Roche announced positive results from the phase III study known as GiACTA, which evaluated Actemra/RoActemra (tocilizumab) in people with giant cell arteritis (GCA). The study met its primary and key secondary endpoints showing that Actemra/RoActemra, initially combined with a six month steroid (glucocorticoid) regimen, more effectively sustained remission through one year compared to a six or 12 month steroid-only regimen in people with newly diagnosed and relapsing GCA. No new safety signals were observed with Actemra/RoActemra in the study at the time of this analysis. Adverse events were similar to those seen in previous Actemra/RoActemra clinical studies.
GCA is a serious condition where arteries, commonly in the head but also the aorta and its branches, become inflamed.
This inflammation can lead to persistent and severe headaches, scalp tenderness and jaw and arm pain. It is difficult to diagnose and if left untreated, GCA may lead to blindness, stroke or aortic aneurysms. Vision problems occur in approximately 30 per cent of people with GCA, and about 15 per cent experience permanent vision loss.
“These results are encouraging for patients with this rare disease, for which there have been no new treatments in more than 50 years,” said Sandra Horning, MD, 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/RoActemra will provide an important new alternative to long-term steroid use for people with GCA.”
Approximately 80 per cent of people with GCA who are exposed to long-term steroid use experience steroid-related side effects such as cataracts, diabetes, fractures, and hypertension. Reducing the use of steroids in this patient group is an important goal for physicians and people living with GCA.
GiACTA (NCT01791153) is a phase III, global, randomised, double-blind, placebo-controlled trial investigating the efficacy and safety of Actemra/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 multicenter study was conducted in 251 patients across 76 sites in 14 countries. The study's primary and key secondary endpoints were evaluated at 52 weeks.
GiACTA data will be submitted for presentation at an upcoming medical conference and to regulatory authorities around the world for approval consideration.
The occurrence of GCA has been estimated at over 200 per 100,000 persons in the United States over the age of 50. An even higher frequency has been reported in northern Europe.6 GCA is two to three times more likely to affect women and is often difficult to diagnose due to the wide and variable spectrum of signs and symptoms. With no new treatments in more than 50 years, people with GCA are limited to high-dose steroid treatment that generally fails to cure GCA or induce long-term steroid-free remissions.
Actemra/RoActemra is the only approved anti-IL-6 receptor biologic, available in both intravenous (IV) and subcutaneous formulations, for the treatment of adult patients with moderate to severe active rheumatoid arthritis (RA). Actemra/RoActemra can be used alone or with methotrexate (MTX) in adults who are intolerant to, or have failed to respond to, other anti-rheumatic medications. In the most recent update to the European League Against Rheumatism (EULAR) RA management guidelines, Actemra/RoActemra is highlighted as the only biologic that has been repeatedly demonstrated to be superior as a monotherapy over MTX or other conventional disease-modifying antirheumatic drugs (DMARDs). Actemra/RoActemra IV formulation is approved in most major countries for polyarticular juvenile idiopathic arthritis (pJIA) and systemic juvenile idiopathic arthritis (sJIA) in children two years of age and older. In Europe, Actemra/RoActemra is also approved for use in patients with severe, active and progressive RA who previously have not been treated with MTX. Actemra/RoActemra is part of a co-development agreement with Chugai Pharmaceutical Co., Ltd and has been approved in Japan since April 2005. Actemra/RoActemra is approved in more than 100 countries worldwide.