TY  - JOUR
A1  - Wilde, Anne-Christin Beatrice
A1  - Lieb, Charlotte
A1  - Leicht, Elise
A1  - Greverath, Lena Maria
A1  - Steinhagen, Lara Marleen
A1  - Wald de Chamorro, Nina
A1  - Petersen, Jörg
A1  - Hofmann, Wolf Peter
A1  - Hinrichsen, Holger
A1  - Heyne, Renate
A1  - Berg, Thomas
A1  - Naumann, Uwe
A1  - Schwenzer, Jeannette
A1  - Vermehren, Johannes
A1  - Geier, Andreas
A1  - Tacke, Frank
A1  - Müller, Tobias
T1  - Real-world clinical management of patients with primary biliary cholangitis — a retrospective multicenter study from Germany
JF  - Journal of Clinical Medicine
N2  - Background: Clinical practice guidelines for patients with primary biliary cholangitis (PBC) have been recently revised and implemented for well-established response criteria to standard first-line ursodeoxycholic acid (UDCA) therapy at 12 months after treatment initiation for the early identification of high-risk patients with inadequate treatment responses who may require treatment modification. However, there are only very limited data concerning the real-world clinical management of patients with PBC in Germany. Objective: The aim of this retrospective multicenter study was to evaluate response rates to standard first-line UDCA therapy and subsequent Second-line treatment regimens in a large cohort of well-characterized patients with PBC from 10 independent hepatological referral centers in Germany prior to the introduction of obeticholic acid as a licensed second-line treatment option. Methods: Diagnostic confirmation of PBC, standard first-line UDCA treatment regimens and response rates at 12 months according to Paris-I, Paris-II, and Barcelona criteria, the follow-up cut-off alkaline phosphatase (ALP) ≤ 1.67 × upper limit of normal (ULN) and the normalization of bilirubin (bilirubin ≤ 1 × ULN) were retrospectively examined between June 1986 and March 2017. The management and hitherto applied second-line treatment regimens in patients with an inadequate response to UDCA and subsequent response rates at 12 months were also evaluated. Results: Overall, 480 PBC patients were included in this study. The median UDCA dosage was 13.2 mg UDCA/kg bodyweight (BW)/d. Adequate UDCA treatment response rates according to Paris-I, Paris-II, and Barcelona criteria were observed in 91, 71.3, and 61.3% of patients, respectively. In 83.8% of patients, ALP ≤ 1.67 × ULN were achieved. A total of 116 patients (24.2%) showed an inadequate response to UDCA according to at least one criterion. The diverse second-line treatment regimens applied led to significantly higher response rates according to Paris-II (35 vs. 60%, p = 0.005), Barcelona (13 vs. 34%, p = 0.0005), ALP ≤ 1.67 × ULN and bilirubin ≤ 1 × ULN (52.1 vs. 75%, p = 0.002). The addition of bezafibrates appeared to induce the strongest beneficial effect in this cohort (Paris II: 24 vs. 74%, p = 0.004; Barcelona: 50 vs. 84%, p = 0.046; ALP < 1.67 × ULN and bilirubin ≤ 1 × ULN: 33 vs. 86%, p = 0.001). Conclusion: Our large retrospective multicenter study confirms high response rates following UDCA first-line standard treatment in patients with PBC and highlights the need for close monitoring and early treatment modification in high-risk patients with an insufficient response to UDCA since early treatment modification significantly increases subsequent response rates of these patients.
KW  - primary biliary cholangitis
KW  - autoantibodies
KW  - ursodeoxycholic acid
KW  - treatment response
KW  - second line therapy
Y1  - 2021
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-234003
SN  - 2077-0383
VL  - 10
IS  - 5
ER  - 
TY  - JOUR
A1  - Graf, Christiana
A1  - Mondorf, Antonia
A1  - Knop, Viola
A1  - Peiffer, Kai-Henrik
A1  - Dietz, Julia
A1  - Friess, Julia
A1  - Wedemeyer, Heiner
A1  - Buggisch, Peter
A1  - Mauss, Stefan
A1  - Berg, Thomas
A1  - Rausch, Michael
A1  - Sprinzl, Martin
A1  - Klinker, Hartwig
A1  - Hinrichsen, Holger
A1  - Bronowicki, Jean-Pierre
A1  - Haag, Sebastian
A1  - Hüppe, Dietrich
A1  - Lutz, Thomas
A1  - Poynard, Thierry
A1  - Zeuzem, Stefan
A1  - Friedrich-Rust, Mireen
A1  - Sarrazin, Christoph
A1  - Vermehren, Johannes
T1  - Evaluation of point shear wave elastography using acoustic radiation force impulse imaging for longitudinal fibrosis assessment in patients with HBeAg-Negative HBV infection
JF  - Journal of Clinical Medicine
N2  - Background: Accurate assessment of hepatic fibrosis in patients with chronic HBeAg-negative Hepatitis B is of crucial importance not only to predict the long-term clinical course, but also to evaluate antiviral therapy indication. The aim of this study was to prospectively assess the utility of point shear wave elastography (pSWE) for longitudinal non-invasive fibrosis assessment in a large cohort of untreated patients with chronic HBeAg-negative hepatitis B virus (HBV) infection. Methods: 407 consecutive patients with HBeAg-negative HBV infection who underwent pSWE, transient elastography (TE) as well as laboratory fibrosis markers, including fibrosis index based on four factors (FIB-4), aspartate to platelet ratio index (APRI) and FibroTest, on the same day were prospectively followed up for six years. Patients were classified into one of the three groups: inactive carriers (IC; HBV-DNA <2000 IU/mL and ALT <40 U/L); grey zone group 1 (GZ-1; HBV DNA <2000 IU/mL and ALT >40 U/L); grey zone group 2 (GZ-2; HBV-DNA >2000 IU/mL and ALT <40 U/L). Results: pSWE results were significantly correlated with TE (r = 0.29, p < 0.001) and APRI (r = 0.17; p = 0.005). Median pSWE values did not differ between IC, GZ-1 and GZ-2 patients (p = 0.82, p = 0.17, p = 0.34). During six years of follow-up, median pSWE and TE values did not differ significantly over time (TE: p = 0.27; pSWE: p = 0.05). Conclusion: Our data indicate that pSWE could be useful for non-invasive fibrosis assessment and follow-up in patients with HBeAg-negative chronic HBV infection.
KW  - HBV
KW  - non-invasive fibrosis assessment
KW  - point shear wave elastography
KW  - acoustic radiation force impulse imaging
KW  - transient elastography
KW  - fibrotest
KW  - APRI
KW  - FIB-4
Y1  - 2019
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-193916
SN  - 2077-0383
VL  - 8
IS  - 12
ER  -