ABBOTT RELEASES NEW DATA ON CROHN'S DISEASE DRUG

Abbott Laboratories has announced results from a study showing Humira (adalimumab) induced significantly higher rates of clinical remission compared with placebo in patients with moderately to severely active Crohn's disease who lost response to, or were intolerant to, infliximab therapy.

Crohn's disease is a chronic inflammatory disease of the gastrointestinal (GI) tract that may affect more than one million people in North America and Europe. There is currently no medical or surgical cure for the condition, according to Abbott.

Data from the GAIN study, a randomized, double-blind, placebo-controlled study of 325 patients, 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. Clinical remission was measured by a decrease in the Crohn's Disease Activity Index (CDAI) to less than 150 points.

Humira met the primary endpoint in GAIN, which was the proportion of patients achieving clinical remission at week four compared with placebo. Significantly higher rates of clinical remission were observed for patients receiving Humira compared with those receiving placebo at week four, 21 percent versus 7 percent, respectively.

Results were also significant in the study's secondary endpoints, clinical response 70 (CR-70) defined as a decrease from baseline CDAI of greater than or equal to 70 points, and clinical response 100 (CR-100), defined as a decrease from baseline CDAI of greater than or equal to 100 points. More than half (52 percent) of patients receiving Humira achieved CR-70 at week four, compared with one in three (34 percent) receiving placebo. At week four, 38 percent of patients taking Humira, versus 25 percent of patients receiving placebo, achieved CR-100. In addition, 52 percent of patients receiving Humira achieved CR-70 at week two, compared with 33 percent of patients receiving placebo.