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.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”