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001-es BibID:BIBFORM120677
035-os BibID:(WOS)001032215200024 (Scopus)85165221969
Első szerző:Hirschfield, Gideon M.
Cím:Seladelpar efficacy and safety at 3 months in patients with primary biliary cholangitis : ENHANCE, a phase 3, randomized, placebo-controlled study / Gideon M. Hirschfield, Mitchell L. Shiffman, Aliya Gulamhusein, Kris V. Kowdley, John M. Vierling, Cynthia Levy, Andreas E. Kremer, Ehud Zigmond, Pietro Andreone, Stuart C. Gordon, Christopher L. Bowlus, Eric J. Lawitz, Richard J. Aspinall, Daniel S. Pratt, Karina Raikhelson, Maria S. Gonzalez-Huezo, Michael A. Heneghan, Sook-Hyang Jeong, Alma L. Ladrón de Guevara, Marlyn J. Mayo, George N. Dalekos, Joost P. H. Drenth, Ewa Janczewska, Barbara A. Leggett, Frederik Nevens, Victor Vargas, Eli Zuckerman, Christophe Corpechot, Eduardo Fassio, Holger Hinrichsen, Pietro Invernizzi, Palak J. Trivedi, Lisa Forman, David E. J. Jones, Stephen D. Ryder, Mark G. Swain, Alexandra Steinberg, Pol F. Boudes, Yun-Jung Choi, Charles A. McWherter, ENHANCE Study Group
Dátum:2023
ISSN:0270-9139
Megjegyzések:Background and Aims: ENHANCEwas a phase 3 study that evaluated efficacy and safety of seladelpar, a selective peroxisome proliferator-activated receptor-? (PPAR) agonist, versus placebo in patients with primary biliary cholangitis with inadequate response or intolerance to ursodeoxycholic acid (UDCA). Approach and Results: Patients were randomized 1:1:1 to oral seladelpar 5 mg (n=89), 10 mg (n=89), placebo (n=87) daily (with UDCA, as appropriate). Primary end point was a composite biochemical response [alkaline phosphatase (ALP) < 1.67?upper limit of normal (ULN), ?15% ALP decrease from baseline, and total bilirubin ? ULN] at month 12. Key secondary end points were ALP normalization at month 12 and change in pruritus numerical rating scale (NRS) at month 6 in patients with baseline score ?4. Aminotransferases were assessed. ENHANCE was terminated early following an erroneous safety signal in a concurrent, NASH trial.While blinded, primary and secondary efficacy end points were amended to month 3. Significantly more patients receiving seladelpar met the primary end point (seladelpar 5 mg: 57.1%, 10mg: 78.2%) versus placebo (12.5%) (p < 0.0001). ALP normalization occurred in 5.4% (p=0.08) and 27.3% (p < 0.0001) of patients receiving 5 and 10 mg seladelpar, respectively, versus 0% receiving placebo. Seladelpar 10 mg significantly reduced mean pruritus NRS versus placebo [10 mg: ?3.14 (p=0.02); placebo: ?1.55]. Alanine aminotransferase decreased significantly with seladelpar versus placebo [5 mg: 23.4% (p=0.0008); 10 mg: 16.7% (p=0.03); placebo: 4%]. There were no serious treatment-related adverse events. Conclusions: Patients with primary biliary cholangitis (PBC) with inadequate response or intolerance to UDCA who were treated with seladelpar 10 mg had significant improvements in liver biochemistry and pruritus. Seladelpar appeared safe and well tolerated.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:Hepatology. - 78 : 2 (2023), p. 397-415. -
További szerzők:Shiffman, Mitchell L. Gulamhusein, Aliya Kowdley, Kris V. Vierling, John M. Levy, Cynthia Kremer, Andreas E. Zigmond, Ehud Andreone, Pietro Gordon, Stuart C. Bowlus, Christopher L. Lawitz, Eric J. Aspinall, Richard J. Pratt, Daniel S. Raikhelson, Karina Gonzalez-Huezo, Maria S. Heneghan, Michael A. Jeong, Sook-Hyang Guevara, Alma L. Ladrón de Mayo, Marlyn J. Dalekos, George N. Drenth, Joost P. H. Janczewska, Ewa Leggett, Barbara A. Nevens, Frederik Vargas, Victor Zuckerman, Eli Corpechot, Christophe Fassio, Eduardo Hinrichsen, Holger Invernizzi, Pietro Trivedi, Palak J. Forman, Lisa Jones, David E. J. Ryder, Stephen Swain, Mark G. Steinberg, Alexandra Boudes, Pol F. Choi, Yun-Jung McWherter, Charles A. Papp Mária (1975-) (belgyógyász, gasztroenterológus) ENHANCE Study Group
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2.

001-es BibID:BIBFORM085824
Első szerző:Pape, Simon
Cím:High discontinuation rate of azathioprine in autoimmune hepatitis, independent of time of treatment initiation / Pape Simon, Gevers Tom J. G., Vrolijk Jan Maarten, van Hoek Bart, Bouma Gerd, van Nieuwkerk Carin M. J., Taubert Richard, Jaeckel Elmar, Manns Michael P., Papp Maria, Sipeki Nora, Stickel Felix, Efe Cumali, Ozaslan Ersan, Purnak Tugrul, Nevens Frederik, Kessener Dominik J. N., Kahraman Alisan, Wedemeyer Heiner, Hartl Johannes, Schramm Christoph, Lohse Ansgar W., Heneghan Michael A., Drenth Joost P. H.
Dátum:2020
ISSN:1478-3223
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:Liver International. - 40 : 9 (2020), p. 2164-2171. -
További szerzők:Gevers, Tom J. G. Vrolijk, Jan Maarten van Hoek, Bart Bouma, Gerd van Nieuwkerk, Carin M. J. Taubert, Richard Jaeckel, Elmar Manns, Michael P. Papp Mária (1975-) (belgyógyász, gasztroenterológus) Sipeki Nóra (1987-) (általános orvos) Stickel, Felix Efe, Cumali Ozaslan, Ersan Purnak, Tugrul Nevens, Frederik Kessener, Dominik J. N. Kahraman, Alisan Wedemeyer, Heiner Hartl, Johannes Schramm, Christoph Lohse, Ansgar W. Heneghan, Michael A. Drenth, Joost P. H.
Pályázati támogatás:ÚNKP-19-4
Egyéb
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3.

001-es BibID:BIBFORM081815
035-os BibID:(WoS)000552446400014 (Scopus)85084968025
Első szerző:Pape, Simon
Cím:Rapid Response to Treatment of Autoimmune Hepatitis Associated with Remission at 6 and 12 Months / Simon Pape, Tom J. G. Gevers, Jan Maarten Vrolijk, Bart van Hoek, Gerd Bouma, Carin M. J. van Nieuwkerk, Richard Taubert, Elmar Jaeckel, Michael P. Manns, Maria Papp, Nora Sipeki, Felix Stickel, Cumali Efe, Ersan Ozaslan, Tugrul Purnak, Frederik Nevens, Dominik J. N. Kessener, Alisan Kahraman, Heiner Wedemeyer, Johannes Hartl, Christoph Schramm, Ansgar W. Lohse, Joost P. H. Drenth, Michael A. Heneghan
Dátum:2020
ISSN:1542-3565 1542-7714
Megjegyzések:Background & Aims: Changes in serum levels of transaminases immediately after initiation of treatment for autoimmune hepatitis (AIH) might be associated with biochemical markers of remission and liver-related events. We assessed the outcomes of patients with vs without rapid responses to treatment of AIH in a large international cohort. Methods: We performed a retrospective cohort study, collecting data from 2 independent cohorts of adults with AIH from 12 centers in 7 countries in Europe. We collected information on patient demographics; serologic, histologic, and biochemical analyses; and treatment. We used a receiver operating characteristic curve and Youden index to calculate the optimal percentage decrease in level of aspartate aminotransferase (AST) after 8 weeks of treatment that associated with normalization of transaminase levels after 26 weeks of treatment with predniso(lo)ne (primary outcome) in the first (discovery) cohort (n = 370). We evaluated the results in the second (validation) cohort (n = 370). Secondary outcomes were liver-related death or transplantation. We performed univariate and multivariable logistic and Cox regression with correction for confounders. Results: A significant decrease in level of AST after 8 weeks of treatment was significantly associated with normalization of transaminase levels at 26 and 52 weeks ( P <.001); a decrease of more than 80% in level of AST was associated with optimal normalization. In both cohorts, rapid responders (?80% decrease in level of AST after 8 weeks) were more likely to achieve normalization of transaminases at 26 and 52 weeks when compared to non-rapid responders. Rapid responders in the discovery cohort had lower risk of liver-related death or transplantation (adjusted hazard ratio 0.18; 95% CI 0.05?0.63; P =.007), although this was not confirmed in the validation cohort. Results from measurement of alanine aminotransferase did not differ significantly from those of AST for the primary outcome. Slow responders (without normalization of transaminases after 1 year) had the highest risk of liver transplantation or liver-related death. Conclusions: In a retrospective study of patients with AIH, we found that a rapid response to treatment, based on level of AST after 8 weeks, associates with normalization of transaminase levels in the following year. Patients with a rapid response also have a lower risk of liver-related death or transplantation than patients without this rapid response.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Induction therapy,
prognostic factor,
liver enzyme,
Megjelenés:Clinical Gastroenterology and Hepatology. - 18 : 7 (2020), p. 1609-1617. -
További szerzők:Gevers, Tom J. G. Maarten Vrolijk, Jan Hoek, Bart van Bouma, Gerd Nieuwkerk, Carin M. J. van Taubert, Richard Jaeckel, Elmar Manns, Michael P. Papp Mária (1975-) (belgyógyász, gasztroenterológus) Sipeki Nóra (1987-) (általános orvos) Stickel, Felix Efe, Cumali Ozaslan, Ersan Purnak, Tugrul Nevens, Frederik Kessener, Dominik J. N. Kahraman, Alisan Wedemeyer, Heiner Hartl, Johannes Schramm, Christoph Lohse, Ansgar W. Drenth, Joost P. H. Heneghan, Michael A.
Internet cím:Intézményi repozitóriumban (DEA) tárolt változat
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4.

001-es BibID:BIBFORM077050
035-os BibID:(WoS)000482217300030 (Scopus)85065040027
Első szerző:Pape, Simon
Cím:Predniso(lo)ne Dosage and Chance of Remission in Patients With Autoimmune Hepatitis / Simon Pape, Tom J. G. Gevers, Michail Belias, Ilyas F. Mustafajev, Jan Maarten Vrolijk, Bart van Hoek, Gerd Bouma, Carin M. J. van Nieuwkerk, Johannes Hartl, Christoph Schramm, Ansgar W. Lohse, Richard Taubert, Elmar Jaeckel, Michael P. Manns, Maria Papp, Felix Stickel, Michael A. Heneghan, Joost P. H. Drenth
Dátum:2019
ISSN:1542-3565 1542-7714
Megjegyzések:BACKGROUND & AIMS: Patients with autoimmune hepatitis (AIH) commonly receive induction therapy with predniso(lo)ne followed by maintenance therapy with azathioprine. European Association for Study of the Liver clinical practice guidelines advise a predniso(lo)ne dose range of 0.50-1 mg/kg/day, which leaves room for practice variation. We performed a multicenter study to determine the efficacy of different dose ranges of predniso(lo)ne induction therapy in a large European cohort of patients with AIH. METHODS: We performed a retrospective cohort study using a comparative effectiveness design. We collected data from 451 adults with AIH who began treatment from 1978 through 2017 at 9 centers in 5 European countries. We assigned patients to a high-dose group (initial predniso(lo)ne dose ?0.50 mg/kg/day; n=281) or a low-dose group (<0.50 mg/kg/day; n=170). Logistic regression was performed to determine difference in outcomes between the groups. The primary outcome was normal serum levels of transaminases at 6 months after initiation of therapy. RESULTS: There was no significant difference in rates of normalization of transaminases between the high-dose predniso(lo)ne group and the low-dose group (70.5% vs 64.7%; P=.20). After multivariable logistic regression with correction for confounders, there was no difference in the likelihood of normalization of transaminases between the groups (odds ratio, 1.21; 95% CI, 0.78 - 1.87; P=.38). Patients given an initial high dose of predniso(lo)ne received more predniso(lo)ne over time than patients started on a lower dose (median doses over 6 months: 3780 mg vs 2573 mg) (P<.01). CONCLUSIONS: In a retrospective study of patients with AIH in Europe, we found that the dose of predniso(lo)ne to induce remission in patients with AIH is less relevant than assumed. An initial predniso(lo)ne dose below 0.50 mg/kg/day substantially decreases unnecessary exposure to predniso(lo)ne in patients with AIH.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
autoimmune hepatitis
EASL guidelines
ALT
AST
IgG
corticosteroid
induction therapy
cirrhosis
prednison
prednisolon
Megjelenés:Clinical Gastroenterology and Hepatology. - 17 : 10 (2019), p. 2068-2075.e2. -
További szerzők:Gevers, Tom J. G. Belias, Michail Mustafajev, Ilyas F. Vrolijk, Jan Maarten van Hoek, Bart Bouma, Gerd van Nieuwkerk, Carin M. J. Hartl, Johannes Schramm, Christoph Lohse, Ansgar W. Taubert, Richard Jaeckel, Elmar Manns, Michael P. Papp Mária (1975-) (belgyógyász, gasztroenterológus) Stickel, Felix Heneghan, Michael A. Drenth, Joost P. H.
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