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Presenter: J, van Hooff, Maastricht, Netherlands
Authors: van Hooff J., Alloway R., Trunečka P., Mourad M.
CLINICAL IMMUNOSUPPRESSION - KIDNEY LATE
J.P. Van hooff1, R.R. Alloway2, P. Trune?ka3, M. Mourad4
1Department Of Nephrology, University Hospital Maastricht, Maastricht/NETHERLANDS, 2Nephrology, University of Cincinnati, cincinnati/UNITED STATES OF AMERICA, 3, IKEM, Prague/CZECH REPUBLIC, 4Surgery And Abdominal Transplantation Division, Clinique Universitaires Saint-Luc, Brussels/BELGIUM
Body: Introduction: This study assessed long-term efficacy and safety of once-daily prolonged-release tacrolimus (Tacrolimus QD) in kidney, liver and heart transplant recipients.
Methods: Adult transplant recipients from 4 Phase II pharmacokinetic studies (stable kidney and heart recipients converted from twice-daily tacrolimus to Tacrolimus QD [12-02, 15-02]; liver and kidney recipients receiving Tacrolimus QD de novo [11-01, 12-01]) entered this long-term follow-up, remaining on original study regimen unless medical needs necessitated change. Primary endpoints were patient and graft survival; secondary endpoints were incidence of BPAR and adverse events (AEs).
Results: Data presented are from the follow-up period only and do not include results from the original studies (5–8 week duration).
240/277 eligible patients entered this follow-up, with 170/240 completing this additional 5-year period: 30/47 de novo liver, 32/47 de novo kidney, 53/67 conversion kidney and 55/79 conversion heart. 14 (5.8%) deaths occurred (none after withdrawal): 4 (8.5%) de novo liver, no de novo kidney, 4 (6.0%) conversion kidney, and 6 (7.6%) conversion heart patients. 56 (23.3%) patients were withdrawn, including 18 due to AEs, 9 due to consent withdrawal, 9 due to non-compliance with the study regimen, and 9 due to switch of immunosuppressive regimen not including Tacrolimus QD.
Tacrolimus dose and whole-blood trough levels decreased over time in all groups, with some atypical levels seen at 5-years’ follow-up due to small patient numbers (Table 1).
At 5 years, 83% de novo liver, 6% de novo kidney, 45% conversion kidney and 4% conversion heart patients were receiving Tacrolimus QD monotherapy (completers only).
Table 2 presents efficacy and renal function data. Graft loss occurred in 4 (8.5%) de novo liver, 0 de novo kidney, 5 (7.5%) conversion kidney, and 6 (7.6%) conversion heart patients (none after withdrawal). All were associated with death of the patient, except 1 de novo kidney patient (increased creatinine).
Most rejections were mild–moderate except 3 severe events (1 de novo liver and 2 conversion heart patients). AEs were similar to tacrolimus twice-daily administration.
Conclusions: Once-daily tacrolimus is effective and well tolerated with both conversion and de novo use. Patient and graft survival exceeded 90% in this 5-year follow-up study in liver, kidney and heart recipients. Rejection was infrequent and renal function maintained.
Disclosure: All authors have declared no conflicts of interest.
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