Hoffman-La-Roche announces that Health Canada has approved Actemra for the treatment of adult patients with giant cell arteritis (GCA). The approval was based on the randomized, double-blind, placebo-controlled outcome of the phase III Giacta study, which showed that Actemra, initially combined with a six-month steroid taper, sustained glucocorticoid-free remission at one year in 56 per cent and 53 per cent of patients with weekly and bi-weekly doses, compared to 14 per cent of patients in the placebo arm with a six-month steroid taper given alone.
Actemra has been 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 key role in the signs and symptoms of giant cell arteritis. It is composed of two heterodimers, each composed of a heavy and a light polypeptide chain. Each light chain and heavy chain consists of 214 and 448 amino acids. The four polypeptide chains are linked intra- and inter-molecularly by disulfide bonds. The molecular weight Actemra is approximately 148 kDa. There have been no other new treatments in more than 50 years.
The drug is administered through subcutaneous injection and is supplied as a sterile yellowish, preservative-free liquid. It is ready-to-use, in single-use pre-filled syringes with needle safety devices.
“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. The disease often affects the arteries in the head, specifically around the temples and if left untreated, it can lead to stroke or blindness. Commonly, GCA affects adults older than 50 years of age and is three times more likely to occur in women than in men. Giant cell arteritis causes headaches, visual impairment, vision loss, claudication (cramping caused by lack of blood flow) of the jaw, arms, and legs, and can lead to an aortic aneurysm, myocardial infarction, and stroke.
The overall safety profile observed in the Actmera GCA study was consistent with the known safety profile of Actemra, that included upper respiratory tract infections (common cold, sinus infections) headaches, and increase in blood pressure. The most common serious infections included pneumonia, urinary tract infection, cellulitis, herpes zoster, gastroenteritis, diverticulitis, sepsis and bacterial arthritis. Lastly, the opportunistic infections included tuberculosis, cryptococcus, aspergillosis, candidiasis, and pneumocystosis.