Phase III GiACTA study of Actemra (tocilizumab) in giant cell arteritis, is published in the New England Journal of Medicine.- Genentech/Roche.

Genentech a member of the Roche Group announced that data from the Phase III GiACTA study, which evaluated Actemra(tocilizumab) in adult patients with Giant Cell Arteritis (GCA), were published in the July 27, 2017 issue of the New England Journal of Medicine. The primary endpoint of the study was met.

Actemra combined with a 26-week steroid taper regimen showed superiority in achieving sustained remission at 52 weeks (56 percent [Actemra-weekly group; p<0.0001] and 53.1 percent [Actemra-biweekly group; p<0.0001]) compared to placebo combined with a 26-week steroid taper regimen (14 percent). 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 (56 percent [Actemra-weekly group; p<0.0001] and 53.1 percent [Actemra-biweekly group; p=0.0002]) compared to placebo combined with a 52-week steroid taper regimen (17.6 percent). 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.

See-"Trial of Tocilizumab in Giant-Cell Arteritis"- John H. Stone, M.D., M.P.H., Katie Tuckwell, Ph.D., Sophie Dimonaco, M.Sc.,et al., N Engl J Med 2017; 377:317-328July 27, 2017DOI: 10.1056/NEJMoa1613849.