Corticosteroid Withdrawal in Simultaneous Pancreas–Kidney Transplantation: A 3-Year Report

Corticosteroids are an important element of immunosuppressive protocols, but their long-term use has detrimental effects on patient health, requiring eventual discontinuation. Herein, we present an evaluation of the safety and feasibility of corticosteroid withdrawal based on the findings of the Eur...

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Bibliographic Details
Published in:Transplantation proceedings 2005-07, Vol.37 (6), p.2853-2855
Main Authors: Malaise, J., Nakache, R., Kahl, A., Bechstein, W., Langrehr, J., Uhl, I., Engelking, A., Neuhaus, P., Van Ophem, D., Squifflet, J.P.
Format: Article
Language:English
Subjects:
Adrenal Cortex Hormones - administration & dosage
Adrenal Cortex Hormones - therapeutic use
Biological and medical sciences
Cyclosporine - therapeutic use
Drug Administration Schedule
Drug Therapy, Combination
Follow-Up Studies
Fundamental and applied biological sciences. Psychology
Fundamental immunology
Humans
Immunosuppressive Agents - therapeutic use
Kidney Transplantation - immunology
Kidney Transplantation - physiology
Medical sciences
Mycophenolic Acid - analogs & derivatives
Mycophenolic Acid - therapeutic use
Pancreas Transplantation - immunology
Pancreas Transplantation - physiology
Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases
Tacrolimus - therapeutic use
Tissue, organ and graft immunology
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Summary:Corticosteroids are an important element of immunosuppressive protocols, but their long-term use has detrimental effects on patient health, requiring eventual discontinuation. Herein, we present an evaluation of the safety and feasibility of corticosteroid withdrawal based on the findings of the Euro-SPK001 study. In this prospective, multicenter study, 205 simultaneous pancreas–kidney (SPK) transplant recipients were randomized to immunosuppressive treatment with either tacrolimus and mycophenolate mofetil (MMF) ( n = 103) or cyclosporine microemulsion (CsA-ME) and MMF ( n = 102). All patients received concomitant rATG induction therapy, MMF, and short-term corticosteroids. Corticosteroid withdrawal was successful in the majority of in-study patients: 66% tacrolimus and 73% cyclosporin-ME. In-study patients selected for corticosteroid withdrawal experienced fewer pancreatic or kidney graft losses and fewer episodes of acute rejection compared with out-of-study patients or those continuing corticosteroid therapy. Acute rejection episodes occurred after corticosteroid withdrawal in two patients who had a previous rejection and in five patients who were rejection free before corticosteroid withdrawal. No rejection episodes were associated with graft loss or immediate serious consequences. Overall, corticosteroid withdrawal was achieved with an increase in both MMF and tacrolimus dosage. Corticosteroid withdrawal was successful in the majority of in-study patients. A long-term survey of corticosteroid withdrawal in SPK transplantation with multifactorial analyses is necessary to confirm these early results and to evaluate possible positive effects on glucose metabolism and hypertension.
ISSN:0041-1345
1873-2623
DOI:10.1016/j.transproceed.2005.05.026