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CellCept Reduces Late Renal Allograft Loss Independent of Acute Rejection

CellCept Reduces Late Renal Allograft Loss Independent of Acute Rejection. Ojo AO, Meier-Kriesche H-U, Hanson JA, Leichtman AB, Cibrik D, Magee JC, Wolfe RA, Agodoa LY, Kaplan B. Study Background.

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CellCept Reduces Late Renal Allograft Loss Independent of Acute Rejection

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  1. CellCept Reduces Late Renal Allograft Loss Independent of Acute Rejection Ojo AO, Meier-Kriesche H-U, Hanson JA, Leichtman AB, Cibrik D, Magee JC,Wolfe RA, Agodoa LY, Kaplan B

  2. Study Background • Chronic allograft nephropathy (CAN) is a major contributor to long-term renal allograft failure • CellCept has been proven to reduce the incidence of acute rejection; however, its impact on long-term graft survival has not yet been documented • Previous multicenter trials were not statistically powered to detect an effect of CellCept over azathioprine (AZA) on late graft loss1,2 1US Renal Transplant MMF Study Group. Am J Kidney Dis. 1999;34:296-303. 2Mathew TH et al. Transplantation. 1998;65:1450-1454.

  3. Study Design Patients • Retrospective study of single renal transplant recipients(N = 66,744) having adequate graft function without need for dialysis at 6 months posttransplantation • Mean follow-up: AZA group = 68.7  26.9 months; CellCept group = 26.0  11.7 months Immunosuppression (at the time of discharge) • AZA group = CsA or tacrolimus, AZA  steroids (n = 48,436) • CellCept group = CsA or tacrolimus, CellCept  steroids (n = 8435) • Other maintenance regimens (n = 9903) Primary End Point • Chronic renal allograft failure (CAF), censored for patient death, or graft loss secondary to acute rejection, graft thrombosis, infection, surgical complications, or recurrent disease

  4. Statistical Methods • Kaplan-Meier Analysis • Used to generate survival plots • Allows for “censoring” of patients • Suited for small sample sizes • Breslow Test • Used to determine statistical significance between survival curves • Cox Proportional Hazard Regression • Used to estimate the independent effect of CellCept on CAF while controlling for other potentially relevant risk factors • Risk Ratio • Determines the effect of a given covariate on survival

  5. Results • Acute rejection was strongest risk factor for graft loss secondary to CAF, with a risk ratio (RR) of 2.41 • After controlling for AR, risk of graft loss secondary to CAF was reduced by 27%(RR = 0.73; P <0.001) in CellCept-treated vs AZA-treated patients • In the subgroup of patients who were acute rejection–free, patients in the CellCept group had a 20% greater reduction in CAF than those in the AZA group (RR = 0.8; P <0.001)

  6. 100 AZA CellCept 95 GraftSurvival (%) 90 85.6% P <0.0001 85 81.9% 0 0 12 24 36 48 Months Posttransplantation Four-Year Death-Censored Graft Survival: AZA vs CellCept

  7. 100 AZA CellCept 95 91.4% Patient Survival (%) 89.8% 90 P = 0.002 85 0 0 12 24 36 48 Months Posttransplantation Four-Year Patient Survival: AZA vs CellCept

  8. Multivariate Analysis for Graft Loss Secondary to CAF: Protective Factors and Risk Factors

  9. Cox Proportional Hazard Model for Patient Death: Protective Factors and Risk Factors

  10. 4 3.7 3.5 2.9 3 2.5 1.9 Relative Risk 2 1.5 1 0.5 0 1988-91 1992-94 1995-97 Years Relative Risk of Acute Rejection on Development of CAF by Era

  11. Conclusions: Key Points • CellCept has a beneficial effect on graft survival independent of its effect in preventing AR • Beneficial effect of CellCept on graft survival is comparable to that of having a living donor • Results are consistent with previous findings in large CellCept trials; AR rate: CellCept, 15.5%; AZA, 24.7% (P <0.001) • Risk factors for CAF were similar to those previously determined

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