Rituxan meets primary endpoint in MS trial

3 September 2006

USA-based firms Genentech and Biogen Idec say that a study of the co-marketed therapeutic antibody Rituxan (rituximab), used in the treatment of relapsing-remitting multiple sclerosis, has met its primary endpoint. Specifically, the agent brought about a statistically-significant reduction in the total number of gadolinium enhancing T1 lesions observed with MRI scans at 12, 16, 20 and 24 weeks of treatment, compared with placebo.

The study, which enrolled a total of 104 RRMS patients at 48 sites in the USA and Canada, also showed that the rate of adverse and serious adverse events was comparable between the treated and placebo cohorts. The firms also reported that there were more infusion-related events associated with Rituxan. In addition, around 5% of the treated patients developed anti-human chimeric antibodies to the agent, although this was not associated with loss of clinical response or additional safety concerns.

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