Efficacy of a Novel Granulocyte Monocyte Apheresis Adsorber Device in the Treatment of Inflammatory Bowel Diseases: A Pilot Study

Abstract

Granulocyte monocyte apheresis (GMA) is a non-pharmacological treatment for inflammatory bowel disease. In our study, we tested a novel GMA adsorber device in terms of clinical efficacy and safety in patients' non-response to pharmacological therapy. Secondary outcomes were the evaluation of adsorber's technical performance, the reduction of inflammatory markers and the improvement of patients' life quality. The prospective study included 18 patients enrolled from 2011 to 2012 with a monitoring of 48 weeks. All patients with Crohn's disease achieved a clinical remission after GMA treatments, sustained until the end of follow up, while 80% of ulcerative colitis patients obtained a clinical benefit, maintained after 48 weeks of monitoring. Leukocytes, neutrophils, monocytes and platelets, compared to erythrocytes and lymphocytes, were effectively removed from peripheral blood. There was no statistically significant result about serological markers of inflammation. A consistent improvement of the patients' quality of life was observed up to the end of follow up. No significant side-effects were recorded. Our study underlines the efficacy and the safety of this novel GMA adsorber device; a prospective randomized clinical trial with adequate sample size should be performed.

A systems pharmacology model for inflammatory bowel disease

“…The outcome of this challenge was similar to the clinical output in IBD patients. By the simulation of TNFα or MACR knockout (simulating Granulocyte and Monocyte Apheresis), a decrease in MMPs node was observed, which is in line with therapy success in clinical practice by a decrease in Crohn's Disease Activity Index (CDAI) Score [ 42 – 46 ],[ 62 – 68 ]. On other hand, IL17 or IFNγ knockout or IL10 overexpression did not show major change in MMPs expression, suggested a failed therapy as was indeed found in clinical practice [ 69 – 72 ].…”

“…The network was evaluated comparing simulations and reported outcomes from clinical trials for six investigated molecules: anti-TNFα [ 62 – 65 ] and anti-IL12-IL23 [ 80 ], two monoclonal antibodies (mAb) approved for IBD disease, anti-IFNγ [ 69 , 70 ], anti-IL17 [ 72 ], anti-IL2 [ 73 , 74 ] and human recombinant IL10 (rhuIL-10) [ 71 ] which failed in clinical trials. Also a new promising therapy: Granulocyte and Monocyte Apheresis (GMA) [ 66 – 68 ] was tested. The reported CDAI (Crohn Disease Activity Index) was compared with the average expression of the MMPs output node in the attractor state.…”