Impact on Renal Function of Stepwise Withdrawal of Tacrolimus Combined with Everolimus and EC-MPS vs Standard Treatment Combining Tacrolimus and EC-MPS in De Novo Liver Transplant Recipients: Results of the SIMCER Study.
1Hôpital Paul Brousse, Villejuif, France
2Hôpital Henri Mondor, Créteil, France
3Hôpital Claude Huriez, Lille, France
4Hôpital Edouard Herriot, Lyon, France
5Hôpital La Pitié-Salpêtrière, Paris, France
6Novartis Pharma SAS, Rueil-Malmaison, France.
Meeting: 2016 American Transplant Congress
Abstract number: 169
Keywords: Immunosuppression, Liver transplantation, Multicenter studies, Renal function
Session Information
Session Time: 8:30am-9:30am
Presentation Time: 9:00am-9:15am
Location: Veterans Auditorium
Introduction: Long-term post-liver transplant (LTx) complications, particularly impaired renal function (RF) and its consequences, remain a concern. Presented here are the results of the SIMCER Study evaluating the efficacy and safety of treatment with everolimus (EVR) combined with enteric-coated mycophenolate sodium (EC-MPS) after the stepwise withdrawal of tacrolimus (TAC) vs standard TAC + EC-MPS treatment.
Methodology: This is a prospective, open-label study conducted in 15 French centers. 188 patients were randomized at 1 month (M1) post-LTx (1:1) to receive EVR (C0 6-10 ng/ml) + EC-MPS (1440 mg/d) + TAC (stepwise withdrawal over 8 weeks on average) or TAC (C0 6-10 ng/mL) + EC-MPS (1440 mg/d). All received basiliximab ± corticosteroids. The primary objective was to evaluate whether EVR + EC-MPS leads to better RF (eGFR, abbreviated MDRD) at 6 months (M6) vs standard treatment.
Results: Patient characteristics were comparable between the EVR + EC-MPS (n = 93) and TAC + EC-MPS (n = 95) groups. The analysis of covariance of eGFR progression between randomization and M6 shows a significant difference in favor of the EVR + EC-MPS group (+14.3 ml/min/1.73m[sup2], 95% CI 7.3-21.3; p<0.0001). The incidence of treatment failures was comparable between EVR+EC-MPS and TAC+EC-MPS (10% vs 4.3%; p=0.139, of which 8 vs 2 treated BPAR, 0 vs 1 graft loss, 1 vs 1 death), and the incidence of adverse events (AEs) was: 90% and 90.4% respectively, p = 0.923. The incidence of serious AEs was significantly higher in the EVR + EC-MPS group than in the TAC + EC-MPS group (46.7% vs 29.8%; p = 0.018) without specific pattern of SAEs.
Conclusion: The SIMCER study has evaluated for the first time the EVR + EC-MPS combination from M1 post-LTx with stepwise withdrawal of TAC compared with the TAC + EC- MPS combination. A significant benefit in terms of renal function was reported in the EVR + EC-MPS group, with efficacy of immunosuppression comparable to the standard treatment despite a higher incidence of SAEs. These results require confirmation over the longer term.
CITATION INFORMATION: Saliba F, Duvoux C, Dharancy S, Dumortier J, Calmus Y, Di Giambattista F, Conti F. Impact on Renal Function of Stepwise Withdrawal of Tacrolimus Combined with Everolimus and EC-MPS vs Standard Treatment Combining Tacrolimus and EC-MPS in De Novo Liver Transplant Recipients: Results of the SIMCER Study. Am J Transplant. 2016;16 (suppl 3).
To cite this abstract in AMA style:
Saliba F, Duvoux C, Dharancy S, Dumortier J, Calmus Y, Giambattista FDi, Conti F. Impact on Renal Function of Stepwise Withdrawal of Tacrolimus Combined with Everolimus and EC-MPS vs Standard Treatment Combining Tacrolimus and EC-MPS in De Novo Liver Transplant Recipients: Results of the SIMCER Study. [abstract]. Am J Transplant. 2016; 16 (suppl 3). https://atcmeetingabstracts.com/abstract/impact-on-renal-function-of-stepwise-withdrawal-of-tacrolimus-combined-with-everolimus-and-ec-mps-vs-standard-treatment-combining-tacrolimus-and-ec-mps-in-de-novo-liver-transplant-recipients-results/. Accessed May 11, 2025.« Back to 2016 American Transplant Congress