Preliminary results from Genentech's ACTEMRA monotherapy study on RA

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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that preliminary results from the ADACTA (ADalimumab ACTemrA) study showed that patients who received ACTEMRA® (tocilizumab) as monotherapy achieved a significantly greater reduction in disease activity (assessed by the mean change of DAS28) after 24 weeks than those given adalimumab monotherapy. Statistical significance was also achieved on key secondary endpoints including DAS28 remission and low disease activity, ACR20, 50 and 70 (standard criteria to assess effectiveness of treatments for rheumatoid arthritis). Preliminary safety analyses showed adverse event rates were similar between the two groups.

"These data add to the growing body of evidence supporting the benefit of ACTEMRA alone when methotrexate is not appropriate," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "Now that there are several therapies approved to treat patients with rheumatoid arthritis, trials comparing two active agents are critical as they provide important information to help healthcare professionals choose the right drug for their patients."

ADACTA is the first study that was specifically designed to determine superiority between two approved biologic therapies for the treatment of rheumatoid arthritis (RA) in the monotherapy setting. The study was designed to evaluate if ACTEMRA was superior to adalimumab based on the mean change from baseline of DAS28 at week 24 in patients with moderately to severely active RA and intolerance or inadequate response to methotrexate (MTX). MTX is widely prescribed for people with RA, although about one in three RA patients on a biologic medicine are currently receiving their medication as monotherapy, largely due to an intolerance to MTX.



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