Alignment of Physician-Stated vs Clinically Derived Reference Fibrosis Score in Patients with Non-Alcoholic Steatohepatitis: A Real-World European Survey

Quentin M Anstee; Kate Hallsworth; Niall Lynch; Adrien Hauvespre; Eid Mansour; Sam Kozma; Juliana Bottomley; Gary Milligan; James Piercy; Victoria Higgins

doi:10.2147/POR.S392320

Alignment of Physician-Stated vs Clinically Derived Reference Fibrosis Score in Patients with Non-Alcoholic Steatohepatitis: A Real-World European Survey

Pragmat Obs Res. 2023 Feb 24:14:13-27. doi: 10.2147/POR.S392320. eCollection 2023.

Authors

Quentin M Anstee^{1

2}, Kate Hallsworth^{1

2}, Niall Lynch³, Adrien Hauvespre⁴, Eid Mansour⁵, Sam Kozma⁵, Juliana Bottomley⁶, Gary Milligan⁷, James Piercy⁸, Victoria Higgins⁹

Affiliations

¹ Translational & Clinical Research Institute, Faculty of Medical Sciences, University of Newcastle, Newcastle Upon Tyne, UK.
² Liver Unit, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
³ Global Value and Access, Gilead Sciences, Hayes, Uxbridge, UK.
⁴ Market Access and Reimbursement, Gilead Sciences, Hayes, Uxbridge, UK.
⁵ Pricing and Market Access (Middle East), Gilead Sciences, Dubai, United Arab Emirates.
⁶ Pricing and Market Access, Gilead Sciences, Hayes, Uxbridge, UK.
⁷ Statistics Department, Adelphi Real World, Bollington, UK.
⁸ Scientific Franchise, Adelphi Real World, Bollington, UK.
⁹ Scientific and NASH Franchise, Adelphi Real World, Bollington, UK.

Abstract

Objective: Stratifying disease severity in patients with non-alcoholic steatohepatitis (NASH) is essential for appropriate treatment and long-term management. Liver biopsy is the reference standard for fibrosis severity in NASH, but less invasive methods are used, eg, Fibrosis-4 Index (FIB-4) and vibration-controlled transient elastography (VCTE), for which reference thresholds for no/early fibrosis and advanced fibrosis are available. We compared subjective physician assessment of NASH fibrosis versus reference thresholds to understand classification in a real-world setting.

Methods: Data were drawn from Adelphi Real World NASH Disease Specific Programme^TM conducted in France, Germany, Italy, Spain and UK in 2018. Physicians (diabetologists, gastroenterologists, hepatologists) completed questionnaires for five consecutive NASH patients presenting for routine care. Physician-stated fibrosis score (PSFS) based on available information was compared with clinically defined reference fibrosis stage (CRFS) determined retrospectively using VCTE and FIB-4 data and eight reference thresholds.

Results: One thousand two hundred and eleven patients had VCTE (n = 1115) and/or FIB-4 (n = 524). Depending on thresholds, physicians underestimated severity in 16-33% (FIB-4) and 27-50% of patients (VCTE). Using VCTE ≥12.2, diabetologists, gastroenterologists and hepatologists underestimated disease severity in 35%, 32%, and 27% of patients, respectively, and overestimated fibrosis in 3%, 4%, and 9%, respectively (p = 0.0083 across specialties). Hepatologists and gastroenterologists had higher liver biopsy rates than diabetologists (52%, 56%, 47%, respectively).

Conclusion: PSFS did not consistently align with CRFS in this NASH real-world setting. Underestimation was more common than overestimation, potentially leading to undertreatment of patients with advanced fibrosis. More guidance on interpreting test results when classifying fibrosis is needed, thereby improving management of NASH.

Keywords: clinically derived reference fibrosis score; fibrosis staging; non-alcoholic steatohepatitis; physician-stated fibrosis score; real-world evidence.

Grants and funding

Data collection was undertaken by Adelphi Real World as part of an independent survey, entitled the Adelphi NASH DSP. Gilead Sciences, Inc. did not influence the original survey through either contribution to the design of questionnaires or data collection. The analysis described here used data from the Adelphi NASH DSP. The DSP is a wholly owned Adelphi product. Gilead Sciences, Inc. is one of multiple subscribers to the DSP. This analysis was funded by Gilead Sciences, Inc.