Activated granulocytes and monocytes/macrophages are implicated in the pathogenesis of ulcerative colitis.
Open-label studies and clinical experience in Japan and Europe have suggested that granulocyte/monocyte apheresis is safe and effective in treating ulcerative colitis.
Dr Bruce Sands and colleagues from Massachussetts, USA evaluated the efficacy of granulocyte/monocyte apheresis in a randomized, double-blind, sham-controlled trial.
The research team evaluated 168 patients with active moderate-to-severe ulcerative colitis in community-based and tertiary care centers.
|Clinical response was found in 44% of the granulocyte/monocyte apheresis treatment group|
The team used intervention, granulocyte/monocyte apheresis with the Adacolumn Apheresis System or sham apheresis in a 2:1 ratio for 9 weeks of treatment in a North American pivotal study.
The research team also conducted a smaller, companion study of identical design in Europe and Japan including 47 patients.
The researchers found in the pivotal study, that clinical remission rates were 17% and 11% for the granulocyte/monocyte apheresis- and sham-treatment groups, respectively.
The team observed clinical response in 44% and 39% of the granulocyte/monocyte apheresis- and sham-treatment groups, respectively.
Similar changes were observed for the apheresis- and sham-treatment groups for endoscopic remission and response, and changes in Mayo and quality-of-life scores.
The researchers noted that the companion study and pooled data from both studies also yielded similar results.
Dr Sands' team concluded, "In this study, granulocyte/monocyte apheresis was well tolerated but did not demonstrate efficacy for induction of clinical remission or response in patients with moderate-to-severe ulcerative colitis."