The data also showed that the safety profile of REMICADE in combination or as monotherapy was similar to that of azathioprine monotherapy in the study.  Through week 30, 24 percent of patients receiving azathioprine monotherapy experienced one or more serious adverse events compared with 16 and 14 percent of patients receiving REMICADE monotherapy and REMICADE with azathioprine, respectively.  This includes two patients receiving azathioprine monotherapy who developed colon cancer, one patient receiving azathioprine monotherapy who died following a colectomy and one patient receiving REMICADE combination therapy who was diagnosed with tuberculosis.  Serious infections were reported in 6 percent of patients in the azathioprine monotherapy group, 5 percent in the REMICADE monotherapy group and 4 percent in the REMICADE combination therapy group.

A final safety analysis for the entire study included data through week 54.  The proportion of patients with one or more serious adverse events during the study was 27 percent>

In 1998, REMICADE became the first anti-TNF-alpha therapy approved by the FDA for the treatment of moderately to severely active Crohn's disease for the reduction of the signs and symptoms in patients who have an inadequate response to conventional therapy.  During the past decade, REMICADE has also become the first and only anti-TNF-alpha therapy approved by the FDA for the treatment of moderately to severely active ulcerative colitis, in patients with an inadequate response to conventional therapy, a related inflammatory bowel disease.  REMICADE is also approved for the treatment of pediatric patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapies.

SOURCE Centocor Ortho Biotech, Inc.