Adequate versus deep response to ursodeoxycholic acid in primary biliary cholangitis: To what extent and under what conditions is normal alkaline phosphatase level associated with complication-free survival gain?
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Corpechot Christophe, Lemoinne Sara, Soret Pierre-Antoine, Hansen Bettina, Hirschfield Gideon, Gulamhusein Aliya, Montano-Loza Aldo J, Lytvyak Ellina, Pares Albert, Olivas Ignasi, Eaton John E, Osman Karim T, Schramm Christoph, Sebode Marcial, Lohse Ansgar W, Dalekos George, Gatselis Nikolaos, Nevens Frederik, Cazzagon Nora, Zago Alessandra, Russo Francesco Paolo, Floreani Annarosa, Abbas Nadir, Trivedi Palak, Thorburn Douglas, Saffioti Francesca, Barkai Laszlo, Roccarina Davide, Calvaruso Vicenza, Fichera Anna, Delamarre Adèle, Sobenko Natalia, Villamil Alejandra Maria, Medina-Morales Esli, Bonder Alan, Patwardhan Vilas, Rigamonti Cristina, Carbone Marco, Invernizzi Pietro, Cristoferi Laura, van der Meer Adriaan, de Veer Rozanne, Zigmond Ehud, Yehezkel Eyal, Kremer Andreas E, Deibel Ansgar, Bruns Tony, Große Karsten, Wetten Aaron, Dyson Jessica Katharine, Jones David, Dumortier Jérôme, Pageaux Georges-Philippe, de Lédinghen Victor, Chazouillères Olivier, Carrat Fabrice, Global & ERN Rare-Liver PBC Study Groups
Аннотация
APPROACH AND RESULTS: We performed a retrospective cohort study of 1047 patients with PBC who attained an adequate response to UDCA according to Paris-2 criteria. Time to liver-related complications, liver transplantation, or death was assessed using adjusted restricted mean survival time (RMST) analysis. The overall incidence rate of events was 17.0 (95% CI: 13.7-21.1) per 1000 out of 4763.2 patient-years. On the whole population, normal serum ALP values (but not normal gamma-glutamyl transpeptidase (GGT), alanine aminotransferase (ALT), or aspartate aminotransferase (AST); or total bilirubin < 0.6 ×ULN) were associated with a significant absolute complication-free survival gain at 10 years (mean 7.6 months, 95% CI: 2.7 - 12.6 mo.; p = 0.003). In subgroup analysis, this association was significant in patients with a liver stiffness measurement ≥ 10 kPa and/or age ≤ 62 years, with a 10-year absolute complication-free survival gain of 52.8 months (95% CI: 45.7-59.9, p < 0.001) when these 2 conditions were met.
CONCLUSIONS: PBC patients with an adequate response to UDCA and persistent ALP elevation between 1.1 and 1.5 ×ULN, particularly those with advanced fibrosis and/or who are sufficiently young, remain at risk of poor outcome. Further therapeutic efforts should be considered for these patients.