Two corticosteroid-free regimens - Tacrolimus monotherapy after basiliximab administration and tacrolimus/mycophenolate mofetil - In comparison with a standard triple regimen in renal transplantation: Results of the Atlas Study

Stefan Vítko, Marian Klinger, Kaija Salmela, Zbigniew Wlodarczyk, Gunnar Tydèn, Grzegorz Senatorski, Marek Ostrowski, Per Fauchald, Franciszek Kokot, Sergio Stefoni, Ferenc Perner, Kerstin Claesson, Marco Castagneto, Uwe Heemann, Mario Carmellini, Jean Paul Squifflet, Markus Weber, Giuseppe Segoloni, Lars Bäckman, Heide SperschneiderBernhard K. Krämer

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Abstract

Background. The side effects associated with corticosteroids have led to efforts to minimize their use in renal transplant patients. In this study we compared two corticosteroid-free tacrolimus-based regimens with a standard triple therapy. Methods. This was a 6-month, phase III, open-label, parallel-group, multicenter study. The total analysis set comprised 451 patients, randomized (1:1:1) to receive tacrolimus (Tac) monotherapy following basiliximab (Bas) administration (n = 153), Tac/mycophenolate mofetil (MMF) (n=151), or, Tac/MMF/corticosteroids triple therapy as a control (n=147). Results. The study was completed by 91.2% (triple therapy), 94.7% (Tac/MMF), and 82.4% (Bas/Tac) of patients. Patient baseline characteristics were similar in all groups. The incidences of biopsy-proven acute rejection were 8.2% (triple therapy), 30.5% (Tac/MMF), and 26.1% (Bas/Tac), p<0.001 (multiple test for comparison with triple therapy); Bas/Tac vs. Tac/MMF, p=ns. The incidences of corticosteroid-resistant acute rejection were 2.0%, 4.0%, and 5.2%, p=ns. Graft survival (95.9%, 96.7%, and 94.7%, p=ns) and patient survival (100%, 99.3%, and 99.3%, p=ns) were similar in all groups. Median serum creatinine at month 6 was 123.0 μmol/L (triple therapy), 134.7 μmol/L (Tac/MMF) and 135.8 μmol/L (Bas/Tac). The overall safety profiles were similar; differences (p<0.05) were reported for anaemia (24.5% vs. 12.6% vs. 14.5%), diarrhoea (12.9% vs. 17.9% vs. 5.9%), and leukopenia (7.5% vs. 18.5% vs. 5.9%) for the triple therapy, Tac/MMF, and Bas/Tac group, respectively. The incidences of new-onset diabetes mellitus were 4.6%, 7.1%, and 1.4%, respectively. Conclusion. Corticosteroid-free immunosuppression was feasible with the Bas/Tac and the Tac/MMF regimens. Both corticosteroid-free regimens were equally effective in preventing acute rejection, with the Bas/Tac therapy offering some safety benefits.

Original languageEnglish
Pages (from-to)1734-1741
Number of pages8
JournalTransplantation
Volume80
Issue number12
DOIs
Publication statusPublished - Dec 1 2005

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Keywords

  • Basiliximab
  • Corticosteroid withdrawal
  • Mycophenolate mofetil
  • Renal transplantation
  • Tacrolimus

ASJC Scopus subject areas

  • Transplantation

Cite this

Vítko, S., Klinger, M., Salmela, K., Wlodarczyk, Z., Tydèn, G., Senatorski, G., Ostrowski, M., Fauchald, P., Kokot, F., Stefoni, S., Perner, F., Claesson, K., Castagneto, M., Heemann, U., Carmellini, M., Squifflet, J. P., Weber, M., Segoloni, G., Bäckman, L., ... Krämer, B. K. (2005). Two corticosteroid-free regimens - Tacrolimus monotherapy after basiliximab administration and tacrolimus/mycophenolate mofetil - In comparison with a standard triple regimen in renal transplantation: Results of the Atlas Study. Transplantation, 80(12), 1734-1741. https://doi.org/10.1097/01.tp.0000188300.26762.74