27 July 2017 - - South San Francisco, California-based biotechnology company Genentech, a member of the Roche Group (SIX: RO, ROG) (OTCQX: RHHBY) has published data from the Phase III GiACTA study of Actemra (tocilizumab) in adult patients with giant cell arteritis (GCA) in the July 27, 2017 issue of the New England Journal of Medicine, the company said.
GiACTA is a Phase III, global, randomized, double-blind, placebo-controlled trial investigating the efficacy and safety of subcutaneous Actemra as a novel treatment for GCA. It is the first successful clinical trial ever conducted in GCA and the first to use blinded, variable-dose, variable-duration steroid regimens. The multicenter study was conducted in 251 patients across 76 sites in 14 countries.
The primary endpoint of the study was met; 56% of patients treated with subcutaneous Actemra weekly with a steroid taper phase achieved steroid-free disease remission at one year, versus 14% in the placebo plus 26-week steroid taper group.
The study also met its key secondary endpoint, demonstrating that Actemra combined with a 26-week steroid taper regimen showed superiority in achieving sustained remission at 52 weeks.
No new safety signals were observed and the safety profile of the Actemra groups was generally consistent with the documented safety profile of Actemra in other indications.
In May 2017, the FDA approved Actemra subcutaneous injection for the treatment of GCA. It is the first therapy approved by the FDA for the treatment of adult patients with GCA, and the sixth FDA approval for Actemra since the medicine was launched in 2010.
Actemra is the first humanized interleukin-6 receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have used one or more disease-modifying antirheumatic drugs (DMARDs) that did not provide enough relief. It is also used as an IV formulation for patients with active polyarticular juvenile idiopathic arthritis or systemic juvenile idiopathic arthritis two years of age and older.
Genentech discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions.