Positive Study Results for Actemra to Treat Giant Cell Arteritis
Compared with current treatments, patients taking Actemra were able to sustain remission.
Results from a recent study suggest that tocilizumab (Actemra) can potentially treat patients with giant cell arteritis (GCA).
GCA is a condition where arteries in the head, aorta, and its branches become inflamed, which can cause headaches, tenderness, jaw pain, and arm pain. If untreated, this condition could potentially cause blindness, stroke, or aortic aneurysms.
Currently, the only treatment is high-dose steroid therapy that typically does not cure the condition and leads to cataracts, diabetes, fractures, and hypertension in 80% of patients with GCA receiving this treatment, according to a press release from Genentech.
The phase 3 study, GiACTA (NCT01791153), evaluated the efficacy and safety of Actemra in 251 patients with GCA. Researchers combined Actemra with a glucocorticoid regimen for the first 6 months of treatment.
Study endpoints were analyzed at 52 weeks, which showed that patients receiving Actemra were able to sustain remission through 1 year compared with a steroid-only regimen, Genentech reported.
Researchers also found that certain severe side effects can occur, including stomach tears, low neutrophil and platelet counts, increases in liver function test levels, increases in blood cholesterol levels, an increase in cancer risk, hepatitis B infection, serious allergic reactions, and nervous system problems.
Other more common side effects such as upper respiratory tract infections, headache, hypertension, injection site reactions, and diarrhea were also reported.
"These results are encouraging for patients with this rare disease, for which there have been no new treatments in more than 50 years," concluded Sandra Horning, MD, Genentech chief medical officer and head of Global Product Development. "Currently, long-term high-dose steroids are the mainstay treatment for GCA but they can cause their own serious adverse effects. If approved, Actemra will provide an important new alternative to long-term steroid use for people with GCA."