Roche study shows benefits of therapy for giant cell arteritis

Roche has announced new clinical trial data showing the safety and efficacy of its drug Actemra/RoActemra in the treatment of giant cell arteritis (GCA).

Results from the GiACTA trial showed that the therapy was able to meet its primary and key secondary endpoints in the study. Roche's drug, when initially combined with a six-month steroid regimen, was able to more effectively sustain remission rates after one year compared to a six or 12-month steroid-only regimen.

No new safety signals were observed with Actemra/RoActemra in the study at the time of this analysis, with the recorded adverse events similar to those seen in previous clinical studies of this therapy.

The results will now be shared with regulatory authorities around the world to support approval processes. There have been no new treatments approved for GCA in more than 50 years.

Dr Sandra Horning, chief medical officer and head of global product development at Roche, said: "Currently, long-term high-dose steroids are the mainstay treatment for GCA but they can cause their own serious adverse effects. If approved, Actemra/RoActemra will provide an important new alternative to long-term steroid use for people with GCA."

Actemra/RoActemra is currently approved in more than 100 countries worldwide for the treatment of a number of conditions, including rheumatoid arthritis and polyarticular juvenile idiopathic arthritis.