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Roche's Actemra successful in late-stage study in giant cell arteritis

Published 11/13/2016, 09:51 PM
Roche's Actemra successful in late-stage study in giant cell arteritis
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  • A Phase 3 clinical trail, GiACTA, assessing Roche unit Genentech's (OTCQX:RHHBY) Actemra (tocilizumab) for the treatment of giant cell arteritis (GCA) met its primary efficacy endpoint. The data were presented at the American College of Rheumatology and Association of Rheumatology Health Professionals Annual Meeting in Washington, D.C.
  • Tocilizumab, initially combined with a six-month steroid taper regimen, demonstrated superiority to a six-month steroid taper regimen alone as measured by the proportion of patients achieving sustained remission at one year. Specifically, 56% of patients in the once/week dose cohort and 53.1% of patients in the once-every-other week dose cohort achieved sustained remission at Year 1 compared to 14% for the six-month steroid taper regimen alone. No new safety signals were observed.
  • According to ClinicalTrials.gov, the estimated study completion date is April 2018.
  • GCA is an inflammation of the lining of the arteries, typically those in the temples. If untreated, it can lead to stroke or blindness. It affects ~0.2% of Americans over the age of 50.
  • Actemra is currently approved for the treatment of certain kinds of arthritis.

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