Genentech presents Actemra ROSE trial data

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.

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.

Genentech said that the data from the Phase III Tender study showed 85% (64/75) of children with sJIA receiving Actemra experienced a 30% improvement (JIA ACR30) in the signs and symptoms of sJIA and an absence of fever after three months of therapy, compared with 24% (18/37) of children receiving placebo.

The Tender study served as the basis for a supplemental biologics license application (sBLA) recently submitted to the US Food and Drug Administration (FDA).

The ROSE study was designed to assess the efficacy of Actemra versus placebo in combination with disease-modifying anti-rheumatic drugs (DMARDs) in reducing signs and symptoms during 24 weeks of treatment in patients with moderate to severe RA who had inadequate clinical response to DMARDs.

The primary end point of the study was reached if patients had a 50% reduction in signs and symptoms of disease activity (ACR50) at 24 weeks.

Genentech’s ROSE study showed RA patients receiving Actemra experienced a rapid response as early as one week after beginning treatment as measured by a disease activity score using 28 joint counts (DAS28), and improvement in disease activity within four weeks.

Genentech Product Development executive vice president and chief medical officer Hal Barron said that data presented provide further evidence of the long-term benefits of Actemra in reducing the signs and symptoms in patients with moderate to severe RA.

"Also, we are very excited about the new data that showed that Actemra helped children who were suffering from systemic Juvenile Idiopathic Arthritis (sJIA)," Barron said.