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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. 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

4. 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

5. 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

6. 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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7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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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15. Temporal trends in stroke incidence and case-fatality rates in Arcadia, Greece: A sequential, prospective, population-based study

Author: Karantali, E. Vemmos, K. Tsampalas, E. Xynos, K. Karachalia, P. Lambrou, D. Angeloglou, S. Kazakou, M. Karagianni, A. Aravantinou-Fatorou, K. Karakatsani, E. Bots, M.L. Karamatzianni, G. Bellos, S. Ntiloudis, R. Lypiridou, M. Gamvoula, A. Georgiopoulos, G. Ajdini, E. Gatselis, N. Makaritsis, K. Korompoki, E. Ntaios, G.
Abstract: Background: Stroke incidence and case-fatality are reported to decline in high-income countries during the last decades. Epidemiological studies are important for health services to organize prevention and treatment strategies. Aims: The aim of this population-based study was to determine temporal trends of stroke incidence and case-fatality rates of first-ever stroke in Arcadia, a prefecture in southern Greece. Methods: All first-ever stroke cases in the Arcadia prefecture were ascertained using the same standard criteria and multiple overlapping sources in three study periods: from November 1993 to October 1995; 2004; and 2015–2016. Crude and age-adjusted to European population incidence rates were compared using Poisson regression. Twenty-eight days case fatality rates were estimated and compared using the same method. Results: In total, 1315 patients with first-ever stroke were identified. The age-standardized incidence to the European population was 252 per 100,000 person-years (95% CI 231–239) in 1993/1995, 252 (95% CI 223–286) in 2004, and 211 (192–232) in 2015/2016. The overall age- and sex-adjusted incidence rates fell by 16% (incidence rates ratio 0.84, 95% CI: 0.72–0.97). Similarly, 28-day case-fatality rate decreased by 28% (case fatality rate ratio = 0.72, 95% CI: 0.58–0.90). Conclusions: This population-based study reports a significant decline in stroke incidence and mortality rates in southern Greece between 1993 and 2016. © 2021 World Stroke Organization.
Published: 2022

16. 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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17. 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

18. 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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19. An open label trial of anakinra to prevent respiratory failure in covid-19

Author: Kyriazopoulou, E. Panagopoulos, P. Metallidis, S. Dalekos, G.N. Poulakou, G. Gatselis, N. Karakike, E. Saridaki, M. Loli, G. Stefos, A. Prasianaki, D. Georgiadou, S. Tsachouridou, O. Petrakis, V. Tsiakos, K. Kosmidou, M. Lygoura, V. Dareioti, M. Milionis, H. Papanikolaou, I.C. Akinosoglou, K. Myrodia, D.-M. Gravvani, A. Stamou, A. Gkavogianni, T. Katrini, K. Marantos, T. Trontzas, I.P. Syrigos, K. Chatzis, L. Chatzis, S. Vechlidis, N. Avgoustou, C. Chalvatzis, S. Kyprianou, M. van der Meer, J.W.M. Eugen-Olsen, J. Netea, M.G. Giamarellos-Bourboulis, E.J.
Abstract: Background It was studied if early suPAR-guided anakinra treatment can prevent severe respiratory failure (SRF) of COVID-19. Methods 130 patients with suPAR ≥6 ng/ml were assigned to subcutaneous anakinra 100mg once daily for 10 days. Primary outcome was SRF incidence by day 14 defined as any respiratory ratio below 150 mmHg necessitating mechanical or non-invasive ventilation. Main secondary outcomes were 30-day mortality and inflammatory mediators; 28-day WHO-CPS was explored. Propensity-matched standard-of care comparators were studied. Results 22.3% with anakinra treatment and 59.2% comparators (hazard ratio, 0.30; 95%CI, 0.20-0.46) progressed into SRF; 30-day mortality was 11.5% and 22.3% respectively (hazard ratio 0.49; 95% CI 0.25-0.97). Anakinra was associated with decrease in circulating interleukin (IL)-6, sCD163 and sIL2-R; IL-10/IL-6 ratio on day 7 was inversely associated with SOFA score; patients were allocated to less severe WHO-CPS strata. Conclusions Early suPAR-guided anakinra decreased SRF and restored the pro-/anti-inflammatory balance. Trial Registration: ClinicalTrials.gov, NCT04357366. © 2021, eLife Sciences Publications Ltd. All rights reserved.
Published: 2021

20. Effect of anakinra on mortality in patients with COVID-19: a systematic review and patient-level meta-analysis

Author: Kyriazopoulou, E. Huet, T. Cavalli, G. Gori, A. Kyprianou, M. Pickkers, P. Eugen-Olsen, J. Clerici, M. Veas, F. Chatellier, G. Kaplanski, G. Netea, M.G. Pontali, E. Gattorno, M. Cauchois, R. Kooistra, E. Kox, M. Bandera, A. Beaussier, H. Mangioni, D. Dagna, L. van der Meer, J.W.M. Giamarellos-Bourboulis, E.J. Hayem, G. Netea, M.G. van der Meer, J.W.M. Giamarellos-Bourboulis, E.J. Volpi, S. Sormani, M.P. Signori, A. Bozzi, G. Minoia, F. Aliberti, S. Grasselli, G. Alagna, L. Lombardi, A. Ungaro, R. Agostoni, C. Blasi, F. Costantino, G. Fracanzani, A.L. Montano, N. Peyvandi, F. Sottocorno, M. Muscatello, A. Filocamo, G. Papadopoulos, A. Mouktaroudi, M. Karakike, E. Saridaki, M. Gkavogianni, T. Katrini, K. Vechlidis, N. Avgoustou, C. Chalvatzis, S. Marantos, T. Damoulari, C. Damoraki, G. Ktena, S. Tsilika, M. Koufargyris, P. Karageorgos, A. Droggiti, D.-I. Koliakou, A. Poulakou, G. Tsiakos, K. Myrodia, D.-M. Gravvani, A. Trontzas, I.P. Syrigos, K. Kalomenidis, I. Kranidioti, E. Panagopoulos, P. Petrakis, V. Metallidis, S. Loli, G. Tsachouridou, O. Dalekos, G.N. Gatselis, N. Stefos, A. Georgiadou, S. Lygoura, V. Milionis, H. Kosmidou, M. Papanikolaou, I.C. Akinosoglou, K. Giannitsioti, E. Chrysos, G. Mavroudis, P. Sidiropoulou, C. Adamis, G. Fragkou, A. Rapti, A. Alexiou, Z. Symbardi, S. Masgala, A. Kostaki, K. Kostis, E. Samarkos, M. Bakakos, P. Tzavara, V. Dimakou, K. Tzatzagou, G. Chini, M. Kotsis, V. Tsoukalas, G. Bliziotis, I. Doumas, M. Argyraki, A. Kainis, I. Fantoni, M. Cingolani, A. Angheben, A. Cardellino, C.S. Castelli, F. Serino, F.S. Nicastri, E. Ippolito, G. Bassetti, M. Selmi, C. International Collaborative Group for Anakinra in COVID-19
Abstract: Background: Anakinra might improve the prognosis of patients with moderate to severe COVID-19 (ie, patients requiring oxygen supplementation but not yet receiving organ support). We aimed to assess the effect of anakinra treatment on mortality in patients admitted to hospital with COVID-19. Methods: For this systematic review and individual patient-level meta-analysis, a systematic literature search was done on Dec 28, 2020, in Medline (PubMed), Cochrane, medRxiv, bioRxiv, and the ClinicalTrials.gov databases for randomised trials, comparative studies, and observational studies of patients admitted to hospital with COVID-19, comparing administration of anakinra with standard of care, or placebo, or both. The search was repeated on Jan 22, 2021. Individual patient-level data were requested from investigators and corresponding authors of eligible studies; if individual patient-level data were not available, published data were extracted from the original reports. The primary endpoint was mortality after 28 days and the secondary endpoint was safety (eg, the risk of secondary infections). This study is registered on PROSPERO (CRD42020221491). Findings: 209 articles were identified, of which 178 full-text articles fulfilled screening criteria and were assessed. Aggregate data on 1185 patients from nine studies were analysed, and individual patient-level data on 895 patients were provided from six of these studies. Eight studies were observational and one was a randomised controlled trial. Most studies used historical controls. In the individual patient-level meta-analysis, after adjusting for age, comorbidities, baseline ratio of the arterial partial oxygen pressure divided by the fraction of inspired oxygen (PaO2/FiO2), C-reactive protein (CRP) concentrations, and lymphopenia, mortality was significantly lower in patients treated with anakinra (38 [11%] of 342) than in those receiving standard of care with or without placebo (137 [25%] of 553; adjusted odds ratio [OR] 0·32 [95% CI 0·20–0·51]). The mortality benefit was similar across subgroups regardless of comorbidities (ie, diabetes), ferritin concentrations, or the baseline PaO2/FiO2. In a subgroup analysis, anakinra was more effective in lowering mortality in patients with CRP concentrations higher than 100 mg/L (OR 0·28 [95% CI 0·17–0·47]). Anakinra showed a significant survival benefit when given without dexamethasone (OR 0·23 [95% CI 0·12–0·43]), but not with dexamethasone co-administration (0·72 [95% CI 0·37–1·41]). Anakinra was not associated with a significantly increased risk of secondary infections when compared with standard of care (OR 1·35 [95% CI 0·59–3·10]). Interpretation: Anakinra could be a safe, anti-inflammatory treatment option to reduce the mortality risk in patients admitted to hospital with moderate to severe COVID-19 pneumonia, especially in the presence of signs of hyperinflammation such as CRP concentrations higher than 100 mg/L. Funding: Sobi. © 2021 Elsevier Ltd
Published: 2021

21. Predictive performance of newer Asian hepatocellular carcinoma risk scores in treated Caucasians with chronic hepatitis B

Author: Papatheodoridis, G.V. Dalekos, G.N. Idilman, R. Sypsa, V. Van Boemmel, F. Buti, M. Calleja, J.L. Goulis, J. Manolakopoulos, S. Loglio, A. Papatheodoridi, M. Gatselis, N. Veelken, R. Lopez-Gomez, M. Hansen, B.E. Savvidou, S. Kourikou, A. Vlachogiannakos, J. Galanis, K. Yurdaydin, C. Esteban, R. Janssen, H.L.A. Berg, T. Lampertico, P.
Subjects: digestive system diseases
Abstract: Background & Aims: Recently, several risk scores for prediction of hepatocellular carcinoma (HCC) were developed in cohorts of treated Asian patients with chronic hepatitis B (CHB), but they have not been assessed in non-Asian patients. We evaluated the predictability and comparative utility of our PAGE-B and recent Asian HCC risk scores in nucleos(t)ide analogue (NA)-treated adult Caucasian patients with CHB, with or without well-documented compensated cirrhosis but not previous diagnosis of HCC. Methods: We included 1,951 patients treated with entecavir/tenofovir and followed up for a median of 7.6 years. The c-statistic was used to estimate the predictability of PAGE-B, HCC-Rescue, CAMD, mPAGE-B, and AASL score for HCC development within 5 or 10 years. The low- and high-risk group cut-offs were used for estimation of negative (NPV) and positive predictive values (PPV), respectively. Results: HCC developed in 103/1,951 (5.3%) patients during the first 5 years and in another 39/1,428 (2.7%) patients between years 5 and 10. The 3-, 5-, and 10-year cumulative HCC rates were 3.3%, 5.9%, and 9.6%, respectively. All scores offered good 5- and 10-year HCC prediction (c-statistic: 0.78–0.82). NPVs were always >99% (99.3–100%), whereas PPV ranged between 13% and 24%. Conclusions: In NA-treated Caucasian patients with CHB including compensated cirrhosis, HCC risk scores developed in NA-treated Asian patients offer good 5- and 10-year HCC predictability, similar to that of PAGE-B. PAGE-B and mPAGE-B scores are simpler in clinical practice, as they do not require an accurate diagnosis of cirrhosis, but the addition of albumin in mPAGE-B score does not seem to offer an advantage in patients with well compensated liver disease. Lay summary: Several risk scores for prediction of hepatocellular carcinoma (HCC) were recently developed in cohorts of treated Asian patients with chronic hepatitis B (CHB). In Caucasian patients with CHB treated with oral antivirals, newer Asian HCC risk scores offer good 5- and 10-year HCC predictability, similar to that of PAGE-B. For clinical practice, PAGE-B and mPAGE-B scores are simpler, as they do not require an accurate diagnosis of cirrhosis. © 2021 The Authors
Published: 2021

22. Evolution of epidemiological characteristics of infective endocarditis in Greece

Author: Giannitsioti, E. Pefanis, A. Gogos, C. Lekkou, A. Dalekos, G.N. Gatselis, N. Georgiadou, S. Nikou, P. Vrettou, A. Rigopoulos, A. Tryfonopoulos, C. Tsaganos, T. Karofilakis, E. Psarrakis, C. Argyriou, M. Gargalianos-Kakolyris, P. Adamis, G. Lourida, P. Kofteridis, D. Andrianaki, A. Loupa, C. Kostis, E. Sinapidis, D. Sympardi, S. Alexiou, N. Karaiskos, I. Masgala, A. Maltezos, E. Panagopoulos, P. Sachpekidis, V. Evdoridis, C. Sipsas, N.V. Daikos, G. Giamarellou, H. Pontikis, K. Lioris, I. Lelekis, M. Trikkas, A. Aggouras, D. Kolias, V. Rokkas, C. Nana-Anastasiou, M. Miyakis, S. On behalf of the Hellenic Society of Chemotherapy
Abstract: Objective: The clinical profile, management and outcome of infective endocarditis (IE) may be influenced by socioeconomic issues. Methods: A nationwide prospective study evaluated IE during the era of deep economic crisis in Greece. Epidemiological data and factors associated with 60-day mortality were analyzed through descriptive statistics, logistic and Cox-regression models. Results: Among 224 patients (male 72.3%, mean age 62.4 years), Staphylococcus aureus (n = 62; methicillin-resistant S. aureus (MRSA) 33.8%) predominated in the young without impact on mortality (p = 0.593), whilst Enterococci (n = 36) predominated in the elderly. Complications of IE were associated with mortality: heart failure [OR 2.415 (95% CI: 1.159–5.029), p = 0.019], stroke [OR 3.206 (95% CI: 1.190–8.632), p = 0.018] and acute kidney injury [OR 2.283 (95% CI: 1.085–4.805), p = 0.029]. A 60-day survival benefit was solely related to cardiac surgery for IE during hospitalization [HR 0.386 (95% CI: 0.165–0.903), p = 0.028] and compliance with antimicrobial treatment guidelines [HR 0.487 (95% CI: 0.259–0.916), p = 0.026]. Compared with a previous country cohort study, history of rheumatic fever and native valve predisposition had declined, whilst underlying renal disease and right-sided IE had increased (p < 0.0001); HIV infection had emerged (p = 0.002). No difference in rates of surgery and outcome was assessed. Conclusions: A country-wide survey of IE highlighted emergence of HIV, right-sided IE and predominance of MRSA in the youth during a severe socioeconomic crisis. Compliance with treatment guidelines promoted survival. © 2021 The Authors
Published: 2021

23. Author Correction: Early treatment of COVID-19 with anakinra guided by soluble urokinase plasminogen receptor plasma levels: a double-blind, randomized controlled phase 3 trial (Nature Medicine, (2021), 27, 10, (1752-1760), 10.1038/s41591-021-01499-z)

Author: Kyriazopoulou, E. Poulakou, G. Milionis, H. Metallidis, S. Adamis, G. Tsiakos, K. Fragkou, A. Rapti, A. Damoulari, C. Fantoni, M. Kalomenidis, I. Chrysos, G. Angheben, A. Kainis, I. Alexiou, Z. Castelli, F. Serino, F.S. Tsilika, M. Bakakos, P. Nicastri, E. Tzavara, V. Kostis, E. Dagna, L. Koufargyris, P. Dimakou, K. Savvanis, S. Tzatzagou, G. Chini, M. Cavalli, G. Bassetti, M. Katrini, K. Kotsis, V. Tsoukalas, G. Selmi, C. Bliziotis, I. Samarkos, M. Doumas, M. Ktena, S. Masgala, A. Papanikolaou, I. Kosmidou, M. Myrodia, D.-M. Argyraki, A. Cardellino, C.S. Koliakou, K. Katsigianni, E.-I. Rapti, V. Giannitsioti, E. Cingolani, A. Micha, S. Akinosoglou, K. Liatsis-Douvitsas, O. Symbardi, S. Gatselis, N. Mouktaroudi, M. Ippolito, G. Florou, E. Kotsaki, A. Netea, M.G. Eugen-Olsen, J. Kyprianou, M. Panagopoulos, P. Dalekos, G.N. Giamarellos-Bourboulis, E.J.
Abstract: In the version of this Article initially published, there was an error in the author affiliations. Specifically, affiliation 27, corresponding to author Carlo Selmi, has been corrected from “Humanitas Research Hospital, Milan, Italy” to read: “Department of Biomedical Sciences, Humanitas University, Milan, Italy & IRCCS Humanitas Research Hospital, Milan, Italy.” The change has been made to the online version of the Article. © The Author(s) 2021.
Published: 2021

24. 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

25. Similar risk of hepatocellular carcinoma during long-term entecavir or tenofovir therapy in Caucasian patients with chronic hepatitis B

Author: Papatheodoridis, G.V. Dalekos, G.N. Idilman, R. Sypsa, V. Van Boemmel, F. Buti, M. Calleja, J.L. Goulis, J. Manolakopoulos, S. Loglio, A. Papatheodoridi, M. Gatselis, N. Veelken, R. Lopez-Gomez, M. Hansen, B.E. Savvidou, S. Kourikou, A. Vlachogiannakos, J. Galanis, K. Yurdaydin, C. Esteban, R. Janssen, H.L.A. Berg, T. Lampertico, P.
Abstract: Background & Aims: A recent study in Asian patients with chronic hepatitis B (CHB) reported that the incidence of hepatocellular carcinoma (HCC) was lower in patients treated with tenofovir disoproxil fumarate (TDF) than entecavir (ETV), but this finding remains controversial. We aimed to identify any differences in HCC incidence, or other patient outcomes, between patients receiving TDF or ETV in the well monitored, multicenter European PAGE-B cohort. Methods: We included 1,935 Caucasians with CHB, with or without compensated cirrhosis, treated with ETV (n = 772) or TDF (n = 1,163) monotherapy. Mean follow-up was 7.1 ± 3.0 years from ETV/TDF onset. Results: The 5-year cumulative HCC incidence was 5.4% in ETV- and 6.0% in TDF-treated patients (log-rank, p = 0.321), with no significant difference in any patient subgroup (with or without cirrhosis, naïve or experienced to oral antiviral(s) [total, with or without cirrhosis]). In multivariable Cox regression analyses, the hazard of HCC was similar between ETV- and TDF-treated patients after adjustment for several HCC risk factors. ETV- and TDF-treated patients had similar rates of on-therapy biochemical and virological remission, HBsAg loss, liver transplantation and/or death. Elastographic reversion of cirrhosis at year 5 (liver stiffness
Published: 2020

26. Hepatocellular carcinoma prediction beyond year 5 of oral therapy in a large cohort of Caucasian patients with chronic hepatitis B

Author: Papatheodoridis, G.V. Sypsa, V. Dalekos, G.N. Yurdaydin, C. Van Boemmel, F. Buti, M. Calleja, J.L. Chi, H. Goulis, J. Manolakopoulos, S. Loglio, A. Voulgaris, T. Gatselis, N. Keskin, O. Veelken, R. Lopez-Gomez, M. Hansen, B.E. Savvidou, S. Kourikou, A. Vlachogiannakos, J. Galanis, K. Idilman, R. Esteban, R. Janssen, H.L.A. Berg, T. Lampertico, P.
Abstract: Background & Aims: Hepatocellular carcinoma (HCC) may develop in patients with chronic hepatitis (CHB) even after 5 years of oral therapy and cannot be easily predicted. We assessed predictors of HCC development and the need for HCC surveillance in this setting. Methods: Of 1,951 adult Caucasians with CHB included in the PAGE-B cohort, 1,427 (73%) had completed >5 years of follow-up under therapy without developing HCC by year 5. Median follow-up was 8.4 years from treatment onset. Points-based risk scores were developed to predict HCC risk after year 5. Results: In years 5–12, HCC was diagnosed in 33/1,427 (2.3%) patients with cumulative incidences of 2.4%, 3.2% and 3.8% at 8, 10 and 12 years, respectively. Older age or age >50 years, baseline cirrhosis and liver stiffness (LSM) ≥12 kPa at year 5 were independently associated with increased HCC risk. The HCC incidence was lower in non-cirrhotics than cirrhotics at baseline with year-5 LSM
Published: 2020

27. 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

28. 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

29. 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

30. 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

31. Serum gamma-glutamyltransferase is a prognostic biomarker in primary biliary cholangitis and improves risk stratification based on the 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

32. 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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33. 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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34. Hepatobiliary and Pancreatic: Primary hepatic lymphoma

Author: Gatselis, N K and Dalekos, G N
Published: 2011
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35. Serum gamma-glutamyltransferase is a prognostic biomarker in primary biliary cholangitis and improves risk stratification based on alkaline phosphatase

Author: Gerussi, A., primary, Bernasconi, D., additional, O’donnell, S.E., additional, Lammers, W.J., additional, Van Buuren, H., additional, Hirschfield, G., additional, Janssen, H., additional, Corpechot, C., additional, Reig, A., additional, Pares, A., additional, Battezzati, P.M., additional, Zuin, M.G., additional, Cazzagon, N., additional, Floreani, A., additional, Nevens, F., additional, Gatselis, N., additional, Dalekos, G., additional, Mayo, M.J., additional, Thorburn, D., additional, Bruns, T., additional, Mason, A.L., additional, Xavier, V., additional, Kowdley, K., additional, Invernizzi, P., additional, Hansen, B., additional, and Carbone, M., additional
Published: 2020
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36. 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

37. 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

38. Effects of Age and Sex of Response to Ursodeoxycholic Acid and Transplant-free Survival in Patients With Primary Biliary Cholangitis

Author: Cheung, A, Lammers, W, Murillo Perez, C, van Buuren, H, Gulamhusein, A, Trivedi, P, Lazaridis, K, Ponsioen, C, Floreani, A, Hirschfield, G, Corpechot, C, Mayo, M, Invernizzi, P, Battezzati, P, Parés, A, Nevens, F, Thorburn, D, Mason, A, Carbone, M, Kowdley, K, Bruns, T, Dalekos, G, Gatselis, N, Verhelst, X, Lindor, K, Lleo, A, Poupon, R, Janssen, H, Hansen, B, Cheung, Angela C, Lammers, Willem J, Murillo Perez, Carla F, van Buuren, Henk R, Gulamhusein, Aliya, Trivedi, Palak J, Lazaridis, Konstantinos N, Ponsioen, Cyriel Y, Floreani, Annarosa, Hirschfield, Gideon M, Corpechot, Christophe, Mayo, Marlyn J, Invernizzi, Pietro, Battezzati, Pier Maria, Parés, Albert, Nevens, Frederik, Thorburn, Douglas, Mason, Andrew L, Carbone, Marco, Kowdley, Kris V, Bruns, Tony, Dalekos, George N, Gatselis, Nikolaos K, Verhelst, Xavier, Lindor, Keith D, Lleo, Ana, Poupon, Raoul, Janssen, Harry L, Hansen, Bettina E, Cheung, A, Lammers, W, Murillo Perez, C, van Buuren, H, Gulamhusein, A, Trivedi, P, Lazaridis, K, Ponsioen, C, Floreani, A, Hirschfield, G, Corpechot, C, Mayo, M, Invernizzi, P, Battezzati, P, Parés, A, Nevens, F, Thorburn, D, Mason, A, Carbone, M, Kowdley, K, Bruns, T, Dalekos, G, Gatselis, N, Verhelst, X, Lindor, K, Lleo, A, Poupon, R, Janssen, H, Hansen, B, Cheung, Angela C, Lammers, Willem J, Murillo Perez, Carla F, van Buuren, Henk R, Gulamhusein, Aliya, Trivedi, Palak J, Lazaridis, Konstantinos N, Ponsioen, Cyriel Y, Floreani, Annarosa, Hirschfield, Gideon M, Corpechot, Christophe, Mayo, Marlyn J, Invernizzi, Pietro, Battezzati, Pier Maria, Parés, Albert, Nevens, Frederik, Thorburn, Douglas, Mason, Andrew L, Carbone, Marco, Kowdley, Kris V, Bruns, Tony, Dalekos, George N, Gatselis, Nikolaos K, Verhelst, Xavier, Lindor, Keith D, Lleo, Ana, Poupon, Raoul, Janssen, Harry L, and Hansen, Bettina E
Abstract: Primary biliary cholangitis (PBC) predominantly affects middle-aged women; there are few data on disease phenotypes and outcomes of PBC in men and younger patients. We investigated whether differences in sex and/or age at the start of ursodeoxycholic acid (UDCA) treatment are associated with response to therapy, based on biochemical markers, or differences in transplant-free survival.
Published: 2019

39. Anti-cardiolipin antibodies in patients with chronic viral hepatitis are independent of beta2-glycoprotein I cofactor or features of antiphospholipid syndrome

Author: Zachou, K., Liaskos, C., Christodoulou, D. K., Kardasi, M., Papadamou, G., Gatselis, N., Georgiadou, S. P., Tsianos, E. V., and Dalekos, G. N.
Published: 2003

40. Rates and predictors of HBsAg loss after discontinuation of effective long-term Entecavir or Tenofovir therapy in non-cirrhotic HBeAg-negative chronic hepatitis B patients: Results from the DARING-B prospective Greek study

Author: Papatheodoridis, M. Rigopoulou, E. Hadziyannis, E. Kalliopi, Z. Xourafas, V. Lyberopoulou, A. Gatselis, N. and Vlachogiannakos, I. Manolakopoulos, S. Dalekos, G. and Papatheodoridis, G.
Published: 2018

41. Correction: Daring-B: Discontinuation of effective entecavir or tenofovir disoproxil fumarate long-term therapy before HBsAg loss in non-cirrhotic HBeAg-negative chronic hepatitis B (Antivir Ther (2018) DOI: 10.3851/IMP3256)

Author: Papatheodoridis, G.V. Rigopoulou, E.I. Papatheodoridi, M. Zachou, K. Xourafas, V. Gatselis, N. Hadziyannis, E. Vlachogiannakos, J. Manolakopoulos, S. Dalekos, G.N.
Subjects: virus diseases, digestive system diseases
Abstract: The publisher would like to report errors in a recently published article [1]. The number of patients who cleared HBsAg during post-treatment follow-up has been corrected. The cumulative rate of HBsAg loss has been corrected. The number of patients (and percentage) that had detectable anti-HBs has also been corrected. The correct paragraph is as follows: ‘Of the 57 patients, 12 cleared HBsAg during post-treatment follow-up (3 between 1 and 6 months, 6 between 7 and 12 months and 3 between 13 and 18 months). Thus, the cumulative rate of HBsAg loss was 5%, 16% and 25% at 6, 12 and 18 months of post-NA(s) follow-up. HBsAg loss was confirmed in all cases at consecutive visits at least 1 month apart and none of the patients who achieved HBsAg clearance reverted to HBsAg seropositivity during follow-up. Anti-HBs have been detected so far in 9 (75%) of the 12 patients with HBsAg loss’. This has been corrected as of 9 August 2018. The authors apologize for these errors. © 2018 International Medical Press.
Published: 2018

42. Eight-year survival in chronic hepatitis B patients under long-term entecavir or tenofovir therapy is similar to the general population

Author: Papatheodoridis, G.V. Sypsa, V. Dalekos, G. Yurdaydin, C. van Boemmel, F. Buti, M. Goulis, J. Calleja, J.L. Chi, H. Manolakopoulos, S. Loglio, A. Siakavellas, S. Gatselis, N. Keskın, O. Lehretz, M. Savvidou, S. de la Revilla, J. Hansen, B.E. Kourikou, A. Vlachogiannakos, I. Galanis, K. Idilman, R. Colombo, M. Esteban, R. Janssen, H.L.A. Berg, T. Lampertico, P.
Abstract: Background & Aims: The effects of long-term antiviral therapy on survival have not been adequately assessed in chronic hepatitis B (CHB). In this 10-centre, ongoing cohort study, we evaluated the probability of survival and factors affecting survival in Caucasian CHB patients who received long-term entecavir/tenofovir therapy. Methods: We included 1,951 adult Caucasians with CHB, with or without compensated cirrhosis and without hepatocellular carcinoma (HCC) at baseline, who received entecavir/tenofovir for ≥12 months (median, six years). Kaplan–Meier estimates of cumulative survival over time were obtained. Standardized mortality ratios (SMRs) were calculated by comparing death rates with those in the Human Mortality Database. Results: The one-, five-, and eight-year cumulative probabilities were 99.7, 95.9, and 94.1% for overall survival, 99.9, 98.3, and 97.4% for liver-related survival, and 99.9, 97.8, and 95.8% for transplantation-free liver-related survival, respectively. Overall mortality was independently associated with older age and HCC development, liver-related mortality was associated with HCC development only, and transplantation-free liver-related mortality was independently associated with HCC development and lower platelet levels at baseline. Baseline cirrhosis was not independently associated with any type of mortality. Compared with the general population, in all CHB patients mortality was not significantly different (SMR 0.82), whereas it was lower in patients without HCC regardless of baseline cirrhosis (SMR 0.58) and was higher in patients who developed HCC (SMR 3.09). Conclusion: Caucasian patients with CHB and compensated liver disease who receive long-term entecavir/tenofovir therapy have excellent overall and liver-related eight-year survival, which is similar to that of the general population. HCC is the main factor affecting their overall mortality, and is the only factor affecting their liver-related mortality. Lay summary: Caucasian patients with chronic hepatitis B with or without compensated cirrhosis who receive long-term entecavir or tenofovir therapy have excellent overall eight-year survival, which is similar to that of the general population. Hepatocellular carcinoma is the main factor affecting their overall mortality, and is the only factor affecting liver-related mortality in this setting. © 2018 European Association for the Study of the Liver
Published: 2018

43. Autoantibodies and defined target autoantigens in autoimmune hepatitis: an overview

Author: Dalekos, G.N, Zachou, K, Liaskos, C, and Gatselis, N
Published: 2002
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44. Platelets represent an independent predictor of sustained virological response (SVR) in patients with advanced chronic hepatitis C (CHC) treated with current direct acting antiviral(s) (DAA). HERACLIS: Hellenic multicenter real-life cohort study

Author: Papatheodoridis, G. Kapatais, A. Sinakos, E. Elefsiniotis, I. Goulis, J. Deutsch, M. Vlachogiannakos, J. Dalekos, G. Koskinas, J. Karatapanis, S. Schina, M. Manesis, E. and Ketikoglou, I. Sevastianos, V. Triantos, C. Cholongitas, E. Papageorgiou, M. -V. Kourikou, A. Karaoulani, T. and Evangelidou, E. Koukoufiki, A. Karagiannakis, D. Gatselis, N. Tampaki, M. Ntetskas, G. Tsolias, C. Voulgaris, T. and Ioannidou, P. Akriviadis, E. Manolakopoulos, S.
Published: 2017

45. The risk of hepatocellular carcinoma decreases after the first 5 years of entecavir or tenofovir in Caucasians with chronic hepatitis B

Author: Papatheodoridis, G.V. Idilman, R. Dalekos, G.N. Buti, M. Chi, H. van Boemmel, F. Calleja, J.L. Sypsa, V. Goulis, J. Manolakopoulos, S. Loglio, A. Siakavellas, S. Keskın, O. Gatselis, N. Hansen, B.E. Lehretz, M. de la Revilla, J. Savvidou, S. Kourikou, A. Vlachogiannakos, I. Galanis, K. Yurdaydin, C. Berg, T. Colombo, M. Esteban, R. Janssen, H.L.A. Lampertico, P.
Subjects: digestive system diseases
Abstract: Whether there is a change of hepatocellular carcinoma (HCC) incidence in chronic hepatitis B patients under long-term therapy with potent nucleos(t)ide analogues is currently unclear. We therefore assessed the HCC incidence beyond year 5 of entecavir/tenofovir (ETV/TDF) therapy and tried to determine possible factors associated with late HCC occurrence. This European, 10-center, cohort study included 1,951 adult Caucasian chronic hepatitis B patients without HCC at baseline who received ETV/TDF for ≥1 year. Of them, 1,205 (62%) patients without HCC within the first 5 years of therapy have been followed for 5-10 (median, 6.8) years. HCCs have been diagnosed in 101/1,951 (5.2%) patients within the first 5 years and 17/1,205 (1.4%) patients within 5-10 years. The yearly HCC incidence rate was 1.22% within and 0.73% after the first 5 years (P = 0.050). The yearly HCC incidence rate did not differ within and after the first 5 years in patients without cirrhosis (0.49% versus 0.47%, P = 0.931), but it significantly declined in patients with cirrhosis (3.22% versus 1.57%, P = 0.039). All HCCs beyond year 5 developed in patients older than 50 years at ETV/TDF onset. Older age, lower platelets at baseline and year 5, and liver stiffness ≥12 kPa at year 5 were independently associated with more frequent HCC development beyond year 5 in multivariable analysis. No patient with low Platelets, Age, Gender-Hepatitis B score at baseline or year 5 developed HCC. Conclusion: The HCC risk decreases beyond year 5 of ETV/TDF therapy in Caucasian chronic hepatitis B patients, particularly in those with compensated cirrhosis; older age (especially ≥50 years), lower platelets, and liver stiffness ≥12 kPa at year 5 represent the main risk factors for late HCC development. (Hepatology 2017;66:1444–1453). © 2017 by the American Association for the Study of Liver Diseases.
Published: 2017

46. DARING-B: discontinuation of effective entecavir or tenofovir therapy in non-cirrhotic HBeAg-negative chronic hepatitis B patients: a prospective Greek study

Author: Papatheodoridis, G. Rigopoulou, E. Papatheodoridi, M. and Zachou, K. Xourafas, V. Gatselis, N. Vlachogiannakos, J. and Dalekos, G.
Published: 2017

47. Decreased serum DNase1-activity in patients with autoimmune liver diseases

Author: Gatselis, N. K. Vakrakou, A. G. Zachou, K. Androutsakos, T. and Azariadi, K. Hatzis, G. Manoussakis, M. N. Dalekos, G. N.
Subjects: digestive system, digestive system diseases
Abstract: Deoxyribonuclease1 (DNase1) is involved in chromatin degradation of apoptotic cells. Its deficiency results in accumulation of self-DNA, which in turn may induce inflammation and autoimmunity. We assessed for the first time serum DNase1-activity in a large consecutive cohort of treatment-naïve patients with autoimmune liver diseases (ALD). DNase1-activity was determined by single radial enzyme-diffusion (SRED) at diagnosis of 224 patients with autoimmune hepatitis (AIH), 249 with primary biliary cirrhosis (PBC) and 36 with primary sclerosing cholangitis (PSC). Sera from 146 patients with chronic hepatitis B or C, 140 with nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH) and 114 healthy individuals served as disease and healthy controls. Available serum samples during remission from 50 AIH and 39 PBC patients were also investigated by paired analyzes. DNase1-activity was significantly lower in AIH, PBC and PSC compared to viral hepatitis (p < 0.02, p < 0.001, p = 0.03), NAFLD/NASH (p < 0.001) and healthy (p < 0.001). No significant difference was found in between each specific ALD. In AIH, DNAse1-activity was positively correlated with aspartate aminotransferase (AST) (p < 0.02), bilirubin (p < 0.01) and increased IgG (>1400 mg/dl; p < 0.05); in PBC, with AST (p < 0.01), alanine aminotransferase (ALT) (p < 0.03) and anti-mitochondrial antibodies (AMA) (p = 0.008). In PSC, DNase1-activity was inversely associated with alkaline phosphatase (ALP) (p < 0.05). In AIH, complete responders were characterized by increased baseline DNase1-activity compared to partial responders, relapsers and non-responders (p < 0.02), whereas it was significantly increased after achievement of remission (p < 0.001). Serum DNase1-activity is significantly decreased in ALD patients, indicating its potential implication in their pathogenesis. Furthermore, DNase1-activity could be used as a new surrogate biomarker for predicting response to AIH treatment. © 2017 Informa UK Limited, trading as Taylor & Francis Group.
Published: 2017

48. Rates and predictors of HBsAg loss after discontinuation of effective long-term Entecavir or Tenofovir therapy in noncirrhotic HBeAg-negative chronic hepatitis B patients: Results from the DARING-B prospective Greek study

Author: Papatheodoridis, M., primary, Rigopoulou, E., additional, Hadziyannis, E., additional, Kalliopi, Z., additional, Xourafas, V., additional, Lyberopoulou, A., additional, Gatselis, N., additional, Vlachogiannakos, I., additional, Manolakopoulos, S., additional, Dalekos, G., additional, and Papatheodoridis, G., additional
Published: 2018
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49. PAGE-B predicts the risk of developing hepatocellular carcinoma in Caucasians with chronic hepatitis B on 5-year antiviral therapy

Author: Papatheodoridis, G. Dalekos, G. Sypsa, V. Yurdaydin, C. Buti, M. Goulis, J. Calleja, J.L. Chi, H. Manolakopoulos, S. Mangia, G. Gatselis, N. Keskin, O. Savvidou, S. De La Revilla, J. Hansen, B.E. Vlachogiannakos, I. Galanis, K. Idilman, R. Colombo, M. Esteban, R. Janssen, H.L.A. Lampertico, P.
Abstract: Background & Aims Risk scores for hepatocellular carcinoma (HCC) developed in Asians offer poor-moderate predictability in Caucasian patients with chronic hepatitis B (CHB). This nine center cohort study aimed to develop and validate an accurate HCC risk score in Caucasian CHB patients treated with the current oral antivirals, entecavir/tenofovir. Methods We included 1815 adult Caucasians with CHB and no HCC at baseline who received entecavir/tenofovir for ≥12 months. Using data from eight centers (derivation dataset, n = 1325), a HCC risk score was developed based on multivariable Cox models and points system for simplification. Harrell's c-index was used as discrimination, bootstrap for internal validation and the data from the 9th and largest center (validation dataset, n = 490) for external validation. Results The 5-year cumulative HCC incidence rates were 5.7% and 8.4% in the derivation and validation dataset, respectively. In the derivation dataset, age, gender, platelets and cirrhosis were independently associated with HCC. The PAGE-B score was developed based on age, gender and platelets (c-index = 0.82, 0.81 after bootstrap validation). The addition of cirrhosis did not substantially improve the discrimination (c-index = 0.84). The predictability of PAGE-B score was similar (c-index = 0.82) in the validation dataset. Patients with PAGE-B ≤9, 10-17, ≥18 had 5-year cumulative HCC incidence rates of 0%, 3%, 17% in the derivation and 0%, 4%, 16% in the validation dataset. Conclusion PAGE-B, which is based only on baseline patients' age, gender and platelets, represents a simple and reliable score for prediction of the 5-year HCC risk in Caucasian CHB patients under entecavir/tenofovir. © 2015 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.
Published: 2016

50. Platelets represent an independent predictor of sustained virological response (SVR) in patients with advanced chronic hepatitis C (CHC) treated with current direct acting antiviral(s) (DAA). HERACLIS: Hellenic multicenter real-life cohort study

Author: Papatheodoridis, G., primary, Kapatais, A., additional, Sinakos, E., additional, Elefsiniotis, I., additional, Goulis, J., additional, Deutsch, M., additional, Vlachogiannakos, J., additional, Dalekos, G., additional, Koskinas, J., additional, Karatapanis, S., additional, Schina, M., additional, Manesis, E., additional, Ketikoglou, I., additional, Sevastianos, V., additional, Triantos, C., additional, Cholongitas, E., additional, Papageorgiou, M.-V., additional, Kourikou, A., additional, Karaoulani, T., additional, Evangelidou, E., additional, Koukoufiki, A., additional, Karagiannakis, D., additional, Gatselis, N., additional, Tampaki, M., additional, Ntetskas, G., additional, Tsolias, C., additional, Voulgaris, T., additional, Ioannidou, P., additional, Akriviadis, E., additional, and Manolakopoulos, S., additional
Published: 2017
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