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The need to find an alternative to prolonged periods of steroid therapy was addressed.
Data from the Phase III GiACTA study, which evaluated Actemra (tocilizumab) in adult patients with giant cell arteritis (GCA), were published in the New England Journal of Medicine, announced Genentech, a member of the Roche Group.
The study’s primary end point was met: Actemra combined with a 26-week steroid taper regimen showed superiority in achieving sustained remission at 52 weeks (56% [Actemra-weekly group] and 53.1% [Actemra-biweekly group]) compared with placebo combined with a 26-week steroid taper regimen (14%).
The key secondary end point also was met: Actemra combined with a 26-week steroid taper regimen showed superiority in achieving sustained remission at 52 weeks (56% [Actemra-weekly group] and 53.1% [Actemra-biweekly group]) compared with placebo combined with a 52-week steroid taper regimen (17.6%).
No new safety signals were observed, and the safety profile of the Actemra groups was generally consistent with the documented safety profile of Actemra in other indications.
“The publication of these Phase III results in the New England Journal of Medicine validates the significance of our considerable basic and clinical autoimmune disease research in medical practice,” said Sandra Horning, MD, chief medical officer and head of Global Product Development. “The data from GiACTA supported the FDA approval of the first new treatment option for patients with GCA in more than 50 years, and we are committed to continuing to explore new treatment options for autoimmune diseases with significant unmet medical need.”
The FDA approved Actemra subcutaneous injection for the treatment of GCA in May 2017. Actemra is the first FDA-approved therapy for the treatment of adult patients with GCA, and this is the sixth FDA approval for Actemra since the medicine was launched in 2010.
GiACTA is a Phase III, global, randomized, double-blind, placebo-controlled trial that investigated the efficacy and safety of subcutaneous Actemra as a novel treatment for GCA. It is the first successful 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 primary and key secondary end points were evaluated at 52 weeks.
Fewer patients reported serious adverse events in the Actemra weekly group (15%) and biweekly group (14.3%) than in the placebo combined with a 26-week steroid taper regimen group (22%) and the placebo combined with a 52-week steroid taper regimen group (25.5%).
“The results of the GiACTA study mark a huge step forward for patients with GCA,” said GiACTA’s lead investigator, John H. Stone, MD, MPH, Professor of Medicine, Harvard Medical School, and Director of Clinical Rheumatology and Edward Fox Chair in Medicine at the Massachusetts General Hospital. “For more than 65 years, no medication besides glucocorticoids has been proven in a convincing way to be effective. This rigorous, randomized, and carefully blinded study addresses one of the greatest needs of physicians who treat GCA-finding an alternative to prolonged periods of steroid therapy.”
The study findings were published in the July 27, 2017 issue of the New England Journal of Medicine.