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2. Fibrosis Progression Rate in Biopsy-Proven Nonalcoholic Fatty Liver Disease Among People With Diabetes Versus People Without Diabetes: A Multicenter Study

Author

Huang, Daniel Q, Wilson, Laura A, Behling, Cynthia, Kleiner, David E, Kowdley, Kris V, Dasarathy, Srinivasan, Amangurbanova, Maral, Terrault, Norah A, Diehl, Anna Mae, Chalasani, Naga, Neuschwander-Tetri, Brent A, Sanyal, Arun J, Tonascia, James, Loomba, Rohit, Allende, Daniela, Bellar, Annette, Dasarathy, Jaividhya, Welch, Nicole, Yerrapothu, Rahul, Bashir, Mustafa, Guy, Cynthia, Kopping, Mariko, Piercy, Dawn, Suzuki, Ayako, Tawadrou, Naglaa, Cruz, Mandy, Cummings, Oscar W, Garrison, Lisa, Gawrieh, Samer, Samala, Niharika, Vuppalanchi, Raj, Carpenter, Danielle, Cattoor, Theresa, Freebersyser, Janet, Angkanaworakul, Pannapat, Berihun, Achashman, Buysse, Andrew, Dorrian, Theresa, Gulati, Breanna, Liu, Kevin, Misic, Sandra, Sohal, Adam, Vuong, Joseph, Ajmera, Veeral, Madamba, Egbert, Middleton, Michael S, Richards, Lisa, Singh, Seema, Sirlin, Claude, Gill, Ryan, Hameed, Bilal, Awe, Remilekun, Olvera, Daisy, Terrault, Norah, Yuan, Liyun, Yeh, Matthew, Albhaisi, Somaya, Asgharpour, Amon, Boyett, Sherry, Contos, Melissa J, Luketic, Velimir AC, Schlosser, Jolene, Siddiqui, Mohammad S, Adamo, Peggy, Belt, Patricia, Clark, Jeanne M, DeSanto, Jennifer M, Meinert, Jill, Miriel, Laura, Mitchell, Emily P, Shade, Carrie, Smith, Jacqueline, Smith, Michael, Sternberg, Alice, Van Natta, Mark L, Wagoner, Annette, Woreta, Tinsay, and Yates, Katherine P

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Hepatitis, Liver Disease, Digestive Diseases, Chronic Liver Disease and Cirrhosis, Clinical Research, Diabetes, Obesity, Metabolic and endocrine, Good Health and Well Being, Adult, Humans, Female, Male, Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2, Cohort Studies, Liver Cirrhosis, Biopsy, Nonalcoholic Steatohepatitis, NAFLD, Cirrhosis, Type 2 Diabetes Mellitus, NASH Clinical Research Network, Neurosciences, Paediatrics and Reproductive Medicine, Gastroenterology & Hepatology, Clinical sciences, Nutrition and dietetics
Abstract

Background & aimsThere are limited data regarding fibrosis progression in biopsy-proven nonalcoholic fatty liver disease (NAFLD) in people with type 2 diabetes mellitus (T2DM) compared with people without T2DM. We assessed the time to fibrosis progression in people with T2DM compared with people without T2DM in a large, multicenter, study of people with NAFLD who had paired liver biopsies.MethodsThis study included 447 adult participants (64% were female) with NAFLD who had paired liver biopsies more than 1 year apart. Liver histology was systematically assessed by a central pathology committee blinded to clinical data. The primary outcome was the cumulative incidence of a ≥1-stage increase in fibrosis in participants with T2DM compared with participants without T2DM.ResultsThe mean (SD) age and body mass index (calculated as weight in kilograms divided by the square of the height in meters) were 50.9 (11.5) years and 34.7 (6.3), respectively. The median time between biopsies was 3.3 years (interquartile range, 1.8-6.1 years). Participants with T2DM had a significantly higher cumulative incidence of fibrosis progression at 4 years (24% vs 20%), 8 years (60% vs 50%), and 12 years (93% vs 76%) (P = .005). Using a multivariable Cox proportional hazards model adjusted for multiple confounders, T2DM remained an independent predictor of fibrosis progression (adjusted hazard ratio, 1.69; 95% CI, 1.17-2.43; P = .005). The cumulative incidence of fibrosis regression by ≥1 stage was similar in participants with T2DM compared with participants without T2DM (P = .24).ConclusionsIn this large, multicenter cohort study of well-characterized participants with NAFLD and paired liver biopsies, we found that fibrosis progressed faster in participants with T2DM compared with participants without T2DM. These data have important implications for clinical practice and trial design.

Published
2023

6. Randomized trial of anakinra plus zinc vs. prednisone for severe alcohol-associated hepatitis

Author

Chalasani, Naga, Patidar, Kavish R., Vuppalanchi, Raj, Samala, Niha, Yoder, Lindsey, Nephew, Lauren, Shah, Vijay H., Simonetto, Douglas A., Kamath, Patrick, Vargas, Hugo E., Yang, Liu, Dasarathy, Srinivasan, Welch, Nicole, Bellar, Annette, Attaway, Amy, Dasarathy, Jaividhya, Growley, Ashley, Streem, David, Nagy, Laura E., Mitchell, Mack C., Herlong, H. Franklin, Kerr, Thomas, Cotter, Thomas, Sanyal, Arun, O'Connor, Sara, Luketic, Velimir, Asgharpour, Amon, Taylor, Stephanie, McClain, Craig J., Vatsalya, Vatsalya, Jophlin, Loretta, Cave, Matt, Jha, Suman Kumar, Marsano, Luis, Barve, Ashutosh, Frimodig, Jane, Bataller, Ramon, Ravi, Samhita, Behari, Jaideep, Shivanekar, Sharvari, Novelli, Paula, Duarte-Rojo, Andres, Jonassaint, Naudia, Szabo, Gyongyi, Curry, Jiang, Zhenghui G., Agarwal, Ushma, Hazel, Mia, Schnabl, Bernd, Gawrieh, Samer, Tu, Wanzhu, Kamath, Patrick S., Chalasani, Naga P., Tang, Qing, Radaeva, Svetlana, Barton, Bruce, and Sanyal, Arun J.

Published
2024
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7. Validation of a Clinical Risk-based Classification System in a Large Nonalcoholic Fatty Liver Disease Real-world Cohort

Author

Abdelmalek, Manal, Aguilar, Humberto, Ahmed, Aijaz, Allen, Alina, Barlow, Sarah, Barritt, Sid, Bernstein, David, Bhamidimarri, Kaylan, Billings, Liana, Brown, Kyle, Brown, Robert, Corbin, Karen, Cusi, Kenneth, deLemos, Andrew, Emerick, Karan, Firpi-Morell, Roberto, Ghali, Maged Adel, Henry, Zachary, Jackson, Whitney, Janardhan, Sujit, Kabbany, Mohammad, Kemmer, Nyingi, Koch, David, Kupec, Justin, Landis, Charles, Lawrence, Mary Katherine, Levy, Cynthia, Lidofsky, Steven, Lok, Anna, Luketic, Velimir, Martinez, Enrique, McClain, Craig, McKiernan, Patrick, Mitchell, Ellen, Noureddin, Mazen, Palle, Sirish, Pham, Yen, Pound, David, Reddy, Rajender, Regenstein, Fredric, Rinella, Mary, Rochling, Fedja, Rudolph, Bryan, Rustgi, Vinod, Said, Adnan, Samala, Niharika, Sarkar, Souvik, Sherman, Kenneth, Shiffman, Mitchell, Smith, Coleman, Taunk, Jawahar, Tetri, Brent, Thuluvath, Paul, Trinh, Huy, Verna, Elizabeth, Vos, Miriam, Weiss, L. Michael, Wong, Mark, Wyne, Kathleen, Xanthakos, Stavra, Sanyal, Arun J., Munoz, Breda, Barritt, A. Sidney, IV, Muthiah, Mark, Mospan, Andrea R., Reddy, K. Rajender, Thuluvath, Paul J., Bhamidimarri, Kalyan Ram, and Fried, Michael W.

Published
2023
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8. Fibrosis Progression Rate in Biopsy-Proven Nonalcoholic Fatty Liver Disease Among People With Diabetes Versus People Without Diabetes: A Multicenter Study

Author

Allende, Daniela, Bellar, Annette, Dasarathy, Jaividhya, Dasarathy, Srinivasan, Welch, Nicole, Yerrapothu, Rahul, Bashir, Mustafa, Diehl, Anna Mae, Guy, Cynthia, Kopping, Mariko, Piercy, Dawn, Suzuki, Ayako, Tawadrou, Naglaa, Chalasani, Naga, Cruz, Mandy, Cummings, Oscar W., Garrison, Lisa, Gawrieh, Samer, Samala, Niharika, Vuppalanchi, Raj, Carpenter, Danielle, Cattoor, Theresa, Freebersyser, Janet, Neuschwander-Tetri, Brent A., Angkanaworakul, Pannapat, Berihun, Achashman, Buysse, Andrew, Dorrian, Theresa, Gulati, Breanna, Kowdley, Kris V., Liu, Kevin, Misic, Sandra, Sohal, Adam, Vuong, Joseph, Ajmera, Veeral, Behling, Cynthia, Loomba, Rohit, Madamba, Egbert, Middleton, Michael S., Richards, Lisa, Singh, Seema, Sirlin, Claude, Gill, Ryan, Hameed, Bilal, Awe, Remilekun, Olvera, Daisy, Terrault, Norah, Yuan, Liyun, Yeh, Matthew, Albhaisi, Somaya, Asgharpour, Amon, Boyett, Sherry, Contos, Melissa J., Luketic, Velimir A.C., Sanyal, Arun J., Schlosser, Jolene, Siddiqui, Mohammad S., Kleiner, David E., Adamo, Peggy, Belt, Patricia, Clark, Jeanne M., DeSanto, Jennifer M., Meinert, Jill, Miriel, Laura, Mitchell, Emily P., Shade, Carrie, Smith, Jacqueline, Smith, Michael, Sternberg, Alice, Tonascia, James, Van Natta, Mark L., Wagoner, Annette, Wilson, Laura A., Woreta, Tinsay, Yates, Katherine P., Huang, Daniel Q., Amangurbanova, Maral, and Terrault, Norah A.

Published
2023
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9. A Pilot Genome‐Wide Analysis Study Identifies Loci Associated With Response to Obeticholic Acid in Patients With NASH

Author

Gawrieh, Samer, Guo, Xiuqing, Tan, Jingyi, Lauzon, Marie, Taylor, Kent D, Loomba, Rohit, Cummings, Oscar W, Pillai, Sreekumar, Bhatnagar, Pallav, Kowdley, Kris V, Yates, Katherine, Wilson, Laura A, Chen, Yii‐Der Ida, Rotter, Jerome I, Chalasani, Naga, Allende, Daniela, Dasarathy, Srinivasan, McCullough, Arthur J, Penumatsa, Revathi, Dasarathy, Jaividhya, Lavine, Joel E, Abdelmalek, Manal F, Bashir, Mustafa, Buie, Stephanie, Diehl, Anna Mae, Guy, Cynthia, Kigongo, Christopher, Kopping, Mariko, Malik, David, Piercy, Dawn, Ragozzino, Linda, Sandrasegaran, Kumar, Vuppalanchi, Raj, Brunt, Elizabeth M, Cattoor, Theresa, Carpenter, Danielle, Freebersyser, Janet, King, Debra, Lai, Jinping, Neuschwander, Brent A, Siegner, Joan, Stewart, Susan, Torretta, Susan, Wriston, Kristina, Gonzalez, Maria Cardona, Davila, Jodie, Jhaveri, Manan, Mukhtar, Nizar, Ness, Erik, Poitevin, Michelle, Quist, Brook, Soo, Sherilynn, Ang, Brandon, Behling, Cynthia, Bhatt, Archana, Middleton, Michael S, Sirlin, Claude, Akhter, Maheen F, Bass, Nathan M, Brandman, Danielle, Gill, Ryan, Hameed, Bilal, Maher, Jacqueline, Terrault, Norah, Ungermann, Ashley, Yeh, Matthew, Boyett, Sherry, Contos, Melissa J, Kirwin, Sherri, Luketic, Velimir AC, Puri, Puneet, Sanyal, Arun J, Schlosser, Jolene, Siddiqui, Mohammad S, Yost‐Schomer, Leslie, Fowler, Kathryn, Kleiner, David E, Doo, Edward C, Hall, Sherry, Hoofnagle, Jay H, Robuck, Patricia R, Sherker, Averell H, Torrance, Rebecca, Belt, Patricia, Clark, Jeanne M, Dodge, John, Donithan, Michele, Isaacson, Milana, Lazo, Mariana, Meinert, Jill, Miriel, Laura, Smith, Jacqueline, Smith, Michael, Sternberg, Alice, Tonascia, James, Natta, Mark L, Wagoner, Annette, and Yamada, Goro

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Liver Disease, Digestive Diseases, Clinical Trials and Supportive Activities, Human Genome, Hepatitis, Clinical Research, Genetics, Chronic Liver Disease and Cirrhosis, 2.1 Biological and endogenous factors, Aetiology, Oral and gastrointestinal, NASH Clinical Research Network, Clinical sciences
Abstract

A significantly higher proportion of patients with nonalcoholic steatohepatitis (NASH) who received obeticholic acid (OCA) had histological improvement relative to placebo in the FLINT (farnesoid X nuclear receptor ligand obeticholic acid for noncirrhotic, NASH treatment) trial. However, genetic predictors of response to OCA are unknown. We conducted a genome-wide association study (GWAS) in FLINT participants to identify variants associated with NASH resolution and fibrosis improvement. Genotyping was performed using the Omni2.5 content GWAS chip. To avoid false positives introduced by population stratification, we focused our GWAS on white participants. Six regions on chromosomes 1, 4, 6, 7, 15, and 17 had multiple single nucleotide polymorphisms (SNPs) with suggestive association (P

Published
2019

11. Diagnostic Accuracy of Noninvasive Fibrosis Models to Detect Change in Fibrosis Stage

Author

Siddiqui, Mohammad Shadab, Yamada, Goro, Vuppalanchi, Raj, Van Natta, Mark, Loomba, Rohit, Guy, Cynthia, Brandman, Danielle, Tonascia, James, Chalasani, Naga, Neuschwander-Tetri, Brent, Sanyal, Arun J, Allende, Daniela, Dasarathy, Srinivasan, McCullough, Arthur J, Penumatsa, Revathi, Dasarathy, Jaividhya, Lavine, Joel E, Abdelmalek, Manal F, Bashir, Mustafa, Buie, Stephanie, Diehl, Anna Mae, Kigongo, Christopher, Kopping, Mariko, Malik, David, Piercy, Dawn, Cummings, Oscar W, Gawrieh, Samer, Ragozzino, Linda, Sandrasegaran, Kumar, Brunt, Elizabeth M, Cattoor, Theresa, Carpenter, Danielle, Freebersyser, Janet, King, Debra, Lai, Jinping, Neuschwander-Tetri, Brent A, Siegner, Joan, Stewart, Susan, Torretta, Susan, Wriston, Kristina, Gonzalez, Maria Cardona, Davila, Jodie, Jhaveri, Manan, Kowdley, Kris V, Mukhtar, Nizar, Ness, Erik, Poitevin, Michelle, Quist, Brook, Soo, Sherilynn, Ang, Brandon, Behling, Cynthia, Bhatt, Archana, Middleton, Michael S, Sirlin, Claude, Akhter, Maheen F, Bass, Nathan M, Gill, Ryan, Hameed, Bilal, Maher, Jacqueline, Terrault, Norah, Ungermann, Ashley, Yeh, Matthew, Boyett, Sherry, Contos, Melissa J, Kirwin, Sherri, Luketic, Velimir AC, Puri, Puneet, Schlosser, Jolene, Siddiqui, Mohammad S, Yost-Schomer, Leslie, Fowler, Kathryn, Kleiner, David E, Doo, Edward C, Hall, Sherry, Hoofnagle, Jay H, Lee, Jessica J, Robuck, Patricia R, Sherker, Averell H, Torrance, Rebecca, Belt, Patricia, Clark, Jeanne M, Dodge, John, Donithan, Michele, Hallinan, Erin, Isaacson, Milana, Lazo, Mariana, Meinert, Jill, Miriel, Laura, Smith, Jacqueline, Smith, Michael, Sternberg, Alice, and Van Natta, Mark L

Subjects
Clinical Research, Chronic Liver Disease and Cirrhosis, Liver Disease, Digestive Diseases, Detection, screening and diagnosis, 4.2 Evaluation of markers and technologies, Good Health and Well Being, Adult, Alanine Transaminase, Aspartate Aminotransferases, Biopsy, Disease Progression, Female, Humans, Liver, Liver Cirrhosis, Male, Middle Aged, Non-alcoholic Fatty Liver Disease, Platelet Count, Predictive Value of Tests, Retrospective Studies, Sensitivity and Specificity, Severity of Illness Index, Nonalcoholic Steatohepatitis, Diagnostic, Prognostic, Scoring System Comparison, NASH Clinical Research Network, Clinical Sciences, Gastroenterology & Hepatology
Abstract

Background & aimsNoninvasive methods are needed to determine disease stage in patients with nonalcoholic fatty liver disease (NAFLD). We evaluated the diagnostic performance of several widely available fibrosis models for the assessment of hepatic fibrosis in patients with NAFLD.MethodsWe performed a retrospective analysis of data from individuals enrolled in the NIDDK NASH Clinical Research Network, from 2004 through 2018. Using biopsy as the reference standard, we determined the diagnostic performance of the aspartate aminotransferase (AST):platelet ratio (APRI), FIB-4, ratio of AST:alanine aminotransferase (ALT) and the NAFLD fibrosis score (NFS) in a cross-sectional study of 1904 subjects. The ability of these models to detect changes in fibrosis stage was assessed in a longitudinal data set of 292 subjects with 2 biopsies and accompanying laboratory data. Outcomes were detection of fibrosis of any stage (stages 0-4), detection of moderate fibrosis (stages 0-1 vs 2-4), and detection of advanced fibrosis (stages 0-2 vs 3-4). Diagnostic performance was evaluated using the C-statistic, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) analyses.ResultsIn the cross-sectional study, FIB-4 and NFS outperformed other non-invasive models for detecting advanced fibrosis; the C-statistics were 0.80 for FIB-4 and 0.78 for NFS. In the longitudinal study, 216 patients had non-advanced fibrosis at baseline and 35 patients progressed to advanced fibrosis after median follow up of 2.6 years. After we adjusted for fibrosis stage and model score at initial biopsy, change in APRI, FIB-4, and NFS were significantly associated with change in fibrosis. A unit change in APRI, FIB-4, or NFS was associated with changes in fibrosis stage of 0.33 (95% CI, 0.20-0.45; P < .001), 0.26 (95% CI, 0.15-0.37; P < .001), and 0.19 (95% CI, 0.07-0.31; P = .002), respectively. The cross-validated C-statistic for detecting progression to advanced fibrosis for APRI was 0.82 (95% CI, 0.74-0.89), for FIB-4 was 0.81 (95% CI, 0.73-0.81), and for NFS was 0.80 (95% CI, 0.71-0.88).ConclusionsIn a combined analysis of data from 2 large studies, we found that FIB-4, APRI, and NFS can detect advanced fibrosis and fibrosis progression in patients with NAFLD.

Published
2019

12. A Randomized, Controlled, Phase 2 Study of Maralixibat in the Treatment of Itching Associated With Primary Biliary Cholangitis

Author

Mayo, Marlyn J, Pockros, Paul J, Jones, David, Bowlus, Christopher L, Levy, Cynthia, Patanwala, Imran, Bacon, Bruce, Luketic, Velimir, Vuppalanchi, Raj, Medendorp, Sharon, Dorenbaum, Alejandro, Kennedy, Ciara, Novak, Patricia, Gu, Joan, Apostol, George, and Hirschfield, Gideon M

Subjects
Clinical Trials and Supportive Activities, Clinical Research, Digestive Diseases, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals
Abstract

Primary biliary cholangitis (PBC) is typically associated with elevated serum bile acid levels and pruritus, but pruritus is often refractory to treatment with existing therapies. This phase 2 study assessed the efficacy and safety of maralixibat, a selective, ileal, apical, sodium-dependent, bile acid transporter inhibitor, in adults with PBC and pruritus. Adults with PBC and pruritus who had received ursodeoxycholic acid (UDCA) for ≥6 months or were intolerant to UDCA were randomized 2:1 to maralixibat (10 or 20 mg/day) or placebo for 13 weeks in combination with UDCA (when tolerated). The primary outcome was change in Adult Itch Reported Outcome (ItchRO™) average weekly sum score (0, no itching; 70, maximum itching) from baseline to week 13/early termination (ET). The study enrolled 66 patients (maralixibat [both doses combined], n = 42; placebo, n = 24). Mean ItchRO™ weekly sum scores decreased from baseline to week 13/ET with maralixibat (-26.5; 95% confidence interval [CI], -31.8, -21.2) and placebo (-23.4; 95% CI, -30.3, -16.4). The difference between groups was not significant (P = 0.48). In the maralixibat and placebo groups, adverse events (AEs) were reported in 97.6% and 70.8% of patients, respectively. Gastrointestinal disorders were the most frequently reported AEs (maralixibat, 78.6%; placebo, 50.0%). Conclusion: Reductions in pruritus did not differ significantly between maralixibat and placebo. However, a large placebo effect may have confounded assessment of pruritus. Lessons learned from this rigorously designed and executed trial are indispensable for understanding how to approach trials assessing pruritus as the primary endpoint and the therapeutic window of bile acid uptake inhibition as a therapeutic strategy in PBC.

Published
2019

15. Genome-wide association study of primary sclerosing cholangitis identifies new risk loci and quantifies the genetic relationship with inflammatory bowel disease

Author

Ji, Sun-Gou, Juran, Brian D, Mucha, Sören, Folseraas, Trine, Jostins, Luke, Melum, Espen, Kumasaka, Natsuhiko, Atkinson, Elizabeth J, Schlicht, Erik M, Liu, Jimmy Z, Shah, Tejas, Gutierrez-Achury, Javier, Boberg, Kirsten M, Bergquist, Annika, Vermeire, Severine, Eksteen, Bertus, Durie, Peter R, Farkkila, Martti, Müller, Tobias, Schramm, Christoph, Sterneck, Martina, Weismüller, Tobias J, Gotthardt, Daniel N, Ellinghaus, David, Braun, Felix, Teufel, Andreas, Laudes, Mattias, Lieb, Wolfgang, Jacobs, Gunnar, Beuers, Ulrich, Weersma, Rinse K, Wijmenga, Cisca, Marschall, Hanns-Ulrich, Milkiewicz, Piotr, Pares, Albert, Kontula, Kimmo, Chazouillères, Olivier, Invernizzi, Pietro, Goode, Elizabeth, Spiess, Kelly, Moore, Carmel, Sambrook, Jennifer, Ouwehand, Willem H, Roberts, David J, Danesh, John, Floreani, Annarosa, Gulamhusein, Aliya F, Eaton, John E, Schreiber, Stefan, Coltescu, Catalina, Bowlus, Christopher L, Luketic, Velimir A, Odin, Joseph A, Chopra, Kapil B, Kowdley, Kris V, Chalasani, Naga, Manns, Michael P, Srivastava, Brijesh, Mells, George, Sandford, Richard N, Alexander, Graeme, Gaffney, Daniel J, Chapman, Roger W, Hirschfield, Gideon M, de Andrade, Mariza, Rushbrook, Simon M, Franke, Andre, Karlsen, Tom H, Lazaridis, Konstantinos N, and Anderson, Carl A

Subjects
Human Genome, Digestive Diseases, Autoimmune Disease, Digestive Diseases - (Gallbladder), Genetics, Rare Diseases, Inflammatory Bowel Disease, 2.1 Biological and endogenous factors, Aetiology, Oral and gastrointestinal, Adaptor Proteins, Signal Transducing, Alleles, Cholangitis, Sclerosing, Colitis, Ulcerative, Genome-Wide Association Study, Humans, Inflammatory Bowel Diseases, Polymorphism, Single Nucleotide, RNA, Messenger, Risk Factors, UK-PSC Consortium, International IBD Genetics Consortium, International PSC Study Group, Biological Sciences, Medical and Health Sciences, Developmental Biology
Abstract

Primary sclerosing cholangitis (PSC) is a rare progressive disorder leading to bile duct destruction; ∼75% of patients have comorbid inflammatory bowel disease (IBD). We undertook the largest genome-wide association study of PSC (4,796 cases and 19,955 population controls) and identified four new genome-wide significant loci. The most associated SNP at one locus affects splicing and expression of UBASH3A, with the protective allele (C) predicted to cause nonstop-mediated mRNA decay and lower expression of UBASH3A. Further analyses based on common variants suggested that the genome-wide genetic correlation (rG) between PSC and ulcerative colitis (UC) (rG = 0.29) was significantly greater than that between PSC and Crohn's disease (CD) (rG = 0.04) (P = 2.55 × 10-15). UC and CD were genetically more similar to each other (rG = 0.56) than either was to PSC (P < 1.0 × 10-15). Our study represents a substantial advance in understanding of the genetics of PSC.

Published
2017

16. Patient Sex, Reproductive Status, and Synthetic Hormone Use Associate With Histologic Severity of Nonalcoholic Steatohepatitis

Author

Yang, Ju Dong, Abdelmalek, Manal F, Guy, Cynthia D, Gill, Ryan M, Lavine, Joel E, Yates, Katherine, Klair, Jagpal, Terrault, Norah A, Clark, Jeanne M, Unalp-Arida, Aynur, Diehl, Anna Mae, Suzuki, Ayako, Dasarathy, Srinivasan, Dasarathy, Jaividhya, Hawkins, Carol, McCullough, Arthur J, Pagadala, Mangesh, Pai, Rish, Sargent, Ruth, Bashir, Mustafa, Buie, Stephanie, Guy, Cynthia, Kigongo, Christopher, Pan, Yi-Ping, Piercy, Dawn, Chalasani, Naga, Cummings, Oscar W, Gawrieh, Samer, Ghabril, Marwan, Marri, Smitha, Ragozzino, Linda, Sandrasegaran, Kumar, Vuppalanchi, Raj, King, Debra, Osmack, Pat, Siegner, Joan, Stewart, Susan, Neuschwander-Tetri, Brent A, Torretta, Susan, Ang, Brandon, Behling, Cynthia, Bhatt, Archana, Loomba, Rohit, Middleton, Michael, Patton, Heather, Sirlin, Claude, Aouizerat, Bradley, Bass, Nathan M, Brandman, Danielle, Ferrell, Linda D, Gill, Ryan, Hameed, Bilal, Ramos, Claudia, Terrault, Norah, Ungermann, Ashley, Atla, Pradeep, Croft, Brandon, Garcia, Rebekah, Garcia, Sonia, Sheikh, Muhammad, Singh, Mandeep, Boyett, Sherry, Carucci, Laura, Contos, Melissa J, Kraft, Kenneth, Luketic, Velimir AC, Puri, Puneet, Sanyal, Arun J, Schlosser, Jolene, Siddiqui, Mohhamad S, Wolford, Ben, Ackermann, Sarah, Cooney, Shannon, Coy, David, Gelinas, Katie, Kowdley, Kris V, Lee, Maximillian, Pierce, Tracey, Mooney, Jody, Nelson, James E, Shaw, Cheryl, Siddique, Asma, Wang, Chia, Brunt, Elizabeth M, Fowler, Kathryn, Kleiner, David E, Grave, Gilman D, Doo, Edward C, Hoofnagle, Jay H, Robuck, Patricia R, Sherker, Averell, Belt, Patricia, Donithan, Michele, Hallinan, Erin, and Isaacson, Milana

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Clinical Sciences, Digestive Diseases, Liver Disease, Contraception/Reproduction, Prevention, Hepatitis, Estrogen, Chronic Liver Disease and Cirrhosis, Aging, Good Health and Well Being, Adolescent, Adult, Aged, Cross-Sectional Studies, Female, Histocytochemistry, Hormones, Humans, Male, Menopause, Middle Aged, Non-alcoholic Fatty Liver Disease, Reproduction, Risk Factors, Sex Factors, United States, Young Adult, Gender Differences, Fibrosis, Risk Factor Analysis., Nonalcoholic Steatohepatitis Clinical Research Network, Risk Factor Analysis, Gastroenterology & Hepatology, Clinical sciences
Abstract

Background & aimsSex and sex hormones can affect responses of patients with nonalcoholic fatty liver disease (NAFLD) to metabolic stress and development of hepatocyte injury and inflammation.MethodsWe collected data from 3 large U.S. studies of patients with NAFLD (between October 2004 and June 2013) to assess the association between histologic severity and sex, menopause status, synthetic hormone use, and menstrual abnormalities in 1112 patients with a histologic diagnosis of NAFLD. We performed logistic or ordinal logistic regression models, adjusting for covariates relevant to an increase of hepatic metabolic stress.ResultsPremenopausal women were at an increased risk of lobular inflammation, hepatocyte ballooning, and Mallory-Denk bodies than men and also at an increased risk of lobular inflammation and Mallory-Denk bodies than postmenopausal women (P < .01). Use of oral contraceptives was associated with an increased risk of lobular inflammation and Mallory-Denk bodies in premenopausal women, whereas hormone replacement therapy was associated with an increased risk of lobular inflammation in postmenopausal women (P < .05).ConclusionsBeing a premenopausal woman or a female user of synthetic hormones is associated with increased histologic severity of hepatocyte injury and inflammation among patients with NAFLD at given levels of hepatic metabolic stress.

Published
2017

18. HBV Genotype-Specific Levels of Hepatitis B Surface Antigen Improve HBV Phenotype Definition

Author

Niu, Jianghe, Javaid, Asad, Nasir, Bilal, Susheela, Ammu, Nasser, Imad, Rusibamayila, Nifasha, Foley, Cara, Stahler, Alisha C., Stadheim, Linda, Lake, John, Lacher, Philip, Rushing, Kathryn, Nagy, Rosemary A., Cerkoski, Jacki, DeMarco Shaw, Debra, Kessels, Lisa, Klebert, Michael K., Noureldin, Seham, La, Danie, Liu, Lucie, Kaznowski, Diana, Chen, Jiayun, Vladutu, Doinita, Cerocchi, Orlando, Rowan, Debra, Bass, Sheila, Lilly, Barbara, French, Samuel, Peacock, Velma, Shobe, Ashley, Davis, Rayshawnda, Kuras, Romuald, Ayala, Claudia, Lau, Ivy, Podolskaya, Veronika, von Bakonyi, Anna, DeVole, Nata, McKenna, Barbara, Choi, Karen, Oberhelman, Kelly, Kaza, Sravanthi, Bowen, Abigail, Kalathil, Sumodh, Huddleston, Leslie, Wong, Richmond, Barritt, A. Sidney, Marsh, Tiffany, Metheny, Vikki, Cardona, Danielle, Luketic, Velimir A., Smith, Paula G., Hofmann, Charlotte, Wolfstone, Alycia, Mooney, Jody, Cardona-Gonzalez, Lupita, Fryzek, Nancy, Rivera, Elenita, Morris, Nevitt, Haynes-Williams, Vanessa, Huang, Amy, Sherker, Averell H., Torrance, Rebecca J., Hall, Sherry R., Valiga, Mary E., Torrey, Keith, Levine, Danielle, Keith, James, Betts, Michael, Montaner, Luis J., Averbach, Frani, Haller, Tamara, Hardison, Regina, Kelley, Stephanie, Lawlor, Sharon, Lin, Hsing-Hua (Sylvia), Liu, Stephen, Lombardero, Manuel, Pelesko, Andrew, Stoliker, Donna, Weiner, Melissa, Zadorozny, Ella, Brouwer, Willem P., Zhao, Qian, Hansen, Bettina E., Lau, Daryl, Khalili, Mandana, Terrault, Norah A., Di Bisceglie, Adrian M., Perrillo, Robert P., Fried, Michael W., Wong, David, Feld, Jordan J., Belle, Steven H., and Janssen, Harry L.A.

Published
2020
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19. Characteristics of Adults in the Hepatitis B Research Network in North America Reflect Their Country of Origin and Hepatitis B Virus Genotype

Author

Ghany, Marc G, Perrillo, Robert, Li, Ruosha, Belle, Steven H, Janssen, Harry LA, Terrault, Norah A, Shuhart, Margaret C, Lau, Daryl T-Y, Kim, W Ray, Fried, Michael W, Sterling, Richard K, Di Bisceglie, Adrian M, Han, Steven-Huy B, Ganova-Raeva, Lilia Milkova, Chang, Kyong-Mi, Lok, Anna Suk-Fong, Network, Hepatitis B Research, Chung, Raymond T, Roberts, Lewis R, Smith, Coleman I, Lisker-Melman, Mauricio, Wong, David K, Juan, Joshua, Feld, Jordan, Yim, Colina, Heathcoate, Jenny, Lee, William M, Do, Son, Tran, Tram T, Khalili, Mandana, Cooper, Stewart L, Fontana, Robert J, Tsai, Naoky, Patel, Keyur, Evon, Donna, Carithers, Robert C, Kowdley, Kris V, Wang, Chia C, Liang, T Jake, Park, Jang-June, Wahed, Abdus, Kleiner, David, Afdhal, Nezam, Javaid, Asad, Niu, Jianghe, Han, Johanna, Nasser, Imad, Stahler, Alisha C, Stadheim, Linda, Hassan, Mohamed, King, Debra L, Nagy, Rosemary A, La, Danie, Liu, Lucie, Minshall, Stacey, Bass, Sheila, French, Samuel, Peacock, Velma, Ungermann, Ashley, Ayala, Claudia, Olson, Emma, Lau, Ivy, Podolskaya, Veronika, DeVole, Nata, McKenna, Barbara, Oberhelman, Kelly, Kaza, Sravanthi, Rodd, Cassandra, Huddleston, Leslie, Poerzgen, Peter, Darling, Jama M, Barritt, A Sidney, Marsh, Tiffany, Metheny, Vikki, Cardona, Danielle, Luketic, Velimir A, Smith, Paula G, Hofmann, Charlotte, Mathisen, Terri, Strom, Susan, Mooney, Jody, Cardona-Gonzalez, Lupita, Fryzek, Nancy, Rivera, Elenita, Morris, Nevitt, Haynes-Williams, Vanessa, Valiga, Mary E, Torrey, Keith, Levine, Danielle, Keith, James, Betts, Michael, Montaner, Luis J, Teo, Chong-Gee, Khudyakov, Yury, Punkova, Lili T, Cloonan, Yona, Danielson, Michelle, Haller, Tamara, Johnson, Geoffrey, and Kelley, Stephanie

Subjects
Liver Disease, Infectious Diseases, Hepatitis, Digestive Diseases, Chronic Liver Disease and Cirrhosis, Hepatitis - B, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, Adolescent, Adult, Aged, Aged, 80 and over, Canada, Emigrants and Immigrants, Female, Genotype, Hepatitis B virus, Hepatitis B, Chronic, Humans, Male, Middle Aged, United States, Young Adult, HBeAg, Chronic Hepatitis B Virus Infection, USA, ALT, Hepatitis B Research Network, Clinical Sciences, Gastroenterology & Hepatology
Abstract

Background & aimsChronic hepatitis B virus (HBV) infection is an important cause of cirrhosis and hepatocellular carcinoma worldwide; populations that migrate to the United States and Canada might be affected disproportionately. The Hepatitis B Research Network (HBRN) is a cooperative network of investigators from the United States and Canada, created to facilitate clinical, therapeutic, and translational research in adults and children with hepatitis B. We describe the structure of the network and baseline characteristics of adults with hepatitis B enrolled in the network.MethodsThe HBRN collected data on the clinical characteristics of 1625 adults with chronic HBV infection who are not receiving antiviral therapy from 21 clinical centers in North America.ResultsHalf of the subjects in the HBRN are men, and the median age is 42 years; 72% are Asian, 15% are black, and 11% are white; with 82% born outside of North America. The most common HBV genotype was B (39%); 74% of subjects were negative for the hepatitis B e antigen. The median serum level of HBV DNA when the study began was 3.6 log10 IU/mL; 68% of male subjects and 67% of female subjects had alanine aminotransferase levels higher than the normal range.ConclusionsThe HBRN cohort is used to address important clinical and therapeutic questions for North Americans infected with chronic HBV and to guide health policies on HBV prevention and management in North America.

Published
2015

20. Diagnostic Accuracy of Noninvasive Fibrosis Models to Detect Change in Fibrosis Stage

Author

Allende, Daniela, Dasarathy, Srinivasan, McCullough, Arthur J., Penumatsa, Revathi, Dasarathy, Jaividhya, Lavine, Joel E., Abdelmalek, Manal F., Bashir, Mustafa, Buie, Stephanie, Diehl, Anna Mae, Guy, Cynthia, Kigongo, Christopher, Kopping, Mariko, Malik, David, Piercy, Dawn, Chalasani, Naga, Cummings, Oscar W., Gawrieh, Samer, Ragozzino, Linda, Sandrasegaran, Kumar, Vuppalanchi, Raj, Brunt, Elizabeth M., Cattoor, Theresa, Carpenter, Danielle, Freebersyser, Janet, King, Debra, Lai, Jinping, Neuschwander-Tetri, Brent A., Siegner, Joan, Stewart, Susan, Torretta, Susan, Wriston, Kristina, Gonzalez, Maria Cardona, Davila, Jodie, Jhaveri, Manan, Kowdley, Kris V., Mukhtar, Nizar, Ness, Erik, Poitevin, Michelle, Quist, Brook, Soo, Sherilynn, Ang, Brandon, Behling, Cynthia, Bhatt, Archana, Loomba, Rohit, Middleton, Michael S., Sirlin, Claude, Akhter, Maheen F., Bass, Nathan M., Brandman, Danielle, Gill, Ryan, Hameed, Bilal, Maher, Jacqueline, Terrault, Norah, Ungermann, Ashley, Yeh, Matthew, Boyett, Sherry, Contos, Melissa J., Kirwin, Sherri, Luketic, Velimir A.C., Puri, Puneet, Sanyal, Arun J., Schlosser, Jolene, Siddiqui, Mohammad S., Yost-Schomer, Leslie, Fowler, Kathryn, Kleiner, David E., Doo, Edward C., Hall, Sherry, Hoofnagle, Jay H., Lee, Jessica J., Robuck, Patricia R., Sherker, Averell H., Torrance, Rebecca, Belt, Patricia, Clark, Jeanne M., Dodge, John, Donithan, Michele, Hallinan, Erin, Isaacson, Milana, Lazo, Mariana, Meinert, Jill, Miriel, Laura, Smith, Jacqueline, Smith, Michael, Sternberg, Alice, Tonascia, James, Van Natta, Mark L., Wagoner, Annette, Wilson, Laura A., Yamada, Goro, Yates, Katherine, Siddiqui, Mohammad Shadab, Van Natta, Mark, and Neuschwander-Tetri, Brent

Published
2019
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21. Validation of a Clinical Risk-based Classification System in a Large Nonalcoholic Fatty Liver Disease Real-world Cohort

Author

Sanyal, Arun J., primary, Munoz, Breda, additional, Cusi, Kenneth, additional, Barritt, A. Sidney, additional, Muthiah, Mark, additional, Mospan, Andrea R., additional, Reddy, K. Rajender, additional, Firpi-Morell, Roberto, additional, Thuluvath, Paul J., additional, Bhamidimarri, Kalyan Ram, additional, Fried, Michael W., additional, Abdelmalek, Manal, additional, Aguilar, Humberto, additional, Ahmed, Aijaz, additional, Allen, Alina, additional, Barlow, Sarah, additional, Barritt, Sid, additional, Bernstein, David, additional, Bhamidimarri, Kaylan, additional, Billings, Liana, additional, Brown, Kyle, additional, Brown, Robert, additional, Corbin, Karen, additional, deLemos, Andrew, additional, Emerick, Karan, additional, Ghali, Maged Adel, additional, Henry, Zachary, additional, Jackson, Whitney, additional, Janardhan, Sujit, additional, Kabbany, Mohammad, additional, Kemmer, Nyingi, additional, Koch, David, additional, Kupec, Justin, additional, Landis, Charles, additional, Lawrence, Mary Katherine, additional, Levy, Cynthia, additional, Lidofsky, Steven, additional, Lok, Anna, additional, Luketic, Velimir, additional, Martinez, Enrique, additional, McClain, Craig, additional, McKiernan, Patrick, additional, Mitchell, Ellen, additional, Noureddin, Mazen, additional, Palle, Sirish, additional, Pham, Yen, additional, Pound, David, additional, Reddy, Rajender, additional, Regenstein, Fredric, additional, Rinella, Mary, additional, Rochling, Fedja, additional, Rudolph, Bryan, additional, Rustgi, Vinod, additional, Said, Adnan, additional, Samala, Niharika, additional, Sarkar, Souvik, additional, Sherman, Kenneth, additional, Shiffman, Mitchell, additional, Smith, Coleman, additional, Taunk, Jawahar, additional, Tetri, Brent, additional, Thuluvath, Paul, additional, Trinh, Huy, additional, Verna, Elizabeth, additional, Vos, Miriam, additional, Weiss, L. Michael, additional, Wong, Mark, additional, Wyne, Kathleen, additional, and Xanthakos, Stavra, additional

Published
2023
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23. Low and High Birth Weights Are Risk Factors for Nonalcoholic Fatty Liver Disease in Children

Author

Abrams, Stephanie H., Barlow, Sarah, Himes, Ryan, Krisnamurthy, Rajesh, Maldonado, Leanel, Mahabir, Rory, Carr, April, Bernstein, Kimberlee, Bramlage, Kristin, Cecil, Kim, DeVore, Stephanie, Kohli, Rohit, Lake, Kathleen, Podberesky, Daniel, Towbin, Alex, Xanthakos, Stavra, Allende, Daniela, Dasarathy, Srinivasan, McCullough, Arthur J., Pagadala, Mangesh, Pai, Rish, Winston, Cha'Ron, Behr, Gerald, Lavine, Joel E., Lefkowitch, Jay H., Mencin, Ali, Reynoso, Elena, Abdelmalek, Manal F., Bashir, Mustafa, Buie, Stephanie, Diehl, Anna Mae, Guy, Cynthia, Kigongo, Christopher, Malik, David, Pan, Yi-Ping, Piercy, Dawn, Kopping, Mariko, Thrasher, Tyler, Alazraki, Adina, Cleeton, Rebecca, Cordero, Maria, Hernandez, Albert, Karpen, Saul, Munos, Jessica Cruz, Raviele, Nicholas, Vos, Miriam, Bozic, Molly, Chalasani, Naga, Cummings, Oscar W., Gawrieh, Samer, Klipsch, Ann, Molleston, Jean P., Ragozzino, Emily, Ragozzino, Linda, Sandrasegaran, Kumar, Subbarao, Girish, Vuppalanchi, Raj, Walker, Laura, Kafka, Kimberly, Scheimann, Ann, Ito, Joy, Fishbein, Mark H., Mohammad, Saeed, Rigsby, Cynthia, Sharda, Lisa, Whitington, Peter F., Cattoor, Theresa, Derdoy, Jose, Freebersyser, Janet, Jain, Ajay, King, Debra, Lai, Jinping, Osmack, Pat, Siegner, Joan, Stewart, Susan, Neuschwander-Tetri, Brent A., Torretta, Susan, Wriston, Kristina, Assadian, Fereshteh, Barone, Vanessa, Gonzalez, Maria Cardona, Davila, Jodie, Fix, Oren, Hennessey, Kelly Anne, Kowdley, Kris V., Lopez, Kacie, Ness, Erik, Poitevin, Michelle, Procaccini, Nicholas, Quist, Brook, Saddic, Alana, Wiseman, Cara, Yeh, Matthew, Baker, Susan S., Lopez-Graham, Diana, Williams, Sonja, Zhu, Lixin, Africa, Jonathan, Ang, Brandon, Awai, Hannah, Behling, Cynthia, Bhatt, Archana, Bross, Craig, Collins, Jennifer, Durelle, Janis, Harlow, Kathryn, Loomba, Rohit, Middleton, Michael, Newton, Kimberly, Paiz, Melissa, Schwimmer, Jeffrey B., Sirlin, Claude, Ugalde-Nicalo, Patricia, Villarreal, Mariana Dominguez, Aouizerat, Bradley, Bass, Nathan M., Brandman, Danielle, Courtier, Jesse, Ferrell, Linda D., Feier, Natasha, Gill, Ryan, Hameed, Bilal, Langlois, Camille, Maher, Jacqueline, Perito, Emily Rothbaum, Ramos, Claudia, Rosenthal, Philip, Terrault, Norah, Tsai, Patrika, Ungermann, Ashley, Atla, Pradeep, Croft, Brandon, Garcia, Rebekah, Garcia, Sonia, Sheikh, Muhammad, Singh, Mandeep, Cooper, Kara, Horslen, Simon, Hsu, Evelyn, Murray, Karen, Otto, Randolph, Young, Melissa, Boyett, Sherry, Carucci, Laura, Contos, Melissa J., Kirwin, Sherri, Kraft, Kenneth, Luketic, Velimir A.C., Puri, Puneet, Sanyal, Arun J., Schlosser, Jolene, Siddiqui, Mohammad S., Brunt, Elizabeth M., Fowler, Kathryn, Kleiner, David E., Brown, Sherry, Doo, Edward C., Hoofnagle, Jay H., Robuck, Patricia R., Sherker, Averell, Torrance, Rebecca, Belt, Patricia, Clark, Jeanne M., Donithan, Michele, Hallinan, Erin, Isaacson, Milana, May, Kevin P., Miriel, Laura, Sternberg, Alice, Tonascia, James, Van Natta, Mark, Wilson, Laura, Yates, Katherine, Newton, Kimberly P., Feldman, Haruna S., and Chambers, Christina D.

Published
2017
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24. Patient Sex, Reproductive Status, and Synthetic Hormone Use Associate With Histologic Severity of Nonalcoholic Steatohepatitis

Author

Dasarathy, Srinivasan, Dasarathy, Jaividhya, Hawkins, Carol, McCullough, Arthur J., Pagadala, Mangesh, Pai, Rish, Sargent, Ruth, Abdelmalek, Manal F., Bashir, Mustafa, Buie, Stephanie, Diehl, Anna Mae, Guy, Cynthia, Kigongo, Christopher, Pan, Yi-Ping, Piercy, Dawn, Chalasani, Naga, Cummings, Oscar W., Gawrieh, Samer, Ghabril, Marwan, Marri, Smitha, Ragozzino, Linda, Sandrasegaran, Kumar, Vuppalanchi, Raj, King, Debra, Osmack, Pat, Siegner, Joan, Stewart, Susan, Neuschwander-Tetri, Brent A., Torretta, Susan, Ang, Brandon, Behling, Cynthia, Bhatt, Archana, Loomba, Rohit, Middleton, Michael, Patton, Heather, Sirlin, Claude, Aouizerat, Bradley, Bass, Nathan M., Brandman, Danielle, Ferrell, Linda D., Gill, Ryan, Hameed, Bilal, Ramos, Claudia, Terrault, Norah, Ungermann, Ashley, Atla, Pradeep, Croft, Brandon, Garcia, Rebekah, Garcia, Sonia, Sheikh, Muhammad, Singh, Mandeep, Boyett, Sherry, Carucci, Laura, Contos, Melissa J., Kraft, Kenneth, Luketic, Velimir A.C., Puri, Puneet, Sanyal, Arun J., Schlosser, Jolene, Siddiqui, Mohhamad S., Wolford, Ben, Ackermann, Sarah, Cooney, Shannon, Coy, David, Gelinas, Katie, Kowdley, Kris V., Lee, Maximillian, Pierce, Tracey, Mooney, Jody, Nelson, James E., Shaw, Cheryl, Siddique, Asma, Wang, Chia, Brunt, Elizabeth M., Fowler, Kathryn, Kleiner, David E., Grave, Gilman D., Doo, Edward C., Hoofnagle, Jay H., Robuck, Patricia R., Sherker, Averell, Belt, Patricia, Clark, Jeanne M., Donithan, Michele, Hallinan, Erin, Isaacson, Milana, May, Kevin P., Miriel, Laura, Sternberg, Alice, Tonascia, James, Ünalp-Arida, Aynur, Van Natta, Mark, Vaughn, Ivana, Wilson, Laura, Yates, Katherine, Yang, Ju Dong, Guy, Cynthia D., Gill, Ryan M., Lavine, Joel E., Klair, Jagpal, Terrault, Norah A., Unalp-Arida, Aynur, and Suzuki, Ayako

Published
2017
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27. Identification of HLA-A2–restricted CD8+ Cytotoxic T Cell Responses in Primary Biliary Cirrhosis

Author

Kita, Hiroto, Lian, Zhe-Xiong, Van de Water, Judy, He, Xiao-Song, Matsumura, Shuji, Kaplan, Marshall, Luketic, Velimir, Coppel, Ross L, Ansari, Aftab A, and Gershwin, M Eric

Subjects
Biomedical and Clinical Sciences, Immunology, Clinical Research, Immunization, Autoimmune Disease, Chronic Liver Disease and Cirrhosis, Digestive Diseases, Liver Disease, Aetiology, 2.1 Biological and endogenous factors, Inflammatory and immune system, Antigen Presentation, Antigen-Antibody Complex, Autoimmunity, Cytokines, Dendritic Cells, Dihydrolipoyllysine-Residue Acetyltransferase, Epitopes, HLA-A2 Antigen, Humans, Lymphocyte Activation, Oligopeptides, Pyruvate Dehydrogenase Complex, T-Lymphocytes, Cytotoxic, autoimmunity, cytotoxic T cells, cholangitis, epitopes, cross-priming, Medical and Health Sciences, Biomedical and clinical sciences, Health sciences
Abstract

Primary biliary cirrhosis (PBC) is characterized by an intense biliary inflammatory CD4(+) and CD8(+) T cell response. Very limited information on autoantigen-specific cytotoxic T lymphocyte (CTL) responses is available compared with autoreactive CD4(+) T cell responses. Using peripheral blood mononuclear cells (PBMCs) from PBC, we identified an HLA-A2-restricted CTL epitope of the E2 component of pyruvate dehydrogenase (PDC-E2), the immunodominant mitochondrial autoantigen. This peptide, amino acids 159-167 of PDC-E2, induces specific MHC class I-restricted CD8(+) CTL lines from 10/12 HLA-A2(+) PBC patients, but not controls, after in vitro stimulation with antigen-pulsed dendritic cells (DCs). PDC-E2-specific CTLs could also be generated by pulsing DCs with full-length recombinant PDC-E2 protein. Furthermore, using soluble PDC-E2 complexed with either PDC-E2-specific human monoclonal antibody or affinity-purified autoantibodies against PDC-E2, the generation of PDC-E2-specific CTLs, occurred at 100-fold and 10-fold less concentration, respectively, compared with soluble antigen alone. Collectively, these data demonstrate that autoantibody, helper, and CTL epitopes all contain a shared peptide sequence. The finding that autoantigen-immune complexes can not only cross-present but also that presentation of the autoantigen is of a higher relative efficiency, for the first time defines a unique role for autoantibodies in the pathogenesis of an autoimmune disease.

Published
2002

28. Daclatasvir and Peginterferon/Ribavirin for Black/African-American and Latino Patients with HCV infection

Author

Rodriguez-Torres, Maribel, Läwitz, Eric, Yangco, Bienvenido, Jeffers, Lennox, Han, Steven-Huy, Thuluvath, Paul J., Rustgi, Vinod, Harrison, Stephen, Ghalib, Reem, Vierling, John M., Luketic, Velimir, Zamor, Philippe J., Ravendhran, Natarajan, Morgan, Timothy R., Pearlman, Brian, O’Brien, Christopher, Khallafi, Hicham, Pyrsopoulos, Nikolaos, Kong, George, McPhee, Fiona, Yin, Philip D., Hughes, Eric, and Treitel, Michelle

Published
2016
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31. Daclatasvir and asunaprevir plus peginterferon alfa and ribavirin in HCV genotype 1 or 4 non-responders

Author

Jensen, Donald, Sherman, Kenneth E., Hézode, Christophe, Pol, Stanislas, Zeuzem, Stefan, de Ledinghen, Victor, Tran, Albert, Elkhashab, Magdy, Younes, Ziad H., Kugelmas, Marcelo, Mauss, Stefan, Everson, Gregory, Luketic, Velimir, Vierling, John, Serfaty, Lawrence, Brunetto, Maurizia, Heo, Jeong, Bernstein, David, McPhee, Fiona, Hennicken, Delphine, Mendez, Patricia, Hughes, Eric, and Noviello, Stephanie

Published
2015
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32. Cognitive Reserve Is a Determinant of Health-related Quality of Life in Patients With Cirrhosis, Independent of Covert Hepatic Encephalopathy and Model for End-Stage Liver Disease Score

Author

Patel, Ankit V., Wade, James B., Thacker, Leroy R., Sterling, Richard K., Siddiqui, Muhammad S., Stravitz, R. Todd, Sanyal, Arun J., Luketic, Velimir, Puri, Puneet, Fuchs, Michael, Matherly, Scott, White, Melanie B., Unser, Ariel, Heuman, Douglas M., and Bajaj, Jasmohan S.

Published
2015
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34. Effects of Obstructive Sleep Apnea on Sleep Quality, Cognition, and Driving Performance in Patients With Cirrhosis

Author

Bajaj, Jasmohan S., Thacker, Leroy R., Leszczyszyn, David, Taylor, Samuel A., Heuman, Douglas M., Raman, Shekar, Sterling, Richard K., Siddiqui, Muhammad S., Stravitz, R. Todd, Sanyal, Arun J., Puri, Puneet, Luketic, Velimir, Matherly, Scott, Fuchs, Michael, White, Melanie B., Noble, Nicole A., Unser, Ariel B., and Wade, James B.

Published
2015
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35. Characteristics of Adults in the Hepatitis B Research Network in North America Reflect Their Country of Origin and Hepatitis B Virus Genotype

Author

Chung, Raymond T., Roberts, Lewis R., Smith, Coleman I., Lisker-Melman, Mauricio, Wong, David K., Juan, Joshua, Feld, Jordan, Yim, Colina, Heathcoate, Jenny, Lee, William M., Do, Son, Tran, Tram T., Khalili, Mandana, Cooper, Stewart L., Fontana, Robert J., Tsai, Naoky, Patel, Keyur, Evon, Donna, Carithers, Robert C., Kowdley, Kris V., Wang, Chia C., Liang, T. Jake, Park, Jang-June, Wahed, Abdus, Kleiner, David, Afdhal, Nezam, Javaid, Asad, Niu, Jianghe, Han, Johanna, Nasser, Imad, Stahler, Alisha C., Stadheim, Linda, Hassan, Mohamed, King, Debra L., Nagy, Rosemary A., La, Danie, Liu, Lucie, Minshall, Stacey, Bass, Sheila, French, Samuel, Peacock, Velma, Ungermann, Ashley, Ayala, Claudia, Olson, Emma, Lau, Ivy, Podolskaya, Veronika, DeVole, Nata, McKenna, Barbara, Oberhelman, Kelly, Kaza, Sravanthi, Rodd, Cassandra, Huddleston, Leslie, Poerzgen, Peter, Darling, Jama M., Barritt, A. Sidney, Marsh, Tiffany, Metheny, Vikki, Cardona, Danielle, Luketic, Velimir A., Smith, Paula G., Hofmann, Charlotte, Mathisen, Terri, Strom, Susan, Mooney, Jody, Cardona-Gonzalez, Lupita, Fryzek, Nancy, Rivera, Elenita, Morris, Nevitt, Haynes-Williams, Vanessa, Valiga, Mary E., Torrey, Keith, Levine, Danielle, Keith, James, Betts, Michael, Montaner, Luis J., Teo, Chong-Gee, Khudyakov, Yury, Punkova, Lili T., Cloonan, Yona, Danielson, Michelle, Haller, Tamara, Johnson, Geoffrey, Kelley, Stephanie, Lawlor, Sharon, Li, Ruosha, Lombardero, Manuel, MacGregor, Joan M., Pelesko, Andrew, Stoliker, Donna, Walters, Barbara, Zadorozny, Ella, Ghany, Marc G., Perrillo, Robert, Belle, Steven H., Janssen, Harry L.A., Terrault, Norah A., Shuhart, Margaret C., Lau, Daryl T.-Y., Kim, W. Ray, Fried, Michael W., Sterling, Richard K., Di Bisceglie, Adrian M., Han, Steven-Huy B., Ganova-Raeva, Lilia Milkova, Chang, Kyong-Mi, and Lok, Anna Suk-Fong

Published
2015
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36. Symptom Domain Groups of the Patient-Reported Outcomes Measurement Information System Tools Independently Predict Hospitalizations and Re-hospitalizations in Cirrhosis

Author

Patidar, Kavish R., Thacker, Leroy R., Wade, James B., White, Melanie B., Gavis, Edith A., Fagan, Andrew, Sterling, Richard K., Fuchs, Michael, Siddiqui, Mohammad S., Matherly, Scott, Stravitz, Richard T., Sanyal, Arun J., Puri, Puneet, Luketic, Velimir A., and Bajaj, Jasmohan S.

Published
2017
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40. Brain Integrity Changes Underlying Cognitive and Functional Recovery Postliver Transplant Continue to Evolve Over 1 Year

Author

Ahluwalia, Vishwadeep, Wade, James B., White, Melanie B., Gilles, HoChong S., Heuman, Douglas M., Fuchs, Michael, Gavis, Edith A., Fagan, Andrew, Thacker, Leroy R., Sterling, Richard K., Stravitz, Richard Todd, Puri, Puneet, Sanyal, Arun J., Siddiqui, Muhammad S., Matherly, Scott, Luketic, Velimir, Steinberg, Joel, Moeller, Frederick Gerard, and Bajaj, Jasmohan S.

Published
2018
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42. Clinical and metabolic effects associated with weight changes and obeticholic acid in non‐alcoholic steatohepatitis

Author

Hameed, B., Terrault, N. A., Gill, R. M., Loomba, R., Chalasani, N., Hoofnagle, J. H., Van Natta, M. L., Allende, Daniela, Dasarathy, Srinivasan, J. McCullough, Arthur, Penumatsa, Revathi, Dasarathy, Jaividhya, E. Lavine, Joel, F. Abdelmalek, Manal, Bashir, Mustafa, Buie, Stephanie, Mae Diehl, Anna, Guy, Cynthia, Kigongo, Christopher, Kopping, Mariko, Malik, David, Piercy, Dawn, Chalasani, Naga, W. Cummings, Oscar, Gawrieh, Samer, Ragozzino, Linda, Sandrasegaran, Kumar, Vuppalanchi, Raj, M. Brunt, Elizabeth, Cattoor, Theresa, Carpenter, Danielle, Freebersyser, Janet, King, Debra, Lai, Jinping, A. Neuschwander‐Tetri, Brent, Siegner, Joan, Stewart, Susan, Torretta, Susan, Wriston, Kristina, Cardona Gonzalez, Maria, Davila, Jodie, Jhaveri, Manan, V. Kowdley, Kris, Mukhtar, Nizar, Ness, Erik, Poitevin, Michelle, Quist, Brook, Soo, Sherilynn, Ang, Brandon, Behling, Cynthia, Bhatt, Archana, Loomba, Rohit, S. Middleton, Michael, Sirlin, Claude, F. Akhter, Maheen, M. Bass, Nathan, Brandman, Danielle, Gill, Ryan, Hameed, Bilal, Maher, Jacqueline, Terrault, Norah, Ungermann, Ashley, Yeh, Matthew, Boyett, Sherry, J. Contos, Melissa, Kirwin, Sherri, AC Luketic, Velimir, Puri, Puneet, J. Sanyal, Arun, Schlosser, Jolene, S. Siddiqui, Mohammad, Yost‐Schomer, Leslie, M. Brunt, Elizabeth, Fowler, Kathryn, E. Kleiner, David, C. Doo, Edward, Hall, Sherry, H. Hoofnagle, Jay, Lee, Jessica J., R. Robuck, Patricia, H. Sherker, Averell, Torrance, Rebecca, Belt, Patricia, M. Clark, Jeanne, Dodge, John, Donithan, Michele, Hallinan, Erin, Isaacson, Milana, Lazo, Mariana, Meinert, Jill, Miriel, Laura, Smith, Jacqueline, Smith, Michael, Sternberg, Alice, Tonascia, James, L. Van Natta, Mark, Wagoner, Annette, A. Wilson, Laura, Yamada, Goro, and Yates, Katherine

Published
2018
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47. Cirrhotic patients have good insight into their daily functional impairment despite prior hepatic encephalopathy: comparison with PROMIS norms

Author

Bajaj, Jasmohan S., White, Melanie B., Unser, Ariel B., Ganapathy, Dinesh, Fagan, Andrew, Gavis, Edith A., Sterling, Richard K., Heuman, Douglas M., Matherly, Scott, Puri, Puneet, Sanyal, Arun J., Luketic, Velimir, Fuchs, Michael, Siddiqui, Muhammad S., Stravitz, R. Todd, John, Binu, Thacker, Leroy R., and Wade, James B.

Published
2016
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48. Impact of bacterial infections and spontaneous bacterial peritonitis prophylaxis on phage‐bacterial dynamics in cirrhosis

Author

Bajaj, Jasmohan S., primary, Rodriguez, Marcela Peňa, additional, Fagan, Andrew, additional, McGeorge, Sara, additional, Sterling, Richard K., additional, Lee, Hannah, additional, Luketic, Velimir, additional, Fuchs, Michael, additional, Davis, Brian C., additional, Sikaroodi, Masoumeh, additional, and Gillevet, Patrick M., additional

Published
2022
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50. Safety and efficacy of the farnesoid X receptor (FXR) agonist cilofexor in a proof-of-concept study in patients with compensated cirrhosis due to primary sclerosing cholangitis (PSC)

Author

Levy, Cynthia, primary, Caldwell, Stephen, additional, Mantry, Parvez, additional, Luketic, Velimir, additional, Landis, Charles, additional, Huang, Jonathan, additional, Mena, Edward, additional, Maheshwari, Rahul, additional, Rank, Kevin, additional, Xu, Jun, additional, Lu, Xiangyu, additional, Lu, Xiaomin, additional, Chung, Chuhan, additional, Myers, Robert, additional, and Kowdley, Kris, additional

Published
2022
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