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1. 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

2. Lack of complete biochemical response in autoimmune hepatitis leads to adverse outcome: First report of the IAIHG retrospective registry

Author

Slooter, C.D., Brand, F.F. van den, Lleo, A., Colapietro, F., Lenzi, M., Muratori, P., Kerkar, N., Dalekos, G.N., Zachou, K., Lucena, M.I., Robles-Díaz, M., Zeo-Sánchez, D.E. Di, Andrade, R.J., Montano-Loza, A.J., Lytvyak, E., Lissenberg-Witte, Birgit I., Maisonneuve, P., Bouma, G., Macedo, G., Drenth, J.P.H., Liberal, R., Boer, Y.S. de, Slooter, C.D., Brand, F.F. van den, Lleo, A., Colapietro, F., Lenzi, M., Muratori, P., Kerkar, N., Dalekos, G.N., Zachou, K., Lucena, M.I., Robles-Díaz, M., Zeo-Sánchez, D.E. Di, Andrade, R.J., Montano-Loza, A.J., Lytvyak, E., Lissenberg-Witte, Birgit I., Maisonneuve, P., Bouma, G., Macedo, G., Drenth, J.P.H., Liberal, R., and Boer, Y.S. de

Abstract

Contains fulltext : 305452.pdf (Publisher’s version ) (Closed access), BACKGROUND AND AIMS: The International Autoimmune Hepatitis Group retrospective registry (IAIHG-RR) is a web-based platform with subjects enrolled with a clinical diagnosis of autoimmune hepatitis (AIH). As prognostic factor studies with enough power are scarce, this study aimed to ascertain data quality and identify prognostic factors in the IAIHG-RR cohort. METHODS: This retrospective, observational, multicenter study included all patients with a clinical diagnosis of AIH from the IAIHG-RR. The quality assessment consisted of external validation of completeness and consistency for 29 predefined variables. Cox regression was used to identify risk factors for liver-related death and liver transplantation (LT). RESULTS: This analysis included 2559 patients across 7 countries. In 1700 patients, follow-up was available, with a completeness of individual data of 90% (range: 30-100). During a median follow-up period of 10 (range: 0-49) years, there were 229 deaths, of which 116 were liver-related, and 143 patients underwent LT. Non-White ethnicity (HR 4.1 95% CI: 2.3-7.1), cirrhosis (HR 3.5 95% CI: 2.3-5.5), variant syndrome with primary sclerosing cholangitis (PSC) (HR 3.1 95% CI: 1.6-6.2), and lack of complete biochemical response within 6 months (HR 5.7 95% CI: 3.4-9.6) were independent prognostic factors. CONCLUSIONS: The IAIHG-RR represents the world's largest AIH cohort with moderate-to-good data quality and a relevant number of liver-related events. The registry is a suitable platform for patient selection in future studies. Lack of complete biochemical response to treatment, non-White ethnicity, cirrhosis, and PSC-AIH were associated with liver-related death and LT.

Published
2024

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

Author

Gatselis, N, Zachou, K, Loza, A, Cancado, E, Arinaga-Hino, T, Muratori, P, Efe, C, Floreani, A, Invernizzi, P, Takahashi, A, Takaki, A, Beretta-Piccoli, B, van Hoek, B, Lytvyak, E, Guedes, L, Purnak, T, Cazzagon, N, Lygoura, V, Arvaniti, P, Rigopoulou, E, Muratori, L, Dalekos, G, Gatselis N. K., Zachou K., Loza A. J. M., Cancado E. L. R., Arinaga-Hino T., Muratori P., Efe C., Floreani A., Invernizzi P., Takahashi A., Takaki A., Beretta-Piccoli B. T., van Hoek B., Lytvyak E., Guedes L. V., Purnak T., Cazzagon N., Lygoura V., Arvaniti P., Rigopoulou E. I., Muratori L., Dalekos G. N., Gatselis, N, Zachou, K, Loza, A, Cancado, E, Arinaga-Hino, T, Muratori, P, Efe, C, Floreani, A, Invernizzi, P, Takahashi, A, Takaki, A, Beretta-Piccoli, B, van Hoek, B, Lytvyak, E, Guedes, L, Purnak, T, Cazzagon, N, Lygoura, V, Arvaniti, P, Rigopoulou, E, Muratori, L, Dalekos, G, Gatselis N. K., Zachou K., Loza A. J. M., Cancado E. L. R., Arinaga-Hino T., Muratori P., Efe C., Floreani A., Invernizzi P., Takahashi A., Takaki A., Beretta-Piccoli B. T., van Hoek B., Lytvyak E., Guedes L. V., Purnak T., Cazzagon N., Lygoura V., Arvaniti P., Rigopoulou E. I., Muratori L., and Dalekos G. N.

Abstract

Background & Aims: Antimitochondrial antibodies (AMA) are specific markers for the diagnosis of primary biliary cholangitis (PBC) but can also be found occasionally in patients with autoimmune hepatitis (AIH). The present large multicentre cohort study assessed the prevalence and significance of AMA in AIH-patients. Methods: 123 AMA-positive AIH-patients were investigated and compared with 711 age-matched AMA-negative AIH-patients and 69 patients with AIH/PBC variant. Results: AMA prevalence in AIH-patients was 5.1% (range: 1.2%-11.8%). AMA-positivity was associated with female sex (p = 0.031) in AMA-positive AIH-patients but not with liver biochemistry, bile duct injury on liver biopsy, disease severity at baseline and response to treatment compared to AMA-negative AIH-patients. Comparing AMA-positive AIH-patients to those with AIH/PBC variant, there was no difference in disease severity. Regarding liver histology, AIH/PBC variant patients were characterized by the presence of at least one feature of bile duct damage (p<0.001). Response to immunosuppressive treatment was similar among groups. From AMA-positive AIH patients only those with evidence of non-specific bile duct injury had higher risk to progress to cirrhosis (HR=4.314, 95%CI: 2.348–7.928; p<0.001). During follow-up, AMA-positive AIH-patients had higher risk to develop histological bile duct injury (HR 4.654, 95%CI 1.829–11.840; p = 0.001). Conclusions: AMA presence is relatively common among AIH-patients, but their clinical significance seems important only when they co-exist with non-specific bile duct injury at the histological level. Therefore, a careful evaluation of liver biopsy seems of utmost importance in these patients.

Published
2023

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

Author

Efe, C, Kulkarni, A, Terziroli Beretta-Piccoli, B, Magro, B, Friedrich Stattermayer, A, Cengiz, M, Clayton-Chubb, D, Lammert, C, Bernsmeier, C, Gul, O, la Tijera, F, Anders, M, Lytvyak, E, Akin, M, Purnak, T, Liberal, R, Peralta, M, Ebik, B, Duman, S, Demir, N, Balaban, Y, Urzua, A, Contreras, F, Venturelli, M, Bilgic, Y, Medina, A, Girala, M, Gunsar, F, Londono, M, Androutsakos, T, Kisch, A, Yurci, A, Guzelbult, F, Cagin, Y, Avci, E, Guzelbulut, M, Dindar-Demiray, E, Harputluoglu, M, Kumar, R, Satapathy, S, Mendizabal, M, Silva, M, Fagiuoli, S, Roberts, S, Soylu, N, Idilman, R, Yoshida, E, Montano-Loza, A, Dalekos, G, Ridruejo, E, Schiano, T, Wahlin, S, Efe C., Kulkarni A. V., Terziroli Beretta-Piccoli B., Magro B., Friedrich Stattermayer A., Cengiz M., Clayton-Chubb D., Lammert C., Bernsmeier C., Gul O., la Tijera F. H. -D., Anders M., Lytvyak E., Akin M., Purnak T., Liberal R., Peralta M., Ebik B., Duman S., Demir N., Balaban Y., Urzua A., Contreras F., Venturelli M. G., Bilgic Y., Medina A., Girala M., Gunsar F., Londono M. -C., Androutsakos T., Kisch A., Yurci A., Guzelbult F., Cagin Y. F., Avci E., Guzelbulut M., Dindar-Demiray E. K., Harputluoglu M., Kumar R., Satapathy S. K., Mendizabal M., Silva M., Fagiuoli S., Roberts S. K., Soylu N. K., Idilman R., Yoshida E. M., Montano-Loza A. J., Dalekos G. N., Ridruejo E., Schiano T. D., Wahlin S., Efe, C, Kulkarni, A, Terziroli Beretta-Piccoli, B, Magro, B, Friedrich Stattermayer, A, Cengiz, M, Clayton-Chubb, D, Lammert, C, Bernsmeier, C, Gul, O, la Tijera, F, Anders, M, Lytvyak, E, Akin, M, Purnak, T, Liberal, R, Peralta, M, Ebik, B, Duman, S, Demir, N, Balaban, Y, Urzua, A, Contreras, F, Venturelli, M, Bilgic, Y, Medina, A, Girala, M, Gunsar, F, Londono, M, Androutsakos, T, Kisch, A, Yurci, A, Guzelbult, F, Cagin, Y, Avci, E, Guzelbulut, M, Dindar-Demiray, E, Harputluoglu, M, Kumar, R, Satapathy, S, Mendizabal, M, Silva, M, Fagiuoli, S, Roberts, S, Soylu, N, Idilman, R, Yoshida, E, Montano-Loza, A, Dalekos, G, Ridruejo, E, Schiano, T, Wahlin, S, Efe C., Kulkarni A. V., Terziroli Beretta-Piccoli B., Magro B., Friedrich Stattermayer A., Cengiz M., Clayton-Chubb D., Lammert C., Bernsmeier C., Gul O., la Tijera F. H. -D., Anders M., Lytvyak E., Akin M., Purnak T., Liberal R., Peralta M., Ebik B., Duman S., Demir N., Balaban Y., Urzua A., Contreras F., Venturelli M. G., Bilgic Y., Medina A., Girala M., Gunsar F., Londono M. -C., Androutsakos T., Kisch A., Yurci A., Guzelbult F., Cagin Y. F., Avci E., Guzelbulut M., Dindar-Demiray E. K., Harputluoglu M., Kumar R., Satapathy S. K., Mendizabal M., Silva M., Fagiuoli S., Roberts S. K., Soylu N. K., Idilman R., Yoshida E. M., Montano-Loza A. J., Dalekos G. N., Ridruejo E., Schiano T. D., and Wahlin S.

Abstract

Background and Aims: A few case reports of autoimmune hepatitis–like liver injury have been reported after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination. We evaluated clinical features, treatment response and outcomes of liver injury following SARS-CoV-2 vaccination in a large case series. Approach and Results: We collected data from cases in 18 countries. The type of liver injury was assessed with the R-value. The study population was categorized according to features of immune-mediated hepatitis (positive autoantibodies and elevated immunoglobulin G levels) and corticosteroid therapy for the liver injury. We identified 87 patients (63%, female), median age 48 (range: 18–79) years at presentation. Liver injury was diagnosed a median 15 (range: 3–65) days after vaccination. Fifty-one cases (59%) were attributed to the Pfizer-BioNTech (BNT162b2) vaccine, 20 (23%) cases to the Oxford-AstraZeneca (ChAdOX1 nCoV-19) vaccine and 16 (18%) cases to the Moderna (mRNA-1273) vaccine. The liver injury was predominantly hepatocellular (84%) and 57% of patients showed features of immune-mediated hepatitis. Corticosteroids were given to 46 (53%) patients, more often for grade 3–4 liver injury than for grade 1–2 liver injury (88.9% vs. 43.5%, p = 0.001) and more often for patients with than without immune-mediated hepatitis (71.1% vs. 38.2%, p = 0.003). All patients showed resolution of liver injury except for one man (1.1%) who developed liver failure and underwent liver transplantation. Steroid therapy was withdrawn during the observation period in 12 (26%) patients after complete biochemical resolution. None had a relapse during follow-up. Conclusions: SARS-CoV-2 vaccination can be associated with liver injury. Corticosteroid therapy may be beneficial in those with immune-mediated features or severe hepatitis. Outcome was generally favorable, but vaccine-associated liver injury led to fulminant liver failure in one patient.

Published
2022

9. 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

10. A44 A 1000 PATIENT CANADIAN NETWORK FOR AUTOIMMUNE LIVER DISEASE EVALUATION OF CLINICAL AND DEMOGRAPHIC PATTERNS OF AUTOIMMUNE HEPATITIS

Author

Plagiannakos, C G, primary, Montano-Loza, A J, additional, Lytvyak, E, additional, Pallotta, J, additional, Mason, A L, additional, Qumosani, K M, additional, Worobetz, L, additional, Flemming, J A, additional, Hercun, J, additional, Vincent, C, additional, Cheung, A, additional, Chen, T, additional, Grbic, D, additional, Swain, M G, additional, Gulamhusein, A, additional, Hansen, B E, additional, and Hirschfield, G M, additional

Published
2023
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11. Incidence and predictors of hepatocellular carcinoma in autoimmune hepatitis: A multicenter international study

Author

Colapietro, F., primary, Maisonneuve, P., additional, Lytvyak, E., additional, Beuers, U., additional, Verdonk, R., additional, van der Meer, A., additional, van Hoek, B., additional, Kuiken, S.J., additional, Brouwer, H., additional, van der Wouden, E.J., additional, Muratori, P., additional, Aghemo, A., additional, van den Berg, A., additional, Dalekos, G. N, additional, Robles, M., additional, Andrade, R.J., additional, Montano-Loza, A.J., additional, van den Brand, F.F., additional, Slooter, C.D., additional, Macedo, G., additional, Liberal, R., additional, de Boer, Y., additional, and Lleo, A., additional

Published
2023
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12. Treatment responses and outcomes in patients with autoimmune hepatitis and concomitant features of non- alcoholic fatty liver disease

Author

Zachou, K., Azariadis, Kalliopi, Lytvyak, E., Snijders, R.J.A.L.M., Takahashi, A., Gatselis, N.K., Drenth, J.P.H., Dalekos, G.N., International Autoimmune Hepatitis Group, International Autoimmune Hepatitis Group, Zachou, K., Azariadis, Kalliopi, Lytvyak, E., Snijders, R.J.A.L.M., Takahashi, A., Gatselis, N.K., Drenth, J.P.H., Dalekos, G.N., and International Autoimmune Hepatitis Group, International Autoimmune Hepatitis Group

Abstract

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Published
2023

13. Risk factors and outcomes associated with recurrent autoimmune hepatitis following liver transplantation

Author

Montano-Loza, A.J., Ronca, V., Ebadi, M., Hansen, B.E., Hirschfield, G., Elwir, S., Alsaed, M., Milkiewicz, P., Janik, M.K., Marschall, H.U., Burza, M.A., Efe, C., Caliskan, A.R., Harputluoglu, M., Kabacam, G., Terrabuio, D., Onofrio, F.D., Selzner, N., Bonder, A., Pares, A., Llovet, L., Akyildiz, M., Arikan, C., Manns, M.P., Taubert, R., Weber, A.L., Schiano, T.D., Haydel, B., Czubkowski, P., Socha, P., Oldak, N., Akamatsu, N., Tanaka, A., Levy, C., Martin, E.F., Goel, A., Sedki, M., Jankowska, I., Ikegami, T., Rodriguez, M., Sterneck, M., Weiler-Normann, C., Schramm, C., Donato, M.F., Lohse, A., Andrade, R.J., Patwardhan, V.R., Hoek, B. van, Biewenga, M., Kremer, A.E., Ueda, Y., Deneau, M., Pedersen, M., Mayo, M.J., Floreani, A., Burra, P., Secchi, M.F., Beretta-Piccoli, B.T., Sciveres, M., Maggiore, G., Jafri, S.M., Debray, D., Girard, M., Lacaille, F., Lytvyak, E., Mason, A.L., Heneghan, M., Oo, Y.H., and Int Autoimmune Hepatitis Grp IAIHG

Subjects
Adult, Male, Hepatology, liver transplantation, recurrent disease, autoimmune liver disease, graft survival, Mycophenolic Acid, survival, Hepatitis, Autoimmune, Recurrence, Risk Factors, Immunoglobulin G, Humans, Female, Immunosuppressive Agents
Abstract

Background & Aims: Autoimmune hepatitis can recur after liver transplantation (LT), though the impact of recurrence on patient and graft survival has not been well characterized. We evaluated a large, international, multicenter cohort to identify the probability and risk factors associated with recurrent AIH and the association between recurrent disease and patient and graft survival.Methods: We included 736 patients (77% female, mean age 42 +/- 1 years) with AIH who underwent LT from January 1987 through June 2020, among 33 centers in North America, South America, Europe and Asia. Clinical data before and after LT, biochemical data within the first 12 months after LT, and immunosuppression after LT were analyzed to identify patients at higher risk of AIH recurrence based on histological diagnosis.Results: AIH recurred in 20% of patients after 5 years and 31% after 10 years. Age at LT

Published
2022

14. Effects of Tumor Necrosis Factor Antagonists in Patients With Primary Sclerosing Cholangitis

Author

Hedin, C, Sado, G, Ndegwa, N, Lytvyak, E, Mason, A, Montano-Loza, A, Gerussi, A, Saffioti, F, Thorburn, D, Nilsson, E, Larsson, G, Moum, B, van Munster, K, Ponsioen, C, Levy, C, Nogueira, N, Bowlus, C, Gotlieb, N, Shibolet, O, Lynch, K, Chapman, R, Rupp, C, Vesterhus, M, Jorgensen, K, Rorsman, F, Schramm, C, Sabino, J, Vermeire, S, Zago, A, Cazzagon, N, Marschall, H, Ytting, H, Ben Belkacem, K, Chazouilleres, O, Almer, S, Bergquist, A, Hedin C. R. H., Sado G., Ndegwa N., Lytvyak E., Mason A., Montano-Loza A., Gerussi A., Saffioti F., Thorburn D., Nilsson E., Larsson G., Moum B. A., van Munster K. N., Ponsioen C. Y., Levy C., Nogueira N. F., Bowlus C. L., Gotlieb N., Shibolet O., Lynch K. D., Chapman R. W., Rupp C., Vesterhus M., Jorgensen K. K., Rorsman F., Schramm C., Sabino J., Vermeire S., Zago A., Cazzagon N., Marschall H. -U., Ytting H., Ben Belkacem K., Chazouilleres O., Almer S., Bergquist A., Hedin, C, Sado, G, Ndegwa, N, Lytvyak, E, Mason, A, Montano-Loza, A, Gerussi, A, Saffioti, F, Thorburn, D, Nilsson, E, Larsson, G, Moum, B, van Munster, K, Ponsioen, C, Levy, C, Nogueira, N, Bowlus, C, Gotlieb, N, Shibolet, O, Lynch, K, Chapman, R, Rupp, C, Vesterhus, M, Jorgensen, K, Rorsman, F, Schramm, C, Sabino, J, Vermeire, S, Zago, A, Cazzagon, N, Marschall, H, Ytting, H, Ben Belkacem, K, Chazouilleres, O, Almer, S, Bergquist, A, Hedin C. R. H., Sado G., Ndegwa N., Lytvyak E., Mason A., Montano-Loza A., Gerussi A., Saffioti F., Thorburn D., Nilsson E., Larsson G., Moum B. A., van Munster K. N., Ponsioen C. Y., Levy C., Nogueira N. F., Bowlus C. L., Gotlieb N., Shibolet O., Lynch K. D., Chapman R. W., Rupp C., Vesterhus M., Jorgensen K. K., Rorsman F., Schramm C., Sabino J., Vermeire S., Zago A., Cazzagon N., Marschall H. -U., Ytting H., Ben Belkacem K., Chazouilleres O., Almer S., and Bergquist A.

Abstract

Background & Aims: Few patients with primary sclerosing cholangitis (PSC) and inflammatory bowel diseases (IBDs) are exposed to tumor necrosis factor (TNF) antagonists because of the often mild symptoms of IBD. We assessed the effects of anti-TNF agents on liver function in patients with PSC and IBD, and their efficacy in treatment of IBD. Methods: We performed a retrospective analysis of 141 patients with PSC and IBD receiving treatment with anti-TNF agents (infliximab or adalimumab) at 20 sites (mostly tertiary-care centers) in Europe and North America. We collected data on the serum level of alkaline phosphatase (ALP). IBD response was defined as either endoscopic response or, if no endoscopic data were available, clinical response, as determined by the treating clinician or measurements of fecal calprotectin. Remission was defined more stringently as endoscopic mucosal healing. We used linear regression analysis to identify factors associated significantly with level of ALP during anti-TNF therapy. Results: Anti-TNF treatment produced a response of IBD in 48% of patients and remission of IBD in 23%. There was no difference in PSC symptom frequency before or after drug exposure. The most common reasons for anti-TNF discontinuation were primary nonresponse of IBD (17%) and side effects (18%). At 3 months, infliximab-treated patients had a median reduction in serum level of ALP of 4% (interquartile range, reduction of 25% to increase of 19%) compared with a median 15% reduction in ALP in adalimumab-treated patients (interquartile range, reduction of 29% to reduction of 4%; P =.035). Factors associated with lower ALP were normal ALP at baseline (P <.01), treatment with adalimumab (P =.090), and treatment in Europe (P =.083). Conclusions: In a retrospective analysis of 141 patients with PSC and IBD, anti-TNF agents were moderately effective and were not associated with exacerbation of PSC symptoms or specific side effects. Prospective studies are needed to inv

Published
2020

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

Author

Efe, C., Lammert, C., Taşçılar, K., Dhanasekaran, R., Ebik, B., Higuera-de la Tijera, F., Calışkan, A.R., Peralta, M., Gerussi, A., Massoumi, H., Catana, A.M., Purnak, T., Rigamonti, C., Aldana, A.J. Gomez, Khakoo, N., Nazal, L., Frager, S., Demir, N., Irak, K., Melekoğlu-Ellik, Z., Kacmaz, H., Balaban, Y., Atay, K., Eren, F., Alvares-da-Silva, M.R., Cristoferi, L., Urzua, Á., Eşkazan, T., Magro, B., Snijders, R.J.A.L.M., Barutçu, S., Lytvyak, E., Zazueta, G.M., Demirezer-Bolat, A., Aydın, M., Heurgue-Berlot, A., Martin, E., Ekin, N., Yıldırım, S., Yavuz, A., Bıyık, M., Narro, G.C., Kıyıcı, M., Akyıldız, M., Kahramanoğlu-Aksoy, E., Vincent, M., Carr, R.M., Günşar, F., Reyes, E.C., Harputluoğlu, M., Aloman, C., Gatselis, N.K., Üstündağ, Y., Brahm, J., Vargas, N.C.E., Güzelbulut, F., Garcia, S.R., Aguirre, J., Anders, M., Ratusnu, N., Hatemi, I., Mendizabal, M., Floreani, A., Fagiuoli, S., Silva, M., Idilman, R., Satapathy, S.K., Silveira, M., Drenth, J.P.H., Dalekos, G.N., Assis, D.N., Björnsson, E., Boyer, J.L., Yoshida, E.M., Invernizzi, P., Levy, C., Montano-Loza, A.J., Schiano, T.D., Ridruejo, E., Wahlin, S., Efe, C., Lammert, C., Taşçılar, K., Dhanasekaran, R., Ebik, B., Higuera-de la Tijera, F., Calışkan, A.R., Peralta, M., Gerussi, A., Massoumi, H., Catana, A.M., Purnak, T., Rigamonti, C., Aldana, A.J. Gomez, Khakoo, N., Nazal, L., Frager, S., Demir, N., Irak, K., Melekoğlu-Ellik, Z., Kacmaz, H., Balaban, Y., Atay, K., Eren, F., Alvares-da-Silva, M.R., Cristoferi, L., Urzua, Á., Eşkazan, T., Magro, B., Snijders, R.J.A.L.M., Barutçu, S., Lytvyak, E., Zazueta, G.M., Demirezer-Bolat, A., Aydın, M., Heurgue-Berlot, A., Martin, E., Ekin, N., Yıldırım, S., Yavuz, A., Bıyık, M., Narro, G.C., Kıyıcı, M., Akyıldız, M., Kahramanoğlu-Aksoy, E., Vincent, M., Carr, R.M., Günşar, F., Reyes, E.C., Harputluoğlu, M., Aloman, C., Gatselis, N.K., Üstündağ, Y., Brahm, J., Vargas, N.C.E., Güzelbulut, F., Garcia, S.R., Aguirre, J., Anders, M., Ratusnu, N., Hatemi, I., Mendizabal, M., Floreani, A., Fagiuoli, S., Silva, M., Idilman, R., Satapathy, S.K., Silveira, M., Drenth, J.P.H., Dalekos, G.N., Assis, D.N., Björnsson, E., Boyer, J.L., Yoshida, E.M., Invernizzi, P., Levy, C., Montano-Loza, A.J., Schiano, T.D., Ridruejo, E., and Wahlin, S.

Abstract

Item does not contain fulltext, 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

16. 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

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

Author

Efe, C, Lammert, C, Tascilar, K, Dhanasekaran, R, Ebik, B, Higuera-de la Tijera, F, Caliskan, A, Peralta, M, Gerussi, A, Massoumi, H, Catana, A, Purnak, T, Rigamonti, C, Aldana, A, Khakoo, N, Nazal, L, Frager, S, Demir, N, Irak, K, Melekoglu-Ellik, Z, Kacmaz, H, Balaban, Y, Atay, K, Eren, F, Alvares-da-Silva, M, Cristoferi, L, Urzua, A, Eskazan, T, Magro, B, Snijders, R, Barutcu, S, Lytvyak, E, Zazueta, G, Demirezer-Bolat, A, Aydin, M, Heurgue-Berlot, A, De Martin, E, Ekin, N, Yildirim, S, Yavuz, A, Biyik, M, Narro, G, Kiyici, M, Akyildiz, M, Kahramanoglu-Aksoy, E, Vincent, M, Carr, R, Gunsar, F, Reyes, E, Harputluoglu, M, Aloman, C, Gatselis, N, Ustundag, Y, Brahm, J, Vargas, N, Guzelbulut, F, Garcia, S, Aguirre, J, Anders, M, Ratusnu, N, Hatemi, I, Mendizabal, M, Floreani, A, Fagiuoli, S, Silva, M, Idilman, R, Satapathy, S, Silveira, M, Drenth, J, Dalekos, G, Assis, D, Bjornsson, E, Boyer, J, Yoshida, E, Invernizzi, P, Levy, C, Montano-Loza, A, Schiano, T, Ridruejo, E, Wahlin, S, Caliskan, AR, Catana, AM, Aldana, AJG, Alvares-da-Silva, MR, Zazueta, GM, Narro, GC, Carr, RM, Reyes, EC, Gatselis, NK, Vargas, NCE, Garcia, SR, Satapathy, SK, Drenth, JPH, Dalekos, GN, Assis, DN, Boyer, JL, Yoshida, EM, Montano-Loza, AJ, Schiano, TD, Efe, C, Lammert, C, Tascilar, K, Dhanasekaran, R, Ebik, B, Higuera-de la Tijera, F, Caliskan, A, Peralta, M, Gerussi, A, Massoumi, H, Catana, A, Purnak, T, Rigamonti, C, Aldana, A, Khakoo, N, Nazal, L, Frager, S, Demir, N, Irak, K, Melekoglu-Ellik, Z, Kacmaz, H, Balaban, Y, Atay, K, Eren, F, Alvares-da-Silva, M, Cristoferi, L, Urzua, A, Eskazan, T, Magro, B, Snijders, R, Barutcu, S, Lytvyak, E, Zazueta, G, Demirezer-Bolat, A, Aydin, M, Heurgue-Berlot, A, De Martin, E, Ekin, N, Yildirim, S, Yavuz, A, Biyik, M, Narro, G, Kiyici, M, Akyildiz, M, Kahramanoglu-Aksoy, E, Vincent, M, Carr, R, Gunsar, F, Reyes, E, Harputluoglu, M, Aloman, C, Gatselis, N, Ustundag, Y, Brahm, J, Vargas, N, Guzelbulut, F, Garcia, S, Aguirre, J, Anders, M, Ratusnu, N, Hatemi, I, Mendizabal, M, Floreani, A, Fagiuoli, S, Silva, M, Idilman, R, Satapathy, S, Silveira, M, Drenth, J, Dalekos, G, Assis, D, Bjornsson, E, Boyer, J, Yoshida, E, Invernizzi, P, Levy, C, Montano-Loza, A, Schiano, T, Ridruejo, E, Wahlin, S, Caliskan, AR, Catana, AM, Aldana, AJG, Alvares-da-Silva, MR, Zazueta, GM, Narro, GC, Carr, RM, Reyes, EC, Gatselis, NK, Vargas, NCE, Garcia, SR, Satapathy, SK, Drenth, JPH, Dalekos, GN, Assis, DN, Boyer, JL, Yoshida, EM, Montano-Loza, AJ, and Schiano, TD

Abstract

Background: We investigated associations between baseline use of immunosuppressive drugs and severity of Coronavirus Disease 2019 (COVID-19) in autoimmune hepatitis (AIH). Patients and methods: Data of AIH patients with laboratory confirmed COVID-19 were retrospectively collected from 15 countries. The outcomes of AIH patients who were on immunosuppression at the time of COVID-19 were compared to patients who were not on AIH medication. The clinical courses of COVID-19 were classified as (i)-no hospitalization, (ii)-hospitalization without oxygen supplementation, (iii)-hospitalization with oxygen supplementation by nasal cannula or mask, (iv)-intensive care unit (ICU) admission with non-invasive mechanical ventilation, (v)-ICU admission with invasive mechanical ventilation or (vi)-death and analysed using ordinal logistic regression. Results: We included 254 AIH patients (79.5%, female) with a median age of 50 (range, 17-85) years. At the onset of COVID-19, 234 patients (92.1%) were on treatment with glucocorticoids (n = 156), thiopurines (n = 151), mycophenolate mofetil (n = 22) or tacrolimus (n = 16), alone or in combinations. Overall, 94 (37%) patients were hospitalized and 18 (7.1%) patients died. Use of systemic glucocorticoids (adjusted odds ratio [aOR] 4.73, 95% CI 1.12-25.89) and thiopurines (aOR 4.78, 95% CI 1.33-23.50) for AIH was associated with worse COVID-19 severity, after adjusting for age-sex, comorbidities and presence of cirrhosis. Baseline treatment with mycophenolate mofetil (aOR 3.56, 95% CI 0.76-20.56) and tacrolimus (aOR 4.09, 95% CI 0.69-27.00) were also associated with more severe COVID-19 courses in a smaller subset of treated patients. Conclusion: Baseline treatment with systemic glucocorticoids or thiopurines prior to the onset of COVID-19 was significantly associated with COVID-19 severity in patients with AIH.

Published
2022

25. International experience of vedolizumab in primary sclerosis cholangitis and inflammatory bowel disease

Author

Williamson, K., primary, Lytvyak, E., additional, Kremer, A.E., additional, de Krijger, M., additional, Trivedi, P., additional, Estes, D., additional, Yu, L., additional, Pratt, D., additional, de Vries, A., additional, Yimam, K.K., additional, Daretti, L., additional, Liu, C.H., additional, Bowlus, C., additional, Vetter, M., additional, Marschall, H.-U., additional, Montano-Loza, A., additional, Chapman, R.W.G., additional, Marzioni, M., additional, Keshav, S., additional, Ponsioen, C., additional, Hirschfield, G., additional, and Levy, C., additional

Published
2018
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36. Liver injury after SARS‐CoV‐2 vaccination: Features of immune‐mediated hepatitis, role of corticosteroid therapy and outcome

Author

Cumali Efe, Anand V. Kulkarni, Benedetta Terziroli Beretta‐Piccoli, Bianca Magro, Albert Stättermayer, Mustafa Cengiz, Daniel Clayton‐Chubb, Craig Lammert, Christine Bernsmeier, Özlem Gül, Fatima Higuera‐de la Tijera, Margarita Anders, Ellina Lytvyak, Mete Akın, Tugrul Purnak, Rodrigo Liberal, Mirta Peralta, Berat Ebik, Serkan Duman, Nurhan Demir, Yasemin Balaban, Álvaro Urzua, Fernando Contreras, Maria Grazia Venturelli, Yılmaz Bilgiç, Adriana Medina, Marcos Girala, Fulya Günşar, Maria‐Carlota Londoño, Theodoros Androutsakos, Ayelen Kisch, Alper Yurci, Fatih Güzelbulut, Yasir Furkan Çağın, Enver Avcı, Murat Akyıldız, Emine Kübra Dindar‐Demiray, Murat Harputluoğlu, Rahul Kumar, Sanjaya K. Satapathy, Manuel Mendizabal, Marcelo Silva, Stefano Fagiuoli, Stuart K. Roberts, Neşe Karadağ Soylu, Ramazan Idilman, Eric M. Yoshida, Aldo J. Montano‐Loza, George N. Dalekos, Ezequiel Ridruejo, Thomas D. Schiano, Staffan Wahlin, Efe, C, Kulkarni, A, Terziroli Beretta-Piccoli, B, Magro, B, Friedrich Stattermayer, A, Cengiz, M, Clayton-Chubb, D, Lammert, C, Bernsmeier, C, Gul, O, la Tijera, F, Anders, M, Lytvyak, E, Akin, M, Purnak, T, Liberal, R, Peralta, M, Ebik, B, Duman, S, Demir, N, Balaban, Y, Urzua, A, Contreras, F, Venturelli, M, Bilgic, Y, Medina, A, Girala, M, Gunsar, F, Londono, M, Androutsakos, T, Kisch, A, Yurci, A, Guzelbult, F, Cagin, Y, Avci, E, Guzelbulut, M, Dindar-Demiray, E, Harputluoglu, M, Kumar, R, Satapathy, S, Mendizabal, M, Silva, M, Fagiuoli, S, Roberts, S, Soylu, N, Idilman, R, Yoshida, E, Montano-Loza, A, Dalekos, G, Ridruejo, E, Schiano, T, and Wahlin, S

Subjects
Male, COVID-19 Vaccines, Hepatology, SARS-CoV-2, Vaccination, VACCINE, COVID-19, Middle Aged, Hepatitis A, Hepatitis, Autoimmune, ChAdOx1 nCoV-19, Humans, Disease, Female, Idiopathic Autoimmune Hepatitis, BNT162 Vaccine
Abstract

© 2022 American Association for the Study of Liver Diseases.Background and Aims: A few case reports of autoimmune hepatitis–like liver injury have been reported after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination. We evaluated clinical features, treatment response and outcomes of liver injury following SARS-CoV-2 vaccination in a large case series. Approach and Results: We collected data from cases in 18 countries. The type of liver injury was assessed with the R-value. The study population was categorized according to features of immune-mediated hepatitis (positive autoantibodies and elevated immunoglobulin G levels) and corticosteroid therapy for the liver injury. We identified 87 patients (63%, female), median age 48 (range: 18–79) years at presentation. Liver injury was diagnosed a median 15 (range: 3–65) days after vaccination. Fifty-one cases (59%) were attributed to the Pfizer-BioNTech (BNT162b2) vaccine, 20 (23%) cases to the Oxford-AstraZeneca (ChAdOX1 nCoV-19) vaccine and 16 (18%) cases to the Moderna (mRNA-1273) vaccine. The liver injury was predominantly hepatocellular (84%) and 57% of patients showed features of immune-mediated hepatitis. Corticosteroids were given to 46 (53%) patients, more often for grade 3–4 liver injury than for grade 1–2 liver injury (88.9% vs. 43.5%, p = 0.001) and more often for patients with than without immune-mediated hepatitis (71.1% vs. 38.2%, p = 0.003). All patients showed resolution of liver injury except for one man (1.1%) who developed liver failure and underwent liver transplantation. Steroid therapy was withdrawn during the observation period in 12 (26%) patients after complete biochemical resolution. None had a relapse during follow-up. Conclusions: SARS-CoV-2 vaccination can be associated with liver injury. Corticosteroid therapy may be beneficial in those with immune-mediated features or severe hepatitis. Outcome was generally favorable, but vaccine-associated liver injury led to fulminant liver failure in one patient.

Published
2022

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

Author

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

Subjects
Liver Cirrhosis, FibroScan, Mortality, PBC, Prognosis, Transplantation, Hepatology, Prognosi, Liver Cirrhosis, Biliary, Liver Cirrhosi, Vibration, Follow-Up Studie, Cohort Studies, Liver, Elasticity Imaging Technique, Retrospective Studie, Humans, Elasticity Imaging Techniques, Cohort Studie, Retrospective Studies, Follow-Up Studies, Human
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

Published
2022

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

Author

George N. Dalekos, Cristina Rigamonti, Godolfino Miranda Zazueta, Ali Rıza Calışkan, Annarosa Floreani, Berat Ebik, Kadri Atay, Aylin Demirezer Bolat, Nazım Ekin, Eric M. Yoshida, Graciela Castro Narro, Fatih Güzelbulut, Murat Biyik, Manuel Mendizabal, Renumathy Dhanasekaran, Stefano Fagiuoli, Thomas D. Schiano, Ellina Lytvyak, Shalom Frager, Nataly Chris Escajadillo Vargas, Yucel Ustundag, Ramazan Idilman, Andreea M. Catana, Alvaro Urzúa, Ahmet Yavuz, Staffan Wahlin, Mesut Aydin, Cumali Efe, Laura Cristoferi, Hatef Massoumi, Maria Vincent, Sandro Ruiz Garcia, Evrim Kahramanoğlu-Aksoy, Natalia Ratusnu, Craig Lammert, Sümeyra Yıldırım, Mário Reis Álvares-da-Silva, Murat Harputoğlu, Marina Silveira, Murat Kiyici, Fátima Higuera-de la Tijera, Nurhan Demir, Cynthia Levy, Einar Bjornsson, Javier Brahm, Rotonya M. Carr, Nidah S. Khakoo, Andres Jose Gomez Aldana, Murat Akyildiz, Leyla Nazal, Alessio Gerussi, Tuğçe Eşkazan, Zeynep Ellik, Pietro Invernizzi, Fulya Gunsar, Ezequiel Ridruejo, Eleonora De Martin, Tugrul Purnak, Fatih Eren, Hüseyin Kaçmaz, Margarita Anders, Nikolaos K. Gatselis, Romee Snijders, Sezgin Barutçu, Costica Aloman, Alexandra Heurgue-Berlot, Bianca Magro, Jonathan Aguirre, Kader Irak, Koray Tascilar, Aldo J. Montano-Loza, Marcelo Silva, David N. Assis, Joost P.H. Drenth, Eira Cerda Reyes, Ibrahim Hatemi, Mirta Peralta, Sanjaya K. Satapathy, James L. Boyer, Yasemin H. Balaban, 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, Akyıldız, Murat (ORCID 0000-0002-2080-7528 & YÖK ID 123080), Efe, Cumalı, Lammert, Craig, Taşçılar, Koray, Dhanasekaran, Renumathy, Ebik, Berat, Higuera-de la Tijera, Fatima, Çalışkan, Ali R., Peralta, Mirta, Gerussi, Alessio, Massoumi, Hatef, Catana, Andreea M., Purnak, Tuğrul, Rigamonti, Cristina, Aldana, Andres J. G., Khakoo, Nidah, Nazal, Leyla, Frager, Shalom, Demir, Nurhan, Irak, Kader, Melekoğlu-Ellik, Zeynep, Kaçmaz, Hüseyin, Balaban, Yasemin, Atay, Kadri, Eren, Fatih, Alvares-da-Silva, Mario R., Cristoferi, Laura, Urzua, Alvaro, Eskazan, Tugce, Magro, Bianca, Snijders, Romee, Barutçu, Sezgin, Lytvyak, Ellina, Zazueta, Godolfino M., Demirezer-Bolat, Aylin, Aydın, Mesut, Heurgue-Berlot, Alexandra, De Martin, Eleonora, Ekin, Nazım, Yıldırım, Sumeyra, Yavuz, Ahmet, Bıyık, Murat, Narro, Graciela C., Kıyıcı, Murat, Kahramanoğlu-Aksoy, Evrim, Vincent, Maria, Carr, Rotonya M., Günsar, Fulya, Reyes, Eira C., Harputluoğlu, Murat, Aloman, Costica, Gatselis, Nikolaos K., Üstündağ, Yücel, Brahm, Javier, Vargas, Nataly C. E., Güzelbulut, Fatih, Garcia, Sandro R., Aguirre, Jonathan, Anders, Margarita, Ratusnu, Natalia, Hatemi, İbrahim, Mendizabal, Manuel, Floreani, Annarosa, Fagiuoli, Stefano, Silva, Marcelo, İdilman, Ramazan, Satapathy, Sanjaya K., Silveira, Marina, Drenth, Joost P. H., Dalekos, George N., Assis, David N., Bjornsson, Einar, Boyer, James L., Yoshida, Eric M., Invernizzi, Pietro, Levy, Cynthia, Montano-Loza, Aldo J., Schiano, Thomas D., Ridruejo, Ezequiel, Wahlin, Staffan, and School of Medicine

Subjects
Adult, Male, medicine.medical_specialty, budesonide, Cirrhosis, Adolescent, Gastroenterology and hepatology, medicine.medical_treatment, Azathioprine, Autoimmune hepatitis, mercaptopurine, Liver transplantation, Gastroenterology, Young Adult, Sars-Cov-2 Infection, Internal medicine, medicine, Humans, Autoimmunity, Budesonide, Mercaptopurine, SARS-CoV-2, Aged, Retrospective Studies, Mechanical ventilation, Aged, 80 and over, azathioprine, liver transplantation, Hepatology, business.industry, autoimmunity, COVID-19, Immunosuppression, Odds ratio, Middle Aged, medicine.disease, Tacrolimus, Liver-Transplant Recipients, Hospitalization, Hepatitis, Autoimmune, Renal disorders Radboud Institute for Molecular Life Sciences [Radboudumc 11], Pharmaceutical Preparations, Female, business, medicine.drug
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., Italian Ministry of University and Research (MIUR)-Department of Excellence project PREMIA (PREcision MedIcine Approach: bringing biomarker research to clinic), A. Gerussi, L. Cristoferi, and P. Invernizzi acknowledge that this research was partially supported by the Italian Ministry of University and Research (MIUR)-Department of Excellence project PREMIA (PREcision MedIcine Approach: bringing biomarker research to clinic).

Published
2021

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

Author

Cumali Efe, Koray Taşçılar, Alessio Gerussi, Francesca Bolis, Craig Lammert, Berat Ebik, Albert Friedrich Stättermayer, Mustafa Cengiz, Dilara Turan Gökçe, Laura Cristoferi, Mirta Peralta, Hatef Massoumi, Pedro Montes, Eira Cerda, Cristina Rigamonti, Suna Yapalı, Gupse Adali, Ali Rıza Çalışkan, Yasemin Balaban, Fatih Eren, Tuğçe Eşkazan, Sezgin Barutçu, Ellina Lytvyak, Godolfino Miranda Zazueta, Meral Akdogan Kayhan, Alexandra Heurgue-Berlot, Eleonora De Martin, Ahmet Yavuz, Murat Bıyık, Graciela Castro Narro, Serkan Duman, Nelia Hernandez, Nikolaos K. Gatselis, Jonathan Aguirre, Ramazan Idilman, Marcelo Silva, Manuel Mendizabal, Kadri Atay, Fatih Güzelbulut, Renumathy Dhanasekaran, Aldo J. Montano-Loza, George N. Dalekos, Ezequiel Ridruejo, Pietro Invernizzi, Staffan Wahlin, Acibadem University Dspace, 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, and Wahlin, S

Subjects
Adult, Aged, 80 and over, Male, COVID-19 Vaccines, Adolescent, SARS-CoV-2, Vaccination, Immunology, Liver failure, COVID-19, Autoimmunity, Middle Aged, Breakthrough infection, Young Adult, Hepatitis, Autoimmune, COVID-19 Testing, Humans, Immunology and Allergy, Female, Vaccine, BNT162 Vaccine, Immunosuppression, Aged, Retrospective Studies
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 SARSCoV-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

40. Extrahepatic autoimmune diseases in primary biliary cholangitis: Prevalence and significance for clinical presentation and disease outcome

Author

Fredrik Rorsman, Ellina Lytvyak, Mårten Werner, Aldo J. Montano-Loza, Fatema Alalkim, Benedetta Terziroli Beretta-Piccoli, Paolo Muratori, Thomas Berg, Thomas D. Schiano, Emma Nilsson, Tugrul Purnak, Ida Henriksson, David Semela, Staffan Wahlin, Eric M. Yoshida, Luigi Muratori, Alan Bonder, Murat Kiyici, Kristina Önnerhag, Janett Fischer, Ersan Ozaslan, Maneerat Chayanupatkul, Hanns-Ulrich Marschall, Murat Torgutalp, Claudia Coppo, Alexandra Heurgué-Berlot, Hirsh D. Trivedi, Nurhan Demir, Cumali Efe, Fatih Eren, Efe C., Torgutalp M., Henriksson I., Alalkim F., Lytvyak E., Trivedi H., Eren F., Fischer J., Chayanupatkul M., Coppo C., Purnak T., Muratori L., Werner M., Muratori P., Rorsman F., Onnerhag K., Nilsson E., Heurgue-Berlot A., Demir N., Semela D., Kiyici M., Schiano T.D., Montano-Loza A.J., Berg T., Ozaslan E., Yoshida E.M., Bonder A., Marschall H.-U., Beretta-Piccoli B.T., Wahlin S., Bursa Uludağ Üniversitesi/Tıp Fakültesi/İç Hastalıkları Anabilim Dalı., CPU-6796-2022, and Eren, Fatih

Subjects
Male, Anti-nuclear antibody, PBC, Gastroenterology, Inflammatory bowel disease, 0302 clinical medicine, Lichen sclerosus et atrophicus, Antiphospholipid syndrome, Ascites, Undifferentiated connective tissue disease, Temporal arteritis, Myasthenia gravis, Hepatic encephalopathy, Hashimoto disease, Addison disease, Crohn disease, Pemphigus vulgaris, IgA nephropathy, Prognosis, Liver cell carcinoma, Management, Risk-factors, Retrospective study, Blood, Cirrhosis, Smooth muscle antibody, Biochemical response, Ursodeoxycholic acid, Primary biliary cirrhosis, 030220 oncology & carcinogenesis, Rheumatoid arthritis, Graves disease, Systemic sclerosis, 030211 gastroenterology & hepatology, Cohort analysis, Lichen planus, Anti-phospholipid syndrome, Human, Sex factor, medicine.medical_specialty, Cholangitis, Biliary Liver Cirrhosis, Obeticholic Acid, Sarcoidosis, Immunology, Major clinical study, Aspartate aminotransferase, Article, Dermatomyositis, Multiple sclerosis, 03 medical and health sciences, Humans, Clinical significance, Aspartate Aminotransferases, Autoimmune hemolytic anemia, Autoantibodies, Polymyositi, Ankylosing spondylitis, Bullous pemphigoid, Wegener granulomatosis, Medical record, Biliary cirrhosis, Follow up, medicine.disease, Event free survival, Ankylosing spondyliti, Ulcerative colitis, Pernicious anemia, Idiopathic thrombocytopenic purpura, Gastroenterology & hepatology, Complication, Biomarkers, Sarcoidosi, Autoantibody, Immunoglobulin A nephropathy, Autoimmune disease, Prevalence, Celiac disease, Middle aged, Variceal bleeding, Liver Cirrhosis, Biliary, Chronic urticaria, Mitochondria, Gastritis, Antibodies, Antinuclear, Female, medicine.symptom, Adult, Vitiligo, Autoimmune Diseases, Antinuclear antibody, Systemic lupus erythematosus, Sex Factors, Decompensated liver cirrhosis, Mitochondrion antibody, Internal medicine, Psoriasis, medicine, Multiple sclerosi, Collagenous colitis, Mitochondrion, Membranous glomerulonephritis, Hepatology, business.industry, Bleeding, Bilirubin, Polyarteritis nodosa, Alkaline Phosphatase, Polymyositis, Biological marker, business, Controlled study, Sjoegren syndrome
Abstract

Background and Aim: The prevalence and clinical significance of extrahepatic autoimmune diseases (EHAIDs) have not been evaluated in a large cohort of primary biliary cholangitis (PBC). Methods: The medical records of 1554 patients with PBC from 20 international centers were retrospectively reviewed. Development of decompensated cirrhosis (ascites, variceal bleeding, and/or hepatic encephalopathy) and hepatocellular carcinoma were considered clinical endpoints. Results: A total of 35 different EHAIDs were diagnosed in 440 (28.3%) patients with PBC. Patients with EHAIDs were more often female (92.5% vs 86.1%, P&nbsp

Published
2021

41. Validation of risk scoring systems in ursodeoxycholic acid-treated patients with primary biliary Cholangitis

Author

Fatema Alalkim, Benedetta Terziroli Beretta-Piccoli, Thomas Berg, Cumali Efe, Fulya Gunsar, Ellina Lytvyak, Janett Fischer, Fredrik Rorsman, Ali Riza Caliskan, Hanns-Ulrich Marschall, Kristina Önnerhag, Tugrul Purnak, Ida Henriksson, Maneerat Chayanupatkul, Claudia Coppo, Can Gonen, David Semela, Staffan Wahlin, Murat Kiyici, Ersan Ozaslan, Alexandra Heurgué-Berlot, Emma Nilsson, Alan Bonder, Koray Tascilar, Luigi Muratori, Fatih Güzelbulut, Murat Aladağ, Aldo J. Montano-Loza, Fatih Eren, Mårten Werner, Nurhan Demir, Henriette Ytting, Paolo Muratori, Thomas D. Schiano, Hirsh D. Trivedi, Eric M. Yoshida, Johanna Eliasson, Bursa Uludağ Üniversitesi/Tıp Fakültesi/Dahili Tıp Bilimleri., Eren, Fatih, AAS-6286-2020, Ege Üniversitesi, Efe C., Tascilar K., Henriksson I., Lytvyak E., Alalkim F., Trivedi H., Eren F., Eliasson J., Beretta-Piccoli B.T., Fischer J., Caliskan A.R., Chayanupatkul M., Coppo C., Ytting H., Purnak T., Muratori L., Werner M., Muratori P., Rorsman F., Onnerhag K., Gunsar F., Nilsson E., Heurgue-Berlot A., Guzelbulut F., Demir N., Gonen C., Semela D., Aladag M., Kiyici M., Schiano T.D., Montano-Loza A.J., Berg T., Ozaslan E., Yoshida E.M., Bonder A., Marschall H.-U., and Wahlin S.

Subjects
Male, Scoring system, Survival rate, Kaplan Meier method, Cholagogues and choleretics, Gastroenterology, 0302 clinical medicine, Cholagogue, Pathology, Histological progression, Treatment outcome, Child, Hepatic encephalopathy, Prognosis, Ursodeoxycholic acid, Multicenter study, Clinical trial, Retrospective study, Cirrhosis, Biochemical response, Primary biliary cirrhosis, liver, autoimmune, human, 030220 oncology & carcinogenesis, Predictive value of tests, Risk stratification, Disease Progression, Dose-response relationship, drug, Cohort studies, 030211 gastroenterology & hepatology, Cohort analysis, Human, medicine.medical_specialty, Sex factor, Cholangitis, Biliary Liver Cirrhosis, Obeticholic Acid, Major clinical study, Article, Adverse outcome, 03 medical and health sciences, Age, Severity of illness, Dose response, Humans, Disease exacerbation, Survival analysis, Confidence interval, Biliary cirrhosis, Follow up, Globe, digestive system diseases, Event free survival, United States, Retrospective studies, International cooperation, Gastroenterology & hepatology, Internationality, Survival, Middle aged, Priority journal, Risk assessment, Liver Cirrhosis, Biliary, Ascites, Validation study, Europe, Female, France, Sex factors, Age factors, medicine.drug, Adult, Canada, Proportional hazards models, Adolescent, Kaplan-Meier estimate, Hazard ratio, Placebo-controlled trial, Predictive value, macromolecular substances, Outcomes, Proportional hazards model, Internal medicine, medicine, Mortality, Hepatology, business.industry, Drug administration, Bleeding, Drug administration schedule, Retrospective cohort study, Severity of illness index, Spain, Bezafibrate, business, Prediction, Controlled study
Abstract

EgeUn###, INTRODUCTION: Risk stratification based on biochemical variables is a useful tool for monitoring ursodeoxycholic acid (UDCA)-treated patients with primary biliary cholangitis (PBC). Several UDCA response criteria and scoring systems have been proposed for risk prediction in PBC, but these have not been validated in large external cohorts. METHODS: We performed a study on data of 1746 UDCA-treated patients with PBC from 25 centers in Europe, United States, and Canada. The prognostic performance of the risk scoring systems (GLOBE and UK-PBC) and the UDCA response criteria (Barcelona, Paris I, Paris II, Rotterdam, and Toronto) were evaluated. We regarded cirrhosis-related complications (ascites, variceal bleeding, and/or hepatic encephalopathy) as clinical end points. RESULTS: A total of 171 patients reached a clinical end point during a median 7 years (range 1-16 years) of follow-up. The 5-, 10- and 15-year adverse outcome-free survivals were 95%, 85%, and 77%. The GLOBE and UK-PBC scores predicted cirrhosis-related complications better than the UDCA response criteria. The hazard ratio (HR) for a 1 standard deviation increase was HR 5.05 (95% confidence interval (CI): 4.43-5.74, P < 0.001) for the GLOBE score and HR 3.39 (95% CI: 3.10-3.72, P < 0.001) for the UK-PBC score. Overall, the GLOBE and UK-PBC risk scores showed similar and excellent prognostic performance (C-statistic, 0.93; 95% CI: 0.91%-95% vs 0.94; 95% CI: 0.91%-0.96%). DISCUSSION: In our international, multicenter PBC cohort, the GLOBE and UK-PBC risk scoring systems were good predictors of future cirrhosis-related complications.

Published
2019

42. Effects of Tumor Necrosis Factor Antagonists in Patients With Primary Sclerosing Cholangitis

Author

Karima Ben Belkacem, Neta Gotlieb, Severine Vermeire, Christoph Schramm, Roger W. Chapman, Nicholas Fonseca Nogueira, Emma Nilsson, Henriette Ytting, Hanns-Ulrich Marschall, João Sabino, Sven Almer, Cyriel Y. Ponsioen, Geir Larsson, Kate D. Lynch, Gina Sado, Ellina Lytvyak, Douglas Thorburn, Bjørn Moum, Olivier Chazouillères, Oren Shibolet, Kim N. van Munster, Christian Rupp, Alessandra Zago, Fredrik Rorsman, Christopher L. Bowlus, K. K. Jørgensen, Cynthia Levy, Mette Vesterhus, Alessio Gerussi, Charlotte R H Hedin, Francesca Saffioti, Aldo J. Montano-Loza, Andrew Mason, Nora Cazzagon, Annika Bergquist, Nelson Ndegwa, Graduate School, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Gastroenterology and Hepatology, Hedin, C, Sado, G, Ndegwa, N, Lytvyak, E, Mason, A, Montano-Loza, A, Gerussi, A, Saffioti, F, Thorburn, D, Nilsson, E, Larsson, G, Moum, B, van Munster, K, Ponsioen, C, Levy, C, Nogueira, N, Bowlus, C, Gotlieb, N, Shibolet, O, Lynch, K, Chapman, R, Rupp, C, Vesterhus, M, Jorgensen, K, Rorsman, F, Schramm, C, Sabino, J, Vermeire, S, Zago, A, Cazzagon, N, Marschall, H, Ytting, H, Ben Belkacem, K, Chazouilleres, O, Almer, S, and Bergquist, A

Subjects
musculoskeletal diseases, medicine.medical_specialty, Exacerbation, Cholangitis, Sclerosing, digestive system, Inflammatory bowel disease, Gastroenterology, Primary sclerosing cholangitis, Anti-Inflammatory, 03 medical and health sciences, 0302 clinical medicine, Hepatic, MED/12 - GASTROENTEROLOGIA, Interquartile range, Internal medicine, medicine, Adalimumab, Humans, Retrospective Studies, Hepatology, Tumor Necrosis Factor-alpha, business.industry, Inflammatory Bowel Diseases, medicine.disease, Infliximab, digestive system diseases, Intestine, Liver Transplantation, 030220 oncology & carcinogenesis, Tumor Necrosis Factor Inhibitors, 030211 gastroenterology & hepatology, Liver function, MED/09 - MEDICINA INTERNA, Calprotectin, business, medicine.drug
Abstract

Background & Aims: Few patients with primary sclerosing cholangitis (PSC) and inflammatory bowel diseases (IBDs) are exposed to tumor necrosis factor (TNF) antagonists because of the often mild symptoms of IBD. We assessed the effects of anti-TNF agents on liver function in patients with PSC and IBD, and their efficacy in treatment of IBD. Methods: We performed a retrospective analysis of 141 patients with PSC and IBD receiving treatment with anti-TNF agents (infliximab or adalimumab) at 20 sites (mostly tertiary-care centers) in Europe and North America. We collected data on the serum level of alkaline phosphatase (ALP). IBD response was defined as either endoscopic response or, if no endoscopic data were available, clinical response, as determined by the treating clinician or measurements of fecal calprotectin. Remission was defined more stringently as endoscopic mucosal healing. We used linear regression analysis to identify factors associated significantly with level of ALP during anti-TNF therapy. Results: Anti-TNF treatment produced a response of IBD in 48% of patients and remission of IBD in 23%. There was no difference in PSC symptom frequency before or after drug exposure. The most common reasons for anti-TNF discontinuation were primary nonresponse of IBD (17%) and side effects (18%). At 3 months, infliximab-treated patients had a median reduction in serum level of ALP of 4% (interquartile range, reduction of 25% to increase of 19%) compared with a median 15% reduction in ALP in adalimumab-treated patients (interquartile range, reduction of 29% to reduction of 4%; P =.035). Factors associated with lower ALP were normal ALP at baseline (P

Published
2020

43. Evaluating the Efficacy of Telehealth-Based Treatments for Depression in Adults: A Rapid Review and Meta-Analysis.

Author

Nowrouzi-Kia B, Bani-Fatemi A, Jackson TD, Li AKC, Chattu VK, Lytvyak E, Deibert D, Dennett L, Ferguson-Pell M, Hagtvedt R, Els C, Durand-Moreau Q, Gross DP, and Straube S

Abstract

Purpose: Major depressive disorder (MDD) is one of the leading causes of work-related disability, and accessing telehealth therapies can be a promising modality for workers with MDD. Barriers to accessing in-person mental healthcare, such as limited availability and accessibility in rural and remote communities, financial constraints, and stigma, have highlighted the need for alternative approaches like telehealth. This study investigated the efficacy of telehealth interventions including CBT for adults over 18 diagnosed with MDD., Methods: This rapid review and meta-analysis followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to ensure a transparent methodology. Out of the 2549 studies screened, 19 were incorporated into the rapid review, and of those, 10 were included in the subsequent meta-analyses. Articles were screened independently by two reviewers, with the disagreements reconciled through discussion. A reviewer extracted data from eligible articles. Descriptive statistics and narrative syntheses were used to describe outcomes. Two meta-analyses were conducted to investigate the efficacy of cognitive behavioral therapy (CBT) delivered by telehealth (tCBT). The first compared tCBT to in-person CBT (pCBT). The second meta-analysis compared tCBT to a control group that did not receive CBT or another telehealth-based treatment. Non-CBT interventions investigated within the non-CBT group included somatic rhythm therapy, problem-solving therapy, psychiatry, behavioral activation, and interpersonal psychotherapy., Results: Overall, individuals with MDD who received tCBT showed significant improvement in depression symptoms. However, the efficacy of tCBT compared to non-telehealth control groups varied across studies. The first meta-analysis indicated the magnitudes of effect were similar for both interventions in reducing depression symptoms 0.023 (95% CI - 0.120 to 0.166); p = 1.00. In the second meta-analysis, the ratio of means comparing tCBT (0.51 ± 0.14 SD) to the control group (0.68 ± 0.12 SD) exhibited a statistically significant 25% reduction with regard to depression scores (one-sided p = 0.002), favouring tCBT to non-telehealth, non-CBT study groups., Conclusions: Telehealth-based CBT demonstrated positive effects on depression symptoms; it was generally superior when compared to control groups not receiving CBT and was on par with pCBT. The growing mental health burden in the community underscores the need for accessible telehealth services like tCBT. Effective policy formulation and implementation in national health agendas are essential to meet the increasing demand for mental health support., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Published
2024
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44. Prognostic scores for ursodeoxycholic acid-treated patients predict graft loss and mortality in recurrent primary biliary cholangitis after liver transplantation.

Author

Montano-Loza AJ, Lytvyak E, Hirschfield G, Hansen BE, Ebadi M, Berney T, Toso C, Magini G, Villamil A, Nevens F, Van den Ende N, Pares A, Ruiz P, Terrabuio D, Trivedi PJ, Abbas N, Donato MF, Yu L, Landis C, Dumortier J, Dyson JK, van der Meer AJ, de Veer R, Pedersen M, Mayo M, Manns MP, Taubert R, Kirchner T, Belli LS, Mazzarelli C, Stirnimann G, Floreani A, Cazzagon N, Russo FP, Burra P, Zigmound U, Houri I, Carbone M, Mulinacci G, Fagiuoli S, Pratt DS, Bonder A, Schiano TD, Haydel B, Lohse A, Schramm C, Rüther D, Casu S, Verhelst X, Beretta-Piccoli BT, Robles M, Mason AL, and Corpechot C

Subjects
Humans, Female, Male, Middle Aged, Prognosis, Graft Survival drug effects, Alkaline Phosphatase blood, Cholangitis diagnosis, Cholangitis etiology, Cholangitis drug therapy, Retrospective Studies, Follow-Up Studies, Liver Transplantation adverse effects, Ursodeoxycholic Acid therapeutic use, Recurrence, Cholagogues and Choleretics therapeutic use, Liver Cirrhosis, Biliary surgery, Liver Cirrhosis, Biliary mortality, Liver Cirrhosis, Biliary diagnosis
Abstract

Background & Aims: Recurrent primary biliary cholangitis (rPBC) develops in approximately 30% of patients and negatively impacts graft and overall patient survival after liver transplantation (LT). There is a lack of data regarding the response rate to ursodeoxycholic acid (UDCA) in rPBC. We evaluated a large, international, multi-center cohort to assess the performance of PBC scores in predicting the risk of graft and overall survival after LT in patients with rPBC., Methods: A total of 332 patients with rPBC after LT were evaluated from 28 centers across Europe, North and South America. The median age at the time of rPBC was 58.0 years [IQR 53.2-62.6], and 298 patients (90%) were female. The biochemical response was measured with serum levels of alkaline phosphatase (ALP) and bilirubin, and Paris-2, GLOBE and UK-PBC scores at 1 year after UDCA initiation., Results: During a median follow-up of 8.7 years [IQR 4.3-12.9] after rPBC diagnosis, 52 patients (16%) had graft loss and 103 (31%) died. After 1 year of UDCA initiation the histological stage at rPBC (hazard ratio [HR] 3.97, 95% CI 1.36-11.55, p = 0.01), use of prednisone (HR 3.18, 95% CI 1.04-9.73, p = 0.04), ALP xULN (HR 1.59, 95% CI 1.26-2.01, p <0.001), Paris-2 criteria (HR 4.14, 95% CI 1.57-10.92, p = 0.004), GLOBE score (HR 2.82, 95% CI 1.71-4.66, p <0.001), and the UK-PBC score (HR 1.06, 95% CI 1.03-1.09, p <0.001) were associated with graft survival in the multivariate analysis. Similar results were observed for overall survival., Conclusion: Patients with rPBC and disease activity, as indicated by standard PBC risk scores, have impaired outcomes, supporting efforts to treat recurrent disease in similar ways to pre-transplant PBC., Impact and Implications: One in three people who undergo liver transplantation for primary biliary cholangitis develop recurrent disease in their new liver. Patients with recurrent primary biliary cholangitis and incomplete response to ursodeoxycholic acid, according to conventional prognostic scores, have worse clinical outcomes, with higher risk of graft loss and mortality in similar ways to the disease before liver transplantation. Our results supportsupport efforts to treat recurrent disease in similar ways to pre-transplant primary biliary cholangitis., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Published
2024
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45. Efficacy and safety of infliximab in patients with autoimmune hepatitis.

Author

Efe C, Lytvyak E, Eşkazan T, Liberal R, Androutsakos T, Turan Gökçe D, Terziroli Beretta-Piccoli B, Janik M, Bernsmeier C, Arvaniti P, Milkiewicz P, Batibay E, Yüksekyayla O, Ergenç I, Arikan Ç, Stättermayer AF, Barutçu S, Cengiz M, Gül Ö, Heurgue A, Heneghan MA, Verma S, Purnak T, Törüner M, Akdogan Kayhan M, Hatemi I, Zachou K, Macedo G, Drenth JPH, Björnsson E, Montano-Loza AJ, Wahlin S, and Higuera-de la Tijera F

Abstract

Background and Aims: A limited number of drugs are used as standard or alternative therapies in autoimmune hepatitis (AIH). No specific recommendations are available for patients failing to respond to these therapies. We analyzed the efficacy and safety of infliximab in patients with AIH., Approach and Results: We performed a retrospective study of 42 patients with AIH who received infliximab at 21 liver centers in 12 countries. Patients were categorized according to the reason for infliximab therapy. Patients in group 1 (n=20) had failed standard, second-line (mycophenolate mofetil and 6-mercaptopurine) or third-line (tacrolimus or cyclosporine) therapy. In group 2 (n=22), infliximab was given for treatment of concomitant extrahepatic autoimmune diseases. Patients received a median of 17 (range: 3-104) infliximab infusions. Complete biochemical response (CR) was achieved or maintained in 33 (78%) patients during infliximab therapy. In group 1, infliximab induced CR in 11 of 20 (55%) patients. In group 2, 16 patients with CR prior to infliximab maintained remission, and the remaining 6 patients with active AIH (5 on standard and 1 on both second-line and third-line therapy) showed CR following infliximab therapy. Infliximab led to CR in 75% (6/8) of nonresponders to second-line and in 46% (6/13) of failing third-line therapy. Overall, 65% (17/26) of the patients with active AIH achieved CR on infliximab. Infliximab was discontinued in 3 patients of group 1. One patient had a severe allergic reaction and 2 developed anti-infliximab autoantibodies., Conclusions: Our study suggests that infliximab may be an effective and safe rescue therapy in AIH., (Copyright © 2024 American Association for the Study of Liver Diseases.)

Published
2024
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46. Treatment response and clinical event-free survival in autoimmune hepatitis: A Canadian multicentre cohort study.

Author

Plagiannakos CG, Hirschfield GM, Lytvyak E, Roberts SB, Ismail M, Gulamhusein AF, Selzner N, Qumosani KM, Worobetz L, Hercun J, Vincent C, Flemming JA, Swain MG, Cheung A, Chen T, Grbic D, Peltekain K, Mason AL, Montano-Loza AJ, and Hansen BE

Subjects
Humans, Female, Male, Middle Aged, Canada epidemiology, Adult, Prednisone therapeutic use, Prednisone administration & dosage, Cohort Studies, Treatment Outcome, Prognosis, Bilirubin blood, Follow-Up Studies, Proportional Hazards Models, Immunoglobulin G blood, Hepatitis, Autoimmune drug therapy, Hepatitis, Autoimmune mortality, Hepatitis, Autoimmune blood, Hepatitis, Autoimmune diagnosis, Alanine Transaminase blood
Abstract

Background & Aims: Treatment outcomes for people living with autoimmune hepatitis (AIH) are limited by a lack of specific therapies, as well as limited well-validated prognostic tools and clinical trial endpoints. We sought to identify predictors of outcome for people living with AIH., Methods: We evaluated the clinical course of people with AIH across 11 Canadian centres. Biochemical changes were analysed using linear mixed-effect and logistic regression. Clinical outcome was dynamically modelled using time-varying Cox proportional hazard modelling and landmark analysis., Results: In 691 patients (median age 49 years, 75.4% female), with a median follow-up of 6 years (25th-75th percentile, 2.5-11), 118 clinical events occurred. Alanine aminotransferase (ALT) normalisation occurred in 63.8% of the cohort by 12 months. Older age at diagnosis (odd ratio [OR] 1.19, 95% CI 1.06-1.35) and female sex (OR 1.94, 95% CI 1.18-3.19) were associated with ALT normalisation at 6 months, whilst baseline cirrhosis status was associated with reduced chance of normalisation at 12 months (OR 0.52, 95% CI 0.33-0.82). Baseline total bilirubin, aminotransferases, and IgG values, as well as initial prednisone dose, did not predict average ALT reduction. At baseline, older age (hazard ratio [HR] 1.25, 95% CI 1.12-1.40), cirrhosis at diagnosis (HR 3.67, 95% CI 2.48-5.43), and elevated baseline total bilirubin (HR 1.36, 95% CI 1.17-1.58) increased the risk of clinical events. Prolonged elevations in ALT (HR 1.07, 95% CI 1.00-1.13) and aspartate aminotransferase (HR 1.13, 95% CI 1.06-1.21), but not IgG (HR 1.01, 95% CI 0.95-1.07), were associated with higher risk of clinical events. Higher ALT at 6 months was associated with worse clinical event-free survival., Conclusion: In people living with AIH, sustained elevated aminotransferase values, but not IgG, are associated with poorer long-term outcomes. Biochemical response and long-term survival are not associated with starting prednisone dose., Impact and Implications: Using clinical data from multiple Canadian liver clinics treating autoimmune hepatitis (AIH), we evaluate treatment response and clinical outcomes. For the first time, we apply mixed-effect and time-varying survival statistical methods to rigorously examine treatment response and the impact of fluctuating liver biochemistry on clinical event-free survival. Key to the study impact, our data is 'real-world', represents a diverse population across Canada, and uses continuous measurements over follow-up. Our results challenge the role of IgG as a marker of treatment response and if normalisation of IgG should remain an important part of the definition of biochemical remission. Our analysis further highlights that baseline markers of disease severity may not prognosticate early treatment response. Additionally, the initial prednisone dose may be less relevant for achieving aminotransferase normalisation. This is important for patients and treating clinicians given the relevance and importance of side effects., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Published
2024
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47. Severe Cholestasis Predicts Recurrent Primary Sclerosing Cholangitis Following Liver Transplantation.

Author

Aziz B, Kok B, Cheah M, Lytvyak E, Moctezuma-Velazquez C, Wasilenko S, Tsochatzis E, Ravikumar R, Jose S, Allison M, Gunson B, Manas D, Monaco A, Mirza D, Fusai G, Owen N, Thorburn D, Roberts K, Srinivasan P, Wigmore S, Athale A, Creamer F, Fernando B, Iyer V, Madanur M, Sen G, Montano-Loza AJ, Hansen B, and Mason AL

Abstract

Background Aims: Primary sclerosing cholangitis (PSC) may reoccur following liver transplantation (LT) and the diagnosis established once imaging studies demonstrate the diagnostic cholangiographic appearance. To evaluate whether the development of recurrent PSC (rPSC) is associated with cholestasis soon after LT, we studied whether changes in hepatic biochemistry within the first 12 months were linked with the development of rPSC and graft loss., Methods: We conducted a retrospective cohort analysis of 158 transplant recipients with PSC in Canada, and 549 PSC transplant recipients from the United Kingdom. We evaluated serum liver tests within 12 months after LT and the subsequent development of a cholangiographic diagnosis of rPSC as a time-dependent covariate using Cox regression. Severe cholestasis was defined as either alkaline phosphatase> 3xupper limit of normal or total bilirubin> 100 μmol/L., Results: Patients who developed rPSC were more likely to have severe cholestasis versus those without at 3 months (20.5% vs 8.2%, p=0.011), at 6 months (17.9% vs. 10.0%, p=0.026) and 12 months (15.4% vs. 7.8%, p=0.051) in the Canadian cohort and at 12 months in the UK cohort (27.9% vs. 12.6%, p<0.0001). By multivariable analysis, development of severe cholestasis in the Canadian cohort at 3 months (HR=2.41, p=0.046) and in the UK cohort at 12 months (HR=3.141, p<0.0001) were both associated with rPSC. Severe cholestasis at 3 months in the Canadian cohort was predictive of graft loss (HR=3.88, p=0.0001)., Conclusions: The development of cholestasis within 3 to 12 months following LT was predictive of rPSC and graft loss., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The American College of Gastroenterology.)

Published
2024
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48. Dynamics of Liver Stiffness Measurement and Clinical Course of Primary Biliary Cholangitis.

Author

Lam L, Soret PA, Lemoinne S, Hansen B, Hirschfield G, Gulamhusein A, Montano-Loza AJ, Lytvyak E, Parés A, Olivas I, Londono MC, Rodríguez-Tajes S, Eaton JE, Osman KT, Schramm C, Sebode M, Lohse AW, Dalekos G, Gatselis N, Nevens F, Cazzagon N, Zago A, Russo FP, Floreani A, Abbas N, Trivedi P, Thorburn D, Saffioti F, Barkai L, Roccarina D, Calvaruso V, Fichera A, Delamarre A, Sobenko N, Villamil AM, 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 AE, Deibel A, Bruns T, Große K, Wetten A, Dyson JK, Jones D, Levy C, Tanaka A, Dumortier J, Pageaux GP, de Lédinghen V, Carrat F, Chazouillères O, and Corpechot C

Abstract

Background & Aims: In primary biliary cholangitis (PBC), static liver stiffness measurement (LSM) has proven prognostic value. However, the added prognostic value of LSM time course in this disease remains uncertain., Methods: We conducted an international retrospective cohort study among patients with PBC treated with ursodeoxycholic acid and followed by vibration-controlled transient elastography between 2003 and 2022. Using joint modeling, the association of LSM trajectory and the incidence of serious clinical events (SCE), defined as cirrhosis complications, liver transplantation, or death, was quantified using the hazard ratio and its confidence interval., Results: A total of 6362 LSMs were performed in 3078 patients (2007 on ursodeoxycholic acid alone; 13% with cirrhosis), in whom 316 SCE occurred over 14,445 person-years (median follow-up, 4.2 years; incidence rate, 21.9 per 1000 person-years). LSM progressed in 59% of patients (mean, 0.39 kPa/year). After adjusting for prognostic factors at baseline, including LSM, any relative change in LSM was associated with a significant variation in SCE risk (P < .001). For example, the adjusted hazard ratios (95% confidence interval) associated with a 20% annual variation in LSM were 2.13 (1.89-2.45) for the increase and 0.40 (0.33-0.46) for the decrease. The association between LSM trajectory and SCE risk persisted regardless of treatment response or duration, when patients with cirrhosis were excluded, and when only death or liver transplantation was considered., Conclusions: Tracking longitudinal changes in LSM using vibration-controlled transient elastography provides valuable insights into PBC prognosis, offering a robust predictive measure for the risk of SCE. LSM could be used as a clinically relevant surrogate end point in PBC clinical trials., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Published
2024
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49. Loss of biochemical response at any time worsens outcomes in UDCA-treated patients with primary biliary cholangitis.

Author

Roberts SB, Choi WJ, Worobetz L, Vincent C, Flemming JA, Cheung A, Qumosani K, Swain M, Grbic D, Ko HH, Peltekian KM, Abrahamyan L, Saini M, Tirona K, Aziz B, Lytvyak E, Invernizzi P, Ponsioen CY, Bruns T, Cazzagon N, Lindor K, Dalekos GN, Gatselis NK, Verhelst X, Floreani A, Corpechot C, Mayo MJ, Levy C, Londoño MC, Battezzati PM, Pares A, Nevens F, van der Meer A, Kowdley KV, Trivedi PJ, Lleo A, Thorburn D, Carbone M, Selzner N, Gulamhusein AF, Janssen H, Montano-Loza AJ, Mason AL, Hirschfield GM, and Hansen BE

Abstract

Background & Aims: Biochemical response to ursodeoxycholic acid (UDCA) therapy is associated with good prognosis in people living with primary biliary cholangitis (PBC). Biochemical response is typically assessed early in disease and it is not known what proportion of patients lose previously attained biochemical response, nor whether this impacts long-term liver transplant (LT)-free survival., Methods: We identified all UDCA-treated patients with PBC from the Canadian Network for Autoimmune Liver disease with biochemical measurements at 1 year, and evaluated their liver biochemistry over time. Inadequate biochemical response was defined as serum alkaline phosphatase ≥1.67x the upper limit of normal or abnormal serum total bilirubin at 1 year of UDCA therapy and all time points thereafter. Multistate Markov models were used to estimate transition rates between biochemical response states and from each state to LT or death. Results were validated in an external cohort (GLOBAL PBC registry)., Results: A total of 823 patients from eight centers were included. Mean age at diagnosis was 53 years, 91% were female, 33% had inadequate biochemical response to UDCA at 1 year (n = 269). Patients who retained initial adequate response had lower rates of LT or death compared to patients who subsequently lost response (relative rate 0.102, 95% CI 0.047-0.223). Patients who regained adequate response had lower rates than patients who did not (0.016, 95% CI 0.001-0.568), and patients who lost response once more (0.010, 95% CI 0.001-0.340). Patients who regained adequate response for a third time also had lower rates than patients who did not (0.151, 95% CI 0.040-0.566). Analyses in the GLOBAL PBC registry (n = 2,237) validated these results., Conclusion: Loss of biochemical response at any time is associated with heightened risks of LT or death in people living with PBC. Achievement of biochemical response is an important goal throughout follow-up, regardless of biochemical response profile early in therapy., Impact and Implications: Early biochemical response to ursodeoxycholic acid is associated with good prognosis in patients with primary biliary cholangitis (PBC). Our work demonstrates that patients with PBC transition between biochemical response states over time, and that these transitions correspond with changes in risk of liver transplantation or death. Clinicians should re-evaluate risk and optimize treatment decisions for patients with PBC throughout follow-up, regardless of early biochemical response to therapy., (© 2024 The Author(s).)

Published
2024
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50. Stronger control of eating 3 months after sleeve gastrectomy predicts successful weight loss outcomes at one year.

Author

Lytvyak E, Zarrinpar A, Ore CD, Lee E, Yazdani-Boset K, Horgan S, and Grunvald E

Abstract

Background: Weight loss response to sleeve gastrectomy (SG) is variable and predicting the effectiveness of surgery is challenging and elusive. The aim of our study was to assess and quantify the association between eating control and weight loss outcomes and identify the control of eating (CoE) attributes during the early postoperative period that might predict good vs. poor response to SG at one year., Methods: A prospective longitudinal cohort study using the Control of Eating Questionnaire (CoEQ) was designed as a series before and at 3-, 6-, and 12-months post-SG. Primary outcomes were changes in CoE attributes and percent of total weight loss (%TWL) 12-months post-surgery. Subjects were categorized based on %TWL as good (GR, ≥25 %) or poor responders (PR, <25 %). A receiver operating characteristic and logistic regression analyses were performed., Results: We included 41 participants (80.5% females, 51.2% Hispanic, mean age 41.7±10.6, median baseline body mass index (BMI) 43.6 kg/m 2 [range 35.2-66.3]) who completed the CoEQ at all four timepoints. The "Difficulty to control eating" score at 3 months revealed the highest area under the curve (AUC) (AUC 0.711; 95%CI 0.524-0.898; p=0.032). In a trade-off between a high Youden index and high sensitivity, the "Difficulty to control eating" score of 7 at 3 months was identified as the optimal cut-off for distinguishing between GRs and PRs. Score ≤7 at 3 months was strongly independently associated with a successful weight loss target of 25%TWL at one-year post-SG (Relative Risk 4.43; 95%CI 1.06-18.54; p=0.042)., Conclusion: "Difficulty to control eating" score at 3 months post-SG is an independent early predictor of optimal response (achieving a successful TWL target of ≥25 % at one-year post-SG). Our results support the utility of this easy-to-administer validated tool for predicting the effectiveness of SG and may assist in identifying individuals with suboptimal response early and helping them with interventions to attain optimal weight loss targets., Competing Interests: The authors declare that they have no conflict of interest., (© 2024 Published by Elsevier Inc. on behalf of Obesity Medicine Association.)

Published
2024
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