Genentech Phase III Study Shows Actemra Effective at Maintaining Steroid-Free Remission in Patients with Giant Cell Arteritis
June 18, 2016
Genentech has announced the topline results of GiACTA, a study assessing Actemra® (tocilizumab) as a treatment for patients with giant cell arteritis (GCA) (also see full press release below). The study met its primary and key secondary endpoints, showing Actemra, 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 Actemra in the study at the time of this analysis. GiACTA is the largest clinical trial ever conducted in patients with GCA.
GCA, a form of vasculitis, is a serious and difficult to diagnose condition where arteries, commonly in the head but also in the aorta and its branches, become inflamed. The condition can lead to a number of complications including blindness.
Currently, GCA patients are limited to high-dose steroid treatments, which generally fail to cure GCA or induce long-term steroid-free remissions. There have been no new treatments for GCA in more than 50 years.
· GCA generally affects adults above the age of 50 and is two to three times more likely to affect women
· It is estimated that more than 200 per 100,000 persons in the United States over the age of 50 have GCA
· Approximately 80 percent of GCA patients exposed to long-term steroid use experience steroid-related side effects such as cataracts, diabetes, fractures and hypertension
· GCA may lead to blindness, stroke or aortic aneurysms. Vision problems occur in approximately 30 percent of GCA patients
“The results of the GiACTA study mark a huge step forward for patients with giant cell arteritis (GCA) – in fifty years no medication other than glucocorticoids has ever been shown in a convincing way to be effective,” said GiACTA’s lead investigator, John H. Stone, M.D., M.P.H, Professor of Medicine, Harvard Medical School, Director of Clinical Rheumatology and Edward Fox Chair in Medicine at the Massachusetts General Hospital. “This rigorous, randomized and carefully-blinded study addresses one of the greatest needs of physicians who treat GCA – finding an alternative to prolonged periods of steroid therapy.”
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