Phase 3 Study Shows Genentech's Actemra (Tocilizumab) Maintained Steroid-Free Remission in People with Giant Cell Arteritis

Source: Genentech

Wednesday, June 08, 2016 | Clinical Trials , Genentech


Genentech announced positive results from the phase 3 study known as GiACTA, which evaluated Actemra (tocilizumab) in people with giant cell arteritis (GCA), according to a company news release. The study met its primary and key secondary endpoints, showing Actemra, initially combined with a 6-month steroid (glucocorticoid) regimen, more effectively sustained remission through 1 year compared to a 6 or 12-month steroid-only regimen in people with newly diagnosed and relapsing GCA. No new safety signals were observed with Actemra in the study at the time of this analysis. Adverse events were similar to those seen in previous Actemra 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 percent of people with GCA, and about 15 percent 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,” Sandra Horning, MD, chief medical officer and head of Global Product Development, said in the news release. "Currently, long-term high-dose steroids are the mainstay treatment for GCA but they can cause their own serious adverse effects. If approved, Actemra will provide an important new alternative to long-term steroid use for people with GCA.”

Approximately 80 percent 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.

About the GiACTA Study

GiACTA (NCT01791153) is a phase 3, global, randomized, double-blind, placebo-controlled trial investigating the efficacy and safety of Actemra 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 the FDA for approval consideration.

 


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