The results from the phase III study known as GiACTA, which evaluated Tocilizumab ( Actemra, RoActemra ), an anti-IL-6 receptor monoclonal antibody, in people with giant cell arteritis ( GCA ) were presented.
The study met its primary and key secondary endpoints showing that Tocilizumab, initially combined with a six month steroid ( glucocorticoid ) regimen, more effectively sustained remission through one year compared to a six or 12 month steroid-only regimen in people with newly diagnosed and relapsing GCA.
No new safety signals were observed with Tocilizumab in the study at the time of this analysis.
Adverse events were similar to those seen in previous clinical studies with Tocilizumab.
Giant cell arteritis is a serious condition where arteries, commonly in the head but also the aorta and its branches, become inflamed.
This inflammation can lead to persistent and severe headaches, scalp tenderness and jaw and arm pain. It is difficult to diagnose and if left untreated, giant cell arteritis may lead to blindness, stroke or aortic aneurysms.
Vision problems occur in approximately 30% of people with giant cell arteritis and about 15% experience permanent vision loss.
Approximately 80% of people with giant cell arteritis who are exposed to long-term steroid use experience steroid-related side effects such as cataracts, diabetes, fractures, and hypertension. Reducing the use of steroids in this patient group is an important goal for physicians and people living with giant cell arteritis.
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 multicenter study was conducted in 251 patients across 76 sites in 14 countries.
The study's primary and key secondary endpoints were evaluated at 52 weeks.
The occurrence of giant cell arteritis has been estimated at over 200 per 100,000 persons in the United States over the age of 50. An even higher frequency has been reported in northern Europe.
Giant cell arteritis is two to three times more likely to affect women and is often difficult to diagnose due to the wide and variable spectrum of signs and symptoms.
With no new treatments in more than 50 years, people with giant cell arteritis are limited to high-dose steroid treatment that generally fails to cure giant cell arteritis or induce long-term steroid-free remissions. ( Xagena )
Fonte: Roche, 2016