Z Gastroenterol 2025; 63(08): e454
DOI: 10.1055/s-0045-1810774
Abstracts | DGVS/DGAV
Kurzvorträge
Autoimmune und cholestatische Lebererkrankungen: neue Wege in der Behandlung Freitag, 19. September 2025, 14:45 – 16:21, Seminarraum 14 + 15

Efficacy and safety of seladelpar in patients with primary biliary cholangitis previously treated with fibrates or obeticholic acid

Authors

  • A Villamil

    1   The Liver Autoimmunity Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentinien

  • D Pratt

    2   Autoimmune and Cholestatic Liver Center, Massachusetts General Hospital, Boston, Vereinigte Staaten

  • A E Kremer

    3   Department of Gastroenterology and Hepatology, University Hospital Zürich, University of Zürich, Zürich, Schweiz

  • V Calvaruso

    4   Gastroenterology and Hepatology Unit, University of Palermo, Palermo, Italien

  • E Gómez Dominguez

    5   Hepatology Unit, University Hospital 12 de Octubre, Madrid, Spanien

  • X Qi

    6   Gilead Sciences, Inc., Foster City, Vereinigte Staaten

  • S Proehl

    6   Gilead Sciences, Inc., Foster City, Vereinigte Staaten

  • W T Barchuk

    6   Gilead Sciences, Inc., Foster City, Vereinigte Staaten

  • T R Watkins

    6   Gilead Sciences, Inc., Foster City, Vereinigte Staaten

  • S C Gordon

    7   Division of Hepatology, Henry Ford Hospital, Wayne State University School of Medicine, Detroit, Vereinigte Staaten
    8   Michigan State University College of Medicine, East Lansing, Vereinigte Staaten
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    Introduction: Seladelpar (SEL) is a first-in-class delpar (selective PPAR-delta agonist) indicated for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in patients (pts) with an inadequate response to UDCA or as monotherapy in pts unable to tolerate UDCA. RESPONSE was a Phase 3, randomised, placebo-controlled clinical trial of SEL in pts with inadequate response/intolerance to UDCA. Pts completing RESPONSE were eligible to roll over into ASSURE (NCT03301506), an ongoing, open-label, long-term, Phase 3 safety trial.

    Objectives: Here, we describe data from month 18 (month 6 of ASSURE) in pts with or without prior use of fibrates or obeticholic acid (OCA) who rolled over from RESPONSE into ASSURE.

    Methodology: Pts received 10 mg SEL orally daily or placebo in RESPONSE; pts received open-label 10 mg SEL in ASSURE. Fibrates and OCA were prohibited during the study period and a 6-week washout was required prior to entry in RESPONSE. Data were described for pts in ASSURE with or without prior use of fibrates/OCA and based on whether they received SEL (continuous SEL pts) or placebo (crossover pts) in RESPONSE. Efficacy included the percentage of pts achieving a composite biochemical response (CBR; alkaline phosphatase [ALP]<1.67×upper limit of normal [ULN], ALP decrease≥15%, and total bilirubin≤ULN). Safety assessments included adverse events (AEs) and laboratory parameters.

    Results: Among pts who continued into ASSURE from RESPONSE (n=158), 16 continuous SEL and 11 crossover pts reported prior use of fibrates/OCA (total, n=27; 17%); 88 continuous SEL and 43 crossover pts reported no prior use of fibrates/OCA (total, n=131; 83%). At month 18, among continuous SEL pts, 9/15 (60%) pts with prior fibrate/OCA use achieved a CBR vs 54/87 (62%) pts without prior fibrate/OCA use. Among crossover pts, 7/11 (64%) pts with prior fibrate/OCA use vs 32/41 (78%) pts without prior fibrate/OCA use achieved a CBR at month 6 of ASSURE. From ASSURE initiation to month 6, incidence of AEs was similar across continuous SEL and crossover pts, regardless of prior OCA/fibrate use; no treatment-related serious AEs were reported.

    Conclusion: In this interim analysis of continuous SEL and crossover pts from ASSURE, pts who reported prior use of fibrates/OCA achieved a similar sustained biochemical response with SEL compared with pts who reported no prior use. SEL appeared safe and well tolerated in this subgroup.


     

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    Artikel online veröffentlicht:
    04. September 2025

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