The U.S. Food and Drug Administration ( FDA ) has approved Actemra [ European Union: RoActemra ] ( Tocilizumab ) subcutaneous injection for the treatment of giant cell arteritis ( GCA ), a chronic and severe autoimmune condition.
Actemra is the first therapy approved by the FDA for the treatment of adult patients withgiant cell arteritis.
This is the sixth FDA approval for Actemra since the medicine was launched in 2010.
The approval is based on the positive outcome of the phase III GiACTA study evaluating Tocilizumab in patients with giant cell arteritis.
The results showed that Tocilizumab, initially combined with a six-month steroid ( glucocorticoid ) regimen, more effectively sustained remission through 52 weeks ( 56% in the Tocilizumab weekly group and 53.1% in the Tocilizumab bi-weekly group ) compared to placebo combined with a 26-week steroid taper ( 14% ) and placebo combined with a 52-week steroid taper ( 17.6% ).
GiACTA is a phase III, global, randomised, double-blind, placebo-controlled trial investigating the efficacy and safety of Tocilizumab as a novel treatment for giant cell arteritis.
It is the first successful clinical trial 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 endpoint was evaluated at 52 weeks.
Giant cell arteritis, also known as temporal arteritis, is a severe autoimmune condition. Giant cell arteritis has a global impact, usually affects those above the age of 50, and is two-to-three-times more likely to affect women than men.
Giant cell arteritis is often difficult to diagnose because of the wide and variable spectrum of signs and symptoms. Giant cell arteritis 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 giant cell arteritis 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 giant cell arteritis are often seen by several physicians including rheumatologists, ophthalmologists and neurologists.
Tocilizumab is an anti-IL-6 receptor antibody. ( Xagena )
Source: Roche, 2017