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news.Genentech, a member of the Roche Group, has reported positive results from the BREVACTA study of Actemra (tocilizumab) given by subcutaneous injection to rheumatoid arthritis (RA) patients.
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The randomised, double-blind, parallel-group study 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 has met its primary end point
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.
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.
The adverse event profile of Actemra SC observed in the preliminary safety analysis was consistent with previous findings.