Clinical Research
Copyright ©2005 Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Nov 28, 2005; 11(44): 7001-7006
Published online Nov 28, 2005. doi: 10.3748/wjg.v11.i44.7001
Open label trial of granulocyte apheresis suggests therapeutic efficacy in chronically active steroid refractory ulcerative colitis
Wolfgang Kruis, Axel Dignass, Elisabeth Steinhagen-Thiessen, Julia Morgenstern, Joachim Mössner, Stephan Schreiber, Maurizio Vecchi, Alberto Malesci, Max Reinshagen, Robert Löfberg
Wolfgang Kruis, Julia Morgenstern, Evangelisches Krankenhaus Kalk, Innere Abteilung, Universität zu Köln, Germany
Axel Dignass, Elisabeth Steinhagen-Thiessen, Medizinische Klinik für Hepatologie und Gastroenterologie, Campus Virchow-Klinikum, Universitätsklinikum, Charité, Berlin, Germany
Joachim Mössner, Medizinische Klinik und Poliklinik II, Universitätsklinikum Leipzig, Germany
Stephan Schreiber, Medizinische Klinik, Universität Kiel, Germany
Maurizio Vecchi, Dep of Int Medicine IRCCS Ospedale Policlinico, University of Milano, Italy
Alberto Malesci, Istituto Clinico Humanitas, Milano, Italy
Max Reinshagen, Innere Medizin, Universitätsklinikum Ulm, Germany
Robert Löfberg, Karolinska Institute at the IBD unit, Sophia Hemmet, Stockholm, Sweden
Author contributions: All authors contributed equally to the work.
Correspondence to: Wolfgang Kruis, MD, Professor of Medicine, Evangelisches Krankenhaus Kalk. Buchforststr. 2, 51103 Cologne (Köln), Germany.
Telephone: +49-2-21-8289-5289 Fax: +49-2-21-8289-5291
Received: April 4, 2005
Revised: April 15, 2005
Accepted: April 18, 2005
Published online: November 28, 2005

AIM: To study the efficacy, safety, and feasibility of a granulocyte adsorptive type apheresis system for the treatment of patients with chronically active ulcerative colitis despite standard therapy.

METHODS: An open label multicenter study was carried out in 39 patients with active ulcerative colitis (CAI 6-8) despite continuous use of steroids (a minimum total dose of 400 mg prednisone within the last 4 wk). Patients received a total of five aphereses using a granulocyte adsorptive technique (Adacolumn®, Otsuka Pharmaceutical Europe, UK). Assessments at wk 6 and during follow-up until 4 mo comprised clinical (CAI) and endoscopic (EI) activity index, histology, quality of life (IBDQ), and laboratory tests.

RESULTS: Thirty-five out of thirty-nine patients were qualified for intent-to-treat analysis. After the apheresis treatment at wk 6, 13/35 (37.1%) patients achieved clinical remission and 10/35 (28.6%) patients had endoscopic remission (CAI<4, EI<4). Quality of life (IBDQ) increased significantly (24 points, P<0.01) at wk 6. Apheresis could be performed in all but one patient. Aphereses were well tolerated, only one patient experienced anemia.

CONCLUSION: In patients with steroid refractory ulcerative colitis, five aphereses with a granulocyte/monocyte depleting filter show potential short-term efficacy. Tolerability and technical feasibility of the procedure are excellent.

Keywords: Steroid, Refractory colitis, Ulcerative colitis, Granulocyte, Apheresis