Hoffmann-La Roche Limited (Roche Canada) today announced that Health Canada has approved ACTEMRA (tocilizumab) for the treatment of adult patients with giant cell arteritis (GCA). The approval was based on the outcome of the phase III GiACTA study, which showed that ACTEMRA, initially combined with a six-month steroid taper, sustained remission at one year in 56 per cent and 53 per cent of patients (with the weekly and bi-weekly doses respectively), compared to 14 per cent of patients in the placebo arm with a six-month steroid taper given alone.3
ACTEMRA is designed to directly target the interleukin-6 (IL-6) receptor, a protein that is made by the immune system, which the body uses to manage infections and plays a major role in the signs and symptoms of GCA. There have been no new treatments in more than 50 years.
“When GCA is diagnosed too late or left untreated, it can cause serious, even potentially life-threatening, complications,” says Dr. Christian Pagnoux, Internal Medicine Specialist and Rheumatologist at Mount Sinai Hospital in Toronto. “Treatment of GCA patients was limited to high-dose, long-duration steroids, and relapses were almost constant. The approval of Actemra provides physicians in Canada with a new treatment option.”
GCA is the most common form of vasculitis that occurs in adults. It is caused by inflammation of the lining of the arteries.7 The disease often affects the arteries in the head, specifically around the temples and if GCA is left untreated, it can lead to stroke or blindness.8 Generally, GCA affects adults older than 50 years of age and is three times more likely to occur in women than in men.9 GCA causes headaches, visual impairment, vision loss, claudication (cramping caused by lack of blood flow)10 of the jaw, arms and legs,11 and can lead to aortic aneurysm, myocardial infarction, and stroke.12
Filed Under: Drug Discovery