Abstract

The pathogenesis of ulcerative colitis involves activated granulocytes, monocytes and macrophages. Apheresis has been suggested as a safe and effective treatment for ulcerative colitis. This Practice Point commentary discusses the findings and limitations of a multicenter, randomized, sham-controlled trial by Sands and colleagues, who investigated the efficacy of leukocyte apheresis in patients with moderate-to-severe ulcerative colitis. The results of this trial show no significant difference in outcomes between sham-treated and apheresis-treated patients. Rates of clinical remission, clinical response, endoscopic remission and response, and changes in Mayo score and Quality of Life score were similar between sham-treated and apheresis-treated patients. These findings contradict the results of previous studies, and serve to emphasize the importance of performing rigorous and appropriately designed clinical trials with established end points to determine the efficacy of therapy in IBD. The same standard of rigorous evaluation must be applied to new devices as is applied to pharmaceutical products.

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