Biopsy rate and nonalcoholic steatohepatitis (NASH) in patients with nonalcoholic fatty liver disease (NAFLD)

Abstract

Background: Licensed therapies for nonalcoholic fatty liver disease (NAFLD) do not yet exist, but clinical trials are testing treatment options. Inclusion criteria often require liver biopsy showing fibrosis (F2/3) or cirrhosis (F4) and nonalcoholic steatohepatitis (NASH). However, histological criteria pose a serious obstacle for recruitment.

Aims: Characterize the relevance of liver biopsies in the selection of patients with NAFLD.

Methods: Patients between 2013 and 2018 with the ICD-10 code K76.0 were analyzed. Fibrosis was defined by the NASH clinical research network (CRN) fibrosis staging system, NASH by a NAFLD activity score (NAS) ≥4. Predictive factors were determined by logistic regression.

Results: Liver biopsy was performed in 87/638 (13.6%) patients (49% female, age 52.5 ± 14.0, BMI 30.4 ± 5.9 kg/m²). Fibrosis stage F0/F1/F2/F3/F4 was observed in N = 7/47/7/17/9, an NAS ≥4 in N = 27. Fibrosis stage F2/F3 and F4 along with NAS ≥4 was found in 1.7% and 0.5% of cases. Liver stiffness measurement, LSM (OR 2.3 per doubling of value; CI 1.3–4.4, p = .005) and FIB-4 (OR 2.3 per doubling of value; CI 1.2–4.4, p = .012) were significant predictors for fibrosis ≥ F2. Predictive factors for NASH were not identified.

Conclusion: The biopsy rate in NAFLD patients is low and fibrosis ≥ F2 along with NAS ≥4 only present in a few cases. Transient elastography and FIB-4 are useful to select patients at risk for fibrosis for liver biopsy.

Keywords:

• NAFLD
• NASH
• liver biopsy
• clinical trials
• noninvasive diagnostic

Disclosure statement

No potential conflict of interest was reported by the author(s).

Author contributions

FG and JW contributed to the concept of the study. FG, VB, AB, FvB, TB, TK, and JW contributed to patient recruitment/data extraction form databases. CW contributed to histopathological evaluation of liver biopsies. FG, DP, and JW contributed to statistical and data analysis. FG, DP, and JW contributed to manuscript preparation. FG, DP, VB, AB, FvB, CW, TB, TK, and JW contributed to review of the manuscript.