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Acute rejection in low-toxicity regimens: clinical impact and risk factors in the Symphony study
Ulrich Frei1, Pierre Daloze, Stefan Vítko
1Department of Nephrology and Medical Intensive Care, Charité, Virchow-Klinikum, Berlin, Germany.
Abstract:
The Symphony study assessed whether mycophenolate mofetil (MMF)-based regimens containing reduced doses of adjunct immunosuppressants could reduce toxicity while maintaining efficacy. Here, we examined the impact of acute rejection and associated risk factors. The incidence of biopsy-proven acute rejection in the low-dose tacrolimus group was approximately half that of the standard-dose cyclosporine and low-dose cyclosporine groups, and a third of that in the low-dose sirolimus group. The low-dose cyclosporine group had more severe rejection episodes (≥grade II) compared with other groups. Acute rejection was associated with a 10 mL/min glomerular filtration rate (GFR) reduction and a 5.3% absolute increase in graft loss at 12 months. Overall, the highest GFR was found in both rejecters and non-rejecters receiving low-dose tacrolimus, both in an intent-to-treat analysis and in patients successfully treated according to the protocol. In Cox regression models, human leukocyte antigen (HLA) mismatches and expanded criteria donors increased the acute rejection risk, while recipient age, living related donor, and MMF dose were associated with a reduced risk. Acute rejection was associated with worse outcome but did not entirely explain the differences among the treatment groups. The 2 g MMF plus low-dose tacrolimus combination appears to be the most efficient of all regimens examined regardless of acute rejection.
Insights
Reduced immunosuppressant doses in kidney transplants, particularly low-dose tacrolimus with mycophenolate mofetil (MMF), lowered acute rejection rates and improved graft function. This combination offers superior efficacy and reduced toxicity.
Area of Science:
- Nephrology
- Immunology
- Transplantation Medicine
Background:
- Optimizing immunosuppression post-kidney transplant is crucial for balancing efficacy and toxicity.
- Mycophenolate mofetil (MMF)-based regimens with reduced adjunct immunosuppressants were explored in the Symphony study.
- Acute rejection remains a significant factor influencing long-term graft survival and function.
Purpose of the Study:
- To evaluate the impact of acute rejection and its risk factors within the Symphony study.
- To compare the incidence and severity of acute rejection across different immunosuppressive regimens.
- To determine the association between acute rejection and graft function (GFR) and graft loss.
Main Methods:
- Analysis of biopsy-proven acute rejection rates in patients receiving MMF with varying doses of tacrolimus, cyclosporine, or sirolimus.
- Assessment of rejection severity (grade ≥II) and its correlation with graft loss and estimated glomerular filtration rate (eGFR).
- Cox regression modeling to identify risk factors for acute rejection, including HLA mismatches, donor type, recipient age, and MMF dose.
Main Results:
- Low-dose tacrolimus demonstrated significantly lower acute rejection incidence compared to cyclosporine and sirolimus groups.
- Acute rejection was linked to a 10 mL/min GFR reduction and a 5.3% increase in 12-month graft loss.
- The combination of 2g MMF and low-dose tacrolimus yielded the highest GFR, irrespective of rejection status.
- HLA mismatches and expanded criteria donors increased rejection risk; recipient age, living related donor, and MMF dose reduced risk.
Conclusions:
- The 2g MMF plus low-dose tacrolimus regimen is the most effective strategy, showing reduced acute rejection and superior GFR.
- While acute rejection negatively impacts outcomes, it does not fully account for the observed differences between treatment groups.
- Minimizing adjunct immunosuppressant doses, particularly with tacrolimus, can enhance kidney transplant outcomes.
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