (0.6) 5 (71.4) 7 (100.0) 6.64±1.088 Hanzhou (China) China 24–70 (41.2) 30 (2.8) 23 (76.7) 30 (100.0) 5.33±0.761 Hong Kong (China) China 26–70 (46.9) 58 (5.4) 36 (62.1) 33 (56.9) 5.97±0.862 Kuala Lumpur (Malaysia) Malaysia 26–68 (50.6) 90 (8.3) 41 (45.6) 82 (91.1) 6.26±0.764 Nice (France) France 21–62 (42.6) 48 (4.4) 10 (20.8) 43 (89.6) 5.88±0.589 Shanghai Ruijin (China) China 21–70 (49.7) 34 (3.1) 20 (58.8) 34 (100.0) 5.35±0.765 Shanghai Xinhua (China) China 18–66 (39.1) 31 (2.9) 22 (71.0) 24 (77.4) 5.90±0.589 Bern (Switzerland) Switzerland 28–75 (55.3) 31 (2.9) 12 (38.7) 28 (90.3) 5.63±0.558 Tianjin (China) China 18–62 (38.4) 17 (1.6) 9 (52.9) 17 (100.0) 5.25±0.977 Istanbul (Turkey) Turkey 29–70 (48.8) 110 (10.2) 58 (52.7) 101 (91.8) 4.80±1.015 Wenzhou (China) China 12–71 (38.