Biogen Idec, Inc. (California) Release: Positive Results Of Phase III Study Of Rituxan In Rheumatoid Arthritis To Be Presented At American College of Rheumatology Meeting
SAN DIEGO--(BUSINESS WIRE)--Nov. 16, 2005-- Study Shows a Greater Proportion of Rituxan-Treated Patients Achieved American College of Rheumatology 20, 50 and 70 Responses Compared to Placebo Biogen Idec (Nasdaq: BIIB) and Roche (SWX Zurich) today announced positive results of a Phase III clinical study of Rituxan(R) (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 American College of Rheumatology (ACR) 20, 50 and 70 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 anti-TNF therapies. These data were submitted to the U.S. Food and Drug Administration (FDA) as part of a supplemental Biologics License Application for Rituxan that is currently under Priority Review. These findings will be presented today during a plenary session at the ACR Annual Scientific Meeting in San Diego. In the 24-week multi-center, double-blind, and 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; -- 12 percent achieved ACR 70, versus 1 percent of placebo patients.