title: Projecting long-term graft and patient survival after transplantation.
abstract: OBJECTIVE
  In spite of increases in short-term kidney transplant survival rates and reductions in acute rejection rates, increasing long-term graft survival rates remains a major challenge. The objective here was to project long-term graft- and survival-related outcomes occurring among renal transplant recipients based on short-term outcomes including acute rejection and estimated glomerular filtration rates observed in randomized trials.
  
  
  METHODS
  We developed a two-phase decision model including a trial phase and a Markov state transition phase to project long-term outcomes over the lifetimes of hypothetical renal graft recipients who survived the trial period with a functioning graft. Health states included functioning graft stratified by level of renal function, failed graft, functioning regraft, and death. Transitions between health states were predicted using statistical models that accounted for renal function, acute rejection, and new-onset diabetes after transplant and for donor and recipient predictors of long-term graft and patient survival. Models were estimated using data from 38,015 renal transplant recipients from the United States Renal Data System. The model was populated with data from a 3-year, randomized phase III trial comparing belatacept to cyclosporine.
  
  
  RESULTS
  The decision model was well calibrated with data from the United States Renal Data System. Long-term extrapolation of Belatacept Evaluation of Nephroprotection and Efficacy as Firstline Immunosuppression Trial was projected to yield a 1.9-year increase in time alive with a functioning graft and a 1.2 life-year increase over a 20-year time horizon.
  
  
  CONCLUSIONS
  This is the first long-term follow-up model of renal transplant patients to be based on renal function, acute rejection, and new-onset diabetes. It is a useful tool for undertaking comparative effectiveness and cost-effectiveness studies of immunosuppressive medications.
authors.affiliation: Dalhousie University; Halifax, NS, Canada; Oxford Outcomes Ltd., Vancouver, BC, Canada. Electronic address: chehead@dal.ca.
authors.forename: Adrian R
authors.initials: AR
authors.lastname: Levy
authors.affiliation: Oxford Outcomes Ltd., Vancouver, BC, Canada; University of Glasgow, Glasgow, UK.
authors.forename: Andrew H
authors.initials: AH
authors.lastname: Briggs
authors.affiliation: Oxford Outcomes Ltd., Vancouver, BC, Canada.
authors.forename: Karissa
authors.initials: K
authors.lastname: Johnston
authors.affiliation: Bristol-Myers Squibb, Princeton, NJ, USA.
authors.forename: J Ross
authors.initials: JR
authors.lastname: MacLean
authors.affiliation: Bristol-Myers Squibb, Princeton, NJ, USA.
authors.forename: Yong
authors.initials: Y
authors.lastname: Yuan
authors.affiliation: Bristol-Myers Squibb, Princeton, NJ, USA; Yale University School of Medicine, New Haven, CT, USA.
authors.forename: Gilbert J
authors.initials: GJ
authors.lastname: L'Italien
authors.affiliation: Bristol-Myers Squibb, Princeton, NJ, USA.
authors.forename: Anupama
authors.initials: A
authors.lastname: Kalsekar
authors.affiliation: Saint Louis University, St Louis, MO, USA.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Schnitzler
mesh_terms: D000069594:Abatacept; D000328:Adult; D017326:Clinical Trials, Phase III as Topic; D016572:Cyclosporine / Q000627:therapeutic use; D003661:Decision Support Techniques; D003920:Diabetes Mellitus / Q000453:epidemiology; D005260:Female; D005919:Glomerular Filtration Rate; D006084:Graft Rejection / Q000517:prevention & control; D006085:Graft Survival; D006801:Humans; D018796:Immunoconjugates / Q000627:therapeutic use; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D016030:Kidney Transplantation / Q000379:methods*; D008297:Male; D008390:Markov Chains; D015233:Models, Statistical; D017063:Outcome Assessment, Health Care; D016032:Randomized Controlled Trials as Topic; D016019:Survival Analysis; D015996:Survival Rate; D013997:Time Factors
chemical_list: D018796:Immunoconjugates; D007166:Immunosuppressive Agents; D000069594:Abatacept; D016572:Cyclosporine
keywords: decision model; end stage renal disease; modeling; renal transplant