| Title: |
Adequate vs. deep response to UDCA in PBC: To what extent and under what conditions is normal ALP level associated with complication-free survival gain? |
| Authors: |
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 |
| Contributors: |
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, Nikolao; Nevens, Frederik; Cazzagon, Nora; Zago, Alessandra; Russo, Francesco Paolo; Floreani, Annarosa; Abbas, Nadir; Trivedi, Palak; Thorburn, Dougla; Saffioti, Francesca; Barkai, Laszlo; Roccarina, Davide; Calvaruso, Vicenza; Fichera, Anna; Delamarre, Adèle; Sobenko, Natalia; Villamil, Alejandra Maria; Medina-Morales, Esli; Bonder, Alan; Patwardhan, Vila; 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 |
| Publication Year: |
2024 |
| Collection: |
Università degli Studi del Piemonte Orientale: CINECA IRIS |
| Description: |
Background and aims: Normal alkaline phosphatase (ALP) levels in ursodeoxycholic acid (UDCA)-treated patients with primary biliary cholangitis (PBC) are associated with better long-term outcome. However, second-line therapies are currently recommended only when ALP levels remain above 1.5 times the upper limit of normal (xULN) after 12-month UDCA. We assessed whether, in patients considered good responders to UDCA, normal ALP levels were associated with significant survival gains. Approach and results: We performed a retrospective cohort study of 1,047 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 analysis. The overall incidence rate of events was 17.0 (95%CI 13.7 - 21.1) per 1,000 out of 4,763.2 patient-years. On the whole population, normal serum ALP values (but not normal GGT, ALT, or AST; or total bilirubin < 0.6 xULN) were associated with an overall absolute complication-free survival gain at 10 years of 7.6 months (95%CI 2.7 - 12.6, 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 two conditions were met. Conclusions: PBC patients with an adequate response to UDCA and persistent ALP elevation between 1.1 and 1.5 xULN, 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. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/37399238; info:eu-repo/semantics/altIdentifier/wos/WOS:001069317300001; volume:79; issue:1; firstpage:39; lastpage:48; numberofpages:10; journal:HEPATOLOGY; https://hdl.handle.net/11579/158783 |
| DOI: |
10.1097/HEP.0000000000000529 |
| Availability: |
https://hdl.handle.net/11579/158783; https://doi.org/10.1097/HEP.0000000000000529 |
| Rights: |
info:eu-repo/semantics/openAccess |
| Accession Number: |
edsbas.DF911926 |
| Database: |
BASE |