Roche reports second positive study of RoACTEMRA given by subcutaneous injection to patients with rheumatoid arthritis
July 27, 2012 | by F. Hoffmann-La Roche AG
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July 27, 2012, Roche today announced that the BREVACTA study of RoACTEMRA (tocilizumab, known as ACTEMRA outside Europe) given as a subcutaneous (SC) injection to patients with rheumatoid arthritis (RA) met its primary endpoint. After 24 weeks of treatment, RA patients who received RoACTEMRA every two weeks were significantly more likely to have experienced at least a 20% improvement in tender and swollen joint counts than those given placebo injections (ACR20). Preliminary safety analysis showed that the adverse event profile of RoACTEMRA SC was consistent with previous findings.
BREVACTA is the second positive study of an SC formulation of RoACTEMRA and follows results reported in May from the SUMMACTA study. Roche intends to submit these data with health authorities globally to gain approval for the SC formulation of RoACTEMRA.
“These two studies mark a significant milestone for RoACTEMRA consistently demonstrating that a subcutaneous formulation provides clinically meaningful results for patients with rheumatoid arthritis,” said Hal Barron, M.D., Head of Global Product Development and Chief Medical Officer for Roche. “If approved, doctors and patients will have an important alternative treatment option to choose from”.
RA is an autoimmune disease estimated to affect up to 70 million people worldwide, including children. Joints become chronically inflamed, painful and swollen, and patients can become increasingly disabled as cartilage and bone is damaged. Preventing or slowing the progression of damage to RA patients’ joints is an important aim of treatment, preserving functionality and mobility.
Analysis of X ray results, a secondary endpoint in BREVACTA, also showed patients who received RoACTEMRA SC every two weeks were significantly less likely to have experienced worsening joint damage at week 24 than those given a placebo SC injection in combination with DMARDs. Statistical significance was also achieved on other key secondary endpoints including ACR50 and 70, DAS28 low disease activity and DAS28 remission. Data from BREVACTA will be submitted for presentation at an upcoming medical meeting.
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Source: F. Hoffmann-La Roche AG, Press release