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Sub-optimal therapy of patients with primary biliary cholangitis (PBC) in the real-life stetting of the German PBC cohort = Sub-optimale Behandlung von Patienten mit Primär Biliärer Cholangitis (PBC) im klinischen Alltag der deutschen PBC Kohorte

Real-world data on the management of patients with primary biliary cholangitis (PBC) are so far scarce in Germany. Therefore, we aimed to establish a nationwide registry and describe the clinical characteristics and therapy of PBC patients. Three different cohorts defined as ursodeoxycholic acid (UD...

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Main Authors: Wiegand, Johannes Tobias Martin (Author) , Franke, Annegret (Author) , Müller, Tobias (Author) , Stein, Kerstin (Author) , Bantel, Heike (Author) , Günther, Rainer (Author) , Denk, Gerald Ulrich (Author) , Reuken, Philipp Alexander (Author) , Schattenberg, Jörn Markus (Author) , Naumann, Uwe (Author) , Böttler, Tobias (Author) , Weber, Andreas (Author) , Zeuzem, Stefan (Author) , Hinz, Matthias (Author) , Greinert, Robin (Author) , Berg, Christoph Peter (Author) , Wissniowski, Thaddäus Till Hippokrates (Author) , Simon, Karl-Georg (Author) , Trebicka, Jonel (Author) , Behrens, Rüdiger (Author) , Grümmer, Harald (Author) , Hofmann, Wolf-Peter (Author) , Dikopoulos, Nektarios (Author) , Sarrazin, Christoph (Author) , Roeb, Elke (Author) , Kremer, Andreas (Author) , Muche, Marion (Author) , Ringelhan, Marc (Author) , Teufel, Andreas (Author) , Michl, Patrick (Author) , Keitel-Anselmino, Verena (Author) , Marquardt, Jens (Author) , Kautz, Achim (Author) , Tacke, Frank (Author) , Piotrowski, Katja (Author) , Köppe-Bauernfeind, Nicole (Author) , Trautwein, Christian (Author) , Berg, Thomas (Author)
Format: Article (Journal)
Language:English
Published: November 2024
In: Zeitschrift für Gastroenterologie
Year: 2024, Volume: 62, Issue: 11, Pages: 1931-1942
ISSN:1439-7803
DOI:10.1055/a-2382-7720
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1055/a-2382-7720
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Author Notes:Authors: Johannes Wiegand, Annegret Franke, Tobias Müller, Kerstin Stein, Heike Bantel, Rainer Günther, Gerald Denk, Philipp A. Reuken, Jörn M. Schattenberg, Uwe Naumann, Tobias Böttler, Andreas Weber, Stefan Zeuzem, Matthias Hinz, Robin Greinert, Christoph Berg, Thaddäus Till Wissniowski, Karl-Georg Simon, Jonel Trebicka, Rüdiger Behrens, Harald Grümmer, Wolf Peter Hofmann, Nektarios Dikopoulos, Christoph Sarrazin, Elke Roeb, Andreas E. Kremer, Marion Muche, Marc Ringelhan, Andreas Teufel, Patrick Michl, Verena Keitel, Jens U. Marquardt, Achim Kautz, Frank Tacke, Katja Piotrowski, Nicole Köppe-Bauernfeind, Christian Trautwein, Thomas Berg
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Summary:Real-world data on the management of patients with primary biliary cholangitis (PBC) are so far scarce in Germany. Therefore, we aimed to establish a nationwide registry and describe the clinical characteristics and therapy of PBC patients. Three different cohorts defined as ursodeoxycholic acid (UDCA) responders, as inadequate responders according to Paris II criteria, and as newly diagnosed patients were prospectively recruited. This manuscript includes the baseline data of the project. In total, 33/77 (43%) contacted centres (58% of university hospitals, 38% of non-university hospitals, and 24% of private practices) recruited 515 patients including 204 UDCA responders, 221 inadequate responders to UDCA, and 90 newly diagnosed patients. All patients were treated with UDCA; however, a UDCA dosage below the recommended dosage of 13 mg/kg/d was observed in 38.5% of individuals after 12 months of treatment. UDCA dosages were lower in nonacademic compared to academic centres. Only 75/219 (38.5%) of inadequate responders to UDCA received a second-line therapy with obeticholic acid (OCA) and/or bezafibrate (BZF). OCA (13% vs. 4.5%) and BZF (14% vs. 6.5%) were significantly more often prescribed by academic vs. nonacademic centres. Pruritus (27% vs. 15.5%), fatigue (23% vs. 4.5%), and sicca syndrome (14% vs. 1%) were significantly more often reported by academic centres. The German PBC registry could be established, which indicates suboptimal therapy in a relevant proportion of patients and shows significant differences between academic and nonacademic centres. Results are fundamental to improving clinical management at different levels of care.
Item Description:Artikel online veröffentlicht: 03. September 2024
Gesehen am 27.01.2025
Physical Description:Online Resource
ISSN:1439-7803
DOI:10.1055/a-2382-7720

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