Genentech reports results of ACTEMRA Phase III study for rheumatoid arthritis

GenentechOct 19 2009

Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced two-year results from a Phase III study, which showed that people with rheumatoid arthritis (RA) who received either a 4 mg/kg or 8 mg/kg dose of ACTEMRA^® (tocilizumab), in combination with methotrexate, had no progression of joint damage, (75 and 83 percent, respectively, as assessed by radiograph) compared with people who received methotrexate alone (66 percent). The overall safety profile of ACTEMRA was consistent across all global clinical studies. The study, known as LITHE, will be featured as an oral presentation during the American College of Rheumatology (ACR) Annual Scientific Meeting along with results from two additional studies evaluating the long-term use of ACTEMRA in people with RA.

The LITHE study also showed that people who received either dose of ACTEMRA plus methotrexate showed significant improvement in physical function, compared with people who received methotrexate plus placebo, as measured by the mean area under the curve (AUC) of the Health Assessment Questionnaire Disability Index (HAQ-DI)change from baseline. In addition, 65 percent of people who received ACTEMRA (8 mg/kg) plus methotrexate for two years had their disease go into remission compared with 48 percent of people treated for just one year. In this study, remission was defined by achieving a disease activity score (called DAS28) of less than 2.6. DAS28 is a commonly used tool that assesses a variety of measures, including swollen and tender joints at multiple time points.

“Two primary goals in treating RA are keeping the disease in remission for as long as possible and reducing the amount of joint damage that occurs,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer, Genentech. “This study showed that ACTEMRA both improved physical function and delayed progression of joint damage in people with moderate to severe RA and importantly, that benefit was sustained for two years.”