Mycophenolic Acid (MPA) Dosing: Effect on Efficacy to 4 Years after Kidney Transplantation in the Mycophenolic Acid Observational Renal Transplant (MORE) Study
University of Colorado School of Medicine, Aurora, CO
University of Utah School of Medicine, Salt Lake City, UT
Erie County Medical Center, Buffalo, NY
Thomas Jefferson University Hospital, Philadelphia, PA
Novartis Pharmaceuticals Corporation, East Hanover, NJ
Vanderbilt University Medical Center, Nashville, TN
Meeting: 2013 American Transplant Congress
Abstract number: B1028
Maintaining adequate MPA dose may be important to optimize efficacy after kidney transplantation, but prospective long-term data are rare.
Methods. MORE was a prospective, observational study of de novo adult living- or deceased-donor kidney transplant patients receiving MPA as enteric-coated mycophenolate sodium (EC-MPS) or mycophenolate mofetil (MMF) at 40 US sites. Study visits took place at baseline and months 1, 3, 6 and 12 then annually to four years post-transplant.
Results: Data from 904 tacrolimus-treated patients (616 EC-MPS, 288 MMF) were analyzed. Living donors were less frequent in the EC-MPS group (39.4% vs 49.0% with MMF, p=0.04); concomitant immunosuppression was similar. Mean MPA daily dose standardized to MMF dosing was 1836, 1726, 1566, 1502, 1454, 1397 and 1333mg at months 1, 3, 6, 12, 24, 36 and 48, respectively. Mean estimated GFR (eGFR, CKD-EPI) at 1 year was 58.8 vs 56.3mL/min/1.73m2 (p=0.90) in patients who were maintained on MPA dose ≥2000mg vs <2000mg, and 58.7 vs 55.3mL/min/1.73m2 at 3 years (p=0.85). EC-MPS patients were maintained on full dose MPA more frequently than MMF-treated patients at month 1 (79.2% vs 71.7%), month 3 (68.5% vs 56.9%) and month 6 (52.9% vs 44.0%) (all p<0.05) with no significant differences thereafter. Mean MPA dose standardized to MMF dosing for EC-MPS vs MMF was 1856 vs 1795mg at month 1, 1755 vs 1661mg at month 3 and 1593 vs 1505mg at month 6 (all p≤0.05). The 4-year incidence of BPAR was 14.0% with EC-MPS vs 10.1% with MMF (log rank p=0.20). Mean eGFR was 58.0 vs 59.1mL/min/1.73m2 with EC-MPS vs MMF at 1 year (p=0.50) and 59.3 vs 55.2mL/min/1.73m2 at 3 years (p=0.12). Graft survival, patient survival and adverse events by organ system (including gastrointestinal events) were similar at 4 years with EC-MPS or MMF.
Conclusion: MPA dose declines progressively over time in kidney transplant patients. MPA dosing was maintained at the recommended level more frequently with EC-MPS than MMF to month 6 post-transplant, with no impact on adverse event profile.
Chan, L.: Grant/Research Support, Novartis, Other, Novartis, Consultant. Shihab, F.: Grant/Research Support, Novartis, Speaker’s Bureau, Novartis, Other, Novartis, Consultant, Astellas, Consultant. Pankewycz, O.: Grant/Research Support, Novartis. Wiland, A.: Employee, Novartis. McCague, K.: Employee, Novartis.
To cite this abstract in AMA style:
Chan L, Shihab F, Pankewycz O, Doria C, Wiland A, McCague K, Langone A. Mycophenolic Acid (MPA) Dosing: Effect on Efficacy to 4 Years after Kidney Transplantation in the Mycophenolic Acid Observational Renal Transplant (MORE) Study [abstract]. Am J Transplant. 2013; 13 (suppl 5). https://atcmeetingabstracts.com/abstract/mycophenolic-acid-mpa-dosing-effect-on-efficacy-to-4-years-after-kidney-transplantation-in-the-mycophenolic-acid-observational-renal-transplant-more-study/. Accessed January 27, 2021.« Back to 2013 American Transplant Congress