Success for Actemra (tocilizumab) in treatment of giant cell arteritis- Genentech + Roche

Genentech, a member of the Roche Group announced positive results from the Phase III study known as GiACTA , which evaluated Actemra (tocilizumab) in people with giant cell arteritis (GCA). The study met its primary and key secondary endpoints, showing Actemra, initially combined with a six-month steroid (glucocorticoid) regimen, more effectively sustained remission through one year compared to a six or 12-month steroid-only regimen in newly diagnosed and relapsing people with GCA. No new safety signals were observed with Actemra in the study at the time of this analysis. Adverse events were similar to those seen in previous Actemra clinical studies.

GiACTA (NCT01791153) is a Phase III, global, randomized, double-blind, placebo-controlled trial investigating the efficacy and safety of Actemra as a novel treatment for GCA. It is the largest 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 study's primary and key secondary endpoints were evaluated at 52 weeks. GiACTA data will be submitted for presentation at an upcoming medical conference and to the FDA for approval consideration.