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Last Phase 3 brodalumab psoriasis trial successful

Nov. 25, 2014 4:47 PM ETAmgen Inc. (AMGN) StockAMGN, JNJ, AZNBy: Douglas W. House, SA News Editor
  • Amgen (AMGN -1.2%) and development partner AstraZeneca (AZN -0.6%) announce that the Amagine-2 Phase 3 trial evaluating two doses (210 mg and 140 mg every two weeks) of brodalumab in patients with moderate-to-severe plaque psoriasis met its primary endpoints compared to J&J's (JNJ -0.1%) Stelara (ustekinumab) and placebo at week 12. The 210 mg arm and the weight-based analysis group both demonstrated superiority to Stelara on achieving total skin clearance as measured by the Psoriasis Area Severity Index (PASI 100 or 100% reduction in score).
  • 44.4% of patients in the brodalumab 210 mg group, 33.6% in the brodalumab weight-based group, 25.7% of patients in the brodalumab 140 mg group, 21.7% of patients in the Stelara group and 0.6% of patients in the placebo group achieved PASI 100. PASI 75 (75% reduction in score) scores for the same groups were: 86.3%, 77.0%, 66.6%, 70.0% and 8.1%, respectively.
  • All secondary endpoints comparing brodalumab to placebo were also met. The first major secondary endpoint comparing PASI 100 for brodalumab 140 mg against Stelara at week 12 was numerically greater but not statistically significant (p=0.078). The remaining secondary endpoints for the 140 mg group versus Stelara were also numerically greater (all p values<0.05) but could not be considered statistically significant due to the sequential testing method.
  • Previously: Positive Phase 3 results for brodalumab
  • Previously: Amgen's brodalumab beats Stelara in Phase 3 trial

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