Reduced-exposure cyclosporine is safe and efficacious in de novo renal transplant recipients treated with enteric-coated mycophenolic acid and basiliximab

Budde, Klemens; Bosmans, Johan; Sennesael, Jacques; Zeier, M; Pisarski, P.; Schütz, Manuela; Fischer, Wolfgang; Neumayer, Hans H.; Glander, Petra

doi:10.5414/cnp67164

Cited by 15 publications

(12 citation statements)

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“…The role of EC-MPS has been examined in protocols minimizing CsA 2425. In these studies, investigations into the use of EC-MPS with both standard- and low-dose CsA have demonstrated excellent efficacy in both de novo and maintenance patients.…”

Section: Discussionmentioning

confidence: 99%

Cyclosporine Sparing Effect of Enteric-Coated Mycophenolate Sodium inDe NovoKidney Transplantation

Lee

Park

et al. 2017

Yonsei Med J

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PurposeThe increased tolerability of enteric-coated mycophenolate sodium (EC-MPS), compared to mycophenolate mofetil, among kidney transplant recipients has the potential to facilitate cyclosporine (CsA) minimization. Therefore, a prospective trial to determine the optimum EC-MPS dose in CsA-based immunosuppression regimens is necessary.Materials and MethodsA comparative, parallel, randomized, open-label study was performed for 140 patients from four centers to compare the efficacy and tolerability of low dose CsA with standard dose EC-MPS (the investigational group) versus standard dose CsA with low dose EC-MPS (the control group) for six months in de novo kidney transplant recipients. Graft function, the incidence of efficacy failure [biopsy-confirmed acute rejection (BCAR), death, graft loss, loss to follow-up], and adverse events were compared.ResultsThe mean estimated glomerular filtration rate (eGFR) of the investigational group at six months post-transplantation was non-inferior to that of the control group (confidence interval between 57.3 mL/min/1.73m2 and 67.4 mL/min/1.73 m2, p<0.001). One graft loss was reported in the control group, and no patient deaths were reported in either group. The incidence of BCAR of the investigational group was 8.7%, compared to 18.8% in the control group (p=0.137), during the study period. There were no significant differences (p>0.05) in the incidence of discontinuations and serious adverse events (SAE) between the groups.ConclusionCsA minimization using a standard dose of EC-MPS kept the incidence of acute rejection and additional risks as low as conventional immunosuppression and provided therapeutic equivalence in terms of renal graft function and safety issues.

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Section: Discussionmentioning

confidence: 99%

Cyclosporine Sparing Effect of Enteric-Coated Mycophenolate Sodium inDe NovoKidney Transplantation

Lee

Park

et al. 2017

Yonsei Med J

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“…[44][45][46][47] At 6 or 12 months post-transplant, renal function as measured by mean CR CL (primary endpoint), was similar or higher in the reduced exposure dosage CNI groups than in the standard exposure dosage groups (table IV). [44][45][46][47] At 6 or 12 months post-transplant, renal function as measured by mean CR CL (primary endpoint), was similar or higher in the reduced exposure dosage CNI groups than in the standard exposure dosage groups (table IV).…”

Section: Calcineurin Inhibitor-sparing Regimensmentioning

confidence: 96%

“…[46] Graft and patient survival rates were also not significantly different between groups. [44][45][46] At 1 year post-transplant, graft survival rates in reduced-or standard-exposure CNI groups were 100% of patients in both groups in one trial, [44] and 98.7% versus 98.5% in a second trial; [45] at 2 years in a third trial, rates were 82% in the low-dose tacrolimus group, 90% in the low-dose ciclosporin group, and 91% in the standard-dose ciclosporin group. [46] Corresponding patient survival rates at 1 year were 93.1% versus 97.8% of patients [44] and 98.7% versus 100%, [45] and at 2 years, 92% and 96% versus 97%.…”

Section: Calcineurin Inhibitor-sparing Regimensmentioning

confidence: 96%

“…[44][45][46] At 1 year post-transplant, graft survival rates in reduced-or standard-exposure CNI groups were 100% of patients in both groups in one trial, [44] and 98.7% versus 98.5% in a second trial; [45] at 2 years in a third trial, rates were 82% in the low-dose tacrolimus group, 90% in the low-dose ciclosporin group, and 91% in the standard-dose ciclosporin group. [46] Corresponding patient survival rates at 1 year were 93.1% versus 97.8% of patients [44] and 98.7% versus 100%, [45] and at 2 years, 92% and 96% versus 97%. [46] The optimal ciclosporin exposure range was not determined in an exploratory analysis in one trial; [44] however, high ciclosporin exposure levels at 1 year were thought to be associated with deteriorating renal function.…”

Section: Calcineurin Inhibitor-sparing Regimensmentioning

confidence: 96%

“…Patient and donor characteristics were generally similar between treatment groups in each trial, with some trials specifically evaluating outcomes in low- [33,36] or high-risk [31,43] patients. [44][45][46][47] Where the histologic severity of BPAR episodes was assessed, Banff classification criteria were used. [31] In randomized trials, the primary efficacy endpoints included the proportion of patients who experienced an acute rejection episode, [26,28,29] or biopsy-proven acute rejection (BPAR), [34][35][36]38,40,42,51] the time to first BPAR, [51] the requirement for additional immunosuppression, [30] the incidence of DGF, [32] treatment failure [31] (defined as death, graft loss, or an acute rejection episode unless stated otherwise), treatment failure or the time to first BPAR, [50] the glomerular filtration rate (GFR), [39,43] or mean creatinine CL (CR CL ).…”

Section: Therapeutic Efficacymentioning

confidence: 99%

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Basiliximab

McKeage

McCormack²

2010

BioDrugs

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Basiliximab (Simulect) is a recombinant chimeric murine/human IgG1 monoclonal anti-interleukin-2 receptor antibody that is indicated for the prevention of acute organ rejection in adult and pediatric renal transplant recipients in combination with other immunosuppressive agents. Induction therapy with two doses (day 0 and day 4) of intravenous basiliximab as part of double- or triple-immunotherapy regimens in adult renal transplant recipients reduces acute rejection episodes without increasing the incidence of adverse events. Compared with rabbit-derived antithymocyte globulin (RATG), basiliximab is generally associated with similar efficacy in standard-risk patients, but reduced efficacy in high-risk patients. Initial results indicate that induction with basiliximab is associated with a higher rate of biopsy-proven acute rejection than alemtuzumab induction. Basiliximab is generally associated with a tolerability profile that is similar to that reported with placebo, and better than that reported with RATG. As with other induction agents, basiliximab has not demonstrated improved graft or patient survival over the long term (periods of up to 7 years). Basiliximab induction allows for reduced dosage of corticosteroids or calcineurin inhibitors, while maintaining adequate immunosuppression, thereby reducing the potential for adverse effects associated with these coadministered agents. Thus, basiliximab provides an effective, well tolerated option for the prophylaxis of acute renal transplant rejection.

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Interleukin 2 receptor antagonists for kidney transplant recipients

Webster

Ruster

McGee

et al. 2010

Cochrane Database of Systematic Reviews

144

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Given a 38% risk of rejection, per 100 recipients compared with no treatment, nine recipients would need treatment with IL2Ra to prevent one recipient having rejection, 42 to prevent one graft loss, and 38 to prevent one having CMV disease over the first year post-transplantation. Compared with ATG treatment, ATG may prevent some experiencing acute rejection, but 16 recipients would need IL2Ra to prevent one having CMV, but 58 would need IL2Ra to prevent one having malignancy. There are no apparent differences between basiliximab and daclizumab. IL2Ra are as effective as other antibody therapies and with significantly fewer side effects.

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Reduced-exposure cyclosporine is safe and efficacious in de novo renal transplant recipients treated with enteric-coated mycophenolic acid and basiliximab

Cited by 15 publications

References 0 publications

Cyclosporine Sparing Effect of Enteric-Coated Mycophenolate Sodium inDe NovoKidney Transplantation

Cyclosporine Sparing Effect of Enteric-Coated Mycophenolate Sodium inDe NovoKidney Transplantation

Basiliximab

Interleukin 2 receptor antagonists for kidney transplant recipients

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