Evaluating Resmetirom Eligibility Among Patients with MASH: Insights from the German Steatotic Liver Disease-Registry

Abstract

Background

The THR-β agonist resmetirom is the first treatment approved for metabolic dysfunction-associated steatohepatitis (MASH) in the US so far. It can be prescribed given MASH and F2/F3-fibrosis (“at-risk MASH”).

Aims

We analyzed how many patients qualify for resmetirom in a recently recruited Steatotic Liver Disease-cohort involving both tertiary and secondary care centers, the German SLD-Registry.

Methods

Indication for resmetirom was assessed by three different approaches: (i) biopsy-proven MASH with F2/3 fibrosis and NAS-score ≥ 4; (ii) FibroScan-AST (FAST) score ≥ 0.67 and vibration controlled transient elastography (VCTE) < 15 kPa; (iii) US expert recommendations with VCTE 10–15 kPa and platelets ≥ 140×109/L or VCTE 8–15 kPa.

Results

1113 patients were recruited across 8 tertiary and 12 secondary care centers. NAS grading and staging were available for 180 cases (16%) with 179/180 conducted at tertiary care level. Of these, 61 (34%) qualified for resmetirom. FAST score without histologic assessment was available for 638 cases (57.3%), of which 612 (87%) were from tertiary and 26 (11%) from secondary care centers. Based on approach (ii), 41 (6%) of these individuals qualified for resmetirom compared to 117 (18.3%) using approach (iii). Combining approach (iii) with FAST ≥ 0.67 leads to 191 (30.0%) eligible patients. Using VCTE 8–15 kPa results in 182 (28.5%) eligible patients.

Conclusions

Eligibility for resmetirom treatment depends on the available method used to identify “at-risk MASH”. Availability of VCTE was highest among different levels of care.

Zusammenfassung

Hintergrund

Der THR-β-Agonist Resmetirom ist der erste in den USA zugelassene Behandlungsansatz für die metabolische Dysfunktion-assoziierte Steatohepatitis (MASH). Er kann bei MASH und F2/F3-Fibrose („at-risk MASH“) verschrieben werden.

Zielstellung

Analyse der für eine Therapie mit Resmetirom infrage kommenden Patienten aus dem Deutschen SLD-Register, einer kürzlich rekrutierten Kohorte von Patienten mit Steatotischer Lebererkrankung aus der sekundären und tertiären Versorgung.

Methodik

Die Indikation für Resmetirom wurde anhand von drei verschiedenen Ansätzen überprüft: (i) bioptisch nachgewiesene MASH mit F2/3-Fibrose und NAS-Score ≥4; (ii) FibroScan-AST (FAST)-Score ≥0,67 und vibrationskontrollierte transiente Elastographie (VCTE) <15 kPa; (iii) US-Expertenempfehlungen mit VCTE 10–15 kPa und Thrombozyten ≥140×109/L oder VCTE 8–15 kPa.

Ergebnisse

Es wurden 1113 Patienten in 8 tertiären und 12 sekundären Versorgungszentren rekrutiert. NAS-Grading und Staging waren für 180 Fälle (16%) verfügbar, davon wurden 179/180 auf der Ebene der tertiären Versorgung durchgeführt. Von diesen qualifizierten sich 61 (34%) für Resmetirom. Der FAST-Score ohne histologische Beurteilung war für 638 Fälle (57,3%) verfügbar, davon stammten 612 (87%) aus tertiären und 26 (11%) aus sekundären Versorgungszentren. Auf der Grundlage von Ansatz (ii) qualifizierten sich 41 (6%) dieser Personen für Resmetirom, verglichen mit 117 (18,3%) bei Anwendung von Ansatz (iii). Die Kombination von Ansatz (iii) mit FAST ≥0,67 führte zu 191 (30,0%) infrage kommenden Patienten. Die Verwendung von VCTE 8–15 kPa führte zu 182 (28,5%) infrage kommenden Patienten.

Schlussfolgerung

Die Eignung für eine Resmetirom-Behandlung hängt von der verfügbaren Methode zur Identifizierung der „at-risk MASH“ ab. Die Verfügbarkeit der VCTE war auf den verschiedenen Versorgungsebenen am höchsten.

Keywords

MASLD - MASH - Resmetirom - SLD - non-invasive tests

Schlüsselwörter

MASLD - MASH - Resmetirom - SLD - Nicht-invasive Tests

Publikationsverlauf

Eingereicht: 24. Februar 2025

Angenommen nach Revision: 17. April 2025

Artikel online veröffentlicht:
15. Mai 2025

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