Two year results of Certican (Novartis ) in Liver Transplant rejection confirm superiority over tacrolimus

Novartis announced new two-year results from the largest Phase III study ever in Liver Transplantation that confirmed comparable efficacy to control and superior renal function results previously seen at 12 months. The trial evaluated the introduction of Certican (everolimus) with reduced exposure tacrolimus administered twice-daily starting one month after liver transplantation versus standard-exposure tacrolimus.

At 24 months, the incidence of composite efficacy failure (Kaplan-Meier estimates) was numerically lower with Certican with reduced tacrolimus compared to the tacrolimus control group (10.3% vs. 12.5%; risk difference -2.2%; [97.5% CI: -8.8%, 4.4%]; p=0.452). The incidence of Biopsy Proven Acute Rejection (BPAR) was significantly lower with Certican with reduced tacrolimus compared to the tacrolimus control group (6.1% vs. 13.3%; risk difference: -7.2% [95% CI: -13.5%, -0.9%]; p=0.010). The incidence rates of graft loss, death, and Treated Biopsy Proven Acute Rejection were comparable between the two groups. Superior renal function was maintained at month 24 with Certican with reduced tacrolimus compared with standard tacrolimus (mean difference in estimated glomerular filtration rate (eGFR) change: 6.7 mL/min/1.73m2 [97.5% CI: 1.9, 11.42]; p=0.0018) (ITT population). For on-treatment patients, the difference in eGFR at month 24 was 11.5 mL/min in favor of Certican with reduced tacrolimus .The data were presented at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston, MA, USA. Certican was EU approved in October 2012 for the prophylaxis of organ rejection in adult patients receiving a liver transplant.