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New approaches to de novo immunosuppression and steroid elimination

Y Lebranchu1

  • 1University Hospital of Tours, Tours, France. lebranchu@med.univ-tours.fr

Transplantation Proceedings
|August 5, 2009
PubMed

Insights

Sirolimus (SRL) combined with mycophenolate mofetil (MMF) offers improved renal function and allows for steroid withdrawal in kidney transplant patients, without compromising survival or rejection rates compared to calcineurin inhibitors.

Area of Science:

  • Nephrology
  • Transplantation Immunology
  • Pharmacology

Background:

  • Calcineurin inhibitors (CNIs) and steroids, standard immunosuppressants, have significant long-term side effects.
  • Sirolimus (SRL) and mycophenolate mofetil (MMF) are emerging as alternatives to mitigate these adverse effects.
  • Investigating CNI avoidance and early steroid withdrawal is crucial for optimizing long-term transplant outcomes.

Purpose of the Study:

  • To evaluate the efficacy and safety of sirolimus (SRL)-based immunosuppression in renal transplant recipients.
  • To assess the feasibility of de novo CNI avoidance and early steroid withdrawal.
  • To compare SRL-based regimens with standard calcineurin inhibitor (CsA)-based regimens regarding renal function, survival, and rejection rates.

Main Methods:

  • SPIESSER study: Randomized 145 renal recipients to de novo SRL or CsA, with MMF and early steroid withdrawal.
  • CONCEPT study: Randomized 192 renal recipients to switch from CsA to SRL or continue CsA at 12 months post-transplant.
  • Both studies assessed patient/graft survival, biopsy-proven acute rejection (BPAR), steroid withdrawal rates, and estimated glomerular filtration rate (eGFR).

Main Results:

  • No significant differences in patient survival, graft survival, or BPAR rates were observed between SRL and CsA groups in either study.
  • SRL-based regimens showed significantly higher eGFR at 12 months compared to CsA (SPIESSER: 69 vs 60 mL/min; CONCEPT: 68.9 vs 64.4 mL/min).
  • Steroid withdrawal was achieved in a high percentage of patients (82.8% in SPIESSER, 72-78% in CONCEPT) on SRL-based maintenance therapy.

Conclusions:

  • Sirolimus combined with MMF provides comparable efficacy to CsA in terms of survival and rejection rates.
  • SRL-based immunosuppression significantly improves renal function and facilitates early steroid withdrawal in kidney transplant recipients.
  • These findings support SRL and MMF as valuable components of immunosuppressive strategies to enhance long-term graft survival and patient quality of life.

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