Roche's RA Drug Achieves Key Steroid-Free Remission Goal in Phase 3 Study

Roche announced positive results from the phase III GiACTA study, which evaluated Actemra®/RoActemra® (tocilizumab) in people with giant cell arteritis (GCA). GiACTA met its primary and key secondary endpoint, demonstrating that Actemra/RoActemra – 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, 13 November 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 such as vision loss,” said 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/RoActemra could have the potential to fundamentally change the way people with GCA are treated.”

The primary endpoint of the study was met, with Actemra/RoActemra – 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/RoActemra – 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 observed¹ and these results are consistent with Actemra/RoActemra’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/RoActemra’s long-term safety and maintenance of efficacy beyond one year, as well as any potential long-term steroid sparing effects. Actemra has been granted Breakthrough Therapy Designation for GCA by the US Food and Drug Administration (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/RoActemra in RA and demonstrates Roche’s commitment to follow the science, and to do now what patients need next.