December 7, 2005

Infliximab induces remission of ulcerative colitis

NEW YORK (Reuters Health) - Treatment of moderate-to-severe
active ulcerative colitis, a severe inflammatory disease of the
colon, with the drug infliximab is associated with sustained
clinical responses and intestinal healing, according to results
of two studies reported in The New England Journal of Medicine.

Infliximab, an antibody that binds to an inflammatory
protein, is effective for treatment of Crohn's disease, Dr.
William J. Sandborn, from Mayo Clinic in Rochester, Minnesota,
and his co-investigators note. However, the drug's
effectiveness for treating ulcerative colitis remains unknown.
The Active Ulcerative Colitis Trials (ACT) 1 and 2 were
designed to address this issue.

Both trials involved 364 patients who were randomly
selected to receive intravenous inactive "placebo," infliximab
5 milligram/kilogram or infliximab 10 milligram/kilogram.
Treatment was given at the beginning of the study, at weeks 2
and 6, and then every 8 weeks through week 46 (in ACT 1) or
week 22 (in ACT 2).

In both studies, the authors report, the proportion of
patients who had a clinical response or remission was higher in
the infliximab groups than in the placebo groups.

For example, in ACT 1 at week eight, 70 percent of those
receiving 5 milligram/kilogram infliximab and 62 percent of
those receiving 10 milligram/kilogram had a clinical response,
compared with 37 percent of those in the placebo group. In ACT
2, corresponding rates were 65, 70 and 29 percent.

Improvement in symptoms was noted as early as the second
week, and did not depend on whether patients responded to
steroid treatment or not. More patients in the infliximab
groups were able to discontinue steroid treatment.

Rates of side effects were similar in the treatment groups,
although the number of serious infections, lupus-like
reactions, and neurologic complications was slightly higher in
the infliximab groups.

However, Sandborn's team points out, infliximab risk must
be weighed against the risk of colon removal to treat
ulcerative colitis and its potential complications.

SOURCE: The New England Journal of Medicine, December 8,