Corpechot, Christophe;
Lemoinne, Sara;
Soret, Pierre-Antoine;
Hansen, Bettina;
Hirschfield, Gideon;
Gulamhusein, Aliya;
Montano-Loza, Aldo J;
... Global & ERN Rare-Liver PBC Study, Groups; + view all
(2024)
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?
Hepatology
, 79
(1)
pp. 39-48.
10.1097/HEP.0000000000000529.
Preview |
Text
Adequate_vs__deep_response_to_UDCA_in_PBC__To_what.497.pdf - Accepted Version Download (1MB) | Preview |
Abstract
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.
| Type: | Article |
|---|---|
| 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? |
| Location: | United States |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1097/HEP.0000000000000529 |
| Publisher version: | https://doi.org/10.1097/HEP.0000000000000529 |
| Language: | English |
| Additional information: | This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions. |
| Keywords: | Global & ERN Rare-Liver PBC Study Groups |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10173654 |
Archive Staff Only
 |
View Item |
