Humira met the primary endpoint, which was the proportion of patients achieving clinical remission at week four compared to placebo. Data showed three times the percentage of patients with moderately to severely active Crohn's disease who had lost response to, or were intolerant to, infliximab achieved clinical remission with Humira versus placebo at week four.
The safety profile in the study was consistent with previous reports in Crohn's disease and rheumatoid arthritis studies of Humira.
Humira is already approved for rheumatoid arthritis and Abbott has applied to the FDA to expand the application of the drug.
“The findings of the study are significant, because they provide data showing that Humira induced clinical remission and response in this difficult to treat Crohn's disease patient population,” said Eugene Sun, vice president of global pharmaceutical clinical development at Abbott.
Crohn's disease is a serious, chronic inflammatory disease of the gastrointestinal tract which has no medical or surgical cure.