Phase III study shows improved symptoms

Published: 1-May-2005
Regulatory


A Phase III clinical study of Genentech, Biogen Idec and Roche's Rituxan (Rituximab) met its primary endpoint of a greater proportion of Rituxan-treated patients achieving an American College of Rheumatology (ACR) 20 response at week 24, compared with placebo. The study included patients with active rheumatoid arthritis (RA) who have had an inadequate response or were intolerant to prior treatment with one or more anti-TNF therapies.

Known as REFLEX (Randomised Evaluation of Long-term Efficacy of Rituximab in RA), patients who received a single treatment course of two infusions of Rituxan with a stable dose of methotrexate (MTX) displayed a statistically significant improvement in symptoms compared to patients who received placebo and MTX. Further analyses of the data are ongoing and will be submitted for presentation at a forthcoming medical meeting.

'These results continue to support the potential of Rituxan as a new therapeutic option for RA,' said Dr Burt Adelman, executive vice president, development, Biogen Idec. 'These are the first Phase III Rituxan data to demonstrate clinical improvement in this difficult-to-treat RA patient population. The findings add to the growing body of evidence that selectively targeting B cells may provide an important new treatment.'

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