Promising phase 3 results for giant cell arteritis treatment
Click Here to Manage Email Alerts
Genentech announced positive results from the phase 3 trial, GiACTA, which evaluated Actemra in people with giant cell arteritis, according to a press release from the company.
GiACTA met its primary and key secondary endpoint, which demonstrated that Actemra (tocilizumab), in combination with a 6-month steroid taper, enabled significantly more patients to achieve sustained disease remission (56%) while also significantly reducing steroid exposure compared with steroids alone (14%).
A 104-week open label extension study from GiACTA is still ongoing.
Actemra has been granted Breakthrough Therapy Designation for giant cell arteritis by the FDA, according to the release.
GiACTA (NCT01791153) is a phase 3, global, randomized, double-blind, placebo-controlled trial investigating the efficacy and safety of Actemra as a novel treatment for giant cell arteritis. The multicenter study was conducted in 251 patients across 76 sites in 14 countries. The primary and key secondary endpoints were evaluated at 52 weeks.