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430 results on '"Dalekos G"'

1. Incidence and predictors of hepatocellular carcinoma in patients with autoimmune hepatitis

Author: van Gerven, N., van Erpecum, K., Ouden, J den, Brouwer, J., Vrolijk, J., Gevers, T.J., Drenth, J., Guichelaar, M., Bouma, G., Schreuder, T.C.M.A., van der Wouden, E.J., Baak, L.C., Stadhouders, P., Klemt-Kropp, M., Verhagen, M., Bhalla, A., Kuijvenhoven, J., Almasio, P., Alvarez, F., Andrade, R., Arikan, C., Assis, D., Bardou-Jacquet, E., Biewenga, M., Cancado, E., Cazzagon, N., Chazouillères, O., Colloredo, G., Cuarterolo, M., Dalekos, G., Debray, D., Robles-Díaz, M., Dyson, J., Efe, C., Engel, B., Ferri, S., Fontana, R., Gatselis, N., Gerussi, A., Halilbasic, E., Halliday, N., Heneghan, M., Hirschfield, G., van Hoek, B., Hørby Jørgensen, M., Indolfini, G., Iorio, R., Invernizzi, P., Jeong, S., Jones, D., Kelly, D., Kerkar, N., Lacaille, F., Lammert, C., Leggett, B., Lenzi, M., Levy, C., Liberal, R., Lleo, A., Lohse, A., Lopez, S. Ines, de Martin, E., McLin, V., Mieli-Vergani, G., Milkiewicz, P., Mohan, N., Muratori, L., Nebbia, G., van Nieuwkerk, C., Oo, Y., Ortega, A., Páres, A., Pop, T., Pratt, D., Purnak, T., Ranucci, G., Rushbrook, S., Schramm, C., Stättermayer, A., Swain, M., Tanaka, A., Taubert, R., Terrabuio, D., Terziroli, B., Trauner, M., Valentino, P., van den Brand, F., Vergani, D., Villamil, A., Wahlin, S., Ytting, H., Zachou, K., Zeniya, M., Colapietro, Francesca, Maisonneuve, Patrick, Lytvyak, Ellina, Beuers, Ulrich, Verdonk, Robert C., van der Meer, Adriaan J., van Hoek, Bart, Kuiken, Sjoerd D., Brouwer, Johannes T., Muratori, Paolo, Aghemo, Alessio, Carella, Francesco, van den Berg, Ad P., Zachou, Kalliopi, Dalekos, George N., Di Zeo-Sánchez, Daniel E., Robles, Mercedes, Andrade, Raul J., Montano-Loza, Aldo J., van den Brand, Floris F., Slooter, Charlotte D., Macedo, Guilherme, Liberal, Rodrigo, de Boer, Ynto S., and Lleo, Ana
Published: 2024
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2. Adequate versus deep response to ursodeoxycholic acid in primary biliary cholangitis: To what extent and under what conditions is normal alkaline phosphatase level associated with complication-free survival gain?

Author: Corpechot, C, Lemoinne, S, Soret, P, Hansen, B, Hirschfield, G, Gulamhusein, A, Montano-Loza, A, Lytvyak, E, Pares, A, Olivas, I, Eaton, J, Osman, K, Schramm, C, Sebode, M, Lohse, A, Dalekos, G, Gatselis, N, Nevens, F, Cazzagon, N, Zago, A, Russo, F, Floreani, A, Abbas, N, Trivedi, P, Thorburn, D, Saffioti, F, Barkai, L, Roccarina, D, Calvaruso, V, Fichera, A, Delamarre, A, Sobenko, N, Villamil, A, Medina-Morales, E, Bonder, A, Patwardhan, V, Rigamonti, C, Carbone, M, Invernizzi, P, Cristoferi, L, Van Der Meer, A, De Veer, R, Zigmond, E, Yehezkel, E, Kremer, A, Deibel, A, Bruns, T, Grosse, K, Wetten, A, Dyson, J, Jones, D, Dumortier, J, Pageaux, G, De Ledinghen, V, Chazouilleres, O, Carrat, F, Corpechot C., Lemoinne S., Soret P. -A., Hansen B., Hirschfield G., Gulamhusein A., Montano-Loza A. J., Lytvyak E., Pares A., Olivas I., Eaton J. E., Osman K. T., Schramm C., Sebode M., Lohse A. W., Dalekos G., Gatselis N., Nevens F., Cazzagon N., Zago A., Russo F. P., Floreani A., Abbas N., Trivedi P., Thorburn D., Saffioti F., Barkai L., Roccarina D., Calvaruso V., Fichera A., Delamarre A., Sobenko N., Villamil A. M., Medina-Morales E., Bonder A., Patwardhan V., Rigamonti C., Carbone M., Invernizzi P., Cristoferi L., Van Der Meer A., De Veer R., Zigmond E., Yehezkel E., Kremer A. E., Deibel A., Bruns T., Grosse K., Wetten A., Dyson J. K., Jones D., Dumortier J., Pageaux G. -P., De Ledinghen V., Chazouilleres O., Carrat F., Corpechot, C, Lemoinne, S, Soret, P, Hansen, B, Hirschfield, G, Gulamhusein, A, Montano-Loza, A, Lytvyak, E, Pares, A, Olivas, I, Eaton, J, Osman, K, Schramm, C, Sebode, M, Lohse, A, Dalekos, G, Gatselis, N, Nevens, F, Cazzagon, N, Zago, A, Russo, F, Floreani, A, Abbas, N, Trivedi, P, Thorburn, D, Saffioti, F, Barkai, L, Roccarina, D, Calvaruso, V, Fichera, A, Delamarre, A, Sobenko, N, Villamil, A, Medina-Morales, E, Bonder, A, Patwardhan, V, Rigamonti, C, Carbone, M, Invernizzi, P, Cristoferi, L, Van Der Meer, A, De Veer, R, Zigmond, E, Yehezkel, E, Kremer, A, Deibel, A, Bruns, T, Grosse, K, Wetten, A, Dyson, J, Jones, D, Dumortier, J, Pageaux, G, De Ledinghen, V, Chazouilleres, O, Carrat, F, Corpechot C., Lemoinne S., Soret P. -A., Hansen B., Hirschfield G., Gulamhusein A., Montano-Loza A. J., Lytvyak E., Pares A., Olivas I., Eaton J. E., Osman K. T., Schramm C., Sebode M., Lohse A. W., Dalekos G., Gatselis N., Nevens F., Cazzagon N., Zago A., Russo F. P., Floreani A., Abbas N., Trivedi P., Thorburn D., Saffioti F., Barkai L., Roccarina D., Calvaruso V., Fichera A., Delamarre A., Sobenko N., Villamil A. M., Medina-Morales E., Bonder A., Patwardhan V., Rigamonti C., Carbone M., Invernizzi P., Cristoferi L., Van Der Meer A., De Veer R., Zigmond E., Yehezkel E., Kremer A. E., Deibel A., Bruns T., Grosse K., Wetten A., Dyson J. K., Jones D., Dumortier J., Pageaux G. -P., De Ledinghen V., Chazouilleres O., and Carrat F.
Abstract: Background and Aims: Normal alkaline phosphatase (ALP) levels in ursodeoxycholic acid (UDCA)-treated patients with primary biliary cholangitis (PBC) are associated with better long-term outcome. However, second-line therapies are currently recommended only when ALP levels remain above 1.5 times the upper limit of normal (×ULN) after 12-month UDCA. We assessed whether, in patients considered good responders to UDCA, normal ALP levels were associated with significant survival gains. Approach and Results: We performed a retrospective cohort study of 1047 patients with PBC who attained an adequate response to UDCA according to Paris-2 criteria. Time to liver-related complications, liver transplantation, or death was assessed using adjusted restricted mean survival time (RMST) analysis. The overall incidence rate of events was 17.0 (95% CI: 13.7-21.1) per 1000 out of 4763.2 patient-years. On the whole population, normal serum ALP values (but not normal gamma-glutamyl transpeptidase (GGT), alanine aminotransferase (ALT), or aspartate aminotransferase (AST); or total bilirubin < 0.6 ×ULN) were associated with a significant absolute complication-free survival gain at 10 years (mean 7.6 months, 95% CI: 2.7 - 12.6 mo.; p = 0.003). In subgroup analysis, this association was significant in patients with a liver stiffness measurement ≥ 10 kPa and/or age ≤ 62 years, with a 10-year absolute complication-free survival gain of 52.8 months (95% CI: 45.7-59.9, p < 0.001) when these 2 conditions were met. Conclusions: PBC patients with an adequate response to UDCA and persistent ALP elevation between 1.1 and 1.5 ×ULN, particularly those with advanced fibrosis and/or who are sufficiently young, remain at risk of poor outcome. Further therapeutic efforts should be considered for these patients.
Published: 2024

3. Systematic review of response criteria and endpoints in autoimmune hepatitis by the International Autoimmune Hepatitis Group

Author: Almasio, P., Alvarez, F., Andrade, R., Arikan, C., Assis, D., Bardou-Jacquet, E., Biewenga, M., Cancado, E., Cazzagon, N., Chazouillères, O., Colloredo, G., Cuarterolo, M., Dalekos, G., Debray, D., Robles-Díaz, M., Drenth, J., Dyson, J., Efe, C., Engel, B., Ferri, S., Fontana, R., Gatselis, N., Gerussi, A., Halilbasic, E., Halliday, N., Heneghan, M., Hirschfield, G., van Hoek, B., Hørby Jørgensen, M., Indolfini, G., Iorio, R., Jeong, S., Jones, D., Kelly, D., Kerkar, N., Lacaille, F., Lammert, C., Leggett, B., Lenzi, M., Levy, C., Liberal, R., Lleo, A., Lohse, A., Ines Lopez, S., de Martin, E., McLin, V., Mieli-Vergani, G., Milkiewicz, P., Mohan, N., Muratori, L., Nebbia, G., van Nieuwkerk, C., Oo, Y., Ortega, A., Páres, A., Pop, T., Pratt, D., Purnak, T., Ranucci, G., Rushbrook, S., Schramm, C., Stättermayer, A., Swain, M., Tanaka, A., Taubert, R., Terrabuio, D., Terziroli, B., Trauner, M., Valentino, P., van den Brand, F., Villamil, A., Wahlin, S., Ytting, H., Zachou, K., Zeniya, M., Pape, Simon, Snijders, Romée J.A.L.M., Gevers, Tom J.G., Chazouilleres, Oliver, Dalekos, George N., Hirschfield, Gideon M., Lenzi, Marco, Trauner, Michael, Manns, Michael P., Vierling, John M., Montano-Loza, Aldo J., Lohse, Ansgar W., Schramm, Christoph, Drenth, Joost P.H., and Heneghan, Michael A.
Published: 2022
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4. Lack of complete biochemical response in autoimmune hepatitis leads to adverse outcome: First report of the IAIHG retrospective registry

Author: MS MDL 1, Cancer, Infection & Immunity, Slooter, Charlotte D., Van Den Brand, Floris F., Lleo, Ana, Colapietro, Francesca, Lenzi, Marco, Muratori, Paolo, Kerkar, Nanda, Dalekos, G., Zachou, Kalliopi, Lucena, M. Isabel, Robles-Díaz, Mercedes, Di Zeo-Sánchez, Daniel E., Andrade, Raúl J., Montano-Loza, Aldo J., Lytvyak, Ellina, Lissenberg-Witte, Birgit I., Maisonneuve, Patrick, Bouma, Gerd, MacEdo, Guilherme, Liberal, Rodrigo, De Boer, Ynto S., Van Erpecum, K., Dutch AIH Study Group, International Autoimmune Hepatitis Group, MS MDL 1, Cancer, Infection & Immunity, Slooter, Charlotte D., Van Den Brand, Floris F., Lleo, Ana, Colapietro, Francesca, Lenzi, Marco, Muratori, Paolo, Kerkar, Nanda, Dalekos, G., Zachou, Kalliopi, Lucena, M. Isabel, Robles-Díaz, Mercedes, Di Zeo-Sánchez, Daniel E., Andrade, Raúl J., Montano-Loza, Aldo J., Lytvyak, Ellina, Lissenberg-Witte, Birgit I., Maisonneuve, Patrick, Bouma, Gerd, MacEdo, Guilherme, Liberal, Rodrigo, De Boer, Ynto S., Van Erpecum, K., Dutch AIH Study Group, and International Autoimmune Hepatitis Group
Published: 2024

5. Ursodeoxycholic Acid Treatment-Induced GLOBE Score Changes Are Associated With Liver Transplantation-Free Survival in Patients With Primary Biliary Cholangitis

Author: De Veer, R, Van Hooff, M, Corpechot, C, Thorburn, D, Invernizzi, P, Lammers, W, Janssen, H, Battezzati, P, Nevens, F, Lindor, K, Floreani, A, Ponsioen, C, Mayo, M, Pares, A, Mason, A, Kowdley, K, Trivedi, P, Hirschfield, G, Goet, J, Bruns, T, Dalekos, G, Gatselis, N, Verhelst, X, Hansen, B, Harms, M, Van Der Meer, A, De Veer R. C., Van Hooff M. C., Corpechot C., Thorburn D., Invernizzi P., Lammers W. J., Janssen H. L. A., Battezzati P. M., Nevens F., Lindor K. D., Floreani A., Ponsioen C. Y., Mayo M. J., Pares A., Mason A. L., Kowdley K. V., Trivedi P. J., Hirschfield G. M., Goet J. C., Bruns T., Dalekos G. N., Gatselis N. K., Verhelst X., Hansen B. E., Harms M. H., Van Der Meer A. J., De Veer, R, Van Hooff, M, Corpechot, C, Thorburn, D, Invernizzi, P, Lammers, W, Janssen, H, Battezzati, P, Nevens, F, Lindor, K, Floreani, A, Ponsioen, C, Mayo, M, Pares, A, Mason, A, Kowdley, K, Trivedi, P, Hirschfield, G, Goet, J, Bruns, T, Dalekos, G, Gatselis, N, Verhelst, X, Hansen, B, Harms, M, Van Der Meer, A, De Veer R. C., Van Hooff M. C., Corpechot C., Thorburn D., Invernizzi P., Lammers W. J., Janssen H. L. A., Battezzati P. M., Nevens F., Lindor K. D., Floreani A., Ponsioen C. Y., Mayo M. J., Pares A., Mason A. L., Kowdley K. V., Trivedi P. J., Hirschfield G. M., Goet J. C., Bruns T., Dalekos G. N., Gatselis N. K., Verhelst X., Hansen B. E., Harms M. H., and Van Der Meer A. J.
Published: 2023

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

Author: Hirschfield, G, Shiffman, M, Gulamhusein, A, Kowdley, K, Vierling, J, Levy, C, Kremer, A, Zigmond, E, Andreone, P, Gordon, S, Bowlus, C, Lawitz, E, Aspinall, R, Pratt, D, Raikhelson, K, Gonzalez-Huezo, M, Heneghan, M, Jeong, S, Ladron De Guevara, A, Mayo, M, Dalekos, G, Drenth, J, Janczewska, E, Leggett, B, Nevens, F, Vargas, V, Zuckerman, E, Corpechot, C, Fassio, E, Hinrichsen, H, Invernizzi, P, Trivedi, P, Forman, L, Jones, D, Ryder, S, Swain, M, Steinberg, A, Boudes, P, Choi, Y, Mcwherter, C, Adrover, R, Agrawal, S, Aigner, E, Martinez, A, Alden, A, Bellido, R, Jimenez, M, Ayoub, W, Baum, S, Ben-Ari, Z, Berenguer, M, Berg, C, Bessone, F, Bonder, A, Borg, B, Ruiz, C, Buggisch, P, Panero, J, Carey, E, Carmiel-Haggai, M, Carubbi, F, Grau, P, Ch'Ng, C, Cimpoeru, N, Omana, R, Corless, L, Costentin, C, Deschenes, M, Dorffel, Y, Dugalic, P, Farrell, G, Fernandez, J, Floreani, A, Francque, S, Freilich, B, Saldias, F, Galambos, M, Galati, J, Galli, A, Ganne-Carrie, N, Geyvandova, N, Gheorghe, L, Gilroy, R, Goel, A, Goeser, T, Greenbloom, S, Halota, W, Harrison, S, Hartleb, M, Heo, J, Hofer, H, Horvath, G, Huang, J, Huffman, J, Hunyady, B, Johnson, S, Kallis, Y, Khazanchi, A, Kim, K, Kim, S, Kim, Y, Kohli, A, Kontorinis, N, Lake, J, Lee, K, Mach, T, Manch, R, Maor-Kendler, Y, Mateescu, R, Minuk, G, Modi, A, Moehlen, M, Rodriguez, C, Cunill, R, Mouzas, I, Muir, A, Nagy, I, Ngu, J, Odin, J, Ogurtsov, P, Pabjan, P, Pagadala, M, Papp, M, Pares, A, Peskov, A, Peyton, A, Phillips, J, Porayko, M, Post, A, Pound, D, Rabinovitz, M, Rank, K, Reddy, K, Regula, J, Riley, T, Gomez, M, Safadi, R, Sheridan, D, Silva, M, Silveira, M, Sood, S, Sporea, I, Stanca, C, Stauber, R, Svorcan, P, Tak, W, Taylor, R, Thorburn, D, Tobias, H, Zekry, A, Trauner, M, Triantos, C, Veitsman, E, Thompson, A, Verhelst, X, Verna, E, Von Der Ohe, M, Weilert, F, Wiegand, J, Yimam, K, Yoon, S, Younes, Z, Zivony, A, Zuin, M, Hirschfield G. M., Shiffman M. L., Gulamhusein A., Kowdley K. V., Vierling J. M., Levy C., Kremer A. E., Zigmond E., Andreone P., Gordon S. C., Bowlus C. L., Lawitz E. J., Aspinall R. J., Pratt D. S., Raikhelson K., Gonzalez-Huezo M. S., Heneghan M. A., Jeong S. -H., Ladron De Guevara A. L., Mayo M. J., Dalekos G. N., Drenth J. P. H., Janczewska E., Leggett B. A., Nevens F., Vargas V., Zuckerman E., Corpechot C., Fassio E., Hinrichsen H., Invernizzi P., Trivedi P. J., Forman L., Jones D. E. J., Ryder S. D., Swain M. G., Steinberg A., Boudes P. F., Choi Y. -J., McWherter C. A., Adrover R., Agrawal S., Aigner E., Martinez A. A., Alden A. -M. S., Bellido R. J. A., Jimenez M. A. A., Ayoub W., Baum S. J., Ben-Ari Z., Berenguer M., Berg C., Bessone F. O., Bonder A., Borg B. B., Ruiz C. G. B., Buggisch P., Panero J. L. C., Carey E. J., Carmiel-Haggai M., Carubbi F., Grau P. C., Ch'ng C. L., Cimpoeru N. -C., Omana R. C., Corless L., Costentin C., Deschenes M., Dorffel Y., Dugalic P., Farrell G. C., Fernandez J. L., Floreani A., Francque S., Freilich B. L., Saldias F. A. F., Galambos M. R., Galati J., Galli A., Ganne-Carrie N., Geyvandova N., Gheorghe L. -S., Gilroy R., Goel A., Goeser T., Greenbloom S., Halota W., Harrison S. A., Hartleb M., Heo J., Hofer H., Horvath G., Huang J. C., Huffman J. L., Hunyady B., Johnson S., Kallis Y., Khazanchi A., Kim K. -A., Kim S. U., Kim Y. J., Kohli A., Kontorinis N., Lake J. R., Lee K. S., Mach T., Manch R., Maor-Kendler Y., Mateescu R. -B., Minuk G., Modi A. A., Moehlen M. W., Rodriguez C. M., Cunill R. M. M., Mouzas I., Muir A., Nagy I., Ngu J. H. (., Odin J., Ogurtsov P., Pabjan P., Pagadala M., Papp M., Pares A., Peskov A., Peyton A., Phillips J., Porayko M., Post A., Pound D. C., Rabinovitz M., Rank K., Reddy K. G., Regula J., Riley T., Gomez M. R., Safadi R., Sheridan D. A., Silva M. O., Silveira M. G., Sood S., Sporea I., Stanca C., Stauber R., Svorcan P., Tak W. Y., Taylor R. M., Thorburn D., Tobias H., Zekry A. T., Trauner M., Triantos C., Veitsman E., Thompson A. J. V., Verhelst X., Verna E. C., Von Der Ohe M., Weilert F., Wiegand J., Yimam K. K., Yoon S. K., Younes Z., Zivony A. S., Zuin M., Hirschfield, G, Shiffman, M, Gulamhusein, A, Kowdley, K, Vierling, J, Levy, C, Kremer, A, Zigmond, E, Andreone, P, Gordon, S, Bowlus, C, Lawitz, E, Aspinall, R, Pratt, D, Raikhelson, K, Gonzalez-Huezo, M, Heneghan, M, Jeong, S, Ladron De Guevara, A, Mayo, M, Dalekos, G, Drenth, J, Janczewska, E, Leggett, B, Nevens, F, Vargas, V, Zuckerman, E, Corpechot, C, Fassio, E, Hinrichsen, H, Invernizzi, P, Trivedi, P, Forman, L, Jones, D, Ryder, S, Swain, M, Steinberg, A, Boudes, P, Choi, Y, Mcwherter, C, Adrover, R, Agrawal, S, Aigner, E, Martinez, A, Alden, A, Bellido, R, Jimenez, M, Ayoub, W, Baum, S, Ben-Ari, Z, Berenguer, M, Berg, C, Bessone, F, Bonder, A, Borg, B, Ruiz, C, Buggisch, P, Panero, J, Carey, E, Carmiel-Haggai, M, Carubbi, F, Grau, P, Ch'Ng, C, Cimpoeru, N, Omana, R, Corless, L, Costentin, C, Deschenes, M, Dorffel, Y, Dugalic, P, Farrell, G, Fernandez, J, Floreani, A, Francque, S, Freilich, B, Saldias, F, Galambos, M, Galati, J, Galli, A, Ganne-Carrie, N, Geyvandova, N, Gheorghe, L, Gilroy, R, Goel, A, Goeser, T, Greenbloom, S, Halota, W, Harrison, S, Hartleb, M, Heo, J, Hofer, H, Horvath, G, Huang, J, Huffman, J, Hunyady, B, Johnson, S, Kallis, Y, Khazanchi, A, Kim, K, Kim, S, Kim, Y, Kohli, A, Kontorinis, N, Lake, J, Lee, K, Mach, T, Manch, R, Maor-Kendler, Y, Mateescu, R, Minuk, G, Modi, A, Moehlen, M, Rodriguez, C, Cunill, R, Mouzas, I, Muir, A, Nagy, I, Ngu, J, Odin, J, Ogurtsov, P, Pabjan, P, Pagadala, M, Papp, M, Pares, A, Peskov, A, Peyton, A, Phillips, J, Porayko, M, Post, A, Pound, D, Rabinovitz, M, Rank, K, Reddy, K, Regula, J, Riley, T, Gomez, M, Safadi, R, Sheridan, D, Silva, M, Silveira, M, Sood, S, Sporea, I, Stanca, C, Stauber, R, Svorcan, P, Tak, W, Taylor, R, Thorburn, D, Tobias, H, Zekry, A, Trauner, M, Triantos, C, Veitsman, E, Thompson, A, Verhelst, X, Verna, E, Von Der Ohe, M, Weilert, F, Wiegand, J, Yimam, K, Yoon, S, Younes, Z, Zivony, A, Zuin, M, Hirschfield G. M., Shiffman M. L., Gulamhusein A., Kowdley K. V., Vierling J. M., Levy C., Kremer A. E., Zigmond E., Andreone P., Gordon S. C., Bowlus C. L., Lawitz E. J., Aspinall R. J., Pratt D. S., Raikhelson K., Gonzalez-Huezo M. S., Heneghan M. A., Jeong S. -H., Ladron De Guevara A. L., Mayo M. J., Dalekos G. N., Drenth J. P. H., Janczewska E., Leggett B. A., Nevens F., Vargas V., Zuckerman E., Corpechot C., Fassio E., Hinrichsen H., Invernizzi P., Trivedi P. J., Forman L., Jones D. E. J., Ryder S. D., Swain M. G., Steinberg A., Boudes P. F., Choi Y. -J., McWherter C. A., Adrover R., Agrawal S., Aigner E., Martinez A. A., Alden A. -M. S., Bellido R. J. A., Jimenez M. A. A., Ayoub W., Baum S. J., Ben-Ari Z., Berenguer M., Berg C., Bessone F. O., Bonder A., Borg B. B., Ruiz C. G. B., Buggisch P., Panero J. L. C., Carey E. J., Carmiel-Haggai M., Carubbi F., Grau P. C., Ch'ng C. L., Cimpoeru N. -C., Omana R. C., Corless L., Costentin C., Deschenes M., Dorffel Y., Dugalic P., Farrell G. C., Fernandez J. L., Floreani A., Francque S., Freilich B. L., Saldias F. A. F., Galambos M. R., Galati J., Galli A., Ganne-Carrie N., Geyvandova N., Gheorghe L. -S., Gilroy R., Goel A., Goeser T., Greenbloom S., Halota W., Harrison S. A., Hartleb M., Heo J., Hofer H., Horvath G., Huang J. C., Huffman J. L., Hunyady B., Johnson S., Kallis Y., Khazanchi A., Kim K. -A., Kim S. U., Kim Y. J., Kohli A., Kontorinis N., Lake J. R., Lee K. S., Mach T., Manch R., Maor-Kendler Y., Mateescu R. -B., Minuk G., Modi A. A., Moehlen M. W., Rodriguez C. M., Cunill R. M. M., Mouzas I., Muir A., Nagy I., Ngu J. H. (., Odin J., Ogurtsov P., Pabjan P., Pagadala M., Papp M., Pares A., Peskov A., Peyton A., Phillips J., Porayko M., Post A., Pound D. C., Rabinovitz M., Rank K., Reddy K. G., Regula J., Riley T., Gomez M. R., Safadi R., Sheridan D. A., Silva M. O., Silveira M. G., Sood S., Sporea I., Stanca C., Stauber R., Svorcan P., Tak W. Y., Taylor R. M., Thorburn D., Tobias H., Zekry A. T., Trauner M., Triantos C., Veitsman E., Thompson A. J. V., Verhelst X., Verna E. C., Von Der Ohe M., Weilert F., Wiegand J., Yimam K. K., Yoon S. K., Younes Z., Zivony A. S., and Zuin M.
Published: 2023

7. Prevalence and significance of antimitochondrial antibodies in autoimmune hepatitis (AIH): Results from a large multicentre study of the International AIH Group

Author: Gatselis, N, Zachou, K, Loza, A, Cancado, E, Arinaga-Hino, T, Muratori, P, Efe, C, Floreani, A, Invernizzi, P, Takahashi, A, Takaki, A, Beretta-Piccoli, B, van Hoek, B, Lytvyak, E, Guedes, L, Purnak, T, Cazzagon, N, Lygoura, V, Arvaniti, P, Rigopoulou, E, Muratori, L, Dalekos, G, Gatselis N. K., Zachou K., Loza A. J. M., Cancado E. L. R., Arinaga-Hino T., Muratori P., Efe C., Floreani A., Invernizzi P., Takahashi A., Takaki A., Beretta-Piccoli B. T., van Hoek B., Lytvyak E., Guedes L. V., Purnak T., Cazzagon N., Lygoura V., Arvaniti P., Rigopoulou E. I., Muratori L., Dalekos G. N., Gatselis, N, Zachou, K, Loza, A, Cancado, E, Arinaga-Hino, T, Muratori, P, Efe, C, Floreani, A, Invernizzi, P, Takahashi, A, Takaki, A, Beretta-Piccoli, B, van Hoek, B, Lytvyak, E, Guedes, L, Purnak, T, Cazzagon, N, Lygoura, V, Arvaniti, P, Rigopoulou, E, Muratori, L, Dalekos, G, Gatselis N. K., Zachou K., Loza A. J. M., Cancado E. L. R., Arinaga-Hino T., Muratori P., Efe C., Floreani A., Invernizzi P., Takahashi A., Takaki A., Beretta-Piccoli B. T., van Hoek B., Lytvyak E., Guedes L. V., Purnak T., Cazzagon N., Lygoura V., Arvaniti P., Rigopoulou E. I., Muratori L., and Dalekos G. N.
Abstract: Background & Aims: Antimitochondrial antibodies (AMA) are specific markers for the diagnosis of primary biliary cholangitis (PBC) but can also be found occasionally in patients with autoimmune hepatitis (AIH). The present large multicentre cohort study assessed the prevalence and significance of AMA in AIH-patients. Methods: 123 AMA-positive AIH-patients were investigated and compared with 711 age-matched AMA-negative AIH-patients and 69 patients with AIH/PBC variant. Results: AMA prevalence in AIH-patients was 5.1% (range: 1.2%-11.8%). AMA-positivity was associated with female sex (p = 0.031) in AMA-positive AIH-patients but not with liver biochemistry, bile duct injury on liver biopsy, disease severity at baseline and response to treatment compared to AMA-negative AIH-patients. Comparing AMA-positive AIH-patients to those with AIH/PBC variant, there was no difference in disease severity. Regarding liver histology, AIH/PBC variant patients were characterized by the presence of at least one feature of bile duct damage (p<0.001). Response to immunosuppressive treatment was similar among groups. From AMA-positive AIH patients only those with evidence of non-specific bile duct injury had higher risk to progress to cirrhosis (HR=4.314, 95%CI: 2.348–7.928; p<0.001). During follow-up, AMA-positive AIH-patients had higher risk to develop histological bile duct injury (HR 4.654, 95%CI 1.829–11.840; p = 0.001). Conclusions: AMA presence is relatively common among AIH-patients, but their clinical significance seems important only when they co-exist with non-specific bile duct injury at the histological level. Therefore, a careful evaluation of liver biopsy seems of utmost importance in these patients.
Published: 2023

8. Optimizing therapy in primary biliary cholangitis: Alkaline phosphatase at six months identifies one-year non-responders and predicts survival

Author: Murilloperez, C, Ioannou, S, Hassanally, I, Trivedi, P, Corpechot, C, van der Meer, A, Lammers, W, Battezzati, P, Lindor, K, Nevens, F, Kowdley, K, Bruns, T, Cazzagon, N, Floreani, A, Mason, A, Gulamhusein, A, Ponsioen, C, Carbone, M, Lleo, A, Mayo, M, Dalekos, G, Gatselis, N, Thorburn, D, Verhelst, X, Pares, A, Londono, M, Janssen, H, Invernizzi, P, Vuppalanchi, R, Hirschfield, G, Hansen, B, Levy, C, MurilloPerez C. F., Ioannou S., Hassanally I., Trivedi P. J., Corpechot C., van der Meer A. J., Lammers W. J., Battezzati P. M., Lindor K. D., Nevens F., Kowdley K. V., Bruns T., Cazzagon N., Floreani A., Mason A. L., Gulamhusein A., Ponsioen C. Y., Carbone M., Lleo A., Mayo M. J., Dalekos G. N., Gatselis N. K., Thorburn D., Verhelst X., Pares A., Londono M. -C., Janssen H. L. A., Invernizzi P., Vuppalanchi R., Hirschfield G. M., Hansen B. E., Levy C., Murilloperez, C, Ioannou, S, Hassanally, I, Trivedi, P, Corpechot, C, van der Meer, A, Lammers, W, Battezzati, P, Lindor, K, Nevens, F, Kowdley, K, Bruns, T, Cazzagon, N, Floreani, A, Mason, A, Gulamhusein, A, Ponsioen, C, Carbone, M, Lleo, A, Mayo, M, Dalekos, G, Gatselis, N, Thorburn, D, Verhelst, X, Pares, A, Londono, M, Janssen, H, Invernizzi, P, Vuppalanchi, R, Hirschfield, G, Hansen, B, Levy, C, MurilloPerez C. F., Ioannou S., Hassanally I., Trivedi P. J., Corpechot C., van der Meer A. J., Lammers W. J., Battezzati P. M., Lindor K. D., Nevens F., Kowdley K. V., Bruns T., Cazzagon N., Floreani A., Mason A. L., Gulamhusein A., Ponsioen C. Y., Carbone M., Lleo A., Mayo M. J., Dalekos G. N., Gatselis N. K., Thorburn D., Verhelst X., Pares A., Londono M. -C., Janssen H. L. A., Invernizzi P., Vuppalanchi R., Hirschfield G. M., Hansen B. E., and Levy C.
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 <1.67 × upper limit of normal (ULN) and normal total bilirubin at one year. Various thresholds of ALP at six months were evaluated to predict insufficient response based on negative predictive value (NPV) and that with nearest to 90% NPV was selected. Results: For the study, 1362 patients were included, 1232 (90.5%) female, mean age of 54 years. The POISE criteria were met by 56.4% (n = 768) of patients at one year. The median ALP (IQR) of those who met POISE criteria compared to those who did not was 1.05 × ULN (0.82–1.33) vs. 2.37 × ULN (1.72–3.69) at six months (p <.001). Of 235 patients with serum 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

9. Geographical region and clinical outcomes of patients with primary biliary cholangitis from Western Europe

Author: Murillo Perez, C, Gerussi, A, Trivedi, P, Corpechot, C, Van Der Meer, A, Maria Battezzati, P, Lindor, K, Nevens, F, Kowdley, K, Bruns, T, Cazzagon, N, Floreani, A, Tanaka, A, Ma, X, Mason, A, Gulamhusein, A, Ponsioen, C, Carbone, M, Lleo, A, Mayo, M, Dalekos, G, Gatselis, N, Thorburn, D, Verhelst, X, Pares, A, Janssen, H, Hirschfield, G, Hansen, B, Invernizzi, P, Lammers, W, Murillo Perez C. F., Gerussi A., Trivedi P. J., Corpechot C., Van Der Meer A. J., Maria Battezzati P., Lindor K. D., Nevens F., Kowdley K. V., Bruns T., Cazzagon N., Floreani A., Tanaka A., Ma X., Mason A. L., Gulamhusein A., Ponsioen C. Y., Carbone M., Lleo A., Mayo M. J., Dalekos G. N., Gatselis N. K., Thorburn D., Verhelst X., Pares A., Janssen H. L. A., Hirschfield G. M., Hansen B. E., Invernizzi P., Lammers W. J., Murillo Perez, C, Gerussi, A, Trivedi, P, Corpechot, C, Van Der Meer, A, Maria Battezzati, P, Lindor, K, Nevens, F, Kowdley, K, Bruns, T, Cazzagon, N, Floreani, A, Tanaka, A, Ma, X, Mason, A, Gulamhusein, A, Ponsioen, C, Carbone, M, Lleo, A, Mayo, M, Dalekos, G, Gatselis, N, Thorburn, D, Verhelst, X, Pares, A, Janssen, H, Hirschfield, G, Hansen, B, Invernizzi, P, Lammers, W, Murillo Perez C. F., Gerussi A., Trivedi P. J., Corpechot C., Van Der Meer A. J., Maria Battezzati P., Lindor K. D., Nevens F., Kowdley K. V., Bruns T., Cazzagon N., Floreani A., Tanaka A., Ma X., Mason A. L., Gulamhusein A., Ponsioen C. Y., Carbone M., Lleo A., Mayo M. J., Dalekos G. N., Gatselis N. K., Thorburn D., Verhelst X., Pares A., Janssen H. L. A., Hirschfield G. M., Hansen B. E., Invernizzi P., and Lammers W. J.
Abstract: Background and aims The are geographic variations in the incidence and prevalence of primary biliary cholangitis (PBC). The aim was to explore whether clinical outcomes of patients within Western Europe differ according to geographical region. Methods Ursodeoxycholic acid-treated patients from European centers from the Global PBC database diagnosed from 1990 onwards were included. Patients with a time lag > 1 year from diagnosis to start of follow-up were excluded. Differences in baseline characteristics were studied according to North/South and East/West, whereas outcomes (transplant-free survival and decompensation) were studied with center latitude and longitude. Cox regression analyses were adjusted for age, sex, diagnosis year, biochemical markers, and cirrhosis as a time-dependent covariate. Results One thousand eight hundred seventy-eight patients were included, and there were no geographical differences in age or sex, with a mean age of 54 years and 89% female patients. Those in North Europe were more often of a moderately advanced/advanced Rotterdam biochemical stage (28.4%) compared with South Europe (20.6%). Additionally, they exhibited higher median alkaline phosphatase (2.0 ×ULN vs. 1.4 ×ULN) and transaminases. In multivariable analysis, there was a significant interaction between center latitude and longitude for decompensation (P < 0.001) and a trend for transplant-free survival, in which the Northwestern area demonstrated an increased risk for poor outcomes as compared to the reference (Paris). Conclusion We describe geographic variations in outcomes for patients across Europe from specialist centers in the Global PBC Study Group. Further study is important to explore the potential individual, environmental, and healthcare-related factors that may be contributors.
Published: 2023

10. Incidence and predictors of hepatocellular carcinoma in patients with autoimmune hepatitis

Author: Colapietro, Francesca, primary, Maisonneuve, Patrick, additional, Lytvyak, Ellina, additional, Beuers, Ulrich, additional, Verdonk, Robert C., additional, van der Meer, Adriaan J., additional, van Hoek, Bart, additional, Kuiken, Sjoerd D., additional, Brouwer, Johannes T., additional, Muratori, Paolo, additional, Aghemo, Alessio, additional, Carella, Francesco, additional, van den Berg, Ad P., additional, Zachou, Kalliopi, additional, Dalekos, George N., additional, Di Zeo-Sánchez, Daniel E., additional, Robles, Mercedes, additional, Andrade, Raul J., additional, Montano-Loza, Aldo J., additional, van den Brand, Floris F., additional, Slooter, Charlotte D., additional, Macedo, Guilherme, additional, Liberal, Rodrigo, additional, de Boer, Ynto S., additional, Lleo, Ana, additional, van Gerven, N., additional, van Erpecum, K., additional, Ouden, J den, additional, Brouwer, J., additional, Vrolijk, J., additional, Gevers, T.J., additional, Drenth, J., additional, Guichelaar, M., additional, Bouma, G., additional, Schreuder, T.C.M.A., additional, van der Wouden, E.J., additional, Baak, L.C., additional, Stadhouders, P., additional, Klemt-Kropp, M., additional, Verhagen, M., additional, Bhalla, A., additional, Kuijvenhoven, J., additional, Almasio, P., additional, Alvarez, F., additional, Andrade, R., additional, Arikan, C., additional, Assis, D., additional, Bardou-Jacquet, E., additional, Biewenga, M., additional, Cancado, E., additional, Cazzagon, N., additional, Chazouillères, O., additional, Colloredo, G., additional, Cuarterolo, M., additional, Dalekos, G., additional, Debray, D., additional, Robles-Díaz, M., additional, Dyson, J., additional, Efe, C., additional, Engel, B., additional, Ferri, S., additional, Fontana, R., additional, Gatselis, N., additional, Gerussi, A., additional, Halilbasic, E., additional, Halliday, N., additional, Heneghan, M., additional, Hirschfield, G., additional, van Hoek, B., additional, Hørby Jørgensen, M., additional, Indolfini, G., additional, Iorio, R., additional, Invernizzi, P., additional, Jeong, S., additional, Jones, D., additional, Kelly, D., additional, Kerkar, N., additional, Lacaille, F., additional, Lammert, C., additional, Leggett, B., additional, Lenzi, M., additional, Levy, C., additional, Liberal, R., additional, Lleo, A., additional, Lohse, A., additional, Lopez, S. Ines, additional, de Martin, E., additional, McLin, V., additional, Mieli-Vergani, G., additional, Milkiewicz, P., additional, Mohan, N., additional, Muratori, L., additional, Nebbia, G., additional, van Nieuwkerk, C., additional, Oo, Y., additional, Ortega, A., additional, Páres, A., additional, Pop, T., additional, Pratt, D., additional, Purnak, T., additional, Ranucci, G., additional, Rushbrook, S., additional, Schramm, C., additional, Stättermayer, A., additional, Swain, M., additional, Tanaka, A., additional, Taubert, R., additional, Terrabuio, D., additional, Terziroli, B., additional, Trauner, M., additional, Valentino, P., additional, van den Brand, F., additional, Vergani, D., additional, Villamil, A., additional, Wahlin, S., additional, Ytting, H., additional, Zachou, K., additional, and Zeniya, M., additional
Published: 2023
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11. Longer transplant-free and liver-related event-free survival in obeticholic acid-treated patients with primary biliary cholangitis compared to external controls from two large real-world cohorts

Author: Terracciani, F., De Vincentis, A., D'Amato, D., Invernizzi, P., Morgando, A., Vanni, E., Viganò, M., Alvaro, D., Venere, R., Lleo, A., Colapietro, F., Degasperi, E., Viganò, R., Giannini, E.G., Labanca, S., Feletti, V., Mussetto, A., Cozzolongo, R., Losito, F., Pompili, M., Ponziani, F.R., Niro, G.A., Cotugno, R., Pozzoni, P., Chessa, L., Cuccorese, G., Pace Palitti, V., Russello, M., Cannavò, M., Frazzetto, E., Bertino, G., Marzioni, M., Terreni, N., Zolfino, T., Saitta, C., Pellicelli, A., Coco, B., Brunetto, M., Cazzagon, N., Floreani, A., Muratori, L., Rosina, F., Stefano, M. Di, Scifo, G., Baiocchi, L., Grassi, G., Sacco, R., Izzi, A., Crocè, S.L., Fiorini, C., Marra, F., Galli, A., Simone, L., Morelli, O., Abenavoli, L., Pizzolante, F., De Matthaeis, N., Scaravaglio, M., Gimignani, G., Boano, V., Manfredi, G.F., Marignani, M., Fanella, S., Giacchetto, M., Castellaneta, A., Poggi, G., Buzzanca, V., Scivetti, P., Tortora, A., Casella, S., Bellia, V., Omazzi, B.F., Alagna, G., Ricci, C., Poisa, P., Rigamonti, C., Calvaruso, V., Corpechot, C., Carrat, F., Hirschfield, G., Gulamhusein, A., Levy, C., Tananka, A., Montano-Loza, A. J, Londono, M., Eaton, J. E, Dalekos, G. N, Gatselis, N., Abbas, N., Trivedi, P., Thorburn, D., Bonder, A., van der Meer, A., Zigmond, E., Kremer, A. E, Bruns, T., Chazouilleres, O., Hansen, B. E, Carbone, M., and Vespasiani-Gentilucci, U.
Published: 2024
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12. Greater Transplant-Free Survival in Patients Receiving Obeticholic Acid for Primary Biliary Cholangitis in a Clinical Trial Setting Compared to Real-World External Controls

Author: Murillo Perez, C, Fisher, H, Hiu, S, Kareithi, D, Adekunle, F, Mayne, T, Malecha, E, Ness, E, van der Meer, A, Lammers, W, Trivedi, P, Battezzati, P, Nevens, F, Kowdley, K, Bruns, T, Cazzagon, N, Floreani, A, Mason, A, Pares, A, Londono, M, Invernizzi, P, Carbone, M, Lleo, A, Mayo, M, Dalekos, G, Gatselis, N, Thorburn, D, Verhelst, X, Gulamhusein, A, Janssen, H, Smith, R, Flack, S, Mulcahy, V, Trauner, M, Bowlus, C, Lindor, K, Corpechot, C, Jones, D, Mells, G, Hirschfield, G, Wason, J, Hansen, B, Sturgess, R, Healey, C, Gunasekera, A, Kallis, Y, Wright, G, Mathialahan, T, Evans, R, Gasem, J, Ramanaden, D, Ward, E, Bhalme, M, Southern, P, Maggs, J, Yousif, M, Srivastava, B, Foxton, M, Collins, C, Prasad, Y, Porras-Perez, F, Yapp, T, Patel, M, Ede, R, Carte, M, Koss, K, Sattianayagam, P, Grimley, C, Tidbury, J, Mansour, D, Beckley, M, Hollywood, C, Ramag, J, Gordon, H, Ridpath, J, Grover, B, Abouda, G, Rees, I, Narain, M, Salam, I, Banim, P, Das, D, Matthews, H, Mohammed, F, Jones, R, Sen, S, Bird, G, Prince, M, Prasad, G, Kitchen, P, Hutchinson, J, Gupta, P, Shah, A, Saha, S, Pollock, K, Barclay, S, Mcdonald, N, Rushbrook, S, Przemioslo, R, Millar, A, Mitchell, S, Davis, A, Naqvi, A, Lee, T, Ryder, S, Collier, J, Cramp, M, Aspinal, R, Booth, J, Williams, E, Hussaini, H, Christie, J, Chaudhry, T, Mann, S, Ala, A, Maltby, J, Corbett, C, Singhal, S, Hoeroldt, B, Butterworth, J, Douglas, A, Sinha, R, Panter, S, Shearman, J, Bray, G, Roberts, M, Forton, D, Taylor, N, Jafar, W, Cowan, M, Ch'Ng, C, Rahman, M, Wesley, E, Jain, S, Mandal, A, Wright, M, Gordon, F, Unitt, E, Austin, A, Palegwala, A, Vemala, V, Higham, A, Fraser, J, Li, A, Ramakrishnan, S, King, A, Whalley, S, Gee, I, Keld, R, Fellows, H, Gotto, J, Millson, C, Murillo Perez C. F., Fisher H., Hiu S., Kareithi D., Adekunle F., Mayne T., Malecha E., Ness E., van der Meer A. J., Lammers W. J., Trivedi P. J., Battezzati P. M., Nevens F., Kowdley K. V., Bruns T., Cazzagon N., Floreani A., Mason A. L., Pares A., Londono M. -C., Invernizzi P., Carbone M., Lleo A., Mayo M. J., Dalekos G. N., Gatselis N. K., Thorburn D., Verhelst X., Gulamhusein A., Janssen H. L. A., Smith R., Flack S., Mulcahy V., Trauner M., Bowlus C. L., Lindor K. D., Corpechot C., Jones D., Mells G., Hirschfield G. M., Wason J., Hansen B. E., Sturgess R., Healey C., Gunasekera A., Kallis Y., Wright G., Mathialahan T., Evans R., Gasem J., Ramanaden D., Ward E., Bhalme M., Southern P., Maggs J., Yousif M., Srivastava B., Foxton M., Collins C., Prasad Y., Porras-Perez F., Yapp T., Patel M., Ede R., Carte M., Koss K., Sattianayagam P., Grimley C., Tidbury J., Mansour D., Beckley M., Hollywood C., Ramag J., Gordon H., Ridpath J., Grover B., Abouda G., Rees I., Narain M., Salam I., Banim P., Das D., Matthews H., Mohammed F., Jones R., Sen S., Bird G., Prince M., Prasad G., Kitchen P., Hutchinson J., Gupta P., Shah A., Saha S., Pollock K., Barclay S., McDonald N., Rushbrook S., Przemioslo R., Millar A., Mitchell S., Davis A., Naqvi A., Lee T., Ryder S., Collier J., Cramp M., Aspinal R., Booth J., Williams E., Hussaini H., Christie J., Chaudhry T., Mann S., Ala A., Maltby J., Corbett C., Singhal S., Hoeroldt B., Butterworth J., Douglas A., Sinha R., Panter S., Shearman J., Bray G., Roberts M., Forton D., Taylor N., Jafar W., Cowan M., Ch'ng C. L., Rahman M., Wesley E., Jain S., Mandal A., Wright M., Trivedi P., Gordon F., Unitt E., Austin A., Palegwala A., Vemala V., Higham A., Fraser J., Li A., Ramakrishnan S., King A., Whalley S., Gee I., Keld R., Fellows H., Gotto J., Millson C., Murillo Perez, C, Fisher, H, Hiu, S, Kareithi, D, Adekunle, F, Mayne, T, Malecha, E, Ness, E, van der Meer, A, Lammers, W, Trivedi, P, Battezzati, P, Nevens, F, Kowdley, K, Bruns, T, Cazzagon, N, Floreani, A, Mason, A, Pares, A, Londono, M, Invernizzi, P, Carbone, M, Lleo, A, Mayo, M, Dalekos, G, Gatselis, N, Thorburn, D, Verhelst, X, Gulamhusein, A, Janssen, H, Smith, R, Flack, S, Mulcahy, V, Trauner, M, Bowlus, C, Lindor, K, Corpechot, C, Jones, D, Mells, G, Hirschfield, G, Wason, J, Hansen, B, Sturgess, R, Healey, C, Gunasekera, A, Kallis, Y, Wright, G, Mathialahan, T, Evans, R, Gasem, J, Ramanaden, D, Ward, E, Bhalme, M, Southern, P, Maggs, J, Yousif, M, Srivastava, B, Foxton, M, Collins, C, Prasad, Y, Porras-Perez, F, Yapp, T, Patel, M, Ede, R, Carte, M, Koss, K, Sattianayagam, P, Grimley, C, Tidbury, J, Mansour, D, Beckley, M, Hollywood, C, Ramag, J, Gordon, H, Ridpath, J, Grover, B, Abouda, G, Rees, I, Narain, M, Salam, I, Banim, P, Das, D, Matthews, H, Mohammed, F, Jones, R, Sen, S, Bird, G, Prince, M, Prasad, G, Kitchen, P, Hutchinson, J, Gupta, P, Shah, A, Saha, S, Pollock, K, Barclay, S, Mcdonald, N, Rushbrook, S, Przemioslo, R, Millar, A, Mitchell, S, Davis, A, Naqvi, A, Lee, T, Ryder, S, Collier, J, Cramp, M, Aspinal, R, Booth, J, Williams, E, Hussaini, H, Christie, J, Chaudhry, T, Mann, S, Ala, A, Maltby, J, Corbett, C, Singhal, S, Hoeroldt, B, Butterworth, J, Douglas, A, Sinha, R, Panter, S, Shearman, J, Bray, G, Roberts, M, Forton, D, Taylor, N, Jafar, W, Cowan, M, Ch'Ng, C, Rahman, M, Wesley, E, Jain, S, Mandal, A, Wright, M, Gordon, F, Unitt, E, Austin, A, Palegwala, A, Vemala, V, Higham, A, Fraser, J, Li, A, Ramakrishnan, S, King, A, Whalley, S, Gee, I, Keld, R, Fellows, H, Gotto, J, Millson, C, Murillo Perez C. F., Fisher H., Hiu S., Kareithi D., Adekunle F., Mayne T., Malecha E., Ness E., van der Meer A. J., Lammers W. J., Trivedi P. J., Battezzati P. M., Nevens F., Kowdley K. V., Bruns T., Cazzagon N., Floreani A., Mason A. L., Pares A., Londono M. -C., Invernizzi P., Carbone M., Lleo A., Mayo M. J., Dalekos G. N., Gatselis N. K., Thorburn D., Verhelst X., Gulamhusein A., Janssen H. L. A., Smith R., Flack S., Mulcahy V., Trauner M., Bowlus C. L., Lindor K. D., Corpechot C., Jones D., Mells G., Hirschfield G. M., Wason J., Hansen B. E., Sturgess R., Healey C., Gunasekera A., Kallis Y., Wright G., Mathialahan T., Evans R., Gasem J., Ramanaden D., Ward E., Bhalme M., Southern P., Maggs J., Yousif M., Srivastava B., Foxton M., Collins C., Prasad Y., Porras-Perez F., Yapp T., Patel M., Ede R., Carte M., Koss K., Sattianayagam P., Grimley C., Tidbury J., Mansour D., Beckley M., Hollywood C., Ramag J., Gordon H., Ridpath J., Grover B., Abouda G., Rees I., Narain M., Salam I., Banim P., Das D., Matthews H., Mohammed F., Jones R., Sen S., Bird G., Prince M., Prasad G., Kitchen P., Hutchinson J., Gupta P., Shah A., Saha S., Pollock K., Barclay S., McDonald N., Rushbrook S., Przemioslo R., Millar A., Mitchell S., Davis A., Naqvi A., Lee T., Ryder S., Collier J., Cramp M., Aspinal R., Booth J., Williams E., Hussaini H., Christie J., Chaudhry T., Mann S., Ala A., Maltby J., Corbett C., Singhal S., Hoeroldt B., Butterworth J., Douglas A., Sinha R., Panter S., Shearman J., Bray G., Roberts M., Forton D., Taylor N., Jafar W., Cowan M., Ch'ng C. L., Rahman M., Wesley E., Jain S., Mandal A., Wright M., Trivedi P., Gordon F., Unitt E., Austin A., Palegwala A., Vemala V., Higham A., Fraser J., Li A., Ramakrishnan S., King A., Whalley S., Gee I., Keld R., Fellows H., Gotto J., and Millson C.
Abstract: Background & Aims: The Primary Biliary Cholangitis (PBC) Obeticholic Acid (OCA) International Study of Efficacy (POISE) randomized, double-blind, placebo-controlled trial demonstrated that OCA reduced biomarkers associated with adverse clinical outcomes (ie, alkaline phosphatase, bilirubin, aspartate aminotransferase, and alanine aminotransferase) in patients with PBC. The objective of this study was to evaluate time to first occurrence of liver transplantation or death in patients with OCA in the POISE trial and open-label extension vs comparable non-OCA–treated external controls. Methods: Propensity scores were generated for external control patients meeting POISE eligibility criteria from 2 registry studies (Global PBC and UK-PBC) using an index date selected randomly between the first and last date (inclusive) on which eligibility criteria were met. Cox proportional hazards models weighted by inverse probability of treatment assessed time to death or liver transplantation. Additional analyses (Global PBC only) added hepatic decompensation to the composite end point and assessed efficacy in patients with or without cirrhosis. Results: During the 6-year follow-up, there were 5 deaths or liver transplantations in 209 subjects in the POISE cohort (2.4%), 135 of 1381 patients in the Global PBC control (10.0%), and 281 of 2135 patients in the UK-PBC control (13.2%). The hazard ratios (HRs) for the primary outcome were 0.29 (95% CI, 0.10–0.83) for POISE vs Global PBC and 0.30 (95% CI, 0.12–0.75) for POISE vs UK-PBC. In the Global PBC study, HR was 0.20 (95% CI, 0.03–1.22) for patients with cirrhosis and 0.31 (95% CI, 0.09–1.04) for those without cirrhosis; HR was 0.42 (95% CI, 0.21–0.85) including hepatic decompensation. Conclusions: Patients treated with OCA in a trial setting had significantly greater transplant-free survival than comparable external control patients.
Published: 2022

13. Liver injury after SARS-CoV-2 vaccination: Features of immune-mediated hepatitis, role of corticosteroid therapy and outcome

Author: Efe, C, Kulkarni, A, Terziroli Beretta-Piccoli, B, Magro, B, Friedrich Stattermayer, A, Cengiz, M, Clayton-Chubb, D, Lammert, C, Bernsmeier, C, Gul, O, la Tijera, F, Anders, M, Lytvyak, E, Akin, M, Purnak, T, Liberal, R, Peralta, M, Ebik, B, Duman, S, Demir, N, Balaban, Y, Urzua, A, Contreras, F, Venturelli, M, Bilgic, Y, Medina, A, Girala, M, Gunsar, F, Londono, M, Androutsakos, T, Kisch, A, Yurci, A, Guzelbult, F, Cagin, Y, Avci, E, Guzelbulut, M, Dindar-Demiray, E, Harputluoglu, M, Kumar, R, Satapathy, S, Mendizabal, M, Silva, M, Fagiuoli, S, Roberts, S, Soylu, N, Idilman, R, Yoshida, E, Montano-Loza, A, Dalekos, G, Ridruejo, E, Schiano, T, Wahlin, S, Efe C., Kulkarni A. V., Terziroli Beretta-Piccoli B., Magro B., Friedrich Stattermayer A., Cengiz M., Clayton-Chubb D., Lammert C., Bernsmeier C., Gul O., la Tijera F. H. -D., Anders M., Lytvyak E., Akin M., Purnak T., Liberal R., Peralta M., Ebik B., Duman S., Demir N., Balaban Y., Urzua A., Contreras F., Venturelli M. G., Bilgic Y., Medina A., Girala M., Gunsar F., Londono M. -C., Androutsakos T., Kisch A., Yurci A., Guzelbult F., Cagin Y. F., Avci E., Guzelbulut M., Dindar-Demiray E. K., Harputluoglu M., Kumar R., Satapathy S. K., Mendizabal M., Silva M., Fagiuoli S., Roberts S. K., Soylu N. K., Idilman R., Yoshida E. M., Montano-Loza A. J., Dalekos G. N., Ridruejo E., Schiano T. D., Wahlin S., Efe, C, Kulkarni, A, Terziroli Beretta-Piccoli, B, Magro, B, Friedrich Stattermayer, A, Cengiz, M, Clayton-Chubb, D, Lammert, C, Bernsmeier, C, Gul, O, la Tijera, F, Anders, M, Lytvyak, E, Akin, M, Purnak, T, Liberal, R, Peralta, M, Ebik, B, Duman, S, Demir, N, Balaban, Y, Urzua, A, Contreras, F, Venturelli, M, Bilgic, Y, Medina, A, Girala, M, Gunsar, F, Londono, M, Androutsakos, T, Kisch, A, Yurci, A, Guzelbult, F, Cagin, Y, Avci, E, Guzelbulut, M, Dindar-Demiray, E, Harputluoglu, M, Kumar, R, Satapathy, S, Mendizabal, M, Silva, M, Fagiuoli, S, Roberts, S, Soylu, N, Idilman, R, Yoshida, E, Montano-Loza, A, Dalekos, G, Ridruejo, E, Schiano, T, Wahlin, S, Efe C., Kulkarni A. V., Terziroli Beretta-Piccoli B., Magro B., Friedrich Stattermayer A., Cengiz M., Clayton-Chubb D., Lammert C., Bernsmeier C., Gul O., la Tijera F. H. -D., Anders M., Lytvyak E., Akin M., Purnak T., Liberal R., Peralta M., Ebik B., Duman S., Demir N., Balaban Y., Urzua A., Contreras F., Venturelli M. G., Bilgic Y., Medina A., Girala M., Gunsar F., Londono M. -C., Androutsakos T., Kisch A., Yurci A., Guzelbult F., Cagin Y. F., Avci E., Guzelbulut M., Dindar-Demiray E. K., Harputluoglu M., Kumar R., Satapathy S. K., Mendizabal M., Silva M., Fagiuoli S., Roberts S. K., Soylu N. K., Idilman R., Yoshida E. M., Montano-Loza A. J., Dalekos G. N., Ridruejo E., Schiano T. D., and Wahlin S.
Abstract: Background and Aims: A few case reports of autoimmune hepatitis–like liver injury have been reported after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination. We evaluated clinical features, treatment response and outcomes of liver injury following SARS-CoV-2 vaccination in a large case series. Approach and Results: We collected data from cases in 18 countries. The type of liver injury was assessed with the R-value. The study population was categorized according to features of immune-mediated hepatitis (positive autoantibodies and elevated immunoglobulin G levels) and corticosteroid therapy for the liver injury. We identified 87 patients (63%, female), median age 48 (range: 18–79) years at presentation. Liver injury was diagnosed a median 15 (range: 3–65) days after vaccination. Fifty-one cases (59%) were attributed to the Pfizer-BioNTech (BNT162b2) vaccine, 20 (23%) cases to the Oxford-AstraZeneca (ChAdOX1 nCoV-19) vaccine and 16 (18%) cases to the Moderna (mRNA-1273) vaccine. The liver injury was predominantly hepatocellular (84%) and 57% of patients showed features of immune-mediated hepatitis. Corticosteroids were given to 46 (53%) patients, more often for grade 3–4 liver injury than for grade 1–2 liver injury (88.9% vs. 43.5%, p = 0.001) and more often for patients with than without immune-mediated hepatitis (71.1% vs. 38.2%, p = 0.003). All patients showed resolution of liver injury except for one man (1.1%) who developed liver failure and underwent liver transplantation. Steroid therapy was withdrawn during the observation period in 12 (26%) patients after complete biochemical resolution. None had a relapse during follow-up. Conclusions: SARS-CoV-2 vaccination can be associated with liver injury. Corticosteroid therapy may be beneficial in those with immune-mediated features or severe hepatitis. Outcome was generally favorable, but vaccine-associated liver injury led to fulminant liver failure in one patient.
Published: 2022

14. SARS-CoV-2 vaccination and risk of severe COVID-19 outcomes in patients with autoimmune hepatitis

Author: Efe, C, Tascilar, K, Gerussi, A, Bolis, F, Lammert, C, Ebik, B, Stattermayer, A, Cengiz, M, Gokce, D, Cristoferi, L, Peralta, M, Massoumi, H, Montes, P, Cerda, E, Rigamonti, C, Yapali, S, Adali, G, Caliskan, A, Balaban, Y, Eren, F, Eskazan, T, Barutcu, S, Lytvyak, E, Zazueta, G, Kayhan, M, Heurgue-Berlot, A, De Martin, E, Yavuz, A, Biyik, M, Narro, G, Duman, S, Hernandez, N, Gatselis, N, Aguirre, J, Idilman, R, Silva, M, Mendizabal, M, Atay, K, Guzelbulut, F, Dhanasekaran, R, Montano-Loza, A, Dalekos, G, Ridruejo, E, Invernizzi, P, Wahlin, S, Efe C., Tascilar K., Gerussi A., Bolis F., Lammert C., Ebik B., Stattermayer A. F., Cengiz M., Gokce D. T., Cristoferi L., Peralta M., Massoumi H., Montes P., Cerda E., Rigamonti C., Yapali S., Adali G., Caliskan A. R., Balaban Y., Eren F., Eskazan T., Barutcu S., Lytvyak E., Zazueta G. M., Kayhan M. A., Heurgue-Berlot A., De Martin E., Yavuz A., Biyik M., Narro G. C., Duman S., Hernandez N., Gatselis N. K., Aguirre J., Idilman R., Silva M., Mendizabal M., Atay K., Guzelbulut F., Dhanasekaran R., Montano-Loza A. J., Dalekos G. N., Ridruejo E., Invernizzi P., Wahlin S., Efe, C, Tascilar, K, Gerussi, A, Bolis, F, Lammert, C, Ebik, B, Stattermayer, A, Cengiz, M, Gokce, D, Cristoferi, L, Peralta, M, Massoumi, H, Montes, P, Cerda, E, Rigamonti, C, Yapali, S, Adali, G, Caliskan, A, Balaban, Y, Eren, F, Eskazan, T, Barutcu, S, Lytvyak, E, Zazueta, G, Kayhan, M, Heurgue-Berlot, A, De Martin, E, Yavuz, A, Biyik, M, Narro, G, Duman, S, Hernandez, N, Gatselis, N, Aguirre, J, Idilman, R, Silva, M, Mendizabal, M, Atay, K, Guzelbulut, F, Dhanasekaran, R, Montano-Loza, A, Dalekos, G, Ridruejo, E, Invernizzi, P, Wahlin, S, Efe C., Tascilar K., Gerussi A., Bolis F., Lammert C., Ebik B., Stattermayer A. F., Cengiz M., Gokce D. T., Cristoferi L., Peralta M., Massoumi H., Montes P., Cerda E., Rigamonti C., Yapali S., Adali G., Caliskan A. R., Balaban Y., Eren F., Eskazan T., Barutcu S., Lytvyak E., Zazueta G. M., Kayhan M. A., Heurgue-Berlot A., De Martin E., Yavuz A., Biyik M., Narro G. C., Duman S., Hernandez N., Gatselis N. K., Aguirre J., Idilman R., Silva M., Mendizabal M., Atay K., Guzelbulut F., Dhanasekaran R., Montano-Loza A. J., Dalekos G. N., Ridruejo E., Invernizzi P., and Wahlin S.
Abstract: Background: Data regarding outcome of Coronavirus disease 2019 (COVID-19) in vaccinated patients with autoimmune hepatitis (AIH) are lacking. We evaluated the outcome of COVID-19 in AIH patients who received at least one dose of Pfizer- BioNTech (BNT162b2), Moderna (mRNA-1273) or AstraZeneca (ChAdOx1-S) vaccine. Patients and methods: We performed a retrospective study on AIH patients with COVID-19. The outcomes of AIH patients who had acute respiratory syndrome coronavirus 2 (SARS-CoV-2) breakthrough infection after at least one dose of COVID-19 vaccine were compared to unvaccinated patients with AIH. COVID-19 outcome was classified according to clinical state during the disease course as: (i) no hospitalization, (ii) hospitalization without oxygen supplementation, (iii) hospitalization with oxygen supplementation by nasal cannula or mask, (iv) intensive care unit (ICU) admission with non-invasive mechanical ventilation, (v) ICU admission with invasive mechanical ventilation or (vi) death, and data was analyzed using ordinal logistic regression. Results: We included 413 (258 unvaccinated and 155 vaccinated) patients (81%, female) with a median age of 52 (range: 17–85) years at COVID-19 diagnosis. The rates of hospitalization were (36.4% vs. 14.2%), need for any supplemental oxygen (29.5% vs. 9%) and mortality (7% vs. 0.6%) in unvaccinated and vaccinated AIH patients with COVID-19. Having received at least one dose of SARS-CoV-2 vaccine was associated with a significantly lower risk of worse COVID-19 severity, after adjusting for age, sex, comorbidities and presence of cirrhosis (adjusted odds ratio [aOR] 0.18, 95% confidence interval [CI], 0.10–0.31). Overall, vaccination against SARS-CoV-2 was associated with a significantly lower risk of mortality from COVID-19 (aOR 0.20, 95% CI 0.11–0.35). Conclusions: SARS-CoV-2 vaccination significantly reduced the risk of COVID-19 severity and mortality in patients with AIH.
Published: 2022

15. Systematic review of response criteria and endpoints in autoimmune hepatitis by the International Autoimmune Hepatitis Group

Author: Pape, S, Snijders, R, Gevers, T, Chazouilleres, O, Dalekos, G, Hirschfield, G, Lenzi, M, Trauner, M, Manns, M, Vierling, J, Montano-Loza, A, Lohse, A, Schramm, C, Drenth, J, Heneghan, M, Almasio, P, Alvarez, F, Andrade, R, Arikan, C, Assis, D, Bardou-Jacquet, E, Biewenga, M, Cancado, E, Cazzagon, N, Colloredo, G, Cuarterolo, M, Debray, D, Robles-Diaz, M, Dyson, J, Efe, C, Engel, B, Ferri, S, Fontana, R, Gatselis, N, Gerussi, A, Halilbasic, E, Halliday, N, van Hoek, B, Horby Jorgensen, M, Indolfini, G, Iorio, R, Jeong, S, Jones, D, Kelly, D, Kerkar, N, Lacaille, F, Lammert, C, Leggett, B, Levy, C, Liberal, R, Lleo, A, Ines Lopez, S, de Martin, E, Mclin, V, Mieli-Vergani, G, Milkiewicz, P, Mohan, N, Muratori, L, Nebbia, G, van Nieuwkerk, C, Oo, Y, Ortega, A, Pares, A, Pop, T, Pratt, D, Purnak, T, Ranucci, G, Rushbrook, S, Stattermayer, A, Swain, M, Tanaka, A, Taubert, R, Terrabuio, D, Terziroli, B, Valentino, P, van den Brand, F, Villamil, A, Wahlin, S, Ytting, H, Zachou, K, Zeniya, M, Pape S., Snijders R. J. A. L. M., Gevers T. J. G., Chazouilleres O., Dalekos G. N., Hirschfield G. M., Lenzi M., Trauner M., Manns M. P., Vierling J. M., Montano-Loza A. J., Lohse A. W., Schramm C., Drenth J. P. H., Heneghan M. A., Almasio P., Alvarez F., Andrade R., Arikan C., Assis D., Bardou-Jacquet E., Biewenga M., Cancado E., Cazzagon N., Colloredo G., Cuarterolo M., Dalekos G., Debray D., Robles-Diaz M., Drenth J., Dyson J., Efe C., Engel B., Ferri S., Fontana R., Gatselis N., Gerussi A., Halilbasic E., Halliday N., Heneghan M., Hirschfield G., van Hoek B., Horby Jorgensen M., Indolfini G., Iorio R., Jeong S., Jones D., Kelly D., Kerkar N., Lacaille F., Lammert C., Leggett B., Levy C., Liberal R., Lleo A., Lohse A., Ines Lopez S., de Martin E., McLin V., Mieli-Vergani G., Milkiewicz P., Mohan N., Muratori L., Nebbia G., van Nieuwkerk C., Oo Y., Ortega A., Pares A., Pop T., Pratt D., Purnak T., Ranucci G., Rushbrook S., Stattermayer A., Swain M., Tanaka A., Taubert R., Terrabuio D., Terziroli B., Valentino P., van den Brand F., Villamil A., Wahlin S., Ytting H., Zachou K., Zeniya M., Pape, S, Snijders, R, Gevers, T, Chazouilleres, O, Dalekos, G, Hirschfield, G, Lenzi, M, Trauner, M, Manns, M, Vierling, J, Montano-Loza, A, Lohse, A, Schramm, C, Drenth, J, Heneghan, M, Almasio, P, Alvarez, F, Andrade, R, Arikan, C, Assis, D, Bardou-Jacquet, E, Biewenga, M, Cancado, E, Cazzagon, N, Colloredo, G, Cuarterolo, M, Debray, D, Robles-Diaz, M, Dyson, J, Efe, C, Engel, B, Ferri, S, Fontana, R, Gatselis, N, Gerussi, A, Halilbasic, E, Halliday, N, van Hoek, B, Horby Jorgensen, M, Indolfini, G, Iorio, R, Jeong, S, Jones, D, Kelly, D, Kerkar, N, Lacaille, F, Lammert, C, Leggett, B, Levy, C, Liberal, R, Lleo, A, Ines Lopez, S, de Martin, E, Mclin, V, Mieli-Vergani, G, Milkiewicz, P, Mohan, N, Muratori, L, Nebbia, G, van Nieuwkerk, C, Oo, Y, Ortega, A, Pares, A, Pop, T, Pratt, D, Purnak, T, Ranucci, G, Rushbrook, S, Stattermayer, A, Swain, M, Tanaka, A, Taubert, R, Terrabuio, D, Terziroli, B, Valentino, P, van den Brand, F, Villamil, A, Wahlin, S, Ytting, H, Zachou, K, Zeniya, M, Pape S., Snijders R. J. A. L. M., Gevers T. J. G., Chazouilleres O., Dalekos G. N., Hirschfield G. M., Lenzi M., Trauner M., Manns M. P., Vierling J. M., Montano-Loza A. J., Lohse A. W., Schramm C., Drenth J. P. H., Heneghan M. A., Almasio P., Alvarez F., Andrade R., Arikan C., Assis D., Bardou-Jacquet E., Biewenga M., Cancado E., Cazzagon N., Colloredo G., Cuarterolo M., Dalekos G., Debray D., Robles-Diaz M., Drenth J., Dyson J., Efe C., Engel B., Ferri S., Fontana R., Gatselis N., Gerussi A., Halilbasic E., Halliday N., Heneghan M., Hirschfield G., van Hoek B., Horby Jorgensen M., Indolfini G., Iorio R., Jeong S., Jones D., Kelly D., Kerkar N., Lacaille F., Lammert C., Leggett B., Levy C., Liberal R., Lleo A., Lohse A., Ines Lopez S., de Martin E., McLin V., Mieli-Vergani G., Milkiewicz P., Mohan N., Muratori L., Nebbia G., van Nieuwkerk C., Oo Y., Ortega A., Pares A., Pop T., Pratt D., Purnak T., Ranucci G., Rushbrook S., Stattermayer A., Swain M., Tanaka A., Taubert R., Terrabuio D., Terziroli B., Valentino P., van den Brand F., Villamil A., Wahlin S., Ytting H., Zachou K., and Zeniya M.
Abstract: Background & Aims: Autoimmune hepatitis (AIH) has been well characterised and codified through the development of diagnostic criteria. These criteria have been adapted and simplified and are widely used in clinical practice. However, there is a need to update and precisely define the criteria for both treatment response and treatment. Methods: A systematic review was performed and a modified Delphi consensus process was used to identify and redefine the response criteria in autoimmune hepatitis. Results: The consensus process initiated by the International Autoimmune Hepatitis Group proposes that the term ‘complete biochemical response’ defined as ‘normalization of serum transaminases and IgG below the upper limit of normal’ be adopted to include a time point at 6 months after initiation of treatment. An insufficient response by 6 months was a failure to meet the above definition. Non-response was defined as ‘<50% decrease of serum transaminases within 4 weeks after initiation of treatment’. Remission is defined as liver histology with a Hepatitis Activity Index <4/18. Intolerance to treatment was agreed to stand for ‘any adverse event possibly related to treatment leading to potential drug discontinuation’. Conclusions: These definitions provide a simple and reproducible framework to define treatment response and non-response, irrespective of the therapeutic intervention. A consensus on endpoints is urgently required to set a global standard for the reporting of study results and to enable inter-study comparisons. Future prospective database studies are needed to validate these endpoints. Lay summary: Consensus among international experts on response criteria and endpoints in autoimmune hepatitis is lacking. A consensus on endpoints is urgently required to set a global standard for the reporting of study results and to enable the comparison of results between clinical trials. Therefore, the International Autoimmune Hepatitis Group (IAIHG) herein presents
Published: 2022

16. Global multi-stakeholder endorsement of the MAFLD definition

Author: Mendez-Sanchez, N, Bugianesi, E, Gish, R, Lammert, F, Tilg, H, Nguyen, M, Sarin, S, Fabrellas, N, Zelber-Sagi, S, Fan, J, Shiha, G, Targher, G, Zheng, M, Chan, W, Vinker, S, Kawaguchi, T, Castera, L, Yilmaz, Y, Korenjak, M, Spearman, C, Ungan, M, Palmer, M, El-Shabrawi, M, Gruss, H, Dufour, J, Dhawan, A, Wedemeyer, H, George, J, Valenti, L, Fouad, Y, Romero-Gomez, M, Eslam, M, Abate, M, Abbas, B, Abbassy, A, Abd El Ghany, W, Abd Elkhalek, A, Abd ElMajeed, E, Abdalgaber, M, Abdallah, M, Abdallah, N, Abdelaleem, S, Abdelghani, Y, Abdelghany, W, Abdelhalim, S, Abdelhamid, W, Abdelhamid, N, Abdelkader, N, Abdelkreem, E, Abdelmohsen, A, Abdelrahman, A, Abd-elsalam, S, Abdeltawab, D, Abduh, A, Abdulhakam, N, Abdulla, M, Abedpoor, N, Abenavoli, L, Aberg, F, Ablack, O, Abo elftouh, M, Abo-Amer, Y, Aboubkr, A, Aboud, A, Abouelnaga, A, Aboufarrag, G, Aboutaleb, A, Abundis, L, Adali, G, Adames, E, Adams, L, Adda, D, Adel, N, Adel Sayed, M, Afaa, T, Afredj, N, Aghayeva, G, Aghemo, A, Aguilar-Salinas, C, Ahlenstiel, G, Ahmady, W, Ahmed, W, Ahmed, A, Ahmed, S, Ahmed, H, Ahmed, R, Aigner, E, Akarsu, M, Akroush, M, Akyuz, U, Al Mahtab, M, Al Qadiri, T, Al Rawahi, Y, AL rubaee, R, Al Saffar, M, Alam, S, Al-Ani, Z, Albillos, A, Alboraie, M, Al-Busafi, S, Al-Emam, M, Alharthi, J, Ali, K, Ali, B, Ali, M, Ali, R, Alisi, A, AL-Khafaji, A, Alkhatry, M, Aller, R, Almansoury, Y, Al-Naamani, K, Alnakeeb, A, Alonso, A, Alqahtani, S, Alrabadi, L, Alswat, K, Altaher, M, Altamimi, T, Altamirano, J, Alvares-da-Silva, M, Aly, E, Alzahaby, A, Alzamzamy, A, Amano, K, Amer, M, Amin, M, Amin, S, Amir, A, Ampuero, J, Anas, N, Andreone, P, Andriamandimby, S, Anees, M, Angela, P, Antonios, M, Arafat, W, Araya, J, Armendariz-Borunda, J, Armstrong, M, Ashktorab, H, Aspichueta, P, Assal, F, Atef, M, Attia, D, Atwa, H, Awad, R, Awad, M, Awny, S, Awolowo, O, Awuku, Y, Ayada, I, Aye, T, Ayman, S, Ayman, H, Ayoub, H, Azmy, H, Babaran, R, Badreldin, O, Badry, A, Bahcecioglu, I, Bahour, A, Bai, J, Balaban, Y, Balasubramanyam, M, Bamakhrama, K, Banales, J, Bangaru, B, Bao, J, Barahona, J, Barakat, S, Barbalho, S, Barbra, B, Barranco, B, Barrera, F, Baumann, U, Bazeed, S, Bech, E, Benayad, A, Benesic, A, Bernstein, D, Bessone, F, Birney, S, Bisseye, C, Blake, M, Bobat, B, Bonfrate, L, Bordin, D, Bosques-Padilla, F, Boursier, J, Boushab, B, Bowen, D, Bravo, P, Brennan, P, Bright, B, Broekaert, I, Buque, X, Burgos-Santamaria, D, Burman, J, Busetto, L, Byrne, C, Cabral-Prodigalidad, P, Cabrera-Alvarez, G, Cai, W, Cainelli, F, Caliskan, A, Canbay, A, Cano-Contreras, A, Cao, H, Cao, Z, Carrion, A, Carubbi, F, Casanovas, T, Castellanos Fernandez, M, Chai, J, Chan, S, Charatcharoenwitthaya, P, Chavez-Tapia, N, Chayama, K, Chen, J, Chen, L, Chen, Z, Chen, H, Chen, S, Chen, Q, Chen, Y, Chen, G, Chen, E, Chen, F, Chen, P, Cheng, R, Cheng, W, Chieh, J, Chokr, I, Cholongitas, E, Choudhury, A, Chowdhury, A, Chukwudike, E, Ciardullo, S, Clayton, M, Clement, K, Cloa, M, Coccia, C, Collazos, C, 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M., Fares M., Fassio E., Fathy H., Fathy D., Fathy W., Fayed S., Feng D., Feng G., Fernandez-Bermejo M., Ferreira C. T., Ferrer J. D., Forbes A., Fouad R., Fouad H. M., Frisch T., Fujii H., Fukunaga S., Fukunishi S., Fulya H., Furuhashi M., Gaber Y., Galang A. J. G., Gallardo J. C., Galloso R., Gamal M., Gamal R., Gamal H., Gan J., Ganbold A., Gao X., Garas G., Garba T., Garcia-Cortes M., Garcia-Monzon C., Garcia-Samaniego J., Gastaldelli A., Gatica M., Gatley E., Gegeshidze T., Geng B., Ghazinyan H., Ghoneem S., Giacomelli L., Giannelli G., Giannini E. G., Giefer M., Gines P., Girala M., Giraudi P. J., Goh G. B. -B., Gomaa A. A., Gong B., Gonzales D. H. C., Gonzalez H. C., Gonzalez-Huezo M. S., Graupera I., Grgurevic I., Gronbaek H., Gu X., Guan L., Gueye I., Guingane A. N., Gul O. O., Gul C. B., Guo Q., Gupta P. P., Gurakar A., Gutierrez J. C. R., Habib G., Hafez A., Hagman E., Halawa E., Hamdy O., Hamed A. E., Hamed D. H., Hamid S., Hamoudi W., Han Y., Haridy J., Haridy H., Harris D. C. H. H., Hart M., Hasan F., Hashim A., Hassan I., Hassan A., Hassan E. A., Hassan A. A., Hassan M. S., Hassanin F., Hassnine A., Haukeland J. W., Hawal A. I. M., He J., He Q., He Y., He F. -P., Hegazy M., Hegazy A., Henegil O., Hernandez N., Hernandez-Guerra M., Higuera-de-la-Tijera F., Hindy I., Hirota K., Ho L. C., Hodge A., Hosny M., Hou X., Huang J. -F., Huang Y., Huang Z., Huang A., Huang X. -P., Hui-ping S., Hunyady B., Hussein M. A., Hussein O., Hussien S. M., Ibanez-Samaniego L., Ibdah J., Ibrahim L., Ibrahim M., Ibrahim I., Icaza-Chavez M. E., Idelbi S., Idilman R. I., Ikeda M., Indolfi G., Invernizzi F., Irshad I., Isa H. M. A., Iskandar N. J., Ismaiel A., Ismail M., Ismail Z., Ismail F., Iwamoto H., Jack K., Jacob R., Jafarov F., Jafri W., Jahshan H., Jalal P. K., Jancoriene L., Janicko M., Jayasena H., Jefferies M., Jha V., Ji F., Ji Y., Jia J., Jiang C., Jiang N., Jiang Z. -Z., Jin X., Jin Y., Jing X., Jingyu Q., Jinjolava M., Jong F. H. H., Jucov A., Julius I., Kaddah M., Kamada Y., kamal A., Kamal E. M., Kamel A. S., Kao J. -H., Karin M., Karlas T., Kashwaa M., Katsidzira L., Kaya E., Kayasseh M. A., Keenan B., Keklikkiran C., Keml W., Khalaf D. K., Khalefa R., Khamis S., Khater D., khattab H., Khavkin A., Khlynova O., Khmis N., Kobyliak N., Koffas A., Koike K., Kok K. Y. Y., Koller T., Komas N. P., Korochanskaya N. V., Koulla Y., Koya S., Kraft C., Kraja B., Krawczyk M., Kuchay M. S., Kulkarni A. V., Kumar A., Kumar M., Lakoh S., Lam P., Lan L., Lange N. F., Lankarani K. B., Lanthier N., Lapshyna K., Lashen S. A., Laure K. N. J., Lazebnik L., Lebrec D., Lee S. S., Lee W. S., Lee Y. Y., Leeming D. J., Leite N. C., Leon R., Lesmana C. R. A., Li J., Li Q., Li Y. -Y., Li Y., Li L., Li M., li Y., Liang H., Lijuan T., Lim S. G., Lim L. -L., Lin S., Lin H. -C., Lin R., Lithy R., Liu Y., Liu X., Liu W. -Y., Liu S., Liu K., Liu T., Lonardo A., Lopez M. B., Lopez-Benages E., Lopez-Jaramillo P., Lu H., Lu L. G., Lu Y., Lubel J., Lui R., Lupasco I., Luzina E., Lv X. -H., Lynch K., Ma H. -L., Machado M. V., Maduka N., Madzharova K., Magdaong R., Mahadeva S., Mahfouz A., Mahmood N. R. K. N., Mahmoud E., Mahrous M., Maiwall R., Majeed A., Majumdar A., Mak L., Maklouf M. M., Malekzadeh R., Mandato C., Mangia A., Mann J., Mansour H. H., Mansouri A., Mantovani A., Mao J. Q., Maramag F., Marchesini G., Marcus C., Marinho R. A. R. T., Martinez-Chantar M. L., Martins A. A. S., Marwan R., Mason K. F., Masoud G., Massoud M. N., Matamoros M. A., Mateos R. M., Mawed A., Mbanya J. C., Mbendi C., McColaugh L., McLeod D., Medina J. F. R., Megahed A., Mehrez M., Memon I., Merat S., Mercado R., Mesbah A., Meskini T., Metwally M., Metwaly R., Miao L., Micah E., Miele L., Milivojevic V., Milovanovic T., Mina Y. 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M., Palle S., Pan Z., Pan X. -Y., Pan Q., Papaefthymiou A., Paquissi F. C., Par G., Parkash A., Payawal D., Peltekian K. M., Peng X., Peng L., Peng Y., Pengoria R., Perez M., Perez J. L., Perez N. M., Persico M., Pessoa M. G., Petta S., Philip M., Plaz Torres M. C., Polavarapu N., Poniachik J., Portincasa P., Pu C., Purnak T., Purwanto E., Qi X., Qian Z., Qiang Z., Qiao Z., Qiao L., Queiroz A., Rabiee A., Radwan M., Rahetilahy A. M., Ramadan Y., Ramadan D., Ramli A. S., Ramm G. A., Ran A., Rankovic I., RAO H., Raouf S., Ray S., Reau N., Refaat A., Reiberger T., Remes-Troche J. M., Reyes E. C., Richardson B., Ridruejo E., Riestra Jimenez S., Rizk I., Roberts S., Roblero J. P., Robles J. A. P., Rockey D., Rodriguez M., Rodriguez Hernandez H., Roman E., Romeiro F. G., Romeo S., Rosales-Zabal J. M., Roshdi G. R., Rosso N., Ruf A., Ruiz P. C., Runes N. R., Ruzzenente A., Ryan M., Saad A., Sabbagh E. B., Sabbah M., Saber S., Sabrey R., Sabry R., Saeed M. A., Said D., Said E. M., Sakr M. 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Zuart Ruiz, R, Mendez-Sanchez N., Bugianesi E., Gish R. 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T., Ayman S., Ayman H., Ayoub H., Azmy H. M., Babaran R. P., Badreldin O., Badry A., Bahcecioglu I. H., Bahour A., Bai J., Balaban Y., Balasubramanyam M., Bamakhrama K., Banales J. M., Bangaru B., Bao J., Barahona J. S., Barakat S., Barbalho S. M., Barbra B., Barranco B., Barrera F., Baumann U., Bazeed S., Bech E., Benayad A., Benesic A., Bernstein D., Bessone F., Birney S., Bisseye C., Blake M., Bobat B., Bonfrate L., Bordin D. S., Bosques-Padilla F., Boursier J., Boushab B. M., Bowen D., Bravo P. M., Brennan P. N., Bright B., Broekaert I., Buque X., Burgos-Santamaria D., Burman J., Busetto L., Byrne C. D., Cabral-Prodigalidad P. A. I., Cabrera-Alvarez G., Cai W., Cainelli F., Caliskan A. R., Canbay A., Cano-Contreras A., Cao H. -X., Cao Z., Carrion A., Carubbi F., Casanovas T., Castellanos Fernandez M. I., Chai J., Chan S. P., Charatcharoenwitthaya P., Chavez-Tapia N., Chayama K., Chen J., Chen L., Chen Z. -W., Chen H., Chen S. -D., Chen Q., Chen Y., Chen G., Chen E. -Q., Chen F., Chen P. -J., Cheng R., Cheng W., Chieh J. T. W., Chokr I., Cholongitas E., Choudhury A., Chowdhury A., Chukwudike E. S., Ciardullo S., Clayton M., Clement K., Cloa M. M., Coccia C., Collazos C., Colombo M., Cosar A. M., Cotrim H. P., Couillerot J., Coulibaly A., Crespo G., Crespo J., Cruells M., Cua I. H. Y., Dabbous H. K., Dalekos G. N., D'Alia P., Dan L., Dao V. H., Darwish M., Datz C., Davalos-Moscol M. B., Dawoud H., de Careaga B. O., de Knegt R., de Ledinghen V., de Silva J., Debzi N., Decraecker M., Del Pozo E., Delgado T. C., Delgado-Blanco M., Dembinski L., Depina A., Derbala M., Desalegn H., Desbois-Mouthon C., Desoky M., Dev A., Di Ciaula A., Diago M., Diallo I., Diaz L. A., Dirchwolf M., Dongiovanni P., Dorofeyev A., Dou X., Douglas M. W., Doulberis M., Dovia C. K., Doyle A., Dragojevic I., Drenth J. P., Duan X., Dulskas A., Dumitrascu D. L., Duncan O., Dusabejambo V., Dwawhi R. S. N. A., Eiketsu S., El Amrousy D., El Deeb A., El Deriny G., El Din H. S., El Kamshishy S., El Kassas M., El Raziky M., Elagamy O. A., Elakel W., Elalfy D., Elaraby H., ElAwady H., Elbadawy R., Eldash H. H., Eldefrawy M. S., Elecharri C. L., Elfaramawy A., Elfatih M., Elfiky M., Elgamsy M., Elgendy M., El-Guindi M. A., Elhussieny N., Eliwa A. M., Elkabbany Z., El-Khayat H., El-Koofy N. M., Elmetwalli A., Elrabat A., El-Raey F., Elrashdy F., Elsahhar M., Elsaid E. M., Elsayed S., Elsayed H., Elsayed A., Elsayed A. M., El-Serafy M., Elsharkawy A. M., Elsheemy R. Y., Elshemy E. E., Elsherbini S., Eltoukhy N., Elwakil R., Emad O., Emad S., Embabi M., Ergenc I., Ermolova T., Esmat G., Esmat D. M., Estupinan E. C., Ettair S., Eugen T., Ezz-Eldin M., Falcon L. P. V., Fan Y. -C., Fandari S., Farag M., Farahat T. M., Fares E. M., Fares M., Fassio E., Fathy H., Fathy D., Fathy W., Fayed S., Feng D., Feng G., Fernandez-Bermejo M., Ferreira C. T., Ferrer J. D., Forbes A., Fouad R., Fouad H. M., Frisch T., Fujii H., Fukunaga S., Fukunishi S., Fulya H., Furuhashi M., Gaber Y., Galang A. J. G., Gallardo J. C., Galloso R., Gamal M., Gamal R., Gamal H., Gan J., Ganbold A., Gao X., Garas G., Garba T., Garcia-Cortes M., Garcia-Monzon C., Garcia-Samaniego J., Gastaldelli A., Gatica M., Gatley E., Gegeshidze T., Geng B., Ghazinyan H., Ghoneem S., Giacomelli L., Giannelli G., Giannini E. G., Giefer M., Gines P., Girala M., Giraudi P. J., Goh G. B. -B., Gomaa A. A., Gong B., Gonzales D. H. C., Gonzalez H. C., Gonzalez-Huezo M. S., Graupera I., Grgurevic I., Gronbaek H., Gu X., Guan L., Gueye I., Guingane A. N., Gul O. O., Gul C. B., Guo Q., Gupta P. P., Gurakar A., Gutierrez J. C. R., Habib G., Hafez A., Hagman E., Halawa E., Hamdy O., Hamed A. E., Hamed D. H., Hamid S., Hamoudi W., Han Y., Haridy J., Haridy H., Harris D. C. H. H., Hart M., Hasan F., Hashim A., Hassan I., Hassan A., Hassan E. A., Hassan A. A., Hassan M. S., Hassanin F., Hassnine A., Haukeland J. W., Hawal A. I. M., He J., He Q., He Y., He F. -P., Hegazy M., Hegazy A., Henegil O., Hernandez N., Hernandez-Guerra M., Higuera-de-la-Tijera F., Hindy I., Hirota K., Ho L. C., Hodge A., Hosny M., Hou X., Huang J. -F., Huang Y., Huang Z., Huang A., Huang X. -P., Hui-ping S., Hunyady B., Hussein M. A., Hussein O., Hussien S. M., Ibanez-Samaniego L., Ibdah J., Ibrahim L., Ibrahim M., Ibrahim I., Icaza-Chavez M. E., Idelbi S., Idilman R. I., Ikeda M., Indolfi G., Invernizzi F., Irshad I., Isa H. M. A., Iskandar N. J., Ismaiel A., Ismail M., Ismail Z., Ismail F., Iwamoto H., Jack K., Jacob R., Jafarov F., Jafri W., Jahshan H., Jalal P. K., Jancoriene L., Janicko M., Jayasena H., Jefferies M., Jha V., Ji F., Ji Y., Jia J., Jiang C., Jiang N., Jiang Z. -Z., Jin X., Jin Y., Jing X., Jingyu Q., Jinjolava M., Jong F. H. H., Jucov A., Julius I., Kaddah M., Kamada Y., kamal A., Kamal E. M., Kamel A. S., Kao J. -H., Karin M., Karlas T., Kashwaa M., Katsidzira L., Kaya E., Kayasseh M. A., Keenan B., Keklikkiran C., Keml W., Khalaf D. K., Khalefa R., Khamis S., Khater D., khattab H., Khavkin A., Khlynova O., Khmis N., Kobyliak N., Koffas A., Koike K., Kok K. Y. Y., Koller T., Komas N. P., Korochanskaya N. V., Koulla Y., Koya S., Kraft C., Kraja B., Krawczyk M., Kuchay M. S., Kulkarni A. V., Kumar A., Kumar M., Lakoh S., Lam P., Lan L., Lange N. F., Lankarani K. B., Lanthier N., Lapshyna K., Lashen S. A., Laure K. N. J., Lazebnik L., Lebrec D., Lee S. S., Lee W. S., Lee Y. Y., Leeming D. J., Leite N. C., Leon R., Lesmana C. R. A., Li J., Li Q., Li Y. -Y., Li Y., Li L., Li M., li Y., Liang H., Lijuan T., Lim S. G., Lim L. -L., Lin S., Lin H. -C., Lin R., Lithy R., Liu Y., Liu X., Liu W. -Y., Liu S., Liu K., Liu T., Lonardo A., Lopez M. B., Lopez-Benages E., Lopez-Jaramillo P., Lu H., Lu L. G., Lu Y., Lubel J., Lui R., Lupasco I., Luzina E., Lv X. -H., Lynch K., Ma H. -L., Machado M. V., Maduka N., Madzharova K., Magdaong R., Mahadeva S., Mahfouz A., Mahmood N. R. K. N., Mahmoud E., Mahrous M., Maiwall R., Majeed A., Majumdar A., Mak L., Maklouf M. M., Malekzadeh R., Mandato C., Mangia A., Mann J., Mansour H. H., Mansouri A., Mantovani A., Mao J. Q., Maramag F., Marchesini G., Marcus C., Marinho R. A. R. T., Martinez-Chantar M. L., Martins A. A. S., Marwan R., Mason K. F., Masoud G., Massoud M. N., Matamoros M. A., Mateos R. M., Mawed A., Mbanya J. C., Mbendi C., McColaugh L., McLeod D., Medina J. F. R., Megahed A., Mehrez M., Memon I., Merat S., Mercado R., Mesbah A., Meskini T., Metwally M., Metwaly R., Miao L., Micah E., Miele L., Milivojevic V., Milovanovic T., Mina Y. L., Mishkovik M., Mishriki A., Mitchell T., Mohamed A., Mohamed M., Mohamed S., Mohammed S., Mohammed A., Mohan V., Mohie S., Mokhtar A., Moniem R., Montilla M. S., Morales J. A. O., Morata M. M. S., Moreno-Planas J. M., Morise S., Mosaad S., Moselhy M., Mostafa A. M., Mostafa E., Mouane N., Mousa N., Moustafa H. M., Msherif A., Muller K., Munoz C., Munoz-Urribarri A. B., Murillo O. A., Mustapha F. I., Muzurovic E., Nabil Y., Nafady S., Nagamatsu A., Nakajima A., Nakano D., Nan Y., Nascimbeni F., Naseef M. S., Nashat N., Natalia T., Negro F., Nersesov A. V., Neuman M., Ng'wanasayi M., Ni Y., Nicoll A., Niizeki T., Nikolova D., Ningning W., Niriella M., Nogoibaeva K. A., Nordien R., O Sullivan C., O'Beirne J., Obekpa S., Ocama P., Ochwoto M., Ogolodom M. P., Ojo O., Okrostsvaridze N., Oliveira C. P., Omana R. C., Omar O. M., Omar H., Omar M., Omran S., Omran R., Osman M. M., Owise N., Owusu-Ansah T., Padilla- Machaca P. M., Palle S., Pan Z., Pan X. -Y., Pan Q., Papaefthymiou A., Paquissi F. C., Par G., Parkash A., Payawal D., Peltekian K. M., Peng X., Peng L., Peng Y., Pengoria R., Perez M., Perez J. L., Perez N. M., Persico M., Pessoa M. G., Petta S., Philip M., Plaz Torres M. C., Polavarapu N., Poniachik J., Portincasa P., Pu C., Purnak T., Purwanto E., Qi X., Qian Z., Qiang Z., Qiao Z., Qiao L., Queiroz A., Rabiee A., Radwan M., Rahetilahy A. M., Ramadan Y., Ramadan D., Ramli A. S., Ramm G. A., Ran A., Rankovic I., RAO H., Raouf S., Ray S., Reau N., Refaat A., Reiberger T., Remes-Troche J. M., Reyes E. C., Richardson B., Ridruejo E., Riestra Jimenez S., Rizk I., Roberts S., Roblero J. P., Robles J. A. P., Rockey D., Rodriguez M., Rodriguez Hernandez H., Roman E., Romeiro F. G., Romeo S., Rosales-Zabal J. M., Roshdi G. R., Rosso N., Ruf A., Ruiz P. C., Runes N. R., Ruzzenente A., Ryan M., Saad A., Sabbagh E. B., Sabbah M., Saber S., Sabrey R., Sabry R., Saeed M. A., Said D., Said E. M., Sakr M. A., Salah Y., Salama R. M., Salama A., Saleh H., Saleh A., Salem A., Salem A. T., Salifou A., Salih A. F., Salman A., Samouda H., Sanai F., Sanchez-Avila J. F., Sanker L., Sano T., Sanz M., Saparbu T., Sawhney R., Sayed F., Sayed S. A., Sayed A. O., Sayed M., Sebastiani G., Secadas L., Sediqi K. Q., Seif S., Semida N., Senates E., Serban E. D., Serfaty L., Seto W. -K., Sghaier I., Sha M., Shabaan H. M., Shalaby L., Shaltout I., Sharara A. I., Sharma V., Shawa I. T., Shawkat A., Shawky N., Shehata O., Sheils S., Shewaye A. B., Shi G., Shi J., Shimose S., Shirono T., Shou L., Shrestha A., Shui G., Sievert W., Sigurdardottir S., Sira M. M., Siradj R., Sison C., Smyth L., Soliman R., Sollano J. D., Sombie R., Sonderup M., Sood S., Soriano G., Stedman C. A. M., Stefanyuk O., Stimac D., Strasser S., Strnad P., Stuart K., Su W., Su M., Sumida Y., Sumie S., Sun D. -Q., Sun J., Suzuki H., Svegliati-Baroni G., Swar M. O., TAHARBOUCHT S., Taher Z., Takamura S., Tan L., Tan S. -S., Tanwandee T., Tarek S., Tatiana G., Tavaglione F., Tecson G. Y., Tee H. -P., Teschke R., Tharwat M., Thong V. D., Thursz M., Tine T., Tiribelli C., Tolmane I., Tong J., Tongo M., Torkie M., Torre A., Torres E. A., Trajkovska M., Treeprasertsuk S., Tsutsumi T., Tu T., Tur J. A., Turan D., Turcan S., Turkina S., Tutar E., Tzeuton C., Ugiagbe R., Uygun A., Vacca M., Vajro P., Van der Poorten D., Van Kleef L. A., Vashakidze E., Velazquez C. M., Velazquez M. I., Vento S., Verhoeven V., Vespasiani-Gentilucci U., Vethakkan S. R., Vilaseca J., Vitek L., Volkanovska A., Wallace M., Wan W., Wang Y., Wang X., Wang C., Wang M., Wangchuk P., Weltman M., White M., Wiegand J., Wifi M. -N., Wigg A., Wilhelmi M., William R., Wittenburg H., Wu S., Wubeneh A. M., Xia H., Xiao J., Xiao X., Xiaofeng W., Xiong W., Xu L., Xu J., Xu W., Xu J. -H., Xu K., Xu Y., Xu S. -H., Xu M., Xu A., Xu C., Yan H., Yang J., Yang R. -X., Yang Y., Yang Q., Yang N., Yao J., Yara J., Yaras S., Yilmaz N., Younes R., younes H., Young S., Youssef F., Yu Y., Yu M. -L., Yuan J., Yue Z., Yuen M. -F., Yun W., Yurukova N., Zakaria S., Zaky S., Zaldastanishvili M., Zapata R., Zare N., Zerem E., Zeriban N., Zeshuai X., Zhang H., Zhang X., Zhang Y., Zhang W. -H., Zhang Y. -P., Zhang Z. -Q., Zhao J., Zhao R. -R., Zhao H., Zheng C., Zheng Y., Zheng R., Zheng T. -L., Zheng K., Zhou X. Q., Zhou Y., Zhou Y. -J., Zhou H., Zhou L., Zhu L. D., Zhu Y. F., Zhu Y., Zhu P. -W., Ziada E., Ziring D., Ziyi L., Zou S., Zou Z., Zou H., and Zuart Ruiz R.
Published: 2022

17. Fibrate-Oca (FI-OCA) Study - a Global snapshot of PBC practice around the Globe.

Author: Ronca, V., De Vincentis, A., Terracciani, F., Vespasiani-Gentilucci, U., Cristoferi, L., Gerussi, A., Scaravaglio, M., Corpechot, C., Tanaka, A., Cancado, G., Abbas, N., Olsen, K., Rodriguez-Tajes, S., Londono, MC., Gatselis, N., Lygoura, V., Dalekos, G., Lytvyak, E., Montano-Loza, A., and Culver, E.
Abstract: The introduction of obeticholic acid (OCA) and the emerging evidence on the efficacy of fibrates and other PPAR-agonists have shifted the treatment paradigm for primary biliary cholangitis (PBC) away from the UDCA-only approach. This expanded drug armamentarium has increased the complexity of disease management, resulting in heterogeneous and diverse PBC practices worldwide. We aimed to define who are the patients offered second line treatment and what is the dynamic of add-on, switches or stop of second line treatment across the Globe. We conducted a retrospective, international, multicentric cohort study involving PBC patients who began second-line treatment with either fibric acid derivatives (fibrates) or OCA in 40 tertiary centres across Europe, Japan, South America, and North America. We collected clinical, biochemical, and treatment data at diagnosis and at the initiation of second-line treatment. Adverse effects and treatment changes during follow-up were also recorded. We accrued data on 1,831 patients, 917 initiated on OCA (901 already on UDCA) and 868 on fibrates (863 on UDCA). Among these, 635 patients started on bezafibrate and 233 on fenofibrate. 276 of the patients on Bezafibrate were from 18 centres with restricted access to OCA, in Japan, Argentina and Netherlands. Only 17 patients began bezafibrate and OCA simultaneously. The sex distribution did not differ significantly between the fibrate and OCA groups (female: 87.9% vs 88.9%, p=0.570). Baseline mean ALT, ALP, GGT, and bilirubin (ratios to the upper limit of normal) were 1.47 (±1.29) vs 1.63 (±1.58) (p=0.100), 2.64 (±1.55) vs 2.43 (±2.47) (p=0.070), 5.39 (±4.20) vs 5.06 (±4.79) (p=0.453), and 0.98 (±0.94) vs 0.98 (±0.64) (p=0.986), respectively. Baseline cirrhosis was more frequent in OCA patients (28.3.0%, n=216; vs 19.5%, n=83, p=0.01). Most cirrhotic patients on OCA were Child A (97.7%) compared with 64% on fibrates. The median time from UDCA initiation to second-line treatment was longer for OCA patients (70.7 (28-132) months vs 53 (15-123) months, p< 0.001). During follow-up, 96 OCA patients added a fibrate, while 22 fibrate patients added OCA. OCA was discontinued by 302 patients (33%), primarily due to pruritus (33%). 128 of them switched to fibrates. Fibrates were discontinued by 182 patients (21%) due to increased transaminases (18%) or worsening renal function (10%); 39 switched to OCA. The median time before adding a third medication or switching treatments was 23.5 (12.0-39.8) months for OCA and 27.0 (12.5-53.0) months for fibrates. The management of PBC involves dynamic adjustments to second-line treatments. The high rates of treatment discontinuation and changes highlight the need for better tools to allocate second-line treatments more effectively. Additionally, these data suggest that second-line treatments should be offered earlier in the disease course to optimize management strategies. [ABSTRACT FROM AUTHOR]
Published: 2025
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18. Incidence and predictors of hepatocellular carcinoma in autoimmune hepatitis: A multicenter international study

Author: Colapietro, F., primary, Maisonneuve, P., additional, Lytvyak, E., additional, Beuers, U., additional, Verdonk, R., additional, van der Meer, A., additional, van Hoek, B., additional, Kuiken, S.J., additional, Brouwer, H., additional, van der Wouden, E.J., additional, Muratori, P., additional, Aghemo, A., additional, van den Berg, A., additional, Dalekos, G. N, additional, Robles, M., additional, Andrade, R.J., additional, Montano-Loza, A.J., additional, van den Brand, F.F., additional, Slooter, C.D., additional, Macedo, G., additional, Liberal, R., additional, de Boer, Y., additional, and Lleo, A., additional
Published: 2023
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19. Simplified care-pathway selection for nonspecialist practice: the GLOBAL Primary Biliary Cholangitis Study Group Age, Bilirubin, Alkaline phosphatase risk assessment tool

Author: Murillo Perez, C, Gulamhusein, A, Carbone, M, Trivedi, P, van der Meer, A, Corpechot, C, Battezzati, P, Lammers, W, Cazzagon, N, Floreani, A, Pares, A, Nevens, F, Lleo, A, Mayo, M, Kowdley, K, Ponsioen, C, Dalekos, G, Gatselis, N, Thorburn, D, Mason, A, Janssen, H, Verhelst, X, Bruns, T, Lindor, K, Chazouilleres, O, Invernizzi, P, Hansen, B, Hirschfield, G, Murillo Perez C. F., Gulamhusein A., Carbone M., Trivedi P. J., van der Meer A. J., Corpechot C., Battezzati P. M., Lammers W. J., Cazzagon N., Floreani A., Pares A., Nevens F., Lleo A., Mayo M. J., Kowdley K. V., Ponsioen C. Y., Dalekos G. N., Gatselis N. K., Thorburn D., Mason A. L., Janssen H., Verhelst X., Bruns T., Lindor K. D., Chazouilleres O., Invernizzi P., Hansen B. E., Hirschfield G. M., Murillo Perez, C, Gulamhusein, A, Carbone, M, Trivedi, P, van der Meer, A, Corpechot, C, Battezzati, P, Lammers, W, Cazzagon, N, Floreani, A, Pares, A, Nevens, F, Lleo, A, Mayo, M, Kowdley, K, Ponsioen, C, Dalekos, G, Gatselis, N, Thorburn, D, Mason, A, Janssen, H, Verhelst, X, Bruns, T, Lindor, K, Chazouilleres, O, Invernizzi, P, Hansen, B, Hirschfield, G, Murillo Perez C. F., Gulamhusein A., Carbone M., Trivedi P. J., van der Meer A. J., Corpechot C., Battezzati P. M., Lammers W. J., Cazzagon N., Floreani A., Pares A., Nevens F., Lleo A., Mayo M. J., Kowdley K. V., Ponsioen C. Y., Dalekos G. N., Gatselis N. K., Thorburn D., Mason A. L., Janssen H., Verhelst X., Bruns T., Lindor K. D., Chazouilleres O., Invernizzi P., Hansen B. E., and Hirschfield G. M.
Abstract: BACKGROUND: Opportunity to redefine the care journeys for those living with primary biliary cholangitis (PBC) includes facilitating access to enhanced (PBC-dedicated) programmes by nonspecialist risk 'flagging' of patients. OBJECTIVE: To develop a nonexpert PBC stratification tool to help care pathway choices (standard vs. enhanced) choices in PBC. METHODS: We included ursodeoxycholic acid-treated patients with PBC from the Global PBC Study Group. The performance of baseline and 1-year clinical markers with transplant-free survival was assessed to develop the 'ABA' tool using Age (A), Bilirubin (B), and Alkaline phosphatase (A). Added value of fibrosis estimation was assessed. RESULTS: 'ABA' classification mapped three risk groups (n = 2226): low [Age > 50 years, bilirubin ≤ 1 × ULN, alkaline phosphatase (ALP) ≤ 3 × ULN], high (Age ≤ 50 years, bilirubin > 1 × ULN, ALP > 3 × ULN), and intermediate (other). Transplant-free survival at 10 years in the low-, intermediate-, and high-risk groups were 89, 77, and 59% at baseline and 86, 76, and 40% at 1 year, respectively. We propose that high-risk patients at baseline be directly triaged to enhanced (PBC-dedicated) care and the remaining be reassessed at 1 year. Modelling showed after 1 year 46% patients were proposed to enhanced care and 54% to standard care. The 'ABA' mapped pathways facilitated identification of patients at risk based on a young age, as compared to traditional liver biochemical stratification. In patients proposed to standard care, estimated fibrosis stage had ongoing prognostic value. CONCLUSION: Nonspecialist use of the 'ABA' risk tool could prioritize care journey choices for patients with PBC.
Published: 2021

20. A Comparison of Prognostic Scores (Mayo, UK-PBC, and GLOBE) in Primary Biliary Cholangitis

Author: Goet, J, Murillo Perez, C, Harms, M, Floreani, A, Cazzagon, N, Bruns, T, Prechter, F, Dalekos, G, Verhelst, X, Gatselis, N, Lindor, K, Lammers, W, Gulamhusein, A, Reig, A, Carbone, M, Nevens, F, Hirschfield, G, van der Meer, A, van Buuren, H, Hansen, B, Pares, A, Goet J. C., Murillo Perez C. F., Harms M. H., Floreani A., Cazzagon N., Bruns T., Prechter F., Dalekos G. N., Verhelst X., Gatselis N. K., Lindor K. D., Lammers W. J., Gulamhusein A., Reig A., Carbone M., Nevens F., Hirschfield G. M., van der Meer A. J., van Buuren H. R., Hansen B. E., Pares A., Goet, J, Murillo Perez, C, Harms, M, Floreani, A, Cazzagon, N, Bruns, T, Prechter, F, Dalekos, G, Verhelst, X, Gatselis, N, Lindor, K, Lammers, W, Gulamhusein, A, Reig, A, Carbone, M, Nevens, F, Hirschfield, G, van der Meer, A, van Buuren, H, Hansen, B, Pares, A, Goet J. C., Murillo Perez C. F., Harms M. H., Floreani A., Cazzagon N., Bruns T., Prechter F., Dalekos G. N., Verhelst X., Gatselis N. K., Lindor K. D., Lammers W. J., Gulamhusein A., Reig A., Carbone M., Nevens F., Hirschfield G. M., van der Meer A. J., van Buuren H. R., Hansen B. E., and Pares A.
Abstract: INTRODUCTION: Comparative data on scores that predict outcome in primary biliary cholangitis (PBC) are scarce. We aimed to assess and compare the prognostic value of the Mayo Risk Score (MRS, 1989 and 1994), UK-PBC score, and GLOBE score in a large international cohort of patients with PBC. METHODS: Ursodeoxycholic acid-treated patients from 7 centers participating in the GLOBAL PBC Study Group were included. The discriminatory performance of the scores was assessed with concordance statistics at yearly intervals up to 5 years. Model for End-stage Liver Disease was included for comparison. Prediction accuracy was assessed by comparing predicted survival and actual survival in Kaplan-Meier analyses. RESULTS: A total of 1,100 ursodeoxycholic acid-treated patients with PBC were included, with a mean (SD) age of 53.6 (12.0) years, of whom 1,003 (91%) were female. During a median follow-up of 7.6 (interquartile range 4.1-11.7) years, 42 patients underwent liver transplantation, and 127 patients died. At 1 year, the concordance statistic for Model for End-stage Liver Disease was 0.68 (95% confidence interval [CI] 0.64-0.72), 0.74 (95% CI 0.67-0.80) for the UK-PBC score, 0.76 (95% CI 0.72-0.81) for the MRS (1989 and 1994), and 0.80 (95% CI 0.76-0.84) for the GLOBE score. The GLOBE score showed superior discriminatory performance, but differences were not statistically different. For all scores, discriminatory performance increased in those with bilirubin >0.6 × ULN and advanced fibrosis estimated with Fibrosis-4. The predicted (median) minus observed 5-year transplant-free survival was +0.4% and +2.5% for the MRS (1989) and GLOBE score, respectively. DISCUSSION: All prognostic scores developed for PBC (GLOBE, UK-PBC, and MRS) demonstrated comparable discriminating performance for liver transplantation or death as well as good prediction accuracy.
Published: 2021

21. Toward personalized immunotherapy in sepsis: The PROVIDE randomized clinical trial

Author: Leventogiannis, K. Kyriazopoulou, E. Antonakos, N. Kotsaki, A. Tsangaris, I. Markopoulou, D. Grondman, I. Rovina, N. Theodorou, V. Antoniadou, E. Koutsodimitropoulos, I. Dalekos, G. Vlachogianni, G. Akinosoglou, K. Koulouras, V. Komnos, A. Kontopoulou, T. Prekates, A. Koutsoukou, A. van der Meer, J.W.M. Dimopoulos, G. Kyprianou, M. Netea, M.G. Giamarellos-Bourboulis, E.J. and Leventogiannis, K. Kyriazopoulou, E. Antonakos, N. Kotsaki, A. Tsangaris, I. Markopoulou, D. Grondman, I. Rovina, N. Theodorou, V. Antoniadou, E. Koutsodimitropoulos, I. Dalekos, G. Vlachogianni, G. Akinosoglou, K. Koulouras, V. Komnos, A. Kontopoulou, T. Prekates, A. Koutsoukou, A. van der Meer, J.W.M. Dimopoulos, G. Kyprianou, M. Netea, M.G. Giamarellos-Bourboulis, E.J.
Abstract: The state of immune activation may guide targeted immunotherapy in sepsis. In a double-blind, double-dummy randomized clinical study, 240 patients with sepsis due to lung infection, bacteremia, or acute cholangitis were subjected to measurements of serum ferritin and HLA-DR/CD14. Patients with macrophage activation-like syndrome (MALS) or immunoparalysis were randomized to treatment with anakinra or recombinant interferon-gamma or placebo. Twenty-eight-day mortality was the primary endpoint; sepsis immune classification was the secondary endpoint. Using ferritin >4,420 ng/mL and <5,000 HLA-DR receptors/monocytes as biomarkers, patients were classified into MALS (20.0%), immunoparalysis (42.9%), and intermediate (37.1%). Mortality was 79.1%, 66.9%, and 41.6%, respectively. Survival after 7 days with SOFA score decrease was achieved in 42.9% of patients of the immunotherapy arm and 10.0% of the placebo arm (p = 0.042). Three independent immune classification strata are recognized in sepsis. MALS and immunoparalysis are proposed as stratification for personalized adjuvant immunotherapy. Clinicaltrials.gov registration NCT03332225. © 2022 The Author(s)
Published: 2022

22. Toward personalized immunotherapy in sepsis: The PROVIDE randomized clinical trial

Author: Leventogiannis, K., Kyriazopoulou, E., Antonakos, N., Kotsaki, A., Tsangaris, I., Markopoulou, D., Grondman, I., Rovina, N., Theodorou, V., Antoniadou, E., Koutsodimitropoulos, I., Dalekos, G., Vlachogianni, G., Akinosoglou, K., Koulouras, V., Komnos, A., Kontopoulou, T., Prekates, A., Koutsoukou, A., Meer, J.W.M. van der, Dimopoulos, G., Kyprianou, M., Netea, M.G., Giamarellos-Bourboulis, E.J., Leventogiannis, K., Kyriazopoulou, E., Antonakos, N., Kotsaki, A., Tsangaris, I., Markopoulou, D., Grondman, I., Rovina, N., Theodorou, V., Antoniadou, E., Koutsodimitropoulos, I., Dalekos, G., Vlachogianni, G., Akinosoglou, K., Koulouras, V., Komnos, A., Kontopoulou, T., Prekates, A., Koutsoukou, A., Meer, J.W.M. van der, Dimopoulos, G., Kyprianou, M., Netea, M.G., and Giamarellos-Bourboulis, E.J.
Abstract: Item does not contain fulltext, The state of immune activation may guide targeted immunotherapy in sepsis. In a double-blind, double-dummy randomized clinical study, 240 patients with sepsis due to lung infection, bacteremia, or acute cholangitis were subjected to measurements of serum ferritin and HLA-DR/CD14. Patients with macrophage activation-like syndrome (MALS) or immunoparalysis were randomized to treatment with anakinra or recombinant interferon-gamma or placebo. Twenty-eight-day mortality was the primary endpoint; sepsis immune classification was the secondary endpoint. Using ferritin >4,420 ng/mL and <5,000 HLA-DR receptors/monocytes as biomarkers, patients were classified into MALS (20.0%), immunoparalysis (42.9%), and intermediate (37.1%). Mortality was 79.1%, 66.9%, and 41.6%, respectively. Survival after 7 days with SOFA score decrease was achieved in 42.9% of patients of the immunotherapy arm and 10.0% of the placebo arm (p = 0.042). Three independent immune classification strata are recognized in sepsis. MALS and immunoparalysis are proposed as stratification for personalized adjuvant immunotherapy. Clinicaltrials.gov registration NCT03332225.
Published: 2022

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

Author: Corpechot, C, Carrat, F, Gaouar, F, Chau, F, Hirschfield, G, Gulamhusein, A, Montano-Loza, A, Lytvyak, E, Schramm, C, Pares, A, Olivas, I, Eaton, J, Osman, K, Dalekos, G, Gatselis, N, Nevens, F, Cazzagon, N, Zago, A, Russo, F, Abbas, N, Trivedi, P, Thorburn, D, Saffioti, F, Barkai, L, Roccarina, D, Calvaruso, V, Fichera, A, Delamarre, A, Medina-Morales, E, Bonder, A, Patwardhan, V, Rigamonti, C, Carbone, M, Invernizzi, P, Cristoferi, L, van der Meer, A, de Veer, R, Zigmond, E, Yehezkel, E, Kremer, A, Deibel, A, Dumortier, J, Bruns, T, Große, K, Pageaux, G, Wetten, A, Dyson, J, Jones, D, Chazouillères, O, Hansen, B, de Lédinghen, V, 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, de Lédinghen, Victor, Corpechot, C, Carrat, F, Gaouar, F, Chau, F, Hirschfield, G, Gulamhusein, A, Montano-Loza, A, Lytvyak, E, Schramm, C, Pares, A, Olivas, I, Eaton, J, Osman, K, Dalekos, G, Gatselis, N, Nevens, F, Cazzagon, N, Zago, A, Russo, F, Abbas, N, Trivedi, P, Thorburn, D, Saffioti, F, Barkai, L, Roccarina, D, Calvaruso, V, Fichera, A, Delamarre, A, Medina-Morales, E, Bonder, A, Patwardhan, V, Rigamonti, C, Carbone, M, Invernizzi, P, Cristoferi, L, van der Meer, A, de Veer, R, Zigmond, E, Yehezkel, E, Kremer, A, Deibel, A, Dumortier, J, Bruns, T, Große, K, Pageaux, G, Wetten, A, Dyson, J, Jones, D, Chazouillères, O, Hansen, B, de Lédinghen, V, 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
Abstract: Background & Aims: Liver stiffness measurement (LSM) by vibration-controlled transient elastography (VCTE) has been shown to predict outcomes of patients with primary biliary cholangitis (PBC) in small-size studies. We aimed to validate the prognostic value of LSM in a large cohort study. Methods: We performed an international, multicentre, retrospective follow-up study of 3,985 patients with PBC seen at 23 centres in 12 countries. Eligibility criteria included at least 1 reliable LSM by VCTE and a follow-up ≥ 1 year. Independent derivation (n = 2,740) and validation (n = 568) cohorts were built. The primary endpoint was time to poor clinical outcomes defined as liver-related complications, liver transplantation, or death. Hazard ratios (HRs) with CIs were determined using a time-dependent multivariable Cox regression analysis. Results: LSM was independently associated with poor clinical outcomes in the derivation (5,324 LSMs, mean follow-up 5.0 ± 3.1 years) and validation (1,470 LSMs, mean follow-up 5.0 ± 2.8 years) cohorts: adjusted HRs (95% CI) per additional kPa were 1.040 (1.026–1.054) and 1.042 (1.029–1.056), respectively (p <0.0001 for both). Adjusted C-statistics (95% CI) at baseline were 0.83 (0.79–0.87) and 0.92 (0.89–0.95), respectively. Between 5 and 30 kPa, the log-HR increased as a monotonic function of LSM. The predictive value of LSM was stable in time. LSM improved the prognostic ability of biochemical response criteria, fibrosis scores, and prognostic scores. The 8 kPa and 15 kPa cut-offs optimally separated low-, medium-, and high-risk groups. Forty percent of patients were at medium to high risk according to LSM. Conclusions: LSM by VCTE is a major, independent, validated predictor of PBC outcome. Its value as a surrogate endpoint for clinical benefit in PBC should be considered. Lay summary: Primary biliary cholangitis (PBC) is a chronic autoimmune disease, wherein the body's immune system mistakenly attacks the bile ducts. PBC progresses
Published: 2022

24. Effects of immunosuppressive drugs on COVID-19 severity in patients with autoimmune hepatitis

Author: Efe, C, Lammert, C, Tascilar, K, Dhanasekaran, R, Ebik, B, Higuera-de la Tijera, F, Caliskan, A, Peralta, M, Gerussi, A, Massoumi, H, Catana, A, Purnak, T, Rigamonti, C, Aldana, A, Khakoo, N, Nazal, L, Frager, S, Demir, N, Irak, K, Melekoglu-Ellik, Z, Kacmaz, H, Balaban, Y, Atay, K, Eren, F, Alvares-da-Silva, M, Cristoferi, L, Urzua, A, Eskazan, T, Magro, B, Snijders, R, Barutcu, S, Lytvyak, E, Zazueta, G, Demirezer-Bolat, A, Aydin, M, Heurgue-Berlot, A, De Martin, E, Ekin, N, Yildirim, S, Yavuz, A, Biyik, M, Narro, G, Kiyici, M, Akyildiz, M, Kahramanoglu-Aksoy, E, Vincent, M, Carr, R, Gunsar, F, Reyes, E, Harputluoglu, M, Aloman, C, Gatselis, N, Ustundag, Y, Brahm, J, Vargas, N, Guzelbulut, F, Garcia, S, Aguirre, J, Anders, M, Ratusnu, N, Hatemi, I, Mendizabal, M, Floreani, A, Fagiuoli, S, Silva, M, Idilman, R, Satapathy, S, Silveira, M, Drenth, J, Dalekos, G, Assis, D, Bjornsson, E, Boyer, J, Yoshida, E, Invernizzi, P, Levy, C, Montano-Loza, A, Schiano, T, Ridruejo, E, Wahlin, S, Caliskan, AR, Catana, AM, Aldana, AJG, Alvares-da-Silva, MR, Zazueta, GM, Narro, GC, Carr, RM, Reyes, EC, Gatselis, NK, Vargas, NCE, Garcia, SR, Satapathy, SK, Drenth, JPH, Dalekos, GN, Assis, DN, Boyer, JL, Yoshida, EM, Montano-Loza, AJ, Schiano, TD, Efe, C, Lammert, C, Tascilar, K, Dhanasekaran, R, Ebik, B, Higuera-de la Tijera, F, Caliskan, A, Peralta, M, Gerussi, A, Massoumi, H, Catana, A, Purnak, T, Rigamonti, C, Aldana, A, Khakoo, N, Nazal, L, Frager, S, Demir, N, Irak, K, Melekoglu-Ellik, Z, Kacmaz, H, Balaban, Y, Atay, K, Eren, F, Alvares-da-Silva, M, Cristoferi, L, Urzua, A, Eskazan, T, Magro, B, Snijders, R, Barutcu, S, Lytvyak, E, Zazueta, G, Demirezer-Bolat, A, Aydin, M, Heurgue-Berlot, A, De Martin, E, Ekin, N, Yildirim, S, Yavuz, A, Biyik, M, Narro, G, Kiyici, M, Akyildiz, M, Kahramanoglu-Aksoy, E, Vincent, M, Carr, R, Gunsar, F, Reyes, E, Harputluoglu, M, Aloman, C, Gatselis, N, Ustundag, Y, Brahm, J, Vargas, N, Guzelbulut, F, Garcia, S, Aguirre, J, Anders, M, Ratusnu, N, Hatemi, I, Mendizabal, M, Floreani, A, Fagiuoli, S, Silva, M, Idilman, R, Satapathy, S, Silveira, M, Drenth, J, Dalekos, G, Assis, D, Bjornsson, E, Boyer, J, Yoshida, E, Invernizzi, P, Levy, C, Montano-Loza, A, Schiano, T, Ridruejo, E, Wahlin, S, Caliskan, AR, Catana, AM, Aldana, AJG, Alvares-da-Silva, MR, Zazueta, GM, Narro, GC, Carr, RM, Reyes, EC, Gatselis, NK, Vargas, NCE, Garcia, SR, Satapathy, SK, Drenth, JPH, Dalekos, GN, Assis, DN, Boyer, JL, Yoshida, EM, Montano-Loza, AJ, and Schiano, TD
Abstract: Background: We investigated associations between baseline use of immunosuppressive drugs and severity of Coronavirus Disease 2019 (COVID-19) in autoimmune hepatitis (AIH). Patients and methods: Data of AIH patients with laboratory confirmed COVID-19 were retrospectively collected from 15 countries. The outcomes of AIH patients who were on immunosuppression at the time of COVID-19 were compared to patients who were not on AIH medication. The clinical courses of COVID-19 were classified as (i)-no hospitalization, (ii)-hospitalization without oxygen supplementation, (iii)-hospitalization with oxygen supplementation by nasal cannula or mask, (iv)-intensive care unit (ICU) admission with non-invasive mechanical ventilation, (v)-ICU admission with invasive mechanical ventilation or (vi)-death and analysed using ordinal logistic regression. Results: We included 254 AIH patients (79.5%, female) with a median age of 50 (range, 17-85) years. At the onset of COVID-19, 234 patients (92.1%) were on treatment with glucocorticoids (n = 156), thiopurines (n = 151), mycophenolate mofetil (n = 22) or tacrolimus (n = 16), alone or in combinations. Overall, 94 (37%) patients were hospitalized and 18 (7.1%) patients died. Use of systemic glucocorticoids (adjusted odds ratio [aOR] 4.73, 95% CI 1.12-25.89) and thiopurines (aOR 4.78, 95% CI 1.33-23.50) for AIH was associated with worse COVID-19 severity, after adjusting for age-sex, comorbidities and presence of cirrhosis. Baseline treatment with mycophenolate mofetil (aOR 3.56, 95% CI 0.76-20.56) and tacrolimus (aOR 4.09, 95% CI 0.69-27.00) were also associated with more severe COVID-19 courses in a smaller subset of treated patients. Conclusion: Baseline treatment with systemic glucocorticoids or thiopurines prior to the onset of COVID-19 was significantly associated with COVID-19 severity in patients with AIH.
Published: 2022

25. Systematic review of response criteria and endpoints in autoimmune hepatitis by the International Autoimmune Hepatitis Group

Author: Pape, Simon, primary, Snijders, Romée J.A.L.M., additional, Gevers, Tom J.G., additional, Chazouilleres, Oliver, additional, Dalekos, George N., additional, Hirschfield, Gideon M., additional, Lenzi, Marco, additional, Trauner, Michael, additional, Manns, Michael P., additional, Vierling, John M., additional, Montano-Loza, Aldo J., additional, Lohse, Ansgar W., additional, Schramm, Christoph, additional, Drenth, Joost P.H., additional, Heneghan, Michael A., additional, Almasio, P., additional, Alvarez, F., additional, Andrade, R., additional, Arikan, C., additional, Assis, D., additional, Bardou-Jacquet, E., additional, Biewenga, M., additional, Cancado, E., additional, Cazzagon, N., additional, Chazouillères, O., additional, Colloredo, G., additional, Cuarterolo, M., additional, Dalekos, G., additional, Debray, D., additional, Robles-Díaz, M., additional, Drenth, J., additional, Dyson, J., additional, Efe, C., additional, Engel, B., additional, Ferri, S., additional, Fontana, R., additional, Gatselis, N., additional, Gerussi, A., additional, Halilbasic, E., additional, Halliday, N., additional, Heneghan, M., additional, Hirschfield, G., additional, van Hoek, B., additional, Hørby Jørgensen, M., additional, Indolfini, G., additional, Iorio, R., additional, Jeong, S., additional, Jones, D., additional, Kelly, D., additional, Kerkar, N., additional, Lacaille, F., additional, Lammert, C., additional, Leggett, B., additional, Lenzi, M., additional, Levy, C., additional, Liberal, R., additional, Lleo, A., additional, Lohse, A., additional, Ines Lopez, S., additional, de Martin, E., additional, McLin, V., additional, Mieli-Vergani, G., additional, Milkiewicz, P., additional, Mohan, N., additional, Muratori, L., additional, Nebbia, G., additional, van Nieuwkerk, C., additional, Oo, Y., additional, Ortega, A., additional, Páres, A., additional, Pop, T., additional, Pratt, D., additional, Purnak, T., additional, Ranucci, G., additional, Rushbrook, S., additional, Schramm, C., additional, Stättermayer, A., additional, Swain, M., additional, Tanaka, A., additional, Taubert, R., additional, Terrabuio, D., additional, Terziroli, B., additional, Trauner, M., additional, Valentino, P., additional, van den Brand, F., additional, Villamil, A., additional, Wahlin, S., additional, Ytting, H., additional, Zachou, K., additional, and Zeniya, M., additional
Published: 2022
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26. Expert clinical management of autoimmune hepatitis in the real world

Author: Liberal, R., de Boer, Y. S., Andrade, R. J., Bouma, G., Dalekos, G. N., Floreani, A., Gleeson, D., Hirschfield, G. M., Invernizzi, P., Lenzi, M., Lohse, A. W., Macedo, G., Milkiewicz, P., Terziroli, B., van Hoek, B., Vierling, J. M., and Heneghan, M. A.
Published: 2017
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27. Editorial: autoimmune hepatitis – identifying options for treatment. Authors’ reply

Author: Dalekos, G. N. and Zachou, K.
Published: 2016
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28. A real-world study focused on the long-term efficacy of mycophenolate mofetil as first-line treatment of autoimmune hepatitis

Author: Zachou, K., Gatselis, N. K., Arvaniti, P., Gabeta, S., Rigopoulou, E. I., Koukoulis, G. K., and Dalekos, G. N.
Published: 2016
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29. Addressing barriers to the prevention, diagnosis and treatment of hepatitis B and C in the face of persisting fiscal constraints in Europe: report from a high level conference

Author: Papatheodoridis, G., Thomas, H. C., Golna, C., Bernardi, M., Carballo, M., Cornberg, M., Dalekos, G., Degertekin, B., Dourakis, S., Flisiak, R., Goldberg, D., Gore, C., Goulis, I., Hadziyannis, S., Kalamitsis, G., Kanavos, P., Kautz, A., Koskinas, I., Leite, B. R., Malliori, M., Manolakopoulos, S., Matičič, M., Papaevangelou, V., Pirona, A., Prati, D., Raptopoulou – Gigi, M., Reic, T., Robaeys, G., Schatz, E., Souliotis, K., Tountas, Y., Wiktor, S., Wilson, D., Yfantopoulos, J., and Hatzakis, A.
Published: 2016
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30. Hepatocellular carcinoma risk in HBeAg-negative chronic hepatitis B patients with or without cirrhosis treated with entecavir: HepNet.Greece cohort

Author: Papatheodoridis, G. V., Manolakopoulos, S., Touloumi, G., Nikolopoulou, G., Raptopoulou-Gigi, M., Gogos, C., Vafiadis-Zouboulis, I., Karamanolis, D., Chouta, A., Ilias, A., Drakoulis, C., Mimidis, K., Ketikoglou, I., Manesis, E., Mela, M., Hatzis, G., and Dalekos, G. N.
Published: 2015
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31. Supplement to: Peginterferon plus adefovir vs. either drug alone for hepatitis delta.

Author: Wedemeyer, H, Yurdaydìn, C, and Dalekos, G N
Published: 2011

32. The challenges of primary biliary cholangitis: What is new and what needs to be done

Author: Terziroli Beretta-Piccoli, B, Mieli-Vergani, G, Vergani, D, Vierling, J, Adams, D, Alpini, G, Banales, J, Beuers, U, Bjornsson, E, Bowlus, C, Carbone, M, Chazouilleres, O, Dalekos, G, De Gottardi, A, Harada, K, Hirschfield, G, Invernizzi, P, Jones, D, Krawitt, E, Lanzavecchia, A, Lian, Z, Ma, X, Manns, M, Mavilio, D, Quigley, E, Sallusto, F, Shimoda, S, Strazzabosco, M, Swain, M, Tanaka, A, Trauner, M, Tsuneyama, K, Zigmond, E, Gershwin, M, Terziroli Beretta-Piccoli B., Mieli-Vergani G., Vergani D., Vierling J. M., Adams D., Alpini G., Banales J. M., Beuers U., Bjornsson E., Bowlus C., Carbone M., Chazouilleres O., Dalekos G., De Gottardi A., Harada K., Hirschfield G., Invernizzi P., Jones D., Krawitt E., Lanzavecchia A., Lian Z. -X., Ma X., Manns M., Mavilio D., Quigley E. M., Sallusto F., Shimoda S., Strazzabosco M., Swain M., Tanaka A., Trauner M., Tsuneyama K., Zigmond E., Gershwin M. E., Terziroli Beretta-Piccoli, B, Mieli-Vergani, G, Vergani, D, Vierling, J, Adams, D, Alpini, G, Banales, J, Beuers, U, Bjornsson, E, Bowlus, C, Carbone, M, Chazouilleres, O, Dalekos, G, De Gottardi, A, Harada, K, Hirschfield, G, Invernizzi, P, Jones, D, Krawitt, E, Lanzavecchia, A, Lian, Z, Ma, X, Manns, M, Mavilio, D, Quigley, E, Sallusto, F, Shimoda, S, Strazzabosco, M, Swain, M, Tanaka, A, Trauner, M, Tsuneyama, K, Zigmond, E, Gershwin, M, Terziroli Beretta-Piccoli B., Mieli-Vergani G., Vergani D., Vierling J. M., Adams D., Alpini G., Banales J. M., Beuers U., Bjornsson E., Bowlus C., Carbone M., Chazouilleres O., Dalekos G., De Gottardi A., Harada K., Hirschfield G., Invernizzi P., Jones D., Krawitt E., Lanzavecchia A., Lian Z. -X., Ma X., Manns M., Mavilio D., Quigley E. M., Sallusto F., Shimoda S., Strazzabosco M., Swain M., Tanaka A., Trauner M., Tsuneyama K., Zigmond E., and Gershwin M. E.
Abstract: Primary Biliary Cholangitis (PBC) is an uncommon, chronic, cholangiopathy of autoimmune origin and unknown etiology characterized by positive anti-mitochondrial autoantibodies (AMA), female preponderance and progression to cirrhosis if left untreated. The diagnosis is based on AMA- or PBC-specific anti-nuclear antibody (ANA)-positivity in the presence of a cholestatic biochemical profile, histologic confirmation being mandatory only in seronegative cases. First-line treatment is ursodeoxycholic acid (UDCA), which is effective in preventing disease progression in about two thirds of the patients. The only approved second-line treatment is obeticholic acid. This article summarizes the most relevant conclusions of a meeting held in Lugano, Switzerland, from September 23rd-25th 2018, gathering basic and clinical scientists with various background from around the world to discuss the latest advances in PBC research. The meeting was dedicated to Ian Mackay, pioneer in the field of autoimmune liver diseases. The role of liver histology needs to be reconsidered: liver pathology consistent with PBC in AMA-positive individuals without biochemical cholestasis is increasingly reported, raising the question as to whether biochemical cholestasis is a reliable disease marker for both clinical practice and trials. The urgent need for new biomarkers, including more accurate markers of cholestasis, was also widely discussed during the meeting. Moreover, new insights in interactions of bile acids with biliary epithelia in PBC provide solid evidence of a role for impaired epithelial protection against potentially toxic hydrophobic bile acids, raising the fundamental question as to whether this bile acid-induced epithelial damage is the cause or the consequence of the autoimmune attack to the biliary epithelium. Strategies are needed to identify difficult-to-treat patients at an early disease stage, when new therapeutic approaches targeting immunologic pathways, in addition to bile acid
Published: 2019

33. Fibrosis stage is an independent predictor of outcome in primary biliary cholangitis despite biochemical treatment response

Author: Murillo Perez, C, Hirschfield, G, Corpechot, C, Floreani, A, Mayo, M, van der Meer, A, Ponsioen, C, Lammers, W, Pares, A, Invernizzi, P, Carbone, M, Maria Battezzati, P, Nevens, F, Kowdley, K, Thorburn, D, Mason, A, Trivedi, P, Lindor, K, Bruns, T, Dalekos, G, Gatselis, N, Verhelst, X, Janssen, H, Hansen, B, Gulamhusein, A, Murillo Perez C. F., Hirschfield G. M., Corpechot C., Floreani A., Mayo M. J., van der Meer A., Ponsioen C. Y., Lammers W. J., Pares A., Invernizzi P., Carbone M., Maria Battezzati P., Nevens F., Kowdley K. V., Thorburn D., Mason A. L., Trivedi P. J., Lindor K. D., Bruns T., Dalekos G. N., Gatselis N. K., Verhelst X., Janssen H. L. A., Hansen B. E., Gulamhusein A., Murillo Perez, C, Hirschfield, G, Corpechot, C, Floreani, A, Mayo, M, van der Meer, A, Ponsioen, C, Lammers, W, Pares, A, Invernizzi, P, Carbone, M, Maria Battezzati, P, Nevens, F, Kowdley, K, Thorburn, D, Mason, A, Trivedi, P, Lindor, K, Bruns, T, Dalekos, G, Gatselis, N, Verhelst, X, Janssen, H, Hansen, B, Gulamhusein, A, Murillo Perez C. F., Hirschfield G. M., Corpechot C., Floreani A., Mayo M. J., van der Meer A., Ponsioen C. Y., Lammers W. J., Pares A., Invernizzi P., Carbone M., Maria Battezzati P., Nevens F., Kowdley K. V., Thorburn D., Mason A. L., Trivedi P. J., Lindor K. D., Bruns T., Dalekos G. N., Gatselis N. K., Verhelst X., Janssen H. L. A., Hansen B. E., and Gulamhusein A.
Abstract: Background: Fibrosis stage predicts prognosis in patients with chronic liver disease independent of aetiology, although its precise role in risk stratification in patients with primary biliary cholangitis (PBC) remains undefined. Aim: To assess the utility of baseline fibrosis stage in predicting long-term outcomes in the context of biochemical risk stratification. Methods: In a large and globally representative cohort of patients with PBC, liver biopsies performed from 1980 to 2014 were evaluated. The predictive ability of histologic fibrosis stage in addition to treatment response at 1 year (Toronto/Paris-II criteria), as well as non-invasive markers of fibrosis (AST/ALT ratio [AAR], AST to platelet ratio index [APRI], FIB-4), for transplant-free survival was assessed with Cox proportional-hazards models. Results: There were 1828 patients with baseline liver biopsy. Advanced histologic fibrosis (stage 3/4) was an independent predictor of survival in addition to non-invasive measures of fibrosis with the hazard ratios ranging from 1.59 to 2.73 (P <.001). Patients with advanced histologic fibrosis stage had worse survival despite biochemical treatment response, with a 10-year survival of 76.0%-86.6% compared to 94.5%-95.1% depending on the treatment response criteria used. Poor correlations were observed between non-invasive measures of fibrosis and histologic fibrosis stage. Conclusion: Assessment of fibrosis stage grants prognostic value beyond biochemical treatment response at 1 year. This highlights the need to incorporate fibrosis stage in individual risk stratification in patients with PBC, partly to identify those that may derive benefit from novel therapies.
Published: 2019

34. Monitoring and comorbidities in patients with chronic hepatitis B currently treated with nucleos(t)ide analogs

Author: Siakavellas, S. Goulis, J. Manolakopoulos, S. Triantos, C. Gatselis, N. Tsentemidou, E. Kranidioti, H. Zisimopoulos, K. Tsoulas, C. Dalekos, G. Papatheodoridis, G.V. and Siakavellas, S. Goulis, J. Manolakopoulos, S. Triantos, C. Gatselis, N. Tsentemidou, E. Kranidioti, H. Zisimopoulos, K. Tsoulas, C. Dalekos, G. Papatheodoridis, G.V.
Abstract: Background Long-term monotherapy with nucleos(t)ide analogs (NAs) represents the treatment option for the majority of patients with chronic hepatitis B (CHB), an aging population with a greater likelihood of comorbidities. We assessed the prevalence of concurrent non-hepatic diseases and the safety monitoring in a large cohort of CHB patients receiving NAs and their potential impact on disease outcomes. Methods We included 500 consecutive CHB patients from 5 major tertiary Greek centers, under long-term therapy with an NA. Epidemiological/clinical characteristics and data on concomitant disease, drug use and investigations ordered were collected. Results The mean age was 58 years and 66% were male. Most patients were receiving tenofovir disoproxil fumarate (TDF, 60%) or entecavir (ETV, 37%) monotherapy. Decompensated cirrhosis at baseline was present in 10%, while hepatocellular carcinoma (HCC) under therapy developed in 21 patients. The median duration of total NA therapy was 56 and of latest therapy 42 months. The most common (prevalence >10%) comorbidities were hypertension (28%), non-HCC cancer(s) (12%), and diabetes (11%). Patients with a longer duration of latest therapy (≥4 vs. <4 years) were older (mean age: 58 vs. 56 years, P=0.004), had more frequent history of prior use of NA(s) (53% vs. 35%, P<0.001), and less frequent liver decompensation (5% vs. 13%, P=0.008) and non-HCC cancers (8% vs. 15%, P=0.020). HCC developed more frequently in patients with than in those without diabetes (11% vs. 3%, P=0.022). Conclusion Greek CHB patients currently treated with NAs, almost exclusively ETV or TDF, are often older than 60 years, have several comorbidities, and thus require careful management. © 2021 Hellenic Society of Gastroenterology.
Published: 2021

35. Measurement of Gamma Glutamyl Transferase to Determine Risk of Liver Transplantation or Death in Patients With Primary Biliary Cholangitis

Author: Gerussi, A, Bernasconi, D, O'Donnell, S, Lammers, W, Buuren, H, Hirschfield, G, Janssen, H, Corpechot, C, Reig, A, Pares, A, Battezzati, P, Zuin, M, Cazzagon, N, Floreani, A, Nevens, F, Gatselis, N, Dalekos, G, Mayo, M, Thorburn, D, Bruns, T, Mason, A, Verhelst, X, Kowdley, K, van der Meer, A, Niro, G, Beretta-Piccoli, B, Marzioni, M, Belli, L, Marra, F, Valsecchi, M, Lindor, K, Invernizzi, P, Hansen, B, Carbone, M, Gerussi, Alessio, Bernasconi, Davide Paolo, O'Donnell, Sarah Elisabeth, Lammers, Willem J, Buuren, Henk Van, Hirschfield, Gideon, Janssen, Harry, Corpechot, Christophe, Reig, Anna, Pares, Albert, Battezzati, Pier Maria, Zuin, Massimo Giovanni, Cazzagon, Nora, Floreani, Annarosa, Nevens, Frederik, Gatselis, Nikolaos, Dalekos, George, Mayo, Marlyn J, Thorburn, Douglas, Bruns, Tony, Mason, Andrew L, Verhelst, Xavier, Kowdley, Kris, van der Meer, Adriaan, Niro, Grazia Anna, Beretta-Piccoli, Benedetta Terziroli, Marzioni, Marco, Belli, Luca Saverio, Marra, Fabio, Valsecchi, Maria Grazia, Lindor, Keith D, Invernizzi, Pietro, Hansen, Bettina E, Carbone, Marco, Gerussi, A, Bernasconi, D, O'Donnell, S, Lammers, W, Buuren, H, Hirschfield, G, Janssen, H, Corpechot, C, Reig, A, Pares, A, Battezzati, P, Zuin, M, Cazzagon, N, Floreani, A, Nevens, F, Gatselis, N, Dalekos, G, Mayo, M, Thorburn, D, Bruns, T, Mason, A, Verhelst, X, Kowdley, K, van der Meer, A, Niro, G, Beretta-Piccoli, B, Marzioni, M, Belli, L, Marra, F, Valsecchi, M, Lindor, K, Invernizzi, P, Hansen, B, Carbone, M, Gerussi, Alessio, Bernasconi, Davide Paolo, O'Donnell, Sarah Elisabeth, Lammers, Willem J, Buuren, Henk Van, Hirschfield, Gideon, Janssen, Harry, Corpechot, Christophe, Reig, Anna, Pares, Albert, Battezzati, Pier Maria, Zuin, Massimo Giovanni, Cazzagon, Nora, Floreani, Annarosa, Nevens, Frederik, Gatselis, Nikolaos, Dalekos, George, Mayo, Marlyn J, Thorburn, Douglas, Bruns, Tony, Mason, Andrew L, Verhelst, Xavier, Kowdley, Kris, van der Meer, Adriaan, Niro, Grazia Anna, Beretta-Piccoli, Benedetta Terziroli, Marzioni, Marco, Belli, Luca Saverio, Marra, Fabio, Valsecchi, Maria Grazia, Lindor, Keith D, Invernizzi, Pietro, Hansen, Bettina E, and Carbone, Marco
Abstract: Gamma-glutamyltransferase (GGT) is a serum marker of cholestasis. We investigated whether serum level of GGT is a prognostic marker for patients with primary biliary cholangitis (PBC). Methods: We analyzed data from patients with PBC from the Global PBC Study Group, comprising 14 centers in Europe and North America. We obtained measurements of serum GGT at baseline and time points after treatment. We used Cox model hazard ratios to evaluate the association between GGT and clinical outcomes, including liver transplantation and liver-related death. Results: Of the 2129 patients included in our analysis, 281 (13%) had a liver-related clinical endpoint. Mean age at diagnosis was 53 years and 91% of patients were female patients. We found a correlation between serum levels of GGT and alkaline phosphatase (ALP) (r=0.71). Based on data collected at baseline and yearly for up to 5 years, higher serum level of GGT were associated with lower hazard for transplant-free survival. Serum level of GGT at 12 months after treatment higher than 3.2-fold the upper limit of normal (ULN) identified patients who required liver transplantation or with liver-related death at 10 years with an area under the receiver operating characteristic curve of 0.70. The risk of liver transplantation or liver-related death in patients with serum level of GGT above 3.2-fold the ULN, despite level of ALP lower than 1.5-fold the ULN, was higher compared to patients with level of GGT lower than 3.2-fold the ULN and level of ALP lower than 1.5-fold the ULN (P<.05). Including information on level of GGT increased the prognostic value of the Globe score. Conclusion: Serum level of GGT can be used to identify patients with PBC at risk for liver transplantation or death, and increase the prognostic value of ALP measurement. Our findings support the use of GGT as primary clinical endpoint in clinical trials. In patients with low serum level of ALP, a high level of GGT identifies those who might require treatm
Published: 2021

36. B cells and COVID-19: Lessons from agammaglobulinemia patients and the study of functional B cell polymorphisms

Author: Speletas, M, primary, Raftopoulou, S, additional, Farmaki, E, additional, Gatselis, N, additional, Germanidis, G, additional, Mouchtouri, V, additional, Hatzianastasiou, S, additional, Georgiadou, S, additional, Tsinti, G, additional, Tsachouridou, O, additional, Tseroni, M, additional, Metallidis, S, additional, Dalekos, G, additional, Eibel, H, additional, and Hadjichristodoulou, C, additional
Published: 2021
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37. Review article: autoimmune hepatitis – current management and challenges

Author: Zachou, K., Muratori, P., Koukoulis, G. K., Granito, A., Gatselis, N., Fabbri, A., Dalekos, G. N., and Muratori, L.
Published: 2013
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38. Renal function during treatment with adefovir plus peginterferon alfa-2a vs either drug alone in hepatitis B/D co-infection

Author: Mederacke, I., Yurdaydin, C., Grohennig, A., Erhardt, A., Cakaloglu, Y., Yalcin, K., Gurel, S., Zeuzem, S., Zachou, K., Chatzikyrkou, C., Bozkaya, H., Dalekos, G. N., Manns, M. P., and Wedemeyer, H.
Published: 2012
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39. Anti-α actinin antibodies as new predictors of response to treatment in autoimmune hepatitis type 1

Author: Zachou, K., Oikonomou, K., Renaudineau, Y., Chauveau, A., Gatselis, N., Youinou, P., and Dalekos, G. N.
Published: 2012
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40. Hepatobiliary and Pancreatic: Primary hepatic lymphoma

Author: Gatselis, N K and Dalekos, G N
Published: 2011
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41. Primary retroperitoneal non-Hodgkin lymphoma presenting with torturous generalized pruritus in an elderly

Author: Daponte, A., Ioannou, M., Gioti, C., Kallitsaris, A., Dalekos, G. N., and Messinis, I. E.
Published: 2007
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42. aMAP risk score predicts hepatocellular carcinoma development in patients with chronic hepatitis

Author: Fan, R. Papatheodoridis, G. Sun, J. Innes, H. Toyoda, H. Xie, Q. Mo, S. Sypsa, V. Guha, I.N. Kumada, T. Niu, J. Dalekos, G. Yasuda, S. Barnes, E. Lian, J. Suri, V. Idilman, R. Barclay, S.T. Dou, X. Berg, T. Hayes, P.C. Flaherty, J.F. Zhou, Y. Zhang, Z. Buti, M. Hutchinson, S.J. Guo, Y. Calleja, J.L. Lin, L. Zhao, L. Chen, Y. Janssen, H.L.A. Zhu, C. Shi, L. Tang, X. Gaggar, A. Wei, L. Jia, J. Irving, W.L. Johnson, P.J. Lampertico, P. Hou, J.
Abstract: Background & Aims: Hepatocellular carcinoma (HCC) is the leading cause of death in patients with chronic hepatitis. In this international collaboration, we sought to develop a global universal HCC risk score to predict the HCC development for patients with chronic hepatitis. Methods: A total of 17,374 patients, comprising 10,578 treated Asian patients with chronic hepatitis B (CHB), 2,510 treated Caucasian patients with CHB, 3,566 treated patients with hepatitis C virus (including 2,489 patients with cirrhosis achieving a sustained virological response) and 720 patients with non-viral hepatitis (NVH) from 11 international prospective observational cohorts or randomised controlled trials, were divided into a training cohort (3,688 Asian patients with CHB) and 9 validation cohorts with different aetiologies and ethnicities (n = 13,686). Results: We developed an HCC risk score, called the aMAP score (ranging from 0 to 100), that involves only age, male, albumin–bilirubin and platelets. This metric performed excellently in assessing HCC risk not only in patients with hepatitis of different aetiologies, but also in those with different ethnicities (C-index: 0.82–0.87). Cut-off values of 50 and 60 were best for discriminating HCC risk. The 3- or 5-year cumulative incidences of HCC were 0–0.8%, 1.5–4.8%, and 8.1–19.9% in the low- (n = 7,413, 43.6%), medium- (n = 6,529, 38.4%), and high-risk (n = 3,044, 17.9%) groups, respectively. The cut-off value of 50 was associated with a sensitivity of 85.7–100% and a negative predictive value of 99.3–100%. The cut-off value of 60 resulted in a specificity of 56.6–95.8% and a positive predictive value of 6.6–15.7%. Conclusions: This objective, simple, reliable risk score based on 5 common parameters accurately predicted HCC development, regardless of aetiology and ethnicity, which could help to establish a risk score-guided HCC surveillance strategy worldwide. Lay summary: In this international collaboration, we developed and externally validated a simple, objective and accurate prognostic tool (called the aMAP score), that involves only age, male, albumin–bilirubin and platelets. The aMAP score (ranged from 0 to 100) satisfactorily predicted the risk of hepatocellular carcinoma (HCC) development among over 17,000 patients with viral and non-viral hepatitis from 11 global prospective studies. Our findings show that the aMAP score had excellent discrimination and calibration in assessing the 5-year HCC risk among all the cohorts irrespective of aetiology and ethnicity. © 2020 European Association for the Study of the Liver
Published: 2020

43. Real-time quantification of human telomerase reverse transcriptase mRNA in liver tissues from patients with hepatocellular cancer and chronic viral hepatitis

Author: Satra, M., Gatselis, N., Iliopoulos, D., Zacharoulis, D., Dalekos, G. N., and Tsezou, A.
Published: 2007

44. Diagnostic relevance of anti-filamentous actin antibodies in autoimmune hepatitis

Author: Liaskos, C, Bogdanos, D-P, Davies, E T, and Dalekos, G N
Published: 2007

45. Clinical significance of organ- and non-organ-specific autoantibodies on the response to anti-viral treatment of patients with chronic hepatitis C

Author: GATSELIS, N. K., GEORGIADOU, S. P., KOUKOULIS, G. K., TASSOPOULOS, N., ZACHOU, K., LIASKOS, C., HATZAKIS, A., and DALEKOS, G. N.
Published: 2006

46. Safety and efficacy of lamivudine in patients with severe acute or fulminant hepatitis B, a multicenter experience

Author: Tillmann, H. L., Hadem, J., Leifeld, L., Zachou, K., Canbay, A., Eisenbach, C., Graziadei, I., Encke, J., Schmidt, H., Vogel, W., Schneider, A., Spengler, U., Gerken, G., Dalekos, G. N., Wedemeyer, H., and Manns, M. P.
Published: 2006

47. Goals of Treatment for Improved Survival in Primary Biliary Cholangitis: Treatment Target Should Be Bilirubin Within the Normal Range and Normalization of Alkaline Phosphatase

Author: Murillo Perez, C, Harms, M, Lindor, K, van Buuren, H, Hirschfield, G, Corpechot, C, van der Meer, A, Feld, J, Gulamhusein, A, Lammers, W, Ponsioen, C, Carbone, M, Mason, A, Mayo, M, Invernizzi, P, Battezzati, P, Floreani, A, Lleo, A, Nevens, F, Kowdley, K, Bruns, T, Dalekos, G, Gatselis, N, Thorburn, D, Trivedi, P, Verhelst, X, Parés, A, Janssen, H, Hansen, B, Murillo Perez, Carla F, Harms, Maren H, Lindor, Keith D, van Buuren, Henk R, Hirschfield, Gideon M, Corpechot, Christophe, van der Meer, Adriaan J, Feld, Jordan J, Gulamhusein, Aliya, Lammers, Willem J, Ponsioen, Cyriel Y, Carbone, Marco, Mason, Andrew L, Mayo, Marlyn J, Invernizzi, Pietro, Battezzati, Pier Maria, Floreani, Annarosa, Lleo, Ana, Nevens, Frederik, Kowdley, Kris V, Bruns, Tony, Dalekos, George N, Gatselis, Nikolaos K, Thorburn, Douglas, Trivedi, Palak J, Verhelst, Xavier, Parés, Albert, Janssen, Harry L A, Hansen, Bettina E, Murillo Perez, C, Harms, M, Lindor, K, van Buuren, H, Hirschfield, G, Corpechot, C, van der Meer, A, Feld, J, Gulamhusein, A, Lammers, W, Ponsioen, C, Carbone, M, Mason, A, Mayo, M, Invernizzi, P, Battezzati, P, Floreani, A, Lleo, A, Nevens, F, Kowdley, K, Bruns, T, Dalekos, G, Gatselis, N, Thorburn, D, Trivedi, P, Verhelst, X, Parés, A, Janssen, H, Hansen, B, Murillo Perez, Carla F, Harms, Maren H, Lindor, Keith D, van Buuren, Henk R, Hirschfield, Gideon M, Corpechot, Christophe, van der Meer, Adriaan J, Feld, Jordan J, Gulamhusein, Aliya, Lammers, Willem J, Ponsioen, Cyriel Y, Carbone, Marco, Mason, Andrew L, Mayo, Marlyn J, Invernizzi, Pietro, Battezzati, Pier Maria, Floreani, Annarosa, Lleo, Ana, Nevens, Frederik, Kowdley, Kris V, Bruns, Tony, Dalekos, George N, Gatselis, Nikolaos K, Thorburn, Douglas, Trivedi, Palak J, Verhelst, Xavier, Parés, Albert, Janssen, Harry L A, and Hansen, Bettina E
Abstract: INTRODUCTION: In primary biliary cholangitis (PBC), bilirubin and alkaline phosphatase (ALP) are widely established as independent predictors of prognosis. Current treatment goals do not aim for normalization of surrogate markers because their association with survival has not been defined. METHODS: The patient cohort from the GLOBAL PBC Study Group was used, comprising of long-term follow-up data from European and North American centers. Ursodeoxycholic acid-treated and untreated patients with bilirubin levels ≤1 × upper limit of normal (ULN) at baseline or 1 year were included. The association of normal ALP with transplant-free survival was assessed in a subgroup with ALP ≤1.67 × ULN at 1 year. Optimal thresholds of bilirubin and ALP to predict liver transplantation (LT) or death were evaluated. RESULTS: There were 2,281 patients included in the time zero cohort and 2,555 patients in the 1-year cohort. The bilirubin threshold with the highest ability to predict LT or death at 1 year was 0.6 × ULN (hazard ratio 2.12, 95% CI 1.69-2.66, P < 0.001). The 10-year survival rates of patients with bilirubin ≤0.6 × ULN and >0.6 × ULN were 91.3% and 79.2%, respectively (P < 0.001). The risk for LT or death was stable below the bilirubin levels of 0.6 × ULN, yet increased beyond this threshold. Ursodeoxycholic acid-induced reduction in bilirubin below this threshold was associated with an 11% improvement in 10-year survival. Furthermore, ALP normalization was optimal, with 10-year survival rates of 93.2% in patients with ALP ≤ 1 × ULN and 86.1% in those with ALP 1.0-1.67 × ULN. DISCUSSION: Attaining bilirubin levels ≤0.6 × ULN or normal ALP are associated with the lowest risk for LT or death in patients with PBC. This has important implications for treatment targets.
Published: 2020

48. Factors Associated With Progression and Outcomes of Early Stage Primary Biliary Cholangitis

Author: Gatselis, N, Goet, J, Zachou, K, Lammers, W, Janssen, H, Hirschfield, G, Corpechot, C, Lindor, K, Invernizzi, P, Mayo, M, Battezzati, P, Floreani, A, Pares, A, Lygoura, V, Nevens, F, Mason, A, Kowdley, K, Ponsioen, C, Bruns, T, Thorburn, D, Verhelst, X, Harms, M, van Buuren, H, Hansen, B, Dalekos, G, Gatselis, Nikolaos K, Goet, Jorn C, Zachou, Kalliopi, Lammers, Willem J, Janssen, Harry L A, Hirschfield, Gideon, Corpechot, Christophe, Lindor, Keith D, Invernizzi, Pietro, Mayo, Marlyn J, Battezzati, Pier Maria, Floreani, Annarosa, Pares, Albert, Lygoura, Vasiliki, Nevens, Frederik, Mason, Andrew L, Kowdley, Kris V, Ponsioen, Cyriel Y, Bruns, Tony, Thorburn, Douglas, Verhelst, Xavier, Harms, Maren H, van Buuren, Henk R, Hansen, Bettina E, Dalekos, George N, Gatselis, N, Goet, J, Zachou, K, Lammers, W, Janssen, H, Hirschfield, G, Corpechot, C, Lindor, K, Invernizzi, P, Mayo, M, Battezzati, P, Floreani, A, Pares, A, Lygoura, V, Nevens, F, Mason, A, Kowdley, K, Ponsioen, C, Bruns, T, Thorburn, D, Verhelst, X, Harms, M, van Buuren, H, Hansen, B, Dalekos, G, Gatselis, Nikolaos K, Goet, Jorn C, Zachou, Kalliopi, Lammers, Willem J, Janssen, Harry L A, Hirschfield, Gideon, Corpechot, Christophe, Lindor, Keith D, Invernizzi, Pietro, Mayo, Marlyn J, Battezzati, Pier Maria, Floreani, Annarosa, Pares, Albert, Lygoura, Vasiliki, Nevens, Frederik, Mason, Andrew L, Kowdley, Kris V, Ponsioen, Cyriel Y, Bruns, Tony, Thorburn, Douglas, Verhelst, Xavier, Harms, Maren H, van Buuren, Henk R, Hansen, Bettina E, and Dalekos, George N
Abstract: Background & Aims: Patients usually receive a diagnosis of primary biliary cholangitis (PBC) at an early stage, based on biochemical analyses. We investigated the proportion of patients who progress to moderate or advanced PBC and factors associated with progression and patient survival. Methods: We obtained data from 1615 patients (mean age, 55.4 y) with early stage PBC (based on their normal levels of albumin and bilirubin), collected at the time of initial evaluation or treatment, from the Global PBC Study Group database (comprising patients at 19 liver centers in North American and European countries). We collected data from health care evaluations on progression to moderate PBC (abnormal level of bilirubin or albumin) or advanced-stage PBC (abnormal level of both). The median follow-up time was 7.9 years. The composite end point was decompensation, hepatocellular carcinoma, liver transplantation, or death. Results: Of the 1615 patients identified with early stage PBC, 904 developed moderate PBC and 201 developed advanced disease over the study period. The proportions of patients who transitioned to moderate PBC at 1, 3, and 5 years were 12.9%, 30.2%, and 45.8%. The proportions of these patients who then transitioned to advanced PBC at 1, 3, and 5 years later were 3.4%, 12.5%, and 16.0%, respectively. During the follow-up period, 236 patients had a clinical event. The proportions of patients with moderate PBC and event-free survival were 97.9%, 95.1%, and 91.5% at 1, 3, and 5 years, respectively, and the proportions of patients with advanced PBC and event-free survival were 90.6%, 71.2%, and 58.3% at 1, 3, and 5 years later, respectively. Variables associated with transition from early to moderate PBC included baseline levels of bilirubin, albumin, and alkaline phosphatase; aspartate to alanine aminotransferase ratio; platelet count; and treatment with ursodeoxycholic acid. Transitions from early to moderate PBC and from moderate to advanced PBC were associated
Published: 2020

49. Serum gamma-glutamyltransferase is a prognostic biomarker in primary biliary cholangitis and improves risk stratification based on alkaline phosphatase

Author: Gerussi, A, Bernasconi, D, O'Donnell, S, Lammers, W, Van Buuren, H, Hirschfield, G, Janssen, H, Corpechot, C, Reig, A, Pares, A, Battezzati, P, Zuin, M, Cazzagon, N, Floreani, A, Nevens, F, Gatselis, N, Dalekos, G, Mayo, M, Thorburn, D, Bruns, T, Mason, A, Xavier, V, Kowdley, K, Invernizzi, P, Hansen, B, Carbone, M, O'donnell, SE, Lammers, WJ, Battezzati, PM, Zuin, MG, Mayo, MJ, Mason, AL, Gerussi, A, Bernasconi, D, O'Donnell, S, Lammers, W, Van Buuren, H, Hirschfield, G, Janssen, H, Corpechot, C, Reig, A, Pares, A, Battezzati, P, Zuin, M, Cazzagon, N, Floreani, A, Nevens, F, Gatselis, N, Dalekos, G, Mayo, M, Thorburn, D, Bruns, T, Mason, A, Xavier, V, Kowdley, K, Invernizzi, P, Hansen, B, Carbone, M, O'donnell, SE, Lammers, WJ, Battezzati, PM, Zuin, MG, Mayo, MJ, and Mason, AL
Published: 2020

50. The impact of geographical region on outcomes of patients with primary biliary cholangitis from western Europe

Author: Perez, C, Gerussi, A, Trivedi, P, Corpechot, C, Van der Meer, A, Battezzati, P, Lindor, K, Nevens, F, Kowdley, K, Bruns, T, Floreani, A, Tanaka, A, Ma, X, Mason, A, Gulamhusein, A, Ponsioen, C, Carbone, M, Mayo, M, Lleo, A, Dalekos, G, Gatselis, N, Thorburn, D, Xavier, V, Pares, A, Janssen, H, Hirschfield, G, Hansen, B, Invernizzi, P, Lammers, W, Perez, CFM, Battezzati, PM, Lindor, KD, Kowdley, KV, Mason, AL, Mayo, MJ, Lammers, WJ, Perez, C, Gerussi, A, Trivedi, P, Corpechot, C, Van der Meer, A, Battezzati, P, Lindor, K, Nevens, F, Kowdley, K, Bruns, T, Floreani, A, Tanaka, A, Ma, X, Mason, A, Gulamhusein, A, Ponsioen, C, Carbone, M, Mayo, M, Lleo, A, Dalekos, G, Gatselis, N, Thorburn, D, Xavier, V, Pares, A, Janssen, H, Hirschfield, G, Hansen, B, Invernizzi, P, Lammers, W, Perez, CFM, Battezzati, PM, Lindor, KD, Kowdley, KV, Mason, AL, Mayo, MJ, and Lammers, WJ
Published: 2020

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