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Goals of Treatment for Improved Survival in Primary Biliary Cholangitis: Treatment Target Should Be Bilirubin within the Normal Range and Normalization of Alkaline Phosphatase
dc.creator | Murillo Perez C.F., Harms M.H., Lindor K.D., Van Buuren H.R., Hirschfield G.M., Corpechot C., Van Der Meer A.J., Feld J.J., Gulamhusein A., Lammers W.J., Ponsioen C.Y., Carbone M., Mason A.L., Mayo M.J., Invernizzi P., Battezzati P.M., Floreani A., Lleo A., Nevens F., Kowdley K.V., Bruns T., Dalekos G.N., Gatselis N.K., Thorburn D., Trivedi P.J., Verhelst X., Parés A., Janssen H.L.A., Hansen B.E. | en |
dc.date.accessioned | 2023-01-31T09:02:31Z | |
dc.date.available | 2023-01-31T09:02:31Z | |
dc.date.issued | 2020 | |
dc.identifier | 10.14309/ajg.0000000000000557 | |
dc.identifier.issn | 00029270 | |
dc.identifier.uri | http://hdl.handle.net/11615/76839 | |
dc.description.abstract | INTRODUCTION:In primary biliary cholangitis (PBC), bilirubin and alkaline phosphatase (ALP) are widely established as independent predictors of prognosis. Current treatment goals do not aim for normalization of surrogate markers because their association with survival has not been defined.METHODS:The patient cohort from the GLOBAL PBC Study Group was used, comprising of long-term follow-up data from European and North American centers. Ursodeoxycholic acid-treated and untreated patients with bilirubin levels ≤1 × upper limit of normal (ULN) at baseline or 1 year were included. The association of normal ALP with transplant-free survival was assessed in a subgroup with ALP ≤1.67 × ULN at 1 year. Optimal thresholds of bilirubin and ALP to predict liver transplantation (LT) or death were evaluated.RESULTS:There were 2,281 patients included in the time zero cohort and 2,555 patients in the 1-year cohort. The bilirubin threshold with the highest ability to predict LT or death at 1 year was 0.6 × ULN (hazard ratio 2.12, 95% CI 1.69-2.66, P < 0.001). The 10-year survival rates of patients with bilirubin ≤0.6 × ULN and >0.6 × ULN were 91.3% and 79.2%, respectively (P < 0.001). The risk for LT or death was stable below the bilirubin levels of 0.6 × ULN, yet increased beyond this threshold. Ursodeoxycholic acid-induced reduction in bilirubin below this threshold was associated with an 11% improvement in 10-year survival. Furthermore, ALP normalization was optimal, with 10-year survival rates of 93.2% in patients with ALP ≤ 1 × ULN and 86.1% in those with ALP 1.0-1.67 × ULN.DISCUSSION:Attaining bilirubin levels ≤0.6 × ULN or normal ALP are associated with the lowest risk for LT or death in patients with PBC. This has important implications for treatment targets. © 2020 by The American College of Gastroenterology. | en |
dc.language.iso | en | en |
dc.source | American Journal of Gastroenterology | en |
dc.source.uri | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85087473506&doi=10.14309%2fajg.0000000000000557&partnerID=40&md5=f112ce1617cb58c92c5bcb1d372606c5 | |
dc.subject | alkaline phosphatase | en |
dc.subject | bilirubin | en |
dc.subject | ursodeoxycholic acid | en |
dc.subject | alkaline phosphatase | en |
dc.subject | bilirubin | en |
dc.subject | biological marker | en |
dc.subject | cholagogue | en |
dc.subject | adult | en |
dc.subject | Article | en |
dc.subject | cohort analysis | en |
dc.subject | death | en |
dc.subject | female | en |
dc.subject | follow up | en |
dc.subject | hazard ratio | en |
dc.subject | human | en |
dc.subject | liver transplantation | en |
dc.subject | major clinical study | en |
dc.subject | male | en |
dc.subject | prediction | en |
dc.subject | primary biliary cirrhosis | en |
dc.subject | priority journal | en |
dc.subject | prognosis | en |
dc.subject | risk assessment | en |
dc.subject | survival | en |
dc.subject | blood | en |
dc.subject | cholangitis | en |
dc.subject | clinical trial | en |
dc.subject | middle aged | en |
dc.subject | mortality | en |
dc.subject | multicenter study | en |
dc.subject | reference value | en |
dc.subject | survival rate | en |
dc.subject | Alkaline Phosphatase | en |
dc.subject | Bilirubin | en |
dc.subject | Biomarkers | en |
dc.subject | Cholagogues and Choleretics | en |
dc.subject | Cholangitis | en |
dc.subject | Female | en |
dc.subject | Humans | en |
dc.subject | Male | en |
dc.subject | Middle Aged | en |
dc.subject | Prognosis | en |
dc.subject | Reference Values | en |
dc.subject | Survival Rate | en |
dc.subject | Ursodeoxycholic Acid | en |
dc.subject | Wolters Kluwer Health | en |
dc.title | Goals of Treatment for Improved Survival in Primary Biliary Cholangitis: Treatment Target Should Be Bilirubin within the Normal Range and Normalization of Alkaline Phosphatase | en |
dc.type | journalArticle | en |
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