Roche reports positive data from new giant cell arteritis drug trial

Roche has announced new clinical trial data supporting the safety and efficacy of the drug Actemra/RoActemra in the treatment of giant cell arteritis.

Results from the phase III GiACTA study have been announced, showing how Actemra/RoActemra, when used initially in combination with a six-month steroid taper, enabled significantly more patients to achieve sustained disease remission, while also significantly reducing steroid exposure compared with steroids alone.

The study also met its key secondary endpoint, demonstrating the drug significantly increased the proportion of patients achieving sustained remission at one year compared to a 12-month steroid taper regimen given alone.

No new safety signals were observed and these results are consistent with Actemra/RoActemra's documented safety profile in rheumatoid arthritis.

Dr Sandra Horning, chief medical officer and head of global product development at Roche, said: "If approved, Actemra/RoActemra could have the potential to fundamentally change the way people with giant cell arteritis are treated."

The disease is also known as temporal arteritis and is a potentially life-threatening autoimmune condition that usually affects those above the age of 50, with women two to three times more likely to be affected than men.

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