Genentech Presents Positive Phase 3 Results for Giant Cell Arteritis

Source: Genentech

Tuesday, April 04, 2017 | Clinical Trials , Genentech


Genentech presented for the first time its results from GiACTA, a phase 3 study which evaluated Actemra (tocilizumab) in people with giant cell arteritis (GCA), to an ophthalmology audience. The abstract was 1 of 23 platform presentations chosen from more than 300 submissions for the 2017 North American Neuro-Ophthalmology Society (NANOS) Annual Meeting in Washington, DC. Results of the study were presented Monday at the NANOS Annual Meeting during an oral session in the Thurgood Marshall Ballroom.

GiACTA met its primary and key secondary endpoint, demonstrating that Actemra – initially in combination with a 6-month prednisone taper – enabled significantly more patients to achieve sustained disease remission while also significantly reducing prednisone exposure compared with prednisone alone. Overall, 56 percent of patients treated with Actemra achieved prednisone-free disease remission at 1 year, versus 14 percent with a 6-month prednisone-only taper regimen.

Within the last 6 months, Genentech has announced that Actemra was granted priority review and breakthrough therapy designations for GCA by the FDA.

"The results of Genentech's GiACTA trial are encouraging for GCA patients and the physicians who treat them," Philip R. Rizzuto, MD, FACS, clinical associate professor of ophthalmic surgery at Brown University, Warren Alpert Medical School, said in a company news release. "Long-term, high-dose steroid use can be problematic for many people. Having an alternative treatment would be welcome news."

 


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