P545 An Open-label Prospective Randomized Multicentre Study of Daily Granulocyte and Monocyte Adsorptive Apheresis as Compared with Intensive Treatment in Patients with Active Ulcerative Colitis
K. Mizukami*, A. Sonoda, T. Okimoto, M. Kodama, K. Murakami
Oita university, Gastroenterology, Oita, Japan
Among patients with ulcerative colitis (UC), those who respond to therapeutic granulocyte and monocyte adsorptive apheresis (GMA) with an Adacolumn have avoided pharmacologics and express favourable views on GMA for its good safety profile. This study was to better understand the optimum dosage of GMA in terms of treatment frequency, and the number of sessions for remission induction in UC patients.
This was an open-label randomized multicentre clinical trial using daily and intensive GMA with the Adacolumn in a small number of UC patients (prospective trial setting). Twelve patients who had a clinical activity index (CAI) score of > 6 according to Lichtiger were included. Patients were randomly assigned to daily or intensive GMA in 1:1 ratio. Intensive GMA was performed at two sessions per week, while daily GMA was done at five sessions per week in the first and the second weeks. Treatment efficacy was assessed in the third week. Primary endpoint was clinical remission (CAI ≤4) at week 3. Secondary endpoint was clinical response (decrease in CAI by ≥ 5) at week 3 together with safety. Additionally, endoscopic findings before and after GMA therapy, faecal calprotectin (fCal), faecal lactoferin (fLac) and haematologic variables were evaluated.
Clinical remission was achieved in 4 of 6 patients (66.7%) in each group, while clinical response was achieved by 4 of 6 patients (66.7%) in the intensive GMA and 5 of 6 patients (83.3%) in daily GMA. Further, Matt's endoscopic grade 4 fell to 3 in 1 patient in the intensive GMA and in 2 patients in the daily GMA. C-reactive protein (CRP), fCal, fLac, and white blood cell counts showed improvement post GMA, but did not reach statistical significance level. Mild transient fever and headache were seen in one patient in the daily GMA group.
In this prospective trial, the study end paint (week 3) was not long enough to see the full potential of GMA on mucosal healing, fCal, and fLac. Likewise, no significant difference in efficacy was found between daily and intensive GMA due to small number of patients. The most significant finding of this study could be the treatment safety because daily GMA over a two week period was well tolerated and was without any serious safety concern. Accordingly, we believe that our trial strategy warrants to be undertaken in large cohorts of patients with inflammatory bowel disease.