Positive results from Phase IIIGiACTA study of Actemra (tocilizumab) for Giant Cell Arteritis.- Genentech + Roche

Genentech announced positive results from the Phase III GiACTA study, which evaluated Actemra (tocilizumab) in people with Giant Cell Arteritis (GCA). GiACTA met its primary and key secondary endpoint, demonstrating that Actemra (tocilizumab) – initially in combination with a six-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.

The primary endpoint of the study was met, with Actemra – initially combined with a six-month steroid taper regimen – significantly increasing the proportion of patients achieving sustained remission at one year (56 percent [QW; p <0.0001] and 53.1 percent [Q2W; p<0.0001]) versus 14 percent with a six-month steroid taper regimen given alone.The study also met its key secondary endpoint, demonstrating that Actemra – initially combined with a six-month steroid taper regimen – significantly increased the proportion of patients achieving sustained remission at one 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 one year, as well as any potential long-term steroid sparing effects.