Abbott announced Tuesday that a late-stage trial of Humira (adalimumab) in adults with moderate to severe ulcerative colitis met its main goal of clinical remission compared to placebo. Results from the study were presented at the DDW conference.
The trial randomised 494 adults with ulcerative colitis who had not responded well to conventional therapy to receive Humira or placebo. Abbott noted that 16.5 percent of those who took Humira achieved clinical remission at week eight, compared to 9.3 percent of patients who took placebo, while at week 52, the results were 17.3 percent and 8.5 percent, respectively. The company said both figures for Humira were significant compared to placebo.
Abbott indicated it recently submitted regulatory filings in the US and EU for approval to market the drug for the treatment of moderate to severe ulcerative colitis.