{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T00:56:32Z","timestamp":1791507392050,"version":"4.3.4"},"reference-count":49,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"5","license":[{"start":{"date-parts":[[2021,4,29]],"date-time":"2021-04-29T00:00:00Z","timestamp":1619654400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2021,4,29]],"date-time":"2021-04-29T00:00:00Z","timestamp":1619654400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":["Hepatology"],"published-print":{"date-parts":[[2021,5]]},"abstract":"<jats:sec>\n            <jats:title>Background and Aims<\/jats:title>\n            <jats:p>Tolerance is transplantation\u2019s holy grail, as it denotes allograft health without immunosuppression and its toxicities. Our aim was to determine, among stable long\u2010term pediatric liver transplant recipients, the efficacy and safety of immunosuppression withdrawal to identify operational tolerance.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Approach and Results<\/jats:title>\n            <jats:p>We conducted a multicenter, single\u2010arm trial of immunosuppression withdrawal over 36\u201048\u00a0weeks. Liver tests were monitored biweekly (year 1), monthly (year 2), and bimonthly (years 3\u20104). For\u2010cause biopsies were done at investigators\u2019 discretion but mandated when alanine aminotransferase or gamma glutamyltransferase exceeded 100\u00a0U\/L. All subjects underwent final liver biopsy at trial end. The primary efficacy endpoint was operational tolerance, defined by strict biochemical and histological criteria 1\u00a0year after stopping immunosuppression. Among 88 subjects (median age 11\u00a0years; 39 boys; 57 deceased donor grafts), 33 (37.5%; 95% confidence interval [CI] 27.4%, 48.5%) were operationally tolerant, 16 were nontolerant by histology (met biochemical but failed histological criteria), and 39 were nontolerant by rejection. Rejection, predicted by subtle liver inflammation in trial entry biopsies, typically (n\u00a0=\u00a032) occurred at \u226432% of the trial\u2010entry immunosuppression dose and was treated with corticosteroids (n\u00a0=\u00a032) and\/or tacrolimus (n\u00a0=\u00a038) with resolution (liver tests within 1.5 times the baseline) for all but 1 subject. No death, graft loss, or chronic, severe, or refractory rejection occurred. Neither fibrosis stage nor the expression level of a rejection gene set increased over 4\u00a0years for either tolerant or nontolerant subjects.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p>Immunosuppression withdrawal showed that 37.5% of selected pediatric liver\u2010transplant recipients were operationally tolerant. Allograft histology did not deteriorate for either tolerant or nontolerant subjects. The timing and reversibility of failed withdrawal justifies future trials exploring the efficacy, safety, and potential benefits of immunosuppression minimization.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1002\/hep.31520","type":"journal-article","created":{"date-parts":[[2020,8,12]],"date-time":"2020-08-12T23:49:35Z","timestamp":1597276175000},"page":"1985-2004","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":100,"title":["Efficacy and Safety of Immunosuppression Withdrawal in Pediatric Liver Transplant Recipients: Moving Toward Personalized Management"],"prefix":"10.1097","volume":"73","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2601-4350","authenticated-orcid":false,"given":"Sandy","family":"Feng","sequence":"first","affiliation":[{"name":"Division of Transplantation,Department of Surgery,University of California San Francisco,San Francisco,CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6767-8874","authenticated-orcid":false,"given":"John C.","family":"Bucuvalas","sequence":"additional","affiliation":[{"name":"Mount Sinai Kravis Children\u2019s Hospital and Recanati\/Miller Transplantation Institute,Mount Sinai Health System,New York,NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2624-8632","authenticated-orcid":false,"given":"George V.","family":"Mazariegos","sequence":"additional","affiliation":[{"name":"Hillman Center for Pediatric Transplantation,Children\u2019s Hospital of Pittsburgh,Pittsburgh,PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8416-7905","authenticated-orcid":false,"given":"John C.","family":"Magee","sequence":"additional","affiliation":[{"name":"Section of Transplant Surgery,Department of Surgery,University of Michigan,Ann Arbor,MI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8316-3504","authenticated-orcid":false,"given":"Alberto","family":"Sanchez\u2010Fueyo","sequence":"additional","affiliation":[{"name":"Institute of Liver Studies,King\u2019s College London,London,United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katharine M.","family":"Spain","sequence":"additional","affiliation":[{"name":"Rho, Inc.,Chapel Hill,NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Lesniak","sequence":"additional","affiliation":[{"name":"Department of Pathology,University of Pittsburgh,Pittsburgh,PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sai","family":"Kanaparthi","sequence":"additional","affiliation":[{"name":"The Immune Tolerance Network,Bethesda,MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2911-9684","authenticated-orcid":false,"given":"Emily","family":"Perito","sequence":"additional","affiliation":[{"name":"Division of Pediatric Gastroenterology, Hepatology and Nutrition,Department of Pediatrics,University of California San Francisco,San Francisco,CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Veena L.","family":"Venkat","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Hepatology and Nutrition,Department of Pediatrics,University of Pittsburgh Medical Center,Children\u2019s Hospital of Pittsburgh,Pittsburgh,PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bryna E.","family":"Burrell","sequence":"additional","affiliation":[{"name":"The Immune Tolerance Network,Bethesda,MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Estella M.","family":"Alonso","sequence":"additional","affiliation":[{"name":"Siragusa Transplantation Center,Ann & Robert H. Lurie Children\u2019s Hospital of Chicago,Chicago,IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1140-5201","authenticated-orcid":false,"given":"Nancy D.","family":"Bridges","sequence":"additional","affiliation":[{"name":"Transplantation Branch,Division of Allergy, Immunology, and Transplantation,National Institute of Allergy and Infectious Diseases,Rockville,MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edward","family":"Doo","sequence":"additional","affiliation":[{"name":"Division of Digestive Diseases and Nutrition,National Institute of Diabetes and Digestive and Kidney Diseases,Bethesda,MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6171-4731","authenticated-orcid":false,"given":"Nitika A.","family":"Gupta","sequence":"additional","affiliation":[{"name":"Division of Pediatric Gastroenterology, Hepatology and Nutrition,Department of Pediatrics,Emory University School of Medicine,Atlanta,GA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0116-2613","authenticated-orcid":false,"given":"Ryan W.","family":"Himes","sequence":"additional","affiliation":[{"name":"Section of Gastroenterology, Hepatology, and Nutrition,Texas Children\u2019s Hospital,Houston,TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0091-5246","authenticated-orcid":false,"given":"David","family":"Ikle","sequence":"additional","affiliation":[{"name":"Rho, Inc.,Chapel Hill,NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annette M.","family":"Jackson","sequence":"additional","affiliation":[{"name":"Department of Surgery,Duke University,Durham,NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven J.","family":"Lobritto","sequence":"additional","affiliation":[{"name":"Center for Liver Diseases and Transplantation,Department of Surgery,Columbia University Irving Medical Center,New York,NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7613-3908","authenticated-orcid":false,"given":"Juan","family":"Jose Lozano","sequence":"additional","affiliation":[{"name":"Bioinformatic Platform,Biomedical Research Center in Hepatic and Digestive Diseases,Instituto de Salud Carlos III,Barcelona,Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6128-0155","authenticated-orcid":false,"given":"Mercedes","family":"Martinez","sequence":"additional","affiliation":[{"name":"Center for Liver Diseases and Transplantation,Department of Surgery,Columbia University Irving Medical Center,New York,NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9998-5692","authenticated-orcid":false,"given":"Vicky L.","family":"Ng","sequence":"additional","affiliation":[{"name":"Division of Pediatric Gastroenterology, Hepatology and Nutrition, Transplant and Regenerative Medicine Center,The Hospital for Sick Children,University of Toronto,Toronto,OH,Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1173-4558","authenticated-orcid":false,"given":"Elizabeth B.","family":"Rand","sequence":"additional","affiliation":[{"name":"Liver Transplant Program,The Children\u2019s Hospital of Pennsylvania,Philadelphia,PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0409-6938","authenticated-orcid":false,"given":"Averell H.","family":"Sherker","sequence":"additional","affiliation":[{"name":"Division of Digestive Diseases and Nutrition,National Institute of Diabetes and Digestive and Kidney Diseases,Bethesda,MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shikha S.","family":"Sundaram","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Hepatology, and Nutrition,Children\u2019s Hospital Colorado,University of Colorado School of Medicine,Aurora,CO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yumirle P.","family":"Turmelle","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Hepatology, and Nutrition,Washington University School of Medicine,St. Louis,MO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1880-4926","authenticated-orcid":false,"given":"Michele","family":"Wood\u2010Trageser","sequence":"additional","affiliation":[{"name":"Department of Pathology,University of Pittsburgh,Pittsburgh,PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthony J.","family":"Demetris","sequence":"additional","affiliation":[{"name":"Department of Pathology,University of Pittsburgh,Pittsburgh,PA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2021,4,29]]},"reference":[{"key":"hep31520-bib-0001-20250824","doi-asserted-by":"crossref","first-page":"1582","DOI":"10.1002\/lt.21549","article-title":"Graft histology characteristics in long\u2010term survivors of pediatric liver transplantation","volume":"14","year":"2008","journal-title":"Liver Transpl"},{"key":"hep31520-bib-0002-20250824","doi-asserted-by":"crossref","first-page":"1109","DOI":"10.1002\/hep.21152","article-title":"Progressive histological damage in liver allografts following pediatric liver transplantation","volume":"43","year":"2006","journal-title":"Hepatology"},{"key":"hep31520-bib-0003-20250824","doi-asserted-by":"crossref","first-page":"1838","DOI":"10.1053\/j.gastro.2018.08.023","article-title":"Evidence of chronic allograft injury in liver biopsies from long\u2010term pediatric recipients of liver 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