Genentech, a member of the Roche Group, announced that data from the Phase III GiACTA study, which evaluated Actemra(tocilizumab) in adult patients with 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.
“The publication of these Phase III results in the New England Journal of Medicine validates the significance of our considerable basic and clinical autoimmune disease research in medical practice,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “The data from GiACTA supported the FDA approval of the first new treatment option for patients with GCA in more than 50 years, and we are committed to continuing to explore new treatment options for autoimmune diseases with significant unmet medical need.”
In May 2017, the FDA approved Actemra subcutaneous injection for the treatment of GCA. Actemra is the first therapy approved by the FDA for the treatment of adult patients with GCA. This is the sixth FDA approval for Actemra since the medicine was launched in 2010.
About the GiACTA study
GiACTA is a Phase III, global, randomized, double-blind, placebo-controlled trial investigating the efficacy and safety of subcutaneous Actemra as a novel treatment for GCA. It is the first successful 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.
Data from the Phase III GiACTA study in patients with GCA 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).
- 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).
About Giant Cell Arteritis
GCA, also known as temporal arteritis (TA), affects an estimated 228,000 people over the age of 50 in the United States, and the disease is two to three times more likely to affect women than men. GCA is often difficult to diagnose because of the wide and variable spectrum of signs and symptoms. GCA can cause severe headaches, jaw pain and visual symptoms and if left untreated, can lead to blindness, aortic aneurysm or stroke. Treatment to date for people with GCA has been limited to high-dose steroids that play a role as an effective ‘emergency’ treatment option to prevent damage such as vision loss. Due to the variability of symptoms, complexity of the disease and disease complications, people with GCA are often seen by several physicians including rheumatologists, ophthalmologists and neurologists.