TY - JOUR
T1 - Granulocyte-monocyte apheresis for the treatment of ulcerative colitis - Is this the end of the road?
AU - Ghosh, Subrata
AU - Kaplan, Gilaad
AU - Panaccione, Remo
PY - 2009
Y1 - 2009
N2 - 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.
AB - 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.
UR - https://www.scopus.com/pages/publications/58149485177
U2 - 10.1038/ncpgasthep1299
DO - 10.1038/ncpgasthep1299
M3 - Comment/Debate
AN - SCOPUS:58149485177
SN - 1743-4378
VL - 6
SP - 6
EP - 7
JO - Nature Clinical Practice Gastroenterology and Hepatology
JF - Nature Clinical Practice Gastroenterology and Hepatology
IS - 1
ER -