Open label trial of granulocyte apheresis suggests therapeutic efficacy in chronically active steroid refractory ulcerative colitis.
OBJECTIVE
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 (reg), 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.


CONCLUSIONS
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.
Kruis
Wolfgang
W
Evangelisches Krankenhaus Kalk, Innere Abteilung, Universität zu Köln, Germany. ansorg@evkk.de
Dignass
Axel
A
Steinhagen-Thiessen
Elisabeth
E
Morgenstern
Julia
J
Mössner
Joachim
J
Schreiber
Stephan
S
Vecchi
Maurizio
M
Malesci
Alberto
A
Reinshagen
Max
M
Löfberg
Robert
R
D000328:Adult; D000368:Aged; D001781:Blood Component Removal / Q000379:methods*; D002097:C-Reactive Protein / Q000276:immunology; D003093:Colitis, Ulcerative / Q000276:immunology / Q000628:therapy; D005260:Female; D006098:Granulocytes / Q000276:immunology*; D006801:Humans; D008875:Middle Aged; D009000:Monocytes / Q000276:immunology; D015337:Multicenter Studies as Topic; D009504:Neutrophils / Q000276:immunology; D011446:Prospective Studies; D012074:Remission Induction; D013256:Steroids / Q000627:therapeutic use*; D016896:Treatment Outcome
D013256:Steroids; D002097:C-Reactive Protein