European Commission Approves Tocilizumab for Treatment of Giant Cell Arteritis

The European Commission (EC) has approved tocilizumab (Actemra/RoActemra) for the treatment of giant cell arteritis (GCA), a chronic and potentially life-threatening autoimmune condition, Roche announced.

Actemra/RoActemra is the first GCA treatment therapy approved in Europe. The approval was based on the outcome of the phase 3 GiACTA study.

“We are delighted that Actemra/RoActemra has been approved for the treatment of GCA in Europe,” said Sandra Horning, MD, chief medical officer, global head of product, Roche. “As the first effective non-steroid therapy for GCA, Actemra/RoActemra has the potential to fundamentally change how this condition is treated.”

The phase 3 study, NCT01791153, investigated the efficacy and safety of Actemra/RoActemra as a novel treatment for GCA. It’s the largest clinical trial conducted in GCA and the first to use blinded, variable-dose, variable-duration steroid regimens. The multicenter study was conducted in 251 patients, across 76 sites in 14 countries.

Study results showed that a weekly dose of Actemra/RoActemra, initially combined with a 6-month steroid taper, significantly increased the proportion of patients achieving sustained remission at 1 year, 56%, compared to a 6-month steroid taper given alone, 14%. Primary and secondary endpoints were evaluated at 52 weeks.

An extension study, NCT03202368, to the phase 3 GiACTA study will evaluate long-term safety of subcutaneous tocilizumab in participants with GCA who subsequently have flare or persisting disease activity. A maximum of 11 participants from 6 centers in France that participated in the phase 3 study will be enrolled in the 160-week study. The estimated primary completion date is December 2018.

Treatment to date is limited to high-dose steroids that are an effective emergency treatment option to prevent damage like vision loss, however, in some cases steroids are unable to maintain long-term disease control.

In May 2017, Actemra/RoActemra was approved for treatment by the US Food and Drug Administration (FDA) and New Zealand’s Medsafe.

Results of the phase 3 study were published in the New England Journal of Medicine in July 2017.

A press release was made available.