Title: Prospective multi-center clinical trial of immunosuppressive drug withdrawal in stable adult liver transplant recipients
Authors: Benítez, Carlos ×
Londoño, María-Carlota
Miquel, Rosa
Manzia, Tommaso-Maria
Abraldes, Juan G
Lozano, Juan-José
Martínez-Llordella, Marc
López, Marta
Angelico, Roberta
Bohne, Felix
Sese, Pilar
Daoud, Frederic
Larcier, Patrick
Roelen, Dave L
Claas, Frans
Whitehouse, Gavin
Lerut, Jan
Pirenne, Jacques
Rimola, Antoni
Tisone, Giuseppe
Sánchez-Fueyo, Alberto #
Issue Date: Nov-2013
Publisher: W.B. Saunders
Series Title: Hepatology vol:58 issue:5 pages:1824-1835
Article number: 10.1002/hep.26426
Abstract: Lifelong immunosuppression increases morbidity and mortality in liver transplantation. Discontinuation of immunosuppressive drugs could lessen this burden, but the safety, applicability and clinical outcomes of this strategy need to be carefully defined. We enrolled 102 stable liver recipients at least 3 years after transplantation in a single-arm multi-center immunosuppression withdrawal trial. Drugs were gradually discontinued over a 6-9 month period. The primary end-point was the development of operational tolerance, defined as successful immunosuppressive drug cessation maintained for at least 12 months with stable graft function and no histopathologic evidences of rejection. Out of the 98 recipients evaluated, 57 rejected and 41 successfully discontinued all immunosuppressive drugs. In non-tolerant recipients rejection episodes were mild and resolved over 5.6 months (2 non-tolerant patients still exhibited mild gradually improving cholestasis at the end of follow-up). In tolerant recipients no progressive clinically-significant histological damage was apparent in follow-up protocol biopsies performed up to 3 years following drug withdrawal. Tolerance was independently associated with time since transplantation (OR 1.353; p = 0.0001), recipient age (OR 1.073; p = 0.009), and male gender (OR 4.657; p = 0.016). A predictive model incorporating the two first clinical variables identified subgroups of recipients with very high (79%), intermediate (30-38%), and very low (0%) likelihood of successful withdrawal. Conclusion: When conducted at late time points after transplantation, immunosuppression withdrawal is successful in a high proportion of carefully selected liver recipients. A combination of clinical parameters could be useful to predict the success of this strategy. Additional prospective studies are now needed to confirm these results and to validate clinically-applicable diagnostic biomarkers. (HEPATOLOGY 2013.).
ISSN: 0270-9139
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Laboratory of Abdominal Transplantation
× corresponding author
# (joint) last author

Files in This Item:

There are no files associated with this item.

Request a copy


All items in Lirias are protected by copyright, with all rights reserved.

© Web of science