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P460 Efficacy and Safety of Granulocyte/Monocyte Apheresis in Active Ulcerative Colitis Using an Adsorber Device Based on Cellulosic Filaments

C. Sauvant1, C. Schultheiss2, W. Huber2, W. Ramlow3, J. Emmrich4, F. Bonn*5, H.-D. Lemke1

1eXcorLab GmbH, R & D, Obernburg, Germany, 2Klinikum rechts der Isar, Technical University Munich, Medicine II, Munich, Germany, 3Dialysis Group North, Apheresis Center, Rostock, Germany, 4University of Rostock, Gastroenterology, Rostock, Germany, 5Membrana GmbH, New Business, Wuppertal, Germany

Background

Granulocyte/monocyte apheresis (GMA) is an emerging therapeutic option in ulcerative colitis (UC). The efficacy and safety of a recently introduced adsorber device based on cellulosic filaments (Immuloc® sorbent) was studied for the treatment of active UC.

Methods

Eligible patients in two different centers had to have a clinical activity index according to Rachmilewitz (CAI) > 4 points at baseline. Over a period of 5 consecutive weeks, patients enrolled received 5 to 10 GMA at a blood flow rate of 30 ml/min for 60 to 120 min. CAI, endoscopical index (EI) and C-reactive protein (CRP) were assessed at baseline, after the treatment period and at the end of the observation period.

Results

Of 33 patients totally enrolled, 27 were eligible for the per protocol population (PPP). 3 patients had to discontinue the study early and 3 met an exclusion criterion before treatment initiation. The median baseline CAI and EI of the PPP were 8 (range 5 to 17 points) and 9 points (6 to 12 points), respectively. Nine patients presented mild, 14 moderate (CAI ≥ 8-10 points; EI ≥ 7 points) and 4 patients severe UC (CAI ≥ 11 points; EI ≥ 7 points). At the end of the treatment period, remission (CAI < 4 points) was achieved in 16 patients (59.3 %) and response (reduction in CAI or in CAI plus EI of ≥ 3 points) in 5 patients (18.6 %). Six patients (22.2 %) did not respond to GMA. At the end of the 4-5-week follow-up period, 12 patients were still in remission and 5 patients fulfilled the criteria for response. The mean baseline CRP of 12.02 mg/L decreased to 5.38 mg/L after treatment and was 6.09 mg/L at the end of the follow-up period (not statistically significant). The treatments were overall well tolerated with only mild therapy related adverse symptoms, such as temporary headache, dizziness, and nausea, in only few patients.

Conclusion

The vast majority of patients with active UC benefits from GMA, which is well tolerated with only few side effects. The highly favorable risk to benefit ratio makes GMA with the Immuloc® sorbent a promising therapeutic option even in patients with severe UC.