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1. Seladelpar treatment reduces IL-31 and pruritus in patients with primary biliary cholangitis.

Author

Kremer, Andreas, Mayo, Marlyn, Hirschfield, Gideon, Levy, Cynthia, Bowlus, Christopher, Jones, David, Johnson, Jeff, McWherter, Charles, and Choi, Yun-Jung

Subjects
Humans, Pruritus, Interleukins, Female, Liver Cirrhosis, Biliary, Middle Aged, Male, Adult, Bile Acids and Salts, Aged, Double-Blind Method, PPAR delta, Azetidines, Methylamines, Thiazepines
Abstract

BACKGROUND AND AIMS: Pruritus is a debilitating symptom for many people living with primary biliary cholangitis (PBC). In studies with seladelpar, a selective peroxisome proliferator-activated receptor-delta agonist, patients with PBC experienced significant improvement in pruritus and reduction of serum bile acids. Interleukin-31 (IL-31) is a cytokine known to mediate pruritus, and blocking IL-31 signaling provides relief in pruritic skin diseases. This study examined the connection between seladelpars antipruritic effects and IL-31 and bile acid levels in patients with PBC. APPROACH AND RESULTS: IL-31 levels were quantified in serum samples from the ENHANCE study of patients with PBC receiving daily oral doses of placebo (n = 55), seladelpar 5 mg (n = 53) or 10 mg (n = 53) for 3 months, and for healthy volunteers (n = 55). IL-31 levels were compared with pruritus using a numerical rating scale (NRS, 0-10) and with bile acid levels. Baseline IL-31 levels closely correlated with pruritus NRS ( r = 0.54, p < 0.0001), and total ( r = 0.54, p < 0.0001) and conjugated bile acids (up to 0.64, p < 0.0001). Decreases in IL-31 were observed with seladelpar 5 mg (-30%, p = 0.0003) and 10 mg (-52%, p < 0.0001) versus placebo (+31%). Patients with clinically meaningful improvement in pruritus (NRS ≥ 2 decrease) demonstrated greater dose-dependent reductions in IL-31 compared to those without pruritus improvement (NRS < 2 decrease). Strong correlations were observed for the changes between levels of IL-31 and total bile acids ( r = 0.63, p < 0.0001) in the seladelpar 10 mg group. CONCLUSIONS: Seladelpar decreased serum IL-31 and bile acids in patients with PBC. The reductions of IL-31 and bile acids correlated closely with each other and pruritus improvement, suggesting a mechanism to explain seladelpars antipruritic effects.

Published
2024

3. Seladelpar efficacy and safety at 3 months in patients with primary biliary cholangitis: ENHANCE, a phase 3, randomized, placebo-controlled study.

Author

Hirschfield, Gideon M, 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, Ladrón de Guevara, Alma L, Mayo, Marlyn J, Dalekos, George N, Drenth, Joost PH, 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 EJ, Ryder, Stephen D, Swain, Mark G, Steinberg, Alexandra, Boudes, Pol F, Choi, Yun-Jung, McWherter, Charles A, and ENHANCE Study Group*

Subjects
ENHANCE Study Group*, Humans, Liver Cirrhosis, Biliary, Pruritus, Acetates, Ursodeoxycholic Acid, Alkaline Phosphatase, Cholagogues and Choleretics, Digestive Diseases, Liver Disease, Rare Diseases, Clinical Trials and Supportive Activities, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Medical Biochemistry and Metabolomics, Clinical Sciences, Immunology, Gastroenterology & Hepatology
Abstract

Background and aimsENHANCE was a phase 3 study that evaluated efficacy and safety of seladelpar, a selective peroxisome proliferator-activated receptor-δ (PPAR) agonist, versus placebo in patients with primary biliary cholangitis with inadequate response or intolerance to ursodeoxycholic acid (UDCA).Approach and resultsPatients 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%, 10 mg: 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.ConclusionsPatients 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.

Published
2023

4. Gut Pathobiont–Derived Outer Membrane Vesicles Drive Liver Inflammation and Fibrosis in Primary Sclerosing Cholangitis–Associated Inflammatory Bowel Disease

Author

Dorner, Heidrun, Stolzer, Iris, Mattner, Jochen, Kaminski, Sophie, Leistl, Sofia, Edrich, Lisa-Maria, Schwendner, Raphael, Hobauer, Julia, Sebald, Adrian, Leikam, Stefanie, Gonzalez Acera, Miguel, Düll, Miriam, Lang, Roland, Seidel, Gerald, Seitz, Tatjana, Hellerbrand, Claus, Fuhrmann, Gregor, Distler, Ute, Tenzer, Stefan, Eichhorn, Phillip, Vieth, Michael, Schramm, Christoph, Arnold, Philipp, Becker, Christoph, Weidinger, Carl, Siegmund, Britta, Atreya, Raja, Leppkes, Moritz, Naschberger, Elisabeth, Sampaziotis, Fotios, Dietrich, Peter, Rauh, Manfred, Wirtz, Stefan, Kremer, Andreas E., Neurath, Markus F., and Günther, Claudia

Published
2024
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5. Invasive aspergillosis in liver transplant recipients in the current era

Author

Kimura, Muneyoshi, Rinaldi, Matteo, Kothari, Sagar, Giannella, Maddalena, Anjan, Shweta, Natori, Yoichiro, Phoompoung, Pakpoom, Gault, Emily, Hand, Jonathan, D’Asaro, Matilde, Neofytos, Dionysios, Mueller, Nicolas J., Kremer, Andreas E., Rojko, Tereza, Ribnikar, Marija, Silveira, Fernanda P., Kohl, Joshua, Cano, Angela, Torre-Cisneros, Julian, San-Juan, Rafael, Aguado, Jose Maria, Mansoor, Armaghan-e-Rehman, George, Ige Abraham, Mularoni, Alessandra, Russelli, Giovanna, Luong, Me-Linh, AlJishi, Yamama A., AlJishi, Maram N., Hamandi, Bassem, Selzner, Nazia, and Husain, Shahid

Published
2024
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7. Ex vivo drug sensitivity screening predicts response to temozolomide in glioblastoma patients and identifies candidate biomarkers

Author

Ntafoulis, Ioannis, Kleijn, Anne, Ju, Jie, Jimenez-Cowell, Kevin, Fabro, Federica, Klein, Michelle, Chi Yen, Romain Tching, Balvers, Rutger K., Li, Yunlei, Stubbs, Andrew P., Kers, Trisha V., Kros, Johan M., Lawler, Sean E., Beerepoot, Laurens V., Kremer, Andreas, Idbaih, Ahmed, Verreault, Maite, Byrne, Annette T., O’Farrell, Alice C., Connor, Kate, Biswas, Archita, Salvucci, Manuela, Prehn, Jochen H. M., Lambrechts, Diether, Dilcan, Gonca, Lodi, Francesca, Arijs, Ingrid, van den Bent, Martin J., Dirven, Clemens M. F., Leenstra, Sieger, and Lamfers, Martine L. M.

Published
2023
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8. Rare HCV subtypes and retreatment outcomes in a cohort of European DAA-experienced patients

Author

Antoni, C., Teufel, A., Vogelmann, R., Ebert, M., Balavoine, J., Giostra, E., Berning, M., Hampe, J., Boettler, T., Neumann-Haefelin, C., Thimme, R., De Gottardi, A., Rauch, A., Semmo, N., Ellenrieder, V., Gress, M., Herrmann, A., Stallmach, A., Hoffmann, D., Protzer, U., Kodal, A., Löbermann, M., Götze, T., Keitel-Anselmino, V., Lange, C.M., Zachoval, R., Mayerle, J., Maieron, A., Michl, P., Merle, U., Moradpour, D., Chave, J.-P., Muche, M., Epple, H.-J., Müller-Schilling, M., Kocheise, F., Müller, T., Tacke, F., Roeb, E., Rissland, J., Krawczyk, M., Schulze, P., Semela, D., Spengler, U., Rockstroh, J., Strassburg, C.P., Siebler, J., Schulze zur Wiesch, J., Piecha, F., von Felden, J., Jordan, S., Lohse, A., Sprinzl, M., Galle, P., Stauber, R., Strey, B., Steckstor, W., Schmiegel, W., Brockmeyer, N.H., Canbay, A., Trautwein, C., Uschner, F., Trebicka, J., Weber, T., Wedemeyer, H., Cornberg, M., Manns, M., Wietzke-Braun, P., Günther, R., Willuweit, K., Hilgard, G., Schmidt, H., Zizer, E., Backhus, J., Seufferlein, T., Al-Taie, O., Angeli, W., Beckebaum, S., Erhardt, A., Garrido-Lüneburg, A., Gattringer, H., Genné, D., Gschwantler, M., Gundling, F., Hametner, S., Schöfl, R., Haag, S., Heinzow, H., Heyer, T., Hirschi, C., Jussios, A., Kanzler, S., Kordecki, N., Kraus, M., Kullig, U., Wollschläger, S., Magenta, L., Beretta-Piccoli, B. Terziroli, Menges, M., Mohr, L., Muehlenberg, K., Niederau, C., Paulweber, B., Petrides, A., Pinkernell, M., Piso, R., Rambach, W., Reinhardt, L., Reiser, M., Riecken, B., Rieke, A., Roth, J., Schelling, M., Schlee, P., Schneider, A., Scholz, D., Schott, E., Schuchmann, M., Schulten-Baumer, U., Seelhoff, A., Stich, A., Stickel, F., Ungemach, J., Walter, E., Weber, A., Wege, H., Winzer, T., Abels, W., Adler, M., Audebert, F., Baermann, C., Bästlein, E., Barth, R., Barthel, K., Becker, W., Behrends, J., Benninger, J., Berger, F., Berzow, D., Beyer, T., Bierbaum, M., Blaukat, O., Bodtländer, A., Böhm, G., Börner, N., Bohr, U., Bokemeyer, B., Bruch, H.R., Bucholz, D., Buggisch, P., Matschenz, K., Petersen, J., Burkhard, O., Busch, N., Chirca, C., Delker, R., Diedrich, J., Frank, M., Diehl, M., Tal, A.O., Schneider, M., Dienethal, A., Dietel, P., Dikopoulos, N., Dreck, M., Dreher, F., Drude, L., Ende, K., Ehrle, U., Baumgartl, K., Emke, F., Glosemeyer, R., Felten, G., Hüppe, D., Fischer, J., Fischer, U., Frederking, D., Frick, B., Friese, G., Gantke, B., Geyer, P., Schwind, H.R., Glas, M., Glaunsinger, T., Goebel, F., Göbel, U., Görlitz, B., Graf, R., Gruber, H., Hartmann, C., Klag, C., Härter, G., Herder, M., Heuchel, T., Heuer, S., Hinrichsen, H., Seegers, B., Höffl, K.-H., Hörster, H., Sonne, J.-U., Hofmann, W.P., Holst, F., Hunstiger, M., Hurst, A., Jägel-Guedes, E., John, C., Jung, M., Kallinowski, B., Kapzan, B., Kerzel, W., Khaykin, P., Klarhof, M., Klüppelberg, U., Wolfratshausen, Klugewitz, K., Knapp, B., Knevels, U., Kochsiek, T., Körfer, A., Köster, A., Kuhn, M., Langekamp, A., Künzig, B., Link, R., Littman, M., Löhr, H., Lutz, T., Gute, P., Knecht, G., Lutz, U., Mainz, D., Mahle, I., Maurer, P., Mauss, S., Mayer, C., Möller, H., Heyne, R., Moritzen, D., Mroß, M., Mundlos, M., Naumann, U., Nehls, O., K, Ningel, R., Oelmann, A., Olejnik, H., Gadow, K., Pascher, E., Philipp, A., Pichler, M., Polzien, F., Raddant, R., Riedel, M., Rietzler, S., Rössle, M., Rufle, W., Rump, A., Schewe, C., Hoffmann, C., Schleehauf, D., Schmidt, W., Schmidt-Heinevetter, G., Fabris, J. Schmidtler-von, Schneider, L., Schober, A., Niehaus-Hahn, S., Schwenzer, J., Seidel, T., Seitel, G., Sick, C., Simon, K., Stähler, D., Stenschke, F., Steffens, H., Stein, K., Steinmüller, M., Sternfeld, T., Svensson, K., Tacke, W., Teuber, G., Teubner, K., Thieringer, J., Tomesch, A., Trappe, U., Ullrich, J., Urban, G., Usadel, S., von Lucadou, A., Weinberger, F., Werheid-Dobers, M., Werner, P., Winter, T., Zehnter, E., Zipf, A., Dietz, Julia, Graf, Christiana, Berg, Christoph P., Port, Kerstin, Deterding, Katja, Buggisch, Peter, Peiffer, Kai-Henrik, Vermehren, Johannes, Dultz, Georg, Geier, Andreas, Reiter, Florian P., Bruns, Tony, Schattenberg, Jörn M., Durmashkina, Elena, Gustot, Thierry, Moreno, Christophe, Trauth, Janina, Discher, Thomas, Fischer, Janett, Berg, Thomas, Kremer, Andreas E., Müllhaupt, Beat, Zeuzem, Stefan, and Sarrazin, Christoph

Published
2024
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10. Comparative analysis of deeply phenotyped GBM cohorts of ‘short-term’ and ‘long-term’ survivors

Author

Biswas, Archita, Salvucci, Manuela, Connor, Kate, Düssmann, Heiko, Carberry, Steven, Fichtner, Michael, King, Ellen, Murphy, Brona, O’Farrell, Alice C., Cryan, Jane, Beausang, Alan, Heffernan, Josephine, Cremona, Mattia, Hennessy, Bryan T., Clerkin, James, Sweeney, Kieron J., MacNally, Steve, Brett, Francesca, O’Halloran, Philip, Bacon, Orna, Furney, Simon, Verreault, Maite, Quissac, Emie, Bielle, Franck, Ahmed, Mohammed H., Idbaih, Ahmed, Leenstra, Sieger, Ntafoulis, Ioannis, Fabro, Federica, Lamfers, Martine, Golebiewska, Anna, Hertel, Frank, Niclou, Simone P., Yen, Romain Tching Chi, Kremer, Andreas, Dilcan, Gonca, Lodi, Francesca, Arijs, Ingrid, Lambrechts, Diether, Purushothama, Manasa Kalya, Kel, Alexander, Byrne, Annette T., and Prehn, Jochen H.M.

Published
2023
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11. Dynamics of Liver Stiffness Measurement and Clinical Course of Primary Biliary Cholangitis

Author

Lam, Laurent, Soret, Pierre-Antoine, Lemoinne, Sara, Hansen, Bettina, Hirschfield, Gideon, Gulamhusein, Aliya, Montano-Loza, Aldo J., Lytvyak, Ellina, Parés, Albert, Olivas, Ignasi, Londono, Maria-Carlota, Rodríguez-Tajes, Sergio, Eaton, John E., Osman, Karim T., Schramm, Christoph, Sebode, Marcial, Lohse, Ansgar W., Dalekos, George, Gatselis, Nikolaos, Nevens, Frederik, Cazzagon, Nora, Zago, Alessandra, Russo, Francesco Paolo, Floreani, Annarosa, Abbas, Nadir, Trivedi, Palak, Thorburn, Douglas, Saffioti, Francesca, Barkai, Laszlo, Roccarina, Davide, Calvaruso, Vicenza, Fichera, Anna, Delamarre, Adèle, Sobenko, Natalia, Villamil, Alejandra Maria, Medina-Morales, Esli, Bonder, Alan, Patwardhan, Vilas, Rigamonti, Cristina, Carbone, Marco, Invernizzi, Pietro, Cristoferi, Laura, van der Meer, Adriaan, de Veer, Rozanne, Zigmond, Ehud, Yehezkel, Eyal, Kremer, Andreas E., Deibel, Ansgar, Bruns, Tony, Große, Karsten, Wetten, Aaron, Dyson, Jessica Katharine, Jones, David, Levy, Cynthia, Tanaka, Atsushi, Dumortier, Jérôme, Pageaux, Georges-Philippe, de Lédinghen, Victor, Carrat, Fabrice, Chazouillères, Olivier, and Corpechot, Christophe

Published
2024
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12. Current state-of-the-art and gaps in platform trials: 10 things you should know, insights from EU-PEARL

Author

Sánchez-Montalva, Adrian, Estevez, Ana Belén, Sánchez, Àlex, Sanjuan, Anna, Sena, Elena, Granados, Emma, Arévalo de Andrés, Esther, Nuñez, Fátima, Arteaga, Gara, Fuentes Ruiz, Gabriela Perez, Fernández, Guillermo, Rivera-Esteban, Jesus, Comella, Joan, Ramos-Quiroga, Josep Antoni, Genescà, Joan, Espinosa, Juan, Pericàs, Juan Manuel, Murcia, Lada, Cash-Gibson, Lucinda, de Valles Silvosa, Maria, Barroso de Sousa, María Fernanda, Sánchez-Maroto Carrizo, Olga, Ibañez-Jiménez, Pol, Augustin, Salvador, Perez-Hoyos, Santiago, Rodríguez-Navarro, Sarai, Muñoz-Martínez, Sergio, Serres, Silvia, Kalko, Susana, Michon, Amelie, Ussi, Anton, Lydall, Ben, van de Ketterij, Edwin, Quiles, Ignacio, Carapina, Tamara, Kumaus, Constantin, Ramazanova, Dariga, Meyer, Elias Laurin, Koenig, Franz, Roig, Marta Bofill, Brunner, Martin, Posch, Martin, Krotka, Pavla, Zehetmayer, Sonja, Carton, Charlotte, Legius, Eric, Begum, Amina, Pariante, Carmine, Worrell, Courtney, Lombardo, Giulia, Sforzini, Luca, Brown, Mollie, Gullet, Nancy, Amasi-Hartoonian, Nare, Ferner, Rosalie, Kose, Melisa, Spitaleri, Andrea, Ghodousi, Arash, Di Serio, Clelia, Cirillo, Daniela, Cugnata, Federica, Saluzzo, Francesca, Benedetti, Francesco, Scarale, Maria Giovanna, Zini, Michela, Rancoita, Paola Maria, Alagna, Riccardo, Poletti, Sara, Dhaenens, Britt, Van Der Lei, Johan, de Steenwinkel, Jurriaan, Moinat, Maxim, Oostenbrink, Rianne, Hoogendijk, Witte, Hölscher, Michael, Heinrich, Norbert, Otte, Christian, Potratz, Cornelia, Zocholl, Dario, Kulakova, Eugenia, Tacke, Frank, Brasanac, Jelena, Leubner, Jonas, Krajewska, Maja, Freitag, Michaela Maria, Gold, Stefan, Zoller, Thomas, Chae, Woo Ri, Daniel, Christel, Kara, Leila, Vaterkowski, Morgan, Griffon, Nicolas, Wolkenstein, Pierre, Pais, Raluca, Ratziu, Vlad, Voets, David, Maes, Christophe, Kalra, Dipak, Thienpoint, Geert, Deckerck, Jens, Lea, Nathan, Singleton, Peter, Viele, Kert, Jacko, Peter, Berry, Scott, Parke, Tom, Aydin, Burç, Kubiak, Christine, Demotes, Jacques, Ueda, Keiko, Matei, Mihaela, Contrino, Sergio, Röhl, Claas, Cordero, Estefania, Greenhalgh, Fiona, Jarke, Hannes, Angelova, Juliana, Boudes, Mathieu, Dressler, Stephan, Strammiello, Valentina, Anstee, Quentin, Gutierrez-Ibarluzea, Iñaki, Otte, Maximilian, Heimbach, Natalie, Hofner, Benjamin, Burgwinkel, Cora, Kaestel, Hue, Hees, Katharina, Nguyen, Quynh, Prieto-Alhambra, Daniel, Tan, Eng Hooi (Cheryl), Raviglione, Mario, de Colombani, Pierpaolo, Villa, Simone, Maron, Eduard, Evans, Gareth, Savitz, Adam J., Van Dessel, Ann, Duca, Anna, Kaminski, Anne, Wouters, Bie, Porter, Brandon, Charron, Catherine, Spiertz, Cecile, Zizzamia, Christopher, Millar, Daniel, Hasselbaink, Danny, Orr, David, Kesters, Divya, Hubin, Ellen, Davies, Emma, Didden, Eva-Maria, Guz, Gabriela, Verstraete, Evelyn, Mao, Gary, Capuano, George, Martynowicz, Heddie, De Smedt, Heidi, Larsson, Ingela, Bruegelmans, Ines, Coste, Isabelle, Gonzalez Moreno, Jesus Maria, Niewczas, Julia, Xu, Jiajun, Rombouts, Karin, Woo, Katherine, Wuyts, Kathleen, Hersh, Kathryn, Oldenburg, Khrista, Zhang, Lingjiao, Schmidt, Mark, Szuch, Mark, Todorovic, Marija, Mangelaars, Maartje, Grewal, Melissa, Sandor, Molli, Di Prospero, Nick, Van Houten, Pamela, Minnick, Pansy, Bastos, Polyana, Patrizi, Robert, Morello, Salvatore, De Wilde, Severijn, Sun, Tao, Kline, Timothy, de Marez, Tine, Mielke, Tobias, Reijns, Tom, Popova, Vanina, Flossbach, Yanina, Tymofyeyev, Yevgen, De Groote, Zeger, Sverdlov, Alex, Bobirca, Alexandra, Krause, Annekatrin, Bobrica, Catalin, Heintz, Daniela, Magirr, Dominic, Glimm, Ekkehard, Baffert, Fabienne, Castiglione, Federica, Caruso, Franca, Patalano, Francesco, Bretz, Frank, Heimann, Guenter, Carbarns, Ian, Rodríguez, Ignacio, Ratescu, Ioana, Hampson, Lisa, Pedrosa, Marcos, Hark, Mareile, Mesenbrink, Peter, Penna, Sabina Hernandez, Bergues-Lang, Sarah, Baltes-Engler, Susanne, Arsiwala, Tasneem, Mondragon, Valeria Jordan, Guo, Hua, Da Costa, Jose Leite, Burman, Carl-Fredrik, Kirk, George, Aaes-Jørgensen, Anders, Dirach, Jorgen, Kjær, Mette Skalshøi, Martin, Alexandra, Hristov, Diyan, Rousseaux, Florent, Hittel, Norbert, Dornheim, Robert, Evans, Daniel, Sykes, Nick, Couvert, Camille, Leuven, Catherine, Notelet, Loïc, Gidh-Jain, Madhavi, Jouannin, Mathieu, Ammour, Nadir, Pierre, Suzanne, Haufe, Volker, Dong, Yingwen, Dubanchet, Catherine, de Préville, Nathalie, Baltauss, Tania, Jian, Zhu, Shnider, Sara, Bar-El, Tal, Bakker, Annette, Nievo, Marco, Iloeje, Uche, Conradie, Almari, Auffarrth, Ece, Lombard, Leandra, Benhayoun, Majda, Olugbosi, Morounfolu, Seidel, Stephanie S., Gumí, Berta, Guzmán, Claudia García, Molero, Eva, Pairó, Gisela, Machin, Núria, Cardelús, Raimon, Ramasastry, Saira, Pelzer, Saskia, Kremer, Andreas, Lindfors, Erno, Lynch, Chris, Spiertz, Cécile, Machín, Núria, and Pericàs, Juan M.

Published
2024
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16. Effects of Vedolizumab in Patients With Primary Sclerosing Cholangitis and Inflammatory Bowel Diseases

Author

Lynch, Kate D, Chapman, Roger W, Keshav, Satish, Montano-Loza, Aldo J, Mason, Andrew L, Kremer, Andreas E, Vetter, Marcel, de Krijger, Manon, Ponsioen, Cyriel Y, Trivedi, Palak, Hirschfield, Gideon, Schramm, Christoph, Liu, Chung Heng, Bowlus, Christopher L, Estes, Derek J, Pratt, Daniel, Hedin, Charlotte, Bergquist, Annika, de Vries, Annemarie C, van der Woude, C Janneke, Yu, Lei, Assis, David N, Boyer, James, Ytting, Henriette, Hallibasic, Emina, Trauner, Michael, Marschall, Hanns-Ulrich, Daretti, Luigi M, Marzioni, Marco, Yimam, Kidist K, Perin, Nicola, Floreani, Annarosa, Beretta-Piccoli, Benedetta Terziroli, Rogers, Jennifer K, Group, International Primary Sclerosing Cholangitis Study, and Levy, Cynthia

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Digestive Diseases - (Gallbladder), Liver Disease, Digestive Diseases, Inflammatory Bowel Disease, Autoimmune Disease, Chronic Liver Disease and Cirrhosis, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Oral and gastrointestinal, Adolescent, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Humanized, Child, Cholangitis, Sclerosing, Gastrointestinal Agents, Humans, Inflammatory Bowel Diseases, Integrins, Liver Function Tests, Middle Aged, Retrospective Studies, Young Adult, Cholestatic Liver Disease, Ulcerative Colitis, Crohn's Disease, Integrin alpha4beta7, International Primary Sclerosing Cholangitis Study Group, Crohn’s Disease, Gastroenterology & Hepatology, Clinical sciences
Abstract

Background & aimsGut-homing lymphocytes that express the integrin α4β7 and CCR9 might contribute to development of primary sclerosing cholangitis (PSC). Vedolizumab, which blocks the integrin α4β7, is used to treat patients with inflammatory bowel diseases (IBD), but there are few data on its efficacy in patients with PSC. We investigated the effects of vedolizumab in a large international cohort of patients with PSC and IBD.MethodsWe collected data from European and North American centers participating in the International PSC Study Group from patients with PSC and IBD who received at least 3 doses of vedolizumab (n = 102; median vedolizumab treatment duration, 412 days). Demographic and clinical data were collected from baseline and during the follow-up period (until liver transplantation, death, or 56 days after the final vedolizumab infusion). We analyzed overall changes in biochemical features of liver and proportions of patients with reductions in serum levels of alkaline phosphatase (ALP) of 20% or more, from baseline through last follow-up evaluation. Other endpoints included response of IBD to treatment (improved, unchanged, or worsened, judged by the treating clinician, as well as endoscopic score) and liver-related outcomes.ResultsIn the entire cohort, the median serum level of ALP increased from 1.54-fold the upper limit of normal at baseline to 1.64-fold the upper limit of normal at the last follow-up examination (P = .018); serum levels of transaminases and bilirubin also increased by a small amount between baseline and the last follow-up examination. Serum levels of ALP decreased by 20% or more in 21 patients (20.6%); only the presence of cirrhosis (odds ratio, 4.48; P = .019) was independently associated with this outcome. Of patients with available endoscopic data, 56.8% had a response of IBD to treatment. Liver-related events occurred in 21 patients (20.6%), including bacterial cholangitis, cirrhosis decompensation, or transplantation.ConclusionsIn an analysis of patients with PSC and IBD in an international study group, we found no evidence for a biochemical response to vedolizumab, although serum level of ALP decreased by 20% or more in a subset of patients. Vedolizumab appears to be well tolerated and the overall response of IBD was the same as expected for patients without PSC.

Published
2020

17. Efficacy and safety of immune checkpoint inhibitor rechallenge in individuals with hepatocellular carcinoma

Author

Scheiner, Bernhard, Roessler, Daniel, Phen, Samuel, Lim, Mir, Pomej, Katharina, Pressiani, Tiziana, Cammarota, Antonella, Fründt, Thorben W., von Felden, Johann, Schulze, Kornelius, Himmelsbach, Vera, Finkelmeier, Fabian, Deibel, Ansgar, Siebenhüner, Alexander R., Shmanko, Kateryna, Radu, Pompilia, Schwacha-Eipper, Birgit, Ebert, Matthias P., Teufel, Andreas, Djanani, Angela, Hucke, Florian, Balcar, Lorenz, Philipp, Alexander B., Hsiehchen, David, Venerito, Marino, Sinner, Friedrich, Trauner, Michael, D'Alessio, Antonio, Fulgenzi, Claudia A.M., Pinato, David J., Peck-Radosavljevic, Markus, Dufour, Jean-François, Weinmann, Arndt, Kremer, Andreas E., Singal, Amit G., De Toni, Enrico N., Rimassa, Lorenza, and Pinter, Matthias

Published
2023
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19. LBP-040 Long-term efficacy and safety of open-label seladelpar treatment in patients with primary biliary cholangitis (PBC): interimresults for 2 years from the ASSURE study

Author

Trivedi, Palak J., primary, Levy, Cynthia, additional, Kowdley, Kris V., additional, Gordon, Stuart C., additional, Bowlus, Christopher L., additional, Londoño, María Carlota, additional, Hirschfield, Gideon M., additional, Gulamhusein, Aliya, additional, Lawitz, Eric, additional, Villamil, Alejandra, additional, Ladrón de Guevara, Alma Laura, additional, Mayo, Marlyn J., additional, Younes, Ziad H., additional, Shibolet, Oren, additional, Yimam, Kidist, additional, Pratt, Daniel, additional, Heo, Jeong, additional, Morgera, Ulrike, additional, Andreone, Pietro, additional, Kremer, Andreas E., additional, Corpechot, Christophe, additional, Goel, Aparna, additional, Peyton, Adam, additional, Elbeshbeshy, Hany, additional, Crittenden, Daria B., additional, Heusner, Carrie, additional, Proehl, Sarah, additional, Zhou, Shuqiong, additional, and McWherter, Charles A., additional

Published
2024
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20. THU-457 Outcome of liver transplantation in patients with hepatocellular carcinoma previously treated with immune checkpoint inhibitorbased therapy-first results from an international multicenter registry

Author

Bauer, Ulrike, primary, Ben Khaled, Najib, additional, Grottenthaler, Julia M., additional, Foerster, Friedrich, additional, Blümel, Sena, additional, Heinrich, Sophia, additional, Sinner, Friedrich, additional, Venerito, Marino, additional, Taubert, Richard, additional, Kremer, Andreas E., additional, Weinmann, Arndt, additional, Berg, Christoph P., additional, Lange, Christian M., additional, de Toni, Enrico, additional, Schmid, Roland M., additional, and Ehmer, Ursula, additional

Published
2024
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21. WED-135-YI Impact of metabolic alterations on liver phenotype of patients with homozygous alpha-1 antitrypsin deficiency (Pi*ZZ)

Author

Schrader, Christina, primary, Fromme, Malin, additional, Payancé, Audrey, additional, Mandorfer, Mattias, additional, Thorhauge, Katrine, additional, Pons, Monica, additional, Miravitlles, Marc, additional, Stolk, Jan, additional, van Hoek, Bart, additional, Stirnimann, Guido, additional, Fraňková, Soňa, additional, Sperl, Jan, additional, Kremer, Andreas E., additional, Balcar, Lorenz, additional, Schaefer, Benedikt, additional, Chorostowska-Wynimko, Joanna, additional, Trautwein, Christian, additional, Zoller, Heinz, additional, Trauner, Michael, additional, Genesca, Joan, additional, Griffiths, William J.H., additional, Clark, Virginia C., additional, Krag, Aleksander, additional, McElvaney, Noel G., additional, Turner, Alice, additional, and Strnad, Pavel, additional

Published
2024
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22. TOP-140 Evolution of clinical presentation, treatment and prognosis of patients with alveolar echinococcosis treated at the university hospital Zurich: a 50-year experience

Author

Deibel, Ansgar, primary, Kindler, Yannick, additional, Mita, Rubens, additional, Ghafoor, Soleen, additional, Schwabedissen, Cordula Meyer zu, additional, Schweiger, Alexander, additional, Grimm, Felix, additional, Reinehr, Michael, additional, Weber, Achim, additional, Reiner, Cäcilia, additional, Kremer, Andreas E., additional, Petrowsky, Henrik, additional, Clavien, Pierre-Alain, additional, Deplazes, Peter, additional, von Felten, Stefanie, additional, and Mullhaupt, Beat, additional

Published
2024
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24. TOP-141 Longitudinal assessment of individuals with homozygous alpha-1 antitrypsin deficiency (Pi*ZZ genotype) provides evidence for clinical patient management

Author

Fromme, Malin, primary, Payancé, Audrey, additional, Mandorfer, Mattias, additional, Thorhauge, Katrine, additional, Pons, Monica, additional, Miravitlles, Marc, additional, Stolk, Jan, additional, van Hoek, Bart, additional, Stirnimann, Guido, additional, Fraňková, Soňa, additional, Sperl, Jan, additional, Kremer, Andreas E., additional, Schrader, Christina, additional, Balcar, Lorenz, additional, Schaefer, Benedikt, additional, Chorostowska-Wynimko, Joanna, additional, Ryan, John, additional, Trautwein, Christian, additional, Zoller, Heinz, additional, Trauner, Michael, additional, Genesca, Joan, additional, Griffiths, William J.H., additional, Clark, Virginia C., additional, Krag, Aleksander, additional, Turner, Alice, additional, McElvaney, Noel G., additional, and Strnad, Pavel, additional

Published
2024
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25. THU-098 Appraising gain of an extended 2-year placebo-controlled trial in primary biliary cholangitis: challenges for evaluating clinical outcomes

Author

Hansen, Bettina E., primary, Hirschfield, Gideon M., additional, Perez, Carla Fiorella Murillo, additional, McWherter, Charles A., additional, Dickinson, Klara, additional, Mason, Andrew L., additional, Montano-Loza, Aldo J, additional, Lytvyak, Ellina, additional, Dalekos, George, additional, Gatselis, Nikolaos, additional, Nevens, Frederik, additional, Cazzagon, Nora, additional, Levy, Cynthia, additional, Abbas, Nadir, additional, Trivedi, Palak, additional, Thorburn, Douglas, additional, Bonder, Alan, additional, Patwardhan, Vilas, additional, Londoño, María Carlota, additional, Carbone, Marco, additional, Cristoferi, Laura, additional, van der Meer, Adriaan J., additional, de Veer, Rozanne C., additional, Tanaka, Atsushi, additional, Janssen, Harry L.A., additional, Zigmond, Ehud, additional, Yehezkel, Eyal, additional, Kremer, Andreas E., additional, Deibel, Ansgar, additional, Bruns, Tony, additional, Große, Karsten, additional, Kowdley, Kris V., additional, Lleo, Ana, additional, Mayo, Marlyn J., additional, Verhelst, Xavier, additional, and Corpechot, Christophe, additional

Published
2024
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26. LBP-028 Effect of elafibranor on pruritus in primary biliary cholangitis: symptom severity and quality of life measurements from the phase III ELATIVE® trial

Author

Kremer, Andreas E., primary, Kowdley, Kris V., additional, Levy, Cynthia, additional, J. Mayo, Marlyn, additional, Schattenberg, Jörn M., additional, Antunes, Nuno, additional, Böing, Elaine, additional, Tonev, Dimitar, additional, Touati, Nathan, additional, and Jones, David, additional

Published
2024
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29. SAT-021 Recurrence of autoimmune hepatitis cholestatic variant syndromes after liver transplantation affects graft and patient survival in an international multicentre cohort

Author

Ronca, Vincenzo, primary, Parente, Alessandro, additional, Lytvyak, Ellina, additional, Hansen, Bettina, additional, Hirschfield, Gideon M., additional, Bonder, Alan, additional, Ebadi, Maryam, additional, Elwir, Saleh, additional, Alsaed, Mohamad, additional, Milkiewicz, Piotr, additional, Janik, Maciej, additional, Marschall, Hanns-Ulrich, additional, Burza, Maria Antonella, additional, Efe, Cumali, additional, Caliskan, Ali Riza, additional, Harputluoglu, Murat, additional, Kabaçam, Gökhan, additional, Terrabuio, Debora Raquel, additional, Onofrio, Fernanda, additional, Selzner, Nazia, additional, Pares, Albert, additional, Llovet, Laura Patricia, additional, Akyildiz, Murat, additional, Arıkan, Cigdem, additional, Manns, Michael P., additional, Taubert, Richard, additional, Weber, Anna-Lena, additional, Schiano, Thomas, additional, Haydel, Brandy, additional, Czubkowski, Piotr, additional, Socha, Piotr, additional, Ołdak, Natalia, additional, Akamatsu, Nobuhisa, additional, Tanaka, Atsushi, additional, Levy, Cynthia, additional, Martin, Eric F., additional, Goel, Aparna, additional, Sedki, Mai, additional, Jankowska, Irena, additional, Ikegami, Toru, additional, Rodriguez, Maria, additional, Sterneck, Martina, additional, Weiler-Normann, Christina, additional, Schramm, Christoph, additional, Donato, Maria Francesca, additional, Lohse, Ansgar W., additional, Andrade, Raul J., additional, Patwardhan, Vilas, additional, van Hoek, Bart, additional, Biewenga, Maaike, additional, Kremer, Andreas, additional, Ueda, Yoshihide, additional, Deneau, Mark, additional, Pedersen, Mark, additional, Mayo, Marlyn J., additional, Floreani, Annarosa, additional, Burra, Patrizia, additional, Secchi, Maria Francesca, additional, Terziroli, Benedetta, additional, Sciveres, Marco, additional, Maggiore, Giuseppe, additional, Jafri, Syed-Mohammed, additional, Debray, Dominique, additional, Girard, Muriel, additional, Lacaille, Florence, additional, Heneghan, Michael, additional, Mason, Andrew L., additional, Oo, Ye Htun, additional, and Montano-Loza, Aldo J., additional

Published
2024
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30. Liver stiffness measurement by vibration-controlled transient elastography improves outcome prediction in primary biliary cholangitis

Author

Corpechot, Christophe, Carrat, Fabrice, Gaouar, Farid, Chau, Frederic, Hirschfield, Gideon, Gulamhusein, Aliya, Montano-Loza, Aldo J., Lytvyak, Ellina, Schramm, Christoph, Pares, Albert, Olivas, Ignasi, Eaton, John E., Osman, Karim T., Dalekos, George, Gatselis, Nikolaos, Nevens, Frederik, Cazzagon, Nora, Zago, Alessandra, Russo, Francesco Paolo, Abbas, Nadir, Trivedi, Palak, Thorburn, Douglas, Saffioti, Francesca, Barkai, Laszlo, Roccarina, Davide, Calvaruso, Vicenza, Fichera, Anna, Delamarre, Adèle, Medina-Morales, Esli, Bonder, Alan, Patwardhan, Vilas, Rigamonti, Cristina, Carbone, Marco, Invernizzi, Pietro, Cristoferi, Laura, van der Meer, Adriaan, de Veer, Rozanne, Zigmond, Ehud, Yehezkel, Eyal, Kremer, Andreas E., Deibel, Ansgar, Dumortier, Jérôme, Bruns, Tony, Große, Karsten, Pageaux, Georges-Philippe, Wetten, Aaron, Dyson, Jessica, Jones, David, Chazouillères, Olivier, Hansen, Bettina, and de Lédinghen, Victor

Published
2022
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35. Serum bile acid change correlates with improvement in pruritus in patients with primary biliary cholangitis receiving linerixibat.

Author

Karatza, Eleni, Swift, Brandon, Carreño, Fernando, Mukherjee, Sumanta, Casillas, Linda, Lennie, Janelle, Fettiplace, James, McLaughlin, Megan M., and Kremer, Andreas E.

Subjects
BILE salts, BILE acids, ITCHING, LIVER diseases, CHOLANGITIS
Abstract

Background & Aims: Total serum bile acid (TSBA) levels are elevated in patients with primary biliary cholangitis (PBC) and may mediate cholestatic pruritus. Linerixibat, an ileal bile acid transporter inhibitor, improved pruritus in patients with PBC. We explored the relationship between linerixibat dose, TSBA concentration, and pruritus. Methods: Data from Phase 1/2 trials were used to develop a population kinetic‐pharmacodynamic model to characterize the linerixibat dose–TSBA relationship. Individual Bayesian parameter estimates for participants in the GLIMMER study were used to derive the area under the TSBA concentration curve over 24 h (AUC0–24). Time‐matched post hoc estimates of AUC0–24 were correlated with pruritus reported on a 0–10 numerical rating scale. Baseline TSBA concentration was correlated with change from baseline (ΔBL) in monthly itch score (MIS). ΔBL in model‐estimated TSBA AUC0–24 was correlated with time‐matched ΔBL in weekly itch score (WIS) or MIS. Results: Linerixibat dose dependently reduced TSBA AUC0–24, reaching steady state after 5 days. Baseline TSBA levels in GLIMMER did not correlate with ΔBL in MIS. ΔBL in TSBA AUC0–24 correlated with improved WIS over 12 weeks of treatment (r = 0.52, p < 0.0001). Of participants with a ≥30% decrease in TSBA AUC0–24, 60% were pruritus responders (≥2‐point improvement in WIS from baseline). Conclusions: Linerixibat treatment leads to rapid, dose‐dependent TSBA reductions. Baseline TSBA levels do not correlate with on‐treatment pruritus change, suggesting they do not predict linerixibat response. Change in TSBA AUC0–24 correlates significantly with, and can be predictive of, pruritus improvement in patients with PBC. [ABSTRACT FROM AUTHOR]

Published
2024
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36. Long-term surveillance of gastric varices after cyanoacrylate injection in patients with non-cirrhotic portal hypertension: is it worth the effort?

Author

Morell, Bernhard, Murray, Fritz Ruprecht, Gubler, Christoph, Schlag, Christoph, Kremer, Andreas E., and Deibel, Ansgar

Subjects
PATIENT portals, GASTRIC varices, HEPATIC fibrosis, ENDOSCOPIC ultrasonography, ESOPHAGEAL varices, GASTROINTESTINAL hemorrhage
Abstract

This document provides a summary of a study on the long-term surveillance of gastric varices (GV) in patients with non-cirrhotic portal hypertension (NCPH). The study found that repeat secondary prophylactic interventions for GV rarely occur beyond four years, and rebleeding can still occur despite endoscopic ultrasound (EUS) surveillance and treatment. However, late rebleeding may have a good prognosis. The study suggests that larger prospective cohorts would be valuable to confirm these findings. The document also includes supplementary materials related to the article and information about conflicts of interest and funding. [Extracted from the article]

Published
2024
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38. Efficacy and safety of baricitinib for the treatment of hospitalised adults with COVID-19 (COV-BARRIER): a randomised, double-blind, parallel-group, placebo-controlled phase 3 trial

Author

Ahn, Mi-Young, Akasbi, Miriam, Alatorre-Alexander, Jorge, Altclas, Javier David, Ariel, Federico, Ariza, Horacio Alberto, Atkar, Chandrasekhar, Bertetti, Anselmo, Bhattacharya, Meenakshi, Briones, Maria Luisa, Budhraja, Akshay, Burza, Aaliya, Camacho Ortiz, Adrian, Caricchio, Roberto, Casas, Marcelo, Cevoli Recio, Valeria, Choi, Won Suk, Cohen, Emilia, Comulada-Rivera, Angel, Cook, Paul, Cornejo Juarez, Dora Patricia, Daniel, Carnevali, Degrecci Relvas, Luiz Fernando, Dominguez Cherit, Jose Guillermo, Ellerin, Todd, Enikeev, Dmitry, Erico Tanni Minamoto, Suzana, Estrada, Vicente, Fiss, Elie, Furuichi, Motohiko, Giovanni Luz, Kleber, Goldman, Jason D., Gonzalez, Omar, Gordeev, Ivan, Gruenewald, Thomas, Hamamoto Sato, Victor Augusto, Heo, Eun Young, Heo, Jung Yeon, Hermida, Maria, Hirai, Yuji, Hutchinson, David, Iastrebner, Claudio, Ioachimescu, Octavian, Jain, Manish, Juliani Souza Lima, Maria Patelli, Khan, Akram, Kremer, Andreas E., Lawrie, Thomas, MacElwee, Mark, Madhani-Lovely, Farah, Malhotra, Vinay, Martínez Resendez, Michel Fernando, McKinnell, James, Milligan, Patrick, Minelli, Cesar, Moran Rodriguez, Miguel Angel, Parody, Maria Leonor, Paulin, Priscila, Pellegrini, Rita de Cassia, Pemu, Priscilla, Procopio Carvalho, Ana Carolina, Puoti, Massimo, Purow, Joshua, Ramesh, Mayur, Rea Neto, Alvaro, Robinson, Philip, Rodrigues, Cristhieni, Rojas Velasco, Gustavo, Saraiva, Jose Francisco Kerr, Scheinberg, Morton, Schreiber, Stefan, Scublinsky, Dario, Sevciovic Grumach, Anete, Shawa, Imad, Simon Campos, Jesus, Sofat, Nidhi, Som, Mousumi, Spinner, Christoph D., Sprinz, Eduardo, Stienecker, Roger, Suarez, Jose, Tachikawa, Natsuo, Tahir, Hasan, Tiffany, Brian, Vishnevsky, Alexander, Westheimer Cavalcante, Adilson, Zirpe, Kapil, Marconi, Vincent C, Ramanan, Athimalaipet V, de Bono, Stephanie, Kartman, Cynthia E, Krishnan, Venkatesh, Liao, Ran, Piruzeli, Maria Lucia B, Goldman, Jason D, de Cassia Pellegrini, Rita, Cardoso, Anabela, Chakladar, Sujatro, Crowe, Brenda, Reis, Paulo, Zhang, Xin, Adams, David H, and Ely, E Wesley

Published
2021
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39. Primary biliary cholangitis drug evaluation and regulatory approval: Where do we go from here?

Author

Jones, David EJ, primary, Beuers, Ulrich, additional, Bonder, Alan, additional, Carbone, Marco, additional, Culver, Emma, additional, Dyson, Jessica, additional, Gish, Robert G, additional, Hansen, Bettina E, additional, Hirschfield, Gideon, additional, Jones, Rebecca, additional, Kowdley, Kris, additional, Kremer, Andreas E., additional, Lindor, Keith, additional, Mayo, Marlyn, additional, Mells, George, additional, Neuberger, James, additional, Prince, Martin, additional, Swain, Mark, additional, Tanaka, Atsushi, additional, Thorburn, Douglas, additional, Trauner, Michael, additional, Trivedi, Palak, additional, Weltman, Martin, additional, Yeoman, Andrew, additional, and Levy, Cynthia, additional

Published
2024
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42. Lack of antibodies against seasonal coronavirus OC43 nucleocapsid protein identifies patients at risk of critical COVID-19

Author

Dugas, Martin, Grote-Westrick, Tanja, Merle, Uta, Fontenay, Michaela, Kremer, Andreas E., Hanses, Frank, Vollenberg, Richard, Lorentzen, Eva, Tiwari-Heckler, Shilpa, Duchemin, Jérôme, Ellouze, Syrine, Vetter, Marcel, Fürst, Julia, Schuster, Philipp, Brix, Tobias, Denkinger, Claudia M., Müller-Tidow, Carsten, Schmidt, Hartmut, Tepasse, Phil-Robin, and Kühn, Joachim

Published
2021
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45. Seladelpar treatment reduces interleukin-31 and pruritus in patients with primary biliary cholangitis

Author

Kremer, Andreas E, Mayo, Marlyn J; https://orcid.org/0000-0002-4874-7010, Hirschfield, Gideon M; https://orcid.org/0000-0002-6736-2255, Levy, Cynthia; https://orcid.org/0000-0001-5498-6037, Bowlus, Christopher L; https://orcid.org/0000-0002-3906-6811, Jones, David E, Johnson, Jeff D; https://orcid.org/0009-0001-9384-9577, McWherter, Charles A; https://orcid.org/0000-0002-7613-3008, Choi, Yun-Jung; https://orcid.org/0000-0002-5153-9714, Kremer, Andreas E, Mayo, Marlyn J; https://orcid.org/0000-0002-4874-7010, Hirschfield, Gideon M; https://orcid.org/0000-0002-6736-2255, Levy, Cynthia; https://orcid.org/0000-0001-5498-6037, Bowlus, Christopher L; https://orcid.org/0000-0002-3906-6811, Jones, David E, Johnson, Jeff D; https://orcid.org/0009-0001-9384-9577, McWherter, Charles A; https://orcid.org/0000-0002-7613-3008, and Choi, Yun-Jung; https://orcid.org/0000-0002-5153-9714

Abstract

BACKGROUND AND AIMS: Pruritus is a debilitating symptom for many people living with primary biliary cholangitis (PBC). In studies with seladelpar, a selective PPAR-delta agonist, PBC patients experienced significant improvement in pruritus and reduction of serum bile acids. Interleukin-31 (IL-31) is a cytokine known to mediate pruritus and blocking IL-31 signaling provides relief in pruritic skin diseases. This study examined the connection between seladelpar's anti-pruritic effects, IL-31 and bile acid levels in PBC patients. APPROACH AND RESULTS: IL-31 levels were quantified in serum samples from the ENHANCE study of PBC patients receiving daily oral doses of placebo (n=55), seladelpar 5 mg (n=53) or 10 mg (n=53) for 3 months and for healthy volunteers (n=55). IL-31 levels were compared with pruritus using a numerical rating scale (NRS, 0-10) and with bile acid levels. Baseline IL-31 levels closely correlated with pruritus NRS (r=0.54, p<0.0001), and total (r=0.54, p<0.0001) and conjugated bile acids (up to 0.64, p<0.0001). Decreases in IL-31 were observed with seladelpar 5 mg (-30%, p=0.0003) and 10 mg (-52%, p<0.0001) versus placebo (+31%). Patients with clinically meaningful improvement in pruritus (NRS≥2 decrease) demonstrated greater dose-dependent reductions in IL-31 compared to those without pruritus improvement (NRS<2 decrease). Strong correlations were observed for the changes between levels of IL-31 and total bile acids (r=0.63, p<0.0001) in the seladelpar 10 mg group. CONCLUSIONS: Seladelpar decreased serum IL-31 and bile acids in PBC patients. The reductions of IL-31 and bile acids correlated closely with each other and pruritus improvement suggesting a mechanism to explain seladelpar's anti-pruritic effects.

Published
2024

49. Validierung des Deutschen Pruritusfragebogens zur systematischen Erfassung von chronischem Pruritus.

Author

Weisshaar, Elke, Kupfer, Jörg P., Bentz, Philipp, Staubach‐Renz, Petra, Legat, Franz, Kremer, Andreas E., Ständer, Hartmut, Streit, Markus, Darsow, Ulf, Mettang, Thomas, and Ständer, Sonja

Abstract

Copyright of Journal der Deutschen Dermatologischen Gesellschaft is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2024
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50. Validation of the German Pruritus Questionnaire for the systematic assessment of chronic pruritus.

Author

Weisshaar, Elke, Kupfer, Jörg P., Bentz, Philipp, Staubach‐Renz, Petra, Legat, Franz, Kremer, Andreas E., Ständer, Hartmut, Streit, Markus, Darsow, Ulf, Mettang, Thomas, and Ständer, Sonja

Abstract

Summary: Background: Chronic pruritus is a clinically heterogeneous symptom that manifests itself with varying duration, intensity, or quality. To date, there is no validated German‐language instrument that systematically assesses the relevant parameters. With the support of the Pruritus Research Working Group (Arbeitsgemeinschaft Pruritusforschung, AGP), a questionnaire for the assessment of chronic pruritus (AGP questionnaire) was developed in 2008. The subsequently revised instrument, now called the German Pruritus Questionnaire, records pruritus‐specific parameters such as localization, course, intensity and quality, anamnestic data on the general state of health, sociodemographic data, quality of life, and coping methods. It is to be validated in the study presented here. Patients and methods: The questionnaire was used in 366 patients with chronic pruritus of different etiologies from Germany (University Hospitals Heidelberg, Münster, Mainz, Erlangen, Giessen, private practice Bad Bentheim, TU Munich, Wiesbaden Kidney Center), Austria (Graz University Hospital) and Switzerland (Aarau Cantonal Hospital). Results: The reliability for repeated completion (retest reliability) with regard to localization, first occurrence, and concomitant diseases showed high values for Cohen's kappa (> 0.8). The data on the retest reliability of the pruritus characteristics showed lower values (< 0.7). With regard to the measurability of practically relevant changes (change sensitivity), medium to strong effect sizes were found (0.09–0.19). A statistically significant differentiation of the pruritus etiologies based on the recorded parameters was not possible. Conclusions: The German Pruritus Questionnaire allows a comprehensive and structured recording of patient‐ and clinician‐reported, relevant dimensions of chronic pruritus of different etiologies. Further adaptation and development are planned. [ABSTRACT FROM AUTHOR]

Published
2024
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