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news.Aspreva Pharmaceuticals and Roche said that a study comparing CellCept to intravenous cyclophosphamide, the current standard of care, for lupus nephritis did not meet its trial goals.
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Although response rates were similar in both arms, the trial did not meet its primary objective of demonstrating that CellCept was superior to intravenous cyclophosphamide (IVC) in inducing treatment response in this disease.
The results relate to the induction phase of this study, which was designed to measure treatment response in patients after 24 weeks of induction therapy with 185 patients in the CellCept arm and 185 in the IVC arm. The results indicate similar treatment responses with 56.2% in the CellCept arm and 53% in the IVC arm were observed.
Based on preliminary analysis, it appears that, in general, the adverse events experienced by patients in both arms of the study are consistent with those observed in lupus nephritis patients receiving immunosuppressive therapy. Overall incidence of adverse events was comparable in both treatment arms.