Study suggests TDM for at-risk CellCept patients

Swiss drug major Roche presented data at the 22nd International Congress of the Transplantation Society, held in Sydney, Australia, which suggest that therapeutic dose monitoring of CellCept (mycophenolic acid) should be carried out on patients at high risk of organ rejection to ensure optimal treatment.

Defined as those experiencing delayed function of the transplanted organ, second or third transplantation, raised levels (>15%) of circulating defence antibodies that play a role in initiating rejection, and low donor/recipient compatibility, at-risk subjects on CellCept should receive TDM, according to data from a follow-up analysis of the FDCC study, carried out in 901 kidney transplant patients.

The post-hoc, exploratory study was performed to test the relationship between mycophenolic acid plasma concentrations and the incidence of acute rejection. In the full trial population, an area under the concentration-time curve from zero to 12 hours (AUC0-12) for mycophenolic acid below 30mg*h/L, on day three after transplantation, was associated with a significant risk of acute rejection in the first month (11.4% risk versus 6.4% in patients with MPA-AUC0-12 above 30mg*h/L [p = 0.018]).