Clinical Trials

Date: 2017-07-26

Type of information: Publication of results in a medical journal

phase: 3

Announcement: publication of results in The New English Journal of Medicine

Company: Roche (Switzerland)

Product: Actemra®/RoActemra® (tocilizumab)

Action mechanism:

• monoclonal antibody. Actemra® is a humanized monoclonal antibody against the IL6 receptor. It works by inhibiting biological activity of IL-6 through competitively blocking the binding of IL-6 to its receptor.
• In May 2017, the FDA approved Actemra® subcutaneous injection for the treatment of giant cell arteritis. Actemra® is the first therapy approved by the FDA for the treatment of adult patients with giant cell arteritis. This is the sixth FDA approval for Actemra® since the medicine was launched in 2010.

Disease: giant cell arteritis

Therapeutic area: Autoimmune diseases

Country: Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden, UK, USA

Trial details:

• GiACTA  is a Phase III, global, randomised, double-blind, placebo-controlled trial investigating the efficacy and safety of Actemra®/RoActemra® as a novel treatment for giant cell arteritis. It is the largest clinical trial ever conducted in giant cell arteritis and the first to use blinded, variable-dose, variable-duration steroid regimens. The multicentre study was conducted in 251 patients across 76 sites in 14 countries. The primary and key secondary endpoints were evaluated at 52 weeks. (NCT01791153)

Latest news:

• • On July 26, 2017, Roche announced  that data from the Phase III GiACTA study, which evaluated Actemra®(tocilizumab) in adult patients with giant cell arteritis, 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 observed1 and the safety profile of the Actemra groups was generally consistent with the documented safety profile of Actemra® in other indications. Data from the Phase III GiACTA study in patients with giant cell arteritis showed: Actemra, initially combined with a six-month steroid (glucocorticoid) regimen, more effectively sustained remission through 52 weeks (56 percent in the Actemra weekly group and 53.1 percent in the Actemra biweekly group) compared to placebo combined with a 26-week steroid taper (14 percent) (p<0.0001).1 Actemra, initially combined with a six-month steroid (glucocorticoid) regimen, more effectively sustained remission through 52 weeks (56 percent in the Actemra weekly group and 53.1 percent in the Actemra biweekly group) compared to placebo combined with a 52-week steroid taper (17.6 percent). Fewer patients reported serious adverse events (SAEs) in the Actemra weekly (15 percent) and biweekly groups (14.3 percent) than in the placebo combined with a 26-week steroid taper regimen (22 percent) and placebo combined with a 52-week steroid taper regimen groups (25.5 percent). • On November 13, 2016, Roche presented results from the phase III GiACTA study, at the 2016 American College of Rheumatology (ACR) and Association for Rheumatology Health Professionals (ARHP) Annual Meeting. The trial which evaluated Actemra®/RoActemra® (tocilizumab) in people with giant cell arteritis . 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. 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% [QW; p <0.0001] and 53.1% [Q2W; p<0.0001]) versus 14% 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% [QW; p <0.0001] and 53.1% [Q2W; p= 0.0002]) compared to 17.6% 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 . 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.

Is general: Yes