Genentech announced positive results from the phase 3 GiACTA study, which evaluated Actemra (tocilizumab) in people with giant cell arteritis (GCA), according to a company news release.
GiACTA met its primary and key secondary endpoint, demonstrating that Actemra – initially in combination with a 6-month steroid (glucocorticoid) taper – enabled significantly more patients to achieve sustained disease remission while also significantly reducing steroid exposure compared with steroids alone. Data results will be presented in an oral session on Sunday, November 13 at the 2016 American College of Rheumatology (ACR) and Association for Rheumatology Health Professionals (ARHP) Annual Meeting.
“Treatment to date for GCA has been limited to high-dose steroids to rapidly control inflammation and prevent serious complications,” Sandra Horning, MD, chief medical officer and head of global product development. “However, steroid treatment often fails to control disease in the long-term and can be associated with severe side effects. If approved, Actemra could have the potential to fundamentally change the way people with GCA are treated.”
The primary endpoint of the study was met, with Actemra – initially combined with a 6-month steroid taper regimen – significantly increasing the proportion of patients achieving sustained remission at 1 year (56 percent [QW; P<0.0001] and 53.1 percent [Q2W; p<0.0001]) versus 14 percent with a 6-month steroid taper regimen given alone.
The study also met its key secondary endpoint, demonstrating that Actemra – initially combined with a 6-month steroid taper regimen – significantly increased the proportion of patients achieving sustained remission at 1 year (56 percent [QW; P<0.0001] and 53.1 percent [Q2W; p= 0.0002]) compared to 17.6 percent with a 12-month steroid taper regimen given alone.
No new safety signals were observed and these results are consistent with Actemra’s documented safety profile in rheumatoid arthritis (RA).
A 104-week open label extension study from GiACTA is still ongoing. Data from this analysis will quantify Actemra’s long-term safety and maintenance of efficacy beyond 1 year, as well as any potential long-term steroid sparing effects. Actemra has been granted Breakthrough Therapy Designation for GCA by the FDA. This designation is designed to expedite the development and review of medicines intended to treat serious diseases, and to help ensure patients have access to them as soon as possible. GiACTA builds on our wealth of knowledge and experience with Actemra in RA and demonstrates Genentech’s commitment to follow the science, and to do now what patients need next.
About the GiACTA study
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 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 primary and key secondary endpoints were evaluated at 52 weeks.