Optimizing therapy in primary biliary cholangitis: Alkaline phosphatase at six months identifies one-year non-responders and predicts survival.
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Murillo Perez C Fiorella, Ioannou Stephanie, Hassanally Iman, Trivedi Palak J, Corpechot Christophe, van der Meer Adriaan J, Lammers Willem J, Battezzati Pier Maria, Lindor Keith D, Nevens Frederik, Kowdley Kris V, Bruns Tony, Cazzagon Nora, Floreani Annarosa, Mason Andrew L, Gulamhusein Aliya, Ponsioen Cyriel Y, Carbone Marco, Lleo Ana, Mayo Marlyn J, Dalekos George N, Gatselis Nikolaos K, Thorburn Douglas, Verhelst Xavier, Parés Albert, Londoño Maria-Carlota, Janssen Harry L A, Invernizzi Pietro, Vuppalanchi Raj, Hirschfield Gideon M, Hansen Bettina E, Levy Cynthia, Global PBC Study Group
Аннотация
METHODS: UDCA-treated patients in the GLOBAL PBC database with available liver biochemistries at one year were included. POISE criteria were used to assess response to treatment, defined as ALP <1.67 × upper limit of normal (ULN) and normal total bilirubin at one year. Various thresholds of ALP at six months were evaluated to predict insufficient response based on negative predictive value (NPV) and that with nearest to 90% NPV was selected.
RESULTS: For the study, 1362 patients were included, 1232 (90.5%) female, mean age of 54 years. The POISE criteria were met by 56.4% (n = 768) of patients at one year. The median ALP (IQR) of those who met POISE criteria compared to those who did not was 1.05 × ULN (0.82-1.33) vs. 2.37 × ULN (1.72-3.69) at six months (p < .001). Of 235 patients with serum ALP >1.9 × ULN at six months, 89% did not achieve POISE criteria (NPV) after one year of UDCA. Of those with insufficient response by POISE criteria at one year, 210 (67%) had an ALP >1.9 × ULN at six months and thus would have been identified early.
CONCLUSIONS: We can identify patients for second-line therapy at six months using an ALP threshold of 1.9 × ULN, given that approximately 90% of these patients are non-responders according to POISE criteria.