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

Autor: Anstee QM; Translational & Clinical Research Institute, Faculty of Medical Sciences, University of Newcastle, Newcastle Upon Tyne, UK.; Liver Unit, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK., Hallsworth K; Translational & Clinical Research Institute, Faculty of Medical Sciences, University of Newcastle, Newcastle Upon Tyne, UK.; Liver Unit, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK., Lynch N; Global Value and Access, Gilead Sciences, Hayes, Uxbridge, UK., Hauvespre A; Market Access and Reimbursement, Gilead Sciences, Hayes, Uxbridge, UK., Mansour E; Pricing and Market Access (Middle East), Gilead Sciences, Dubai, United Arab Emirates., Kozma S; Pricing and Market Access (Middle East), Gilead Sciences, Dubai, United Arab Emirates., Bottomley J; Pricing and Market Access, Gilead Sciences, Hayes, Uxbridge, UK., Milligan G; Statistics Department, Adelphi Real World, Bollington, UK., Piercy J; Scientific Franchise, Adelphi Real World, Bollington, UK., Higgins V; Scientific and NASH Franchise, Adelphi Real World, Bollington, UK.
Jazyk: angličtina
Zdroj: Pragmatic and observational research [Pragmat Obs Res] 2023 Feb 24; Vol. 14, pp. 13-27. Date of Electronic Publication: 2023 Feb 24 (Print Publication: 2023).
DOI: 10.2147/POR.S392320
Abstrakt: 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.
Competing Interests: QMA is coordinator of the IMI2 LITMUS consortium, which is funded by the EU Horizon 2020 programme and EFPIA. This multi-stakeholder consortium includes industry partners. He reports research grant funding from AstraZeneca, Boehringer Ingelheim, Intercept; consultancy on behalf of Newcastle University for 89Bio, Alimentiv, Akero, AstraZeneca, Axcella, BMS, Boehringer Ingelheim, Galmed, Genentech, Genfit SA, Gilead, GlaxoSmithKline, Hanmi, HistoIndex, Intercept Pharma Europe Ltd, Inventiva, Ionis, IQVIA, Janssen, Madrigal, Medpace, Merck, NGMBio, Novartis, Novo Nordisk A/S, PathAI, Pfizer Ltd, Poxel, ProSciento, Resolution Therapeutics, Roche, Ridgeline Therapeutics, RTI, Shionogi, Terns; speaker fees from Fishawack, Integritas Communications, Kenes, Madrigal, MedScape, NovoNordisk, Springer Healthcare; participation on a Data Safety Monitoring Board on behalf of Newcastle University from Medpace (North Sea Therapeutics DSMB); and royalties from Elsevier Ltd. KH is supported by a National Institute for Health Research/Health Education England Clinical Lectureship (CAT CL-2013-04-010). NL, AH and EM are employees of Gilead. SK was employed by Gilead at the time this work was undertaken. JB has received consultancy payments from Gilead. GM, JP, and VH are employees of Adelphi Real World. The authors report no other conflicts of interest in this work.
(© 2023 Anstee et al.)
Databáze: MEDLINE
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