Two Drugs Better Than One for Crohn's Patients

ByABC News
June 3, 2009, 6:02 PM

June 4 -- WEDNESDAY, June 3 (HealthDay News) -- Crohn's disease patients who received a combination of the drugs infliximab (Remicade) and azathioprine (Azasan) were more likely to have the disease go into steroid-free remission than those who received only one of the drugs, researchers say.

The study was presented Tuesday at Digestive Disease Week 2009 in Chicago.

Crohn's disease is an inflammation of the digestive tract, most often the lining and wall of the lower small intestine, or the ileum, according to the National Digestive Diseases Information Clearinghouse. When inflamed, the lining of the intestinal wall can become swollen, causing diarrhea. Severe cases can require surgery.

In an international study, researchers divided 508 patients with moderate to severe Crohn's who had not yet received immunomodulator drugs into three groups. One group received infliximab plus azathioprine, a second group received infliximab plus a placebo and the third group received azathioprine plus a placebo for 30 weeks, with the option to continue in a blinded study extension through week 50.

After 50 weeks, 72.2 percent of patients who'd received the infliximab/azathioprine drug combination were in steroid-free remission, compared to 60.8 percent who'd received infliximab alone and 54.7 percent who had taken azathioprine alone, according to a Digestive Disease Week news release.

The researchers used colonoscopies and a Crohn's Disease Activity Index score to measure clinical symptoms. Assuming the patients who did not enroll in the study extension continued to have Crohn's symptoms at week 50, the proportion of the patients who were in steroid-free remission at week 50 was 46.2 percent with infliximab plus azathioprine, 34.9 percent with infliximab monotherapy and 24.1 percent with azathioprine monotherapy, the study found.

Looking at all treatment groups, the percentage of patients who developed serious infections was similar in all groups, and during the study extension there were no new opportunistic infections, malignancies or deaths.