The study enrolled patients with moderately-to-severely active rheumatoid arthritis (RA) who had an inadequate response to prior treatment with methotrexate (MTX), a disease modifying antirheumatic drug (DMARD). In this study, known as Serene, patients who received a single treatment course of two infusions of either 500mg or 1000mg of Rituxan in combination with a stable dose of MTX displayed a statistically significant improvement in ACR20 scores compared to patients who received placebo in combination with MTX. Although the study was not designed to compare the Rituxan doses, treatment efficacy appears to be similar between both Rituxan doses.
Hal Barron, chief medical officer of Genentech, said: “These findings support the potential use of Rituxan earlier in the course of treatment for this debilitating disease.”