Genentech, a member of the Roche Group, has reported that the BREVACTA study of Actemra (tocilizumab) given by subcutaneous injection to rheumatoid arthritis (RA) patients met its primary endpoint.
In the randomised, double-blind, parallel-group study, after 24 weeks of treatment, RA patients who received Actemra every two weeks were significantly more likely to have experienced at least a 20% improvement in tender and swollen joints compared to those given placebo injections (ACR20).
Genentech global product development head and chief medical officer Hal Barron said the two studies mark a significant milestone for Actemra, consistently demonstrating that a subcutaneous formulation provides clinically meaningful results for patients with RA.
"If approved, doctors and patients will have an important alternative treatment option to choose from," Barron added.
BREVACTA was designed to assess the efficacy of treatment with Actemra 162mg SC given every two weeks versus placebo given every two weeks, both in combination with DMARDs, based on ACR20 response at week 24.
The adverse event profile of Actemra SC observed in the preliminary safety analysis was consistent with previous findings.
A secondary endpoint in BREVACTA, analysis of x-ray results, 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.
Statistical significance was also achieved on other key secondary endpoints including ACR50 and 70, DAS28 low disease activity and DAS28 remission, according to Genentech.
Genentech expects to submit the data to the USFDA to gain approval for the SC formulation of ACTEMRA.
Image: Genentech Actemra subcutaneous formulation demonstrated clinically meaningful results in RA patients. Photo: Coolcaesar at en.wikipedia.