title: A longitudinal assessment of adherence with immunosuppressive therapy following kidney transplantation from the Mycophenolic Acid Observational REnal Transplant (MORE) study.
abstract: BACKGROUND
  Nonadherence with immunosuppressive therapy after renal transplantation is a major clinical concern, but longitudinal data are sparse. Adherence data were recorded during the Mycophenolic Acid Observational REnal Transplant (MORE) study to help inform compliance management decisions.
  
  
  METHODS
  Prospective data were analyzed from the four-year, observational MORE study of de novo adult renal transplant recipients receiving mycophenolic acid (MPA) as enteric-coated mycophenolate sodium (EC-MPS) or mycophenolate mofetil (MMF) at 40 US sites under routine management. Adherence was assessed using the Immunosuppressant Therapy Adherence Scale (ITAS): total score 0-12 (12, adherence; <12, nonadherence). A logistic regression model was used to identify factors associated with nonadherence.
  
  
  RESULTS
  In total, 808/946 recipients (85.4%) provided ≥1 ITAS score. Nonadherence was reported by 24.8%, 31.5%, 33.0%, 39.8%, 35.4% and 26.4% at months 3, 6, 12, 24, 36 and 48, respectively. Mean ITAS score was higher with EC-MPS vs. MMF at months 24 (11.3[1.0] vs. 10.9[1.4], p=0.001) and 36 (11.4[1.0] vs. 11.1[11.3], p=0.024). The odds ratio for nonadherence was 1.60 (95% CI 1.17, 2.19; p=0.003) for African Americans vs. non-African Americans. The rate of biopsy-proven acute rejection was 12.7% (51/401) in nonadherent recipients vs. 11.3% (46/406) in adherent recipients (p=0.59); graft loss was 4.7% (19/402) vs. 3.0% (12/406) (p=0.20); death was 1.5% (6/402) vs. 4.7% (19/406) (p=0.013).
  
  
  CONCLUSIONS
  Adherence to the immunosuppressive regimen decreases over time, highlighting the need to monitor and encourage adherence even in long-term maintenance kidney transplant patients. Other than African American race, demographic factors may be of limited value in predicting nonadherence.
authors.affiliation: New York Presbyterian Hospital, Columbia University Medical Center, New York, USA.
authors.forename: Demetra
authors.initials: D
authors.lastname: Tsapepas
authors.affiliation: Vanderbilt University Medical Center, Nashville, USA.
authors.forename: Anthony
authors.initials: A
authors.lastname: Langone
authors.affiliation: School of Medicine, University of Colorado, Aurora, USA.
authors.forename: Laurence
authors.initials: L
authors.lastname: Chan
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, USA.
authors.forename: Anne
authors.initials: A
authors.lastname: Wiland
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, USA.
authors.forename: Kevin
authors.initials: K
authors.lastname: McCague
authors.affiliation: College of Pharmacy, University of Tennessee, Memphis, USA.
authors.forename: Marie
authors.initials: M
authors.lastname: Chisholm-Burns
mesh_terms: D000328:Adult; D001741:Black or African American / Q000706:statistics & numerical data; D005260:Female; D006084:Graft Rejection / Q000188:drug therapy* / Q000208:ethnology / Q000401:mortality; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D016030:Kidney Transplantation / Q000401:mortality*; D016015:Logistic Models; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012307:Risk Factors; D016019:Survival Analysis; D016903:Drug Monitoring
chemical_list: D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid