Z Gastroenterol 2025; 63(08): e456-e457
DOI: 10.1055/s-0045-1810778
Abstracts | DGVS/DGAV
Kurzvorträge
Autoimmune und cholestatische Lebererkrankungen: neue Wege in der Behandlung Freitag, 19. September 2025, 14:45 – 16:21, Seminarraum 14 + 15

Long-term efficacy and safety of elafibranor in primary biliary cholangitis: Interim results from the open-label extension of the ELATIVE trial up to 3 years

Authors

  • K V Kowdley

    1   Liver Institute Northwest, Seattle, Vereinigte Staaten

  • C L Bowlus

    2   UC Davis School of Medicine, Sacramento, Vereinigte Staaten

  • C Levy

    3   University of Miami, Miami, Vereinigte Staaten

  • U Akarca

    4   Ege University Faculty of Medicine, Izmir, Türkei

  • M R Alvares-da-Silva

    5   Hospital de Clinicas de Porto Alegre, Porto Alegre, Brasilien

  • P Andreone

    6   Baggiovara Hospital, Modena, Italien

  • M Arrese

    7   Pontificia Universidad Catolica de Chile, Santiago, Chile

  • C Corpechot

    8   Sorbonne University, Paris, Frankreich

  • H Elbeshbeshy

    9   Saint Louis University School of Medicine, St. Louis, Vereinigte Staaten

  • S Francque

    10   Antwerp University Hospital, Antwerpen, Belgien
    11   Faculty of Medicine and Health Sciences Antwerp University, Antwerpen, Belgien

  • M A Heneghan

    12   King’s College Hospital NHS Foundation Trust, London, Vereinigtes Königreich

  • P Invernizzi

    13   University of Milano-Bicocca, Monza, Italien
    14   Fondazione IRCCS, Monza, Italien

  • I M Jacobson

    15   NYU Langone Health, New York, Vereinigte Staaten

  • D Jones

    16   Newcastle University, Newcastle Upon Tyne, Vereinigtes Königreich

  • F C Kruger

    17   Mediclinic Durbanville, Cape Town, Südafrika
    18   Tiervlei Trial Centre, Cape Townsü, Südafrika

  • E Lawitz

    19   University of Texas Health, San Antonio, Vereinigte Staaten

  • M J Mayo

    20   University of Texas Southwestern Medical Center, Dallas, Vereinigte Staaten

  • M L Shiffman

    21   Bon Secours Mercy Health, Richmond, Vereinigte Staaten

  • M Sonderup

    22   University of Cape Town and Groote Schuur Hospital, Cape Town, Südafrika

  • M G Swain

    23   University of Calgary, Calgary, Kanada

  • J M Valera

    24   Hospital San Juan de la Serena, Coquimbo, Chile

  • V Vargas

    25   Universitat Autònoma de Barcelona, Barcelona, Spanien

  • J M Vierling

    26   Baylor College of Medicine, Houston, Vereinigtes Königreich

  • A Villamil

    27   Hospital Italiano de Buenos Aires, Buenos Aires, Argentinien

  • C Raskino

    28   Ipsen, Cambridge, Vereinigte Staaten

  • N Antunes

    28   Ipsen, Cambridge, Vereinigte Staaten

  • M Sleiman

    29   Ipsen, Boulogne-Billancourt, Frankreich

  • V Cranham

    29   Ipsen, Boulogne-Billancourt, Frankreich

  • B Miller

    28   Ipsen, Cambridge, Vereinigte Staaten

  • J M Schattenberg

    30   Universitätsklinikum des Saarlandes, Klinik für Innere Medizin II, Homburg, Deutschland
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    Background: Elafibranor (ELA) significantly improved biomarkers of cholestasis at Week (W)52 in patients (pts) with primary biliary cholangitis (PBC) in the phase III ELATIVE trial (NCT04526665).

    Aim: To report up to 3-year interim results from the ongoing ELATIVE open-label extension (OLE).

    Method: Pts completing the ELATIVE double-blind period (DBP) were eligible to enter the OLE receiving ELA 80 mg daily. For pts who received placebo (PBO) in the DBP, baseline (BL) was set as the last non-missing value before the first OLE ELA dose; for pts who received ELA in the DBP, BL was the DBP start. Endpoints reported include biochemical response (alkaline phosphatase [ALP]<1.67xULN, with≥15% reduction from BL and total bilirubin [TB]≤ULN), ALP normalization, change in liver stiffness measurement (LSM) and enhanced liver fibrosis (ELF) score, and change in pruritus (PBC Worst Itch Numeric Rating Scale [WI-NRS], PBC-40 Itch, and 5-D Itch) in those with moderate-to-severe pruritus at BL (PBC WI-NRS≥4). Results presented descriptively;safety analyses evaluated events in the OLE.

    Result: At data cutoff (June 2024), 153 pts had received ELA; 108 received ELA and 45 received PBO in the DBP. 138 pts entered the OLE. Pts receiving continuous ELA had data up to W156. At BL for each group, pts crossing over from PBO had increased mean ALP and TB vs pts receiving continuous ELA (335.8U/L vs 321.3U/L; 0.64mg/dL vs 0.57mg/dL).In pts receiving continuous ELA, 34/61(56%) at W104 and 11/13(85%) at W156 had biochemical response; ALP normalization occurred in 8/61(13%) at W104 and 5/13(39%) at W156. In pts crossing over from PBO, 21/41(51%) had biochemical response and 9/41(22%) had ALP normalization at W52. LSM and ELF scores showed a trend for stability in pts receiving continuous ELA for≥104 weeks (median change from BL in LSM: W104:−0.2 kPa[n=48],W156:−0.5 kPa[n=11];ELF:W104:0.0[n=41],W156:−0.6[n=9]).Improvement in pruritus was sustained in pts with moderate-to-severe pruritus at BL receiving continuous ELA (mean change from BL in PBC WI-NRS:W104:−3.1[n=21], W156:−4.4[n=5]; PBC-40 Itch: W104:−3.0[n=22],W156:−4.6[n=5]; 5-D Itch:W104:−5.0[n=22], W156:−7.0[n=5]). No new safety signals were identified.

    Conclusion: In the ongoing ELATIVE OLE, ELA led to sustained improvements in biomarkers of cholestasis and pruritus and stabilization of fibrosis up to W156 and remained well tolerated. Pts crossing over from PBO had similar results at W52 to those who received ELA in the DBP.


     

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    Artikel online veröffentlicht:
    04. September 2025

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