title: An open-label prospective randomized multicenter study of intensive versus weekly granulocyte and monocyte apheresis in active crohn's disease.
abstract: BACKGROUND
  Granulocyte and monocyte adsorptive apheresis (GMA) has shown efficacy in patients with active Crohn's disease (CD). However, with routine weekly therapy, it may take several weeks to achieve remission. This study was performed to assess clinical efficacy and safety of intensive GMA in patients with active CD.
  
  
  METHODS
  In an open-label, prospective, randomized multicentre setting, 104 patients with CD activity index (CDAI) of 200 to 450 received intensive GMA, at two sessions per week (n = 55) or one session per week (n = 49). Clinical remission was defined as a CDAI score <150. Patients in each arm could receive up to 10 GMA sessions. However, GMA treatment could be discontinued when CDAI decreased to <150 (clinical remission level).
  
  
  RESULTS
  Of the 104 patients, 99 were available for efficacy evaluation as per protocol, 45 in the weekly GMA group, and 54 in the intensive GMA group. Remission was achieved in 16 of 45 patients (35.6 %) in the weekly GMA and in 19 of 54 (35.2 %) in the intensive GMA (NS). Further, the mean time to remission was 35.4 ± 5.3 days in the weekly GMA and 21.7 ± 2.7 days in the intensive GMA (P = 0.0373). Elevated leucocytes and erythrocyte sedimentation rate were significantly improved by intensive GMA, from 8005/μL to 6950/μL (P = 0.0461) and from 54.5 mm/hr to 30.0 mm/hr (P = 0.0059), respectively. In both arms, GMA was well tolerated and was without safety concern.
  
  
  CONCLUSIONS
  In this study, with respect to remission rate, intensive GMA was not superior to weekly GMA, but the time to remission was significantly shorter in the former without increasing the incidence of side effects. UMIN registration # 000003666.
authors.affiliation: Department of internal medicine, Division of IBD, Tokyo Yamate Medical Centre, Tokyo, Japan. ynaokun@yahoo.co.jp.
authors.forename: Naoki
authors.initials: N
authors.lastname: Yoshimura
authors.affiliation: Division of Internal Medicine, Department of Inflammatory Bowel Disease, Hyogo College of Medicine, Hyogo, Japan. yoko0502@hyo-med.ac.jp.
authors.forename: Yoko
authors.initials: Y
authors.lastname: Yokoyama
authors.affiliation: Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University, Tokyo, Japan. matsuoka@z2.keio.jp.
authors.forename: Katsuyoshi
authors.initials: K
authors.lastname: Matsuoka
authors.affiliation: Department of General Medicine, National Hospital Organization, Sendai Medical Centre, Miyagi, Japan. hiro-ki@snh.go.jp.
authors.forename: Hiroki
authors.initials: H
authors.lastname: Takahashi
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Saga Medical School, Saga, Japan. iwakiri@cc.saga-u.ac.jp.
authors.forename: Ryuichi
authors.initials: R
authors.lastname: Iwakiri
authors.affiliation: Inflammatory Bowel Disease Centre, Yokkaichi Hazu Medical Centre, Mie, Japan. nao-taka@sannet.ne.jp.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Yamamoto
authors.affiliation: Department of Gastroenterology and Hepatology, Chiba University Hospital, Chiba, Japan. tom20852@yahoo.co.jp.
authors.forename: Tomoo
authors.initials: T
authors.lastname: Nakagawa
authors.affiliation: Department of Gastroenterology and Hepatology, Osakafu Saiseikai Nakatsu Hospital, Osaka, Japan. takuleotakuleo@yahoo.co.jp.
authors.forename: Takumi
authors.initials: T
authors.lastname: Fukuchi
authors.affiliation: IBD Center, Sapporo Kosei General Hospital, Hokkaido, Japan. sa-motoya@nifty.com.
authors.forename: Satoshi
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authors.lastname: Motoya
authors.affiliation: Inflammatory Bowel Centre, Yokohama City University Medical Centre, Kanagawa, Japan. reikok@urahp.yokohama-cu.ac.jp.
authors.forename: Reiko
authors.initials: R
authors.lastname: Kunisaki
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Saitama Medical Centre, Saitama Medical University, Saitama, Japan. skato@saitama-med.ac.jp.
authors.forename: Shingo
authors.initials: S
authors.lastname: Kato
authors.affiliation: Department of Gastroenterology Fukuoka University Chikushi Hospital, Fukuoka, Japan. fuhirai@yahoo.co.jp.
authors.forename: Fumihito
authors.initials: F
authors.lastname: Hirai
authors.affiliation: Department of Gastroenterology and Hematology, Hirosaki National Hospital, Aomori, Japan. yishihki@gmail.com.
authors.forename: Yoh
authors.initials: Y
authors.lastname: Ishiguro
authors.affiliation: Department of Gastroenterology and Metabolism, Nagoya City University, Graduate School of Medical Sciences, Nagoya, Japan. stanida@med.nagoya-cu.ac.jp.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Tanida
authors.affiliation: Department of Gastroenterology and Hepatology, Dentistry and Pharmaceutical Sciences, Okayama University Graduate School of Medicine, Okayama, Japan. sakikoh@cc.okayama-u.ac.jp.
authors.forename: Sakiko
authors.initials: S
authors.lastname: Hiraoka
authors.affiliation: Division of Gastroenterology, Department of Medicine, Inflammatory Bowel Disease Centre, Kurume University School of Medicine, Fukuoka, Japan. ibd@med.kurume-u.ac.jp.
authors.forename: Keiichi
authors.initials: K
authors.lastname: Mitsuyama
authors.affiliation: Department of Internal Medicine II, Faculty of Medicine, Shimane University, Izumo, Japan. si360405@med.shimane-u.ac.jp.
authors.forename: Shunji
authors.initials: S
authors.lastname: Ishihara
authors.affiliation: Department of Endoscopy, Hiroshima University Hospital, Hiroshima, Japan. colon@hiroshima-u.ac.jp.
authors.forename: Shinji
authors.initials: S
authors.lastname: Tanaka
authors.affiliation: Division of Gastroenterology, Kobari General Hospital & Juntendo University, Chiba, Japan. mootaka@juntendo.ac.jp.
authors.forename: Michiro
authors.initials: M
authors.lastname: Otaka
authors.affiliation: Department of Gastroenterology, Juntendo University School of Medicine, Tokyo, Japan. otaro@juntendo.ac.jp.
authors.forename: Taro
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authors.lastname: Osada
authors.affiliation: Department of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan. kagaya@m-kanazawa.jp.
authors.forename: Takashi
authors.initials: T
authors.lastname: Kagaya
authors.affiliation: Internal Medicine, Toho University Sakura Medical Centre, Chiba, Japan. yasuo-suzuki@sakura.med.toho-u.ac.jp.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Suzuki
authors.affiliation: Department of Gastroenterology and Endoscopic Medicine, Kyoto University Hospital, Kyoto, Japan. hiropy_n@kuhp.kyoto-u.ac.jp.
authors.forename: Hiroshi
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authors.lastname: Nakase
authors.affiliation: Centre for Gastroenterology and Inflammatory Bowel Disease Research, Hamamatsu South Hospital, Shizuoka, Japan. hanai@hamamatsu-minami.com.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Hanai
authors.affiliation: Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka, Japan. kenjiw@med.osaka-cu.ac.jp.
authors.forename: Kenji
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authors.lastname: Watanabe
authors.affiliation: Research division, JIMRO Co., Ltd, Gunma, Japan. kashiwagin@jimro.co.jp.
authors.forename: Nobuhito
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authors.lastname: Kashiwagi
authors.affiliation: Kitasato Institute Hospital, Centre for Advanced IBD Research and Treatment, Kitasato University, 108-8642 Minato-ku, Tokyo, Japan. thibi@insti.kitasato-u.ac.jp.
authors.forename: Toshifumi
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mesh_terms: D000293:Adolescent; D000327:Adsorption; D000328:Adult; D000368:Aged; D002648:Child; D003424:Crohn Disease / Q000473:pathology / Q000628:therapy*; D005260:Female; D006098:Granulocytes; D006801:Humans; D007937:Leukapheresis / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009000:Monocytes; D011446:Prospective Studies; D012074:Remission Induction; D016896:Treatment Outcome; D055815:Young Adult