Phase IIb Study Shows Rituxan Improved Symptoms in RA Patients
Genentech, Biogen Idec and Roche have announced preliminary positive results from a large randomized clinical trial of Rituxan in rheumatoid arthritis (RA) showing that a greater proportion of patients treated with a single course of Rituxan, with a stable dose of methotrexate (MTX), achieved American College of Rheumatology (ACR) 20, 50 and 70 response rates compared to placebo.
The improvement in response rates was shown to be independent of corticosteroids. This Phase IIb trial included 465 patients who were inadequately responding to MTX and who had failed prior treatment with one or more disease-modifying anti-rheumatic drugs (DMARDs), including biologics.
The study, known as DANCER (Dose-Ranging Assessment International Clinical Evaluation of Rituximab in RA), evaluated the efficacy and safety of two doses of Rituxan (rituximab) in combination with MTX and explored the role of corticosteroids. Patients, randomized into one of nine treatment arms, received a stable dose of MTX and varying doses of Rituxan and corticosteroids. Regardless of dose, the DANCER results indicated that Rituxan provided clinically and statistically significant improvement in RA symptoms compared to placebo. In the two Rituxan groups, 54 percent and 55 percent achieved ACR 20; 33 percent and 34 percent achieved ACR 50; and 13 percent and 20 percent achieved ACR 70 -- compared to 28 percent, 13 percent and 5 percent for placebo, respectively.