Evaluation of 5 versus 10 granulocyteaphaeresis sessions in steroid-dependent ulcerative colitis: a pilot, prospective, multicenter, randomized study.
OBJECTIVE
To evaluate the efficacy of 5 compared to 10 granulocyteaphaeresis sessions in patients with active steroid-dependent ulcerative colitis.


METHODS
In this pilot, prospective, multicenter randomized trial, 20 patients with moderately active steroid-dependent ulcerative colitis were randomized to 5 or 10 granulocyteaphaeresis sessions. The primary objective was clinical remission at wk 17. Secondary measures included endoscopic remission and steroid consumption.


RESULTS
Nine patients were randomized to 5 granulocyteaphaeresis sessions (group 1) and 11 patients to 10 granulocyteaphaeresis sessions (group 2). At wk 17, 37.5% of patients in group 1 and 45.45% of patients in group 2 were in clinical remission. Clinical remission was accompanied by endoscopic remission in all cases. Eighty-six percent of patients achieving remission were steroid-free at wk 17. Daily steroid requirements were significantly lower in group 2. Eighty-nine per cent of patients remained in remission during a one year follow-up. One serious adverse event, not related to the study therapy, was reported.


CONCLUSIONS
Granulocyteaphaeresis is safe and effective for the treatment of steroid-dependent ulcerative colitis. In this population, increasing the number of aphaeresis sessions is not associated with higher remission rates, but affords a significant steroid-sparing effect.
Ricart
Elena
E
Gastroenterology Department, Hospital Clinic de Barcelona, C/Villarroel 170, 08036-Barcelona, Spain. ericart@clinic.ub.es
Esteve
Maria
M
Andreu
Montserrat
M
Casellas
Francesc
F
Monfort
David
D
Sans
Miquel
M
Oudovenko
Natalia
N
Lafuente
Raul
R
Panes
Julian
J
D000293:Adolescent; D000328:Adult; D000368:Aged; D003093:Colitis, Ulcerative / Q000473:pathology / Q000628:therapy*; D023381:Endpoint Determination; D005260:Female; D006098:Granulocytes / Q000473:pathology*; D006801:Humans; D007937:Leukapheresis / Q000379:methods*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D012074:Remission Induction / Q000379:methods; D013256:Steroids / Q000627:therapeutic use
D013256:Steroids