Conflict of interest: CD, KU, FS, and LC have received speaker's honoraria from Novartis. OP and FS have received research support from Novartis. All authors received research support for the MORE Study. AL, SG, MN, and BS have no conflicts of interest to declare.
Does reduction in mycophenolic acid dose compromise efficacy regardless of tacrolimus exposure level? An analysis of prospective data from the Mycophenolic Renal Transplant (MORE) Registry
Version of Record online: 1 AUG 2012
© 2012 John Wiley & Sons A/S
Volume 27, Issue 1, pages 15–24, January–February 2013
How to Cite
Does reduction in mycophenolic acid dose compromise efficacy regardless of tacrolimus exposure level? An analysis of prospective data from the Mycophenolic Renal Transplant (MORE) Registry., , , , , , , , .
Re-use of this article is permitted in accordance with the Terms and Conditions set out at http://wileyonlinelibrary.com/onlineopen#OnlineOpen_Terms.
- Issue online: 28 JAN 2013
- Version of Record online: 1 AUG 2012
- Manuscript Accepted: 15 MAY 2012
- Novartis Pharmaceuticals Corporation
- kidney transplantation;
- mycophenolate mofetil;
Prospective data are lacking concerning the effect of reduced mycophenolic acid (MPA) dosing on efficacy and the influence of concomitant tacrolimus exposure. The Mycophenolic Renal Transplant (MORE) Registry is a prospective, observational study of de novo kidney transplant patients receiving MPA therapy under routine management. The effect of MPA dose reduction, interruption, or discontinuation (dose changes) was assessed in 870 tacrolimus-treated patients: 375 (43.1%) reduced tacrolimus (≤7 ng/mL at baseline) and 495 (56.9%) standard tacrolimus (>7 ng/mL); enteric-coated mycophenolate sodium 589 (67.7%) and mycophenolate mofetil 281 (32.3%). During baseline to month 1, months 1–3, months 3–6, and months 6–12, 9.3% (78/838), 16.6% (132/794), 20.7% (145/701), and 13.1% (70/535) patients, respectively, required MPA dose changes. These patients experienced an increased risk of biopsy-proven acute rejection at one yr with tacrolimus exposure either included in the model (hazard ratio [HR] 2.60, 95% CI 1.28–5.29, p = 0.008) or excluded (HR 2.58, 95% CI 1.28–5.23, p = 0.008). MPA dose changes were significantly associated with one yr graft failure when tacrolimus exposure was included (HR 2.23; 95% CI 1.01–4.89, p = 0.047) but not when tacrolimus exposure was excluded (HR 2.16; 95% CI 0.99–4.79; p = 0.054). These results suggest that reducing or discontinuing MPA can adversely affect graft outcomes regardless of tacrolimus trough levels.