1 / 11

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.

dennis
Download Presentation

CellCept Reduces Late Renal Allograft Loss Independent of Acute Rejection

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related