1. Optimizing therapy in primary biliary cholangitis: Alkaline phosphatase at six months identifies one-year non-responders and predicts survival
- Author
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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, Gastroenterology & Hepatology, and Epidemiology
- Abstract
Background and Aims: Patients with primary biliary cholangitis (PBC) and insufficient response to ursodeoxycholic acid (UDCA), currently assessed after 1 year, are candidates for second-line therapy. The aims of this study are to assess biochemical response pattern and determine the utility of alkaline phosphatase (ALP) at six months as a predictor of insufficient response. 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 1.9 × 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.
- Published
- 2023