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November 13, 2016

GCA trial’s new data indicates 56% of people treated with RoActemra achieved steroid-free disease remission

New data from giant-cell arteritis (GCA) trial indicates that 56% of people treated with RoActemra (tocilizumab) achieved steroid-free disease remission at one year, compared with only 14% given the present standard of care with steroids alone.

New data from giant-cell arteritis (GCA) trial indicates that 56% of people treated with RoActemra (tocilizumab) achieved steroid-free disease remission at one year, compared with only 14% given the present standard of care with steroids alone.

GCA is an autoimmune condition that impacts 22 for every 100,000 people in the UK.

This disease leads to serious complications such as permanent blindness.

GCA international expert and Southend University Hospital NHS Foundation Trust consultant rheumatologist Professor Bhaskar Dasgupta said: “GCA is a serious autoimmune disease involving blood vessels that can lead to blindness, and aortic aneurysms yet treatment to date has been limited to high-dose steroids, which often fail to control the disease in the long term and can be associated with serious side effects such as diabetes and osteoporosis.

"This is a big breakthrough as tocilizumab could have the potential to redefine the way people with GCA are treated."

"This is a big breakthrough as tocilizumab could have the potential to redefine the way people with GCA are treated.”

The GiACTA study met its primary and key secondary endpoints.

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This trial indicated that RoActemra, initially in combination with a six month steroid (glucocorticoid) taper regimen, enabled significantly more patients to achieve sustained disease remission whilst reducing steroid exposure compared with steroids alone (primary endpoint: 56% [QW; p less than 0.0001] and 53.1% [Q2W; p less than 0.0001]) against 14% with a six month steroid taper regimen given alone, key secondary endpoint: 56% [QW; p less than 0.0001] and 53.1% [Q2W; p= 0.0002]) compared to 17.6% with a 12 month steroid taper regimen given alone.

No new safety signals were observed and these results are in line with RoActemra’s documented safety profile in rheumatoid arthritis.

A 104-week open label extension study from GiACTA is still proceeding.

Data from this analysis will quantify RoActemra’s long-term safety and maintenance of efficacy beyond one year, as well as any potential long-term steroid sparing effects.

The US Food and Drug Administration (FDA) has granted the biologic medicine Breakthrough Therapy Designation for GCA. This drug will be submitted to regulatory authorities worldwide by the end of the year.

GiACTA (NCT01791153) is a Phase III, global, randomised, double-blind, placebo-controlled study investigating the efficacy and safety of RoActemra as a novel treatment for GCA.

It is the largest clinical trial ever conducted in GCA and the first to use blinded, variable-dose, variable-duration steroid regimens.

The multicentre study was conducted in 251 patients across 76 sites in 14 countries, including 16 patients and 11 sites in the UK.

The primary and key secondary endpoints were evaluated at 52 weeks.

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