Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
today announced that the BREVACTA study of ACTEMRA (tocilizumab) 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 ACTEMRA every two weeks were significantly more likely to
have experienced at least a 20 percent improvement in tender and swollen
joints than those given placebo injections (ACR20). A preliminary safety
analysis showed that the adverse event profile of ACTEMRA SC was
consistent with previous findings.
BREVACTA is the second positive study of a SC formulation of ACTEMRA and
follows results reported in May from the SUMMACTA study. Genentech
intends to submit these data to the U.S. Food and Drug Administration
(FDA) to gain approval for the SC formulation of ACTEMRA.
"These two studies mark a significant milestone for ACTEMRA,
consistently demonstrating that a subcutaneous formulation provides
clinically meaningful results for patients with rheumatoid arthritis,"
said Hal Barron, M.D., chief medical officer and head, Global Product
Development. "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 ACTEMRA 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 disease-modifying
antirheumatic drugs (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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