Published on November 8, 2010 at 2:12 AM
Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced updated data from a Phase III study (ROSE) that showed rheumatoid arthritis (RA) patients receiving ACTEMRA® (tocilizumab) experienced a rapid, measured response as early as one week after beginning ACTEMRA, and improvement in disease activity within four weeks. Additionally, combined data from three other Phase III studies showed that RA patients who received ACTEMRA had sustained improvements in signs and symptoms over nearly two years. These data will be presented at the 2010 American College of Rheumatology (ACR) Annual Scientific Meeting in Atlanta, November 7-11, 2010.
“Data presented at ACR provide further evidence of the long-term benefits of Actemra in reducing the signs and symptoms in patients with moderate to severe RA”
Across the pooled studies, the overall safety of ACTEMRA was consistent with earlier data and showed stable rates of serious infections, malignancies, and cardiovascular events with continued exposure.
"Data presented at ACR provide further evidence of the long-term benefits of Actemra in reducing the signs and symptoms in patients with moderate to severe RA," said Hal Barron, M.D., executive vice president, Product Development and chief medical officer. "Also, we are very excited about the new data that showed that Actemra helped children who were suffering from sJIA, the most severe form of juvenile arthritis."
Data from the Phase III TENDER study showed 85 percent (64/75) of children with systemic Juvenile Idiopathic Arthritis (sJIA) receiving ACTEMRA experienced a 30 percent improvement (JIA ACR30) in the signs and symptoms of sJIA and an absence of fever after three months of therapy, compared with 24 percent (18/37) of children receiving placebo (p<0.0001). The TENDER study served as the basis for a supplemental Biologics License Application (sBLA) recently submitted to the U.S. Food and Drug Administration (FDA).
sJIA has the worst long-term prognosis of all childhood arthritis subtypes, accounting for almost two-thirds of all deaths among children with arthritis.
Source: Genentech, Inc