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Re: DewDiligence post# 117070

Tuesday, 05/10/2011 4:19:30 PM

Tuesday, May 10, 2011 4:19:30 PM

Post# of 257559
Humira hits phase-3 primary endpoint in ulcerative colitis:

http://finance.yahoo.com/news/Abbotts-HUMIRA-Adalimumab-prnews-3322579372.html?x=0&.v=1

Co-primary endpoints were the proportion of patients with clinical remission at week 8 and clinical remission at week 52. Clinical remission was defined as a Mayo Score of 2 or less with no individual sub-score greater than 1. The Mayo Score uses a 12-point scoring system to measure disease activity which is evaluated by scoring the following parameters: stool frequency, rectal bleeding, endoscopy findings and physicians global assessment. A higher Mayo Score indicates greater disease severity.

Of the 248 patients treated with HUMIRA in the study, 16.5 percent achieved clinical remission compared to 9.3 percent on placebo at week 8 (p=0.019). At week 52, 17.3 percent achieved clinical remission compared to 8.5 percent on placebo (p=0.004). These results were statistically significant compared to placebo [no kidding!].

The safety results were consistent with the known safety profile of HUMIRA.


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