Biogen Idec and Roche have announced positive results of a Phase III clinical study of Rituxan (Rituximab) in rheumatoid arthritis (RA), showing that a significantly greater proportion of patients who received a single course of two infusions of Rituxan with a stable dose of methotrexate (MTX) achieved better response rates compared to patients who received placebo and MTX. The study included patients with active RA who have had an inadequate response or were intolerant to prior treatment with one or more therapies.
In the 24-week, multicenter, double-blind, placebo-controlled study, known as REFLEX, 520 patients were randomized to receive either Rituxan or placebo, in combination with a stable dose of MTX. At 24 weeks, those receiving Rituxan displayed clinically and statistically significant improvements in RA symptoms compared to placebo. In patients receiving Rituxan: 51 percent achieved ACR 20, the primary endpoint of the study, versus 18 percent of placebo patients; 27 percent achieved ACR 50, versus 5 percent of placebo patients; and 12 percent achieved ACR 70, versus 1 percent of placebo patients.