Phase III study shows improved symptoms

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.

In this study, 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 an upcoming medical meeting.

A preliminary analysis of the data did not reveal any unexpected safety signals. The most common side effects in the Rituxan arm included headache, upper respiratory tract infection and nasopharyngitis. The reported rate of serious adverse events was comparable across the two treatment arms.

'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. 'We look forward to sharing the REFLEX data in our discussions with the FDA.'

'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 approach for this debilitating disease,' said Dr Hal Barron, Genentech's senior vice president, development and chief medical officer. 'While we are encouraged that the preliminary safety results are similar to previous studies, we recognize the importance of monitoring long-term safety in RA patients treated with Rituxan.'

These new Phase III data follow recent positive preliminary findings from a Phase IIb study that evaluated the efficacy and safety of Rituxan in moderate-to-severe RA patients who failed prior treatment with at least one disease-modifying anti-rheumatic drug (DMARD).