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Steroid-Refractory Ulcerative Colitis resists Infliximab. (Responders reduce Steroid Dose).

LAS VEGAS -- Patients with steroid-refractory ulcerative colitis may be less likely to respond to infliximab, compared with steroid-responsive patients, Dr. Chinyu Su reported at the annual meeting of the American College of Gastroenterology.

"Our results support the need for a large, randomized controlled trial to definitively assess both the efficacy and safety of this therapy in the treatment of active ulcerative colitis," said Dr. Su of the department of medicine at the University of Pennsylvania, Philadelphia.

She and her associates studied the effects of infliximab administered to 27 patients with severe ulcerative colitis at four medical centers.

Fourteen patients received a single infusion of infliximab; 13 received more than one infusion. One patient received 5 mg/kg of infliximab as maintenance therapy after three infusions at 3 mg/kg for recurrence. Other patients received infliximab at 5 mg/kg, including one patient who received three infusions at 5 mg/kg at weeks 0, 2, and 6.

The investigators categorized response as remission, partial response, or no response. Remission was defined as returning to baseline stool frequency and absence of rectal bleeding. Partial response was defined as having substantial but incomplete clinical improvement.

Following the first infusion, 18 (66%) of the study participants had a clinical response. Of these, 12 (44%) had remissions, and 6 (22%) had a partial responses. One-third of the patients did not respond. Patients with steroid-refractory disease were less likely to respond than those without steroid-refractory disease (33% vs. 84%).

Among all patients, the median duration of follow-up after the first infusion was 4 months. Among responders, the median time to achieve clinical response was 4 days. The median duration of response was 8 weeks.

Of the 18 patients who responded to the initial infusion, 9 experienced a total of 19 relapses, and 95% of the relapses responded to repeat infusions.

Dr. Su and her associates were able to reduce the steroid dose in 9 of the 10 steroid-dependent patients, from a mean of 37 mg/day to 5 mg/day. Three patients were able to completely withdraw from steroid use.

Five of the nine nonresponders in the study subsequently underwent total colectomy.
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Article Details
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Author:Brunk, Doug
Publication:Internal Medicine News
Geographic Code:1USA
Date:Jan 1, 2002
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