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ARTICLE | Clinical News

CellCept mycophenolate mofetil: Phase III data

November 21, 2011 8:00 AM UTC

A double-blind, double-dummy, international Phase III trial in 227 patients with lupus nephritis who responded to induction therapy showed that once-daily 2 g oral CellCept met the primary endpoint of significantly improving time to treatment failure as measured by the proportion of patients who failed treatment at 36 months vs. 2 mg/kg/day oral Imuran azathioprine (16.4% vs. 32.4%, p=0.003). CellCept also met the secondary endpoints of significantly improving time to renal flare as measured by the proportion of patients who experienced a flare (12.9% vs. 23.4%, p=0.03) and time to rescue therapy as measured by the proportion of patients who required rescue therapy at 36 months vs. Imuran (7.8% vs. 17.1%, p=0.02). CellCept missed the secondary endpoints of significantly improving time to ESRD (0% vs. 2.7%, p=0.07) and time to sustained doubling of serum creatinine levels vs. Imuran (0.9% vs. 4.5%, p=0.07).

The most common adverse events were minor infections and gastrointestinal disorders and there were no significant differences in the rates of adverse events or serious adverse events between treatment groups (p=0.68 and p=0.11, respectively). The rate of withdrawal due to adverse events was significantly lower with CellCept compared to Imuran (25.2% vs. 39.6%, p=0.02). Patients initially received induction therapy consisting of once-daily 3 mg CellCept or once-monthly IV cyclophosphamide for 6 months. Those who responded to induction therapy were re-randomized to receive CellCept or Imuran. Data were published in the New England Journal of Medicine. ...