Background After 1 year of ursodeoxycholic acid (UDCA), patients with primary biliary cholangitis (PBC) may have a normal GLOBE score despite high alkaline phosphatase (ALP) levels. Aim To assess the association between ALP and liver transplantation (LT)-free survival according to the GLOBE score. Methods Among patients with a normal or elevated GLOBE score in the Global PBC cohort, the association between ALP after 1 year of UDCA therapy and the risk of LT/death was assessed. The LT-free survival was compared with that of a matched general population. Results After 1 year of UDCA, ALP was associated with the risk of LT/death (aHR 1.31, 95% CI 1.003-1.72, p = 0.048) among 2729 patients with a normal GLOBE score. The 10-year LT-free survival among these patients with an ALP >2.0 x ULN was 94.0% (95% CI 90.1-97.9) for those <50 years and 82.6% (95% CI 76.5-88.7) for those >= 50 years, which was significantly lower (p = 0.040) and similar (p = 0.736) to that of the matched population, respectively. The 10-year LT-free survival in patients >= 50 years with normal GLOBE score and normal ALP (90.8%, 95% CI 87.7-93.9) was significantly higher (p = 0.022) than the matched population. Among 1045 patients with an elevated GLOBE score, ALP was associated with LT/death only in those <50 years (aHR 1.38, 95% CI 1.06-1.81, p = 0.016). Conclusion The LT-free survival of patients with PBC with a normal GLOBE score is optimal in case of normal ALP levels, also in relation to the general population. Despite their generally favourable prognosis, an elevated ALP level may still indicate a need for add-on therapy.

Liver transplant-free survival according to alkaline phosphatase and GLOBE score in patients with primary biliary cholangitis treated with ursodeoxycholic acid / R.C. de Veer, M.H. Harms, C. Corpechot, D. Thorburn, P. Invernizzi, H.L.A. Janssen, P.M. Battezzati, F. Nevens, K.D. Lindor, A. Floreani, C.Y. Ponsioen, M.J. Mayo, A. Parés, A.L. Mason, K.V. Kowdley, P.J. Trivedi, G.M. Hirschfield, T. Bruns, G.N. Dalekos, N.K. Gatselis, X. Verhelst, W.J. Lammers, B.E. Hansen, H.R. van Buuren, A.J. van der Meer. - In: ALIMENTARY PHARMACOLOGY & THERAPEUTICS. - ISSN 0269-2813. - 56:9(2022 Nov), pp. 1408-1418. [10.1111/apt.17226]

Liver transplant-free survival according to alkaline phosphatase and GLOBE score in patients with primary biliary cholangitis treated with ursodeoxycholic acid

P.M. Battezzati;
2022

Abstract

Background After 1 year of ursodeoxycholic acid (UDCA), patients with primary biliary cholangitis (PBC) may have a normal GLOBE score despite high alkaline phosphatase (ALP) levels. Aim To assess the association between ALP and liver transplantation (LT)-free survival according to the GLOBE score. Methods Among patients with a normal or elevated GLOBE score in the Global PBC cohort, the association between ALP after 1 year of UDCA therapy and the risk of LT/death was assessed. The LT-free survival was compared with that of a matched general population. Results After 1 year of UDCA, ALP was associated with the risk of LT/death (aHR 1.31, 95% CI 1.003-1.72, p = 0.048) among 2729 patients with a normal GLOBE score. The 10-year LT-free survival among these patients with an ALP >2.0 x ULN was 94.0% (95% CI 90.1-97.9) for those <50 years and 82.6% (95% CI 76.5-88.7) for those >= 50 years, which was significantly lower (p = 0.040) and similar (p = 0.736) to that of the matched population, respectively. The 10-year LT-free survival in patients >= 50 years with normal GLOBE score and normal ALP (90.8%, 95% CI 87.7-93.9) was significantly higher (p = 0.022) than the matched population. Among 1045 patients with an elevated GLOBE score, ALP was associated with LT/death only in those <50 years (aHR 1.38, 95% CI 1.06-1.81, p = 0.016). Conclusion The LT-free survival of patients with PBC with a normal GLOBE score is optimal in case of normal ALP levels, also in relation to the general population. Despite their generally favourable prognosis, an elevated ALP level may still indicate a need for add-on therapy.
GLOBE score; primary biliary cholangitis; second-line treatment; treatment response
Settore MED/12 - Gastroenterologia
Settore MED/09 - Medicina Interna
nov-2022
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/967564
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