Catalyst
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Phase III GiACTA study shows Roche’s (RHHBY) Actemra/RoActemra is superior to steroids alone in maintaining steroid-free remission for people with giant cell arteritis
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Additional Information
The primary endpoint of the study was met, with Actemra/RoActemra - initially combined with a six month steroid taper regimen - significantly increasing the proportion of patients achieving sustained remission at one year (56% [QW; p <0.0001] and 53.1% [Q2W; p<0.0001]) versus 14% with a six month steroid taper regimen given alone.¹The study also met its key secondary endpoint, demonstrating that Actemra/RoActemra - initially combined with a six month steroid taper regimen - significantly increased the proportion of patients achieving sustained remission at one year (56% [QW; p <0.0001] and 53.1% [Q2W; p= 0.0002]) compared to 17.6% with a 12 month steroid taper regimen given alone.¹No new safety signals were observed and these results are consistent with Actemra/RoActemra’s documented safety profile in rheumatoid arthritis (RA).
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Catalyst Date
Occurred on:
Nov 12, 2016
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Related Keywords
Giant Cell Arteritis, Steroid-free Remission, Tocilizumab, Glucocorticoid, Rheumatoid Arthritis