An open-label prospective randomized multicenter study shows very rapid remission of ulcerative colitis by intensive granulocyte and monocyte adsorptive apheresis as compared with routine weekly treatment.
OBJECTIVE
Granulocyte and monocyte adsorptive apheresis (GMA) has shown efficacy in patients with active ulcerative colitis (UC). However, with routine weekly treatment, it may take several weeks to achieve remission, and to date, the efficacy of a more frequent treatment schedule remains unknown. The aim of this study was to assess the clinical efficacy and safety of intensive GMA treatment in patients with active UC.


METHODS
This was an open-label, prospective, randomized multicenter study to compare an intensive, two GMA sessions per week, with the routine, one GMA session per week. A total of 163 patients with mild-to-moderately active UC were randomly assigned to routine weekly treatment or intensive treatment. The maximum number of sessions of GMA permitted was 10. However, when patients achieved remission, GMA was discontinued. Remission rate at the end of the study, time to remission, and adverse events were assessed in both groups.


RESULTS
Of the 163 patients, 149 were available for efficacy analysis as per protocol, 76 were in weekly GMA, and 73 were in intensive GMA. At the end of the study period, clinical remission was achieved in 41 of 76 patients (54.0%) in weekly GMA and in 52 of 73 patients (71.2%) in intensive GMA (P=0.029). The mean time to remission was 28.1+/-16.9 days in the weekly GMA treatment group and 14.9+/-9.5 days in the intensive GMA group (P<0.0001). Intensive GMA was well tolerated without GMA-related serious adverse side effects.


CONCLUSIONS
Intensive GMA in patients with active UC seems to be more efficacious than weekly treatment, and significantly reduced the patients' morbidity time without increasing the incidence of side effects.
Sakuraba
Atsushi
A
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
Motoya
Satoshi
S
Watanabe
Kenji
K
Nishishita
Masakazu
M
Kanke
Kazunari
K
Matsui
Toshiyuki
T
Suzuki
Yasuo
Y
Oshima
Tadayuki
T
Kunisaki
Reiko
R
Matsumoto
Takayuki
T
Hanai
Hiroyuki
H
Fukunaga
Ken
K
Yoshimura
Naoki
N
Chiba
Toshimi
T
Funakoshi
Shinsuke
S
Aoyama
Nobuo
N
Andoh
Akira
A
Nakase
Hiroshi
H
Mizuta
Yohei
Y
Suzuki
Ryoichi
R
Akamatsu
Taiji
T
Iizuka
Masahiro
M
Ashida
Toshifumi
T
Hibi
Toshifumi
T
D000293:Adolescent; D000327:Adsorption; D000328:Adult; D000368:Aged; D001781:Blood Component Removal / Q000379:methods*; D003093:Colitis, Ulcerative / Q000628:therapy*; D005260:Female; D006098:Granulocytes; D006801:Humans; D008297:Male; D008875:Middle Aged; D009000:Monocytes; D011446:Prospective Studies; D012074:Remission Induction; D018709:Statistics, Nonparametric; D016896:Treatment Outcome