title: A large-scale, prospective, observational study of leukocytapheresis for ulcerative colitis: treatment outcomes of 847 patients in clinical practice.
abstract: OBJECTIVE
  Leukocytapheresis is an extracorporeal therapy for ulcerative colitis. However, no large-scale study on leukocytapheresis has been reported. This large-scale, prospective, observational study aimed to evaluate the treatment outcomes of leukocytapheresis for active ulcerative colitis in clinical practice.
  
  
  METHODS
  Patients with active ulcerative colitis treated with leukocytapheresis using a Cellsorba E column between May 2010 and December 2012 were enrolled from 116 medical facilities in Japan.
  
  
  RESULTS
  A total of 847 patients were enrolled, and 623 were available for efficacy analysis. Out of 847 patients, 80.3% of the patients had moderate to severe disease activity, and 67.6% were steroid refractory. As concomitant medications, 5-aminosalicylic acids, corticosteroids, and thiopurines were administered to 94.8%, 63.8%, and 32.8% of the patients, respectively. In addition, infliximab and tacrolimus were concomitantly used in 5.8% and 12.3%, respectively. Intensive leukocytapheresis (≥4 leukocytapheresis sessions within the first 2 weeks) was used in >70% of the patients. Adverse events were seen in 10.3% (87/847), which were severe in only 5 patients (0.6%). Any concomitant medications did not increase the incidence of adverse events. Intensive leukocytapheresis was as safe as the conventional weekly procedure. The overall clinical remission rate was 68.9% (429/623), and the mucosal healing rate was 62.5% (145/232). Clinical remission was achieved more frequently and rapidly in the intensive group than in the weekly group.
  
  
  CONCLUSIONS
  This large-scale study indicates that leukocytapheresis, including intensive procedure, is a safe and effective therapeutic option for active ulcerative colitis.
authors.affiliation: Division of Lower Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine, Hyogo, Japan.
authors.forename: Yoko
authors.initials: Y
authors.lastname: Yokoyama
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Japan.
authors.forename: Katsuyoshi
authors.initials: K
authors.lastname: Matsuoka
authors.affiliation: Center for Advanced IBD Research and Treatment, Kitasato University, Kitasato Institute Hospital, Tokyo, Japan.
authors.forename: Taku
authors.initials: T
authors.lastname: Kobayashi
authors.affiliation: Ikoma Digestive Tract Internal Medicine Clinic, Osaka, Japan.
authors.forename: Koji
authors.initials: K
authors.lastname: Sawada
authors.affiliation: Fujiyoshi Clinic, Kumamoto, Japan.
authors.forename: Tateshi
authors.initials: T
authors.lastname: Fujiyoshi
authors.affiliation: Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
authors.forename: Takafumi
authors.initials: T
authors.lastname: Ando
authors.affiliation: Department of Gastroenterology, National Hospital Organization Shizuoka Medical Center, Shizuoka, Japan.
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Ohnishi
authors.affiliation: Department of Gastroenterology, Oita Red Cross Hospital, Oita, Japan.
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Ishida
authors.affiliation: Department of Gastroenterology and Hepatology, Faculty of Medicine, Saitama Medical University, Saitama, Japan.
authors.forename: Masashi
authors.initials: M
authors.lastname: Oka
authors.affiliation: Department of Gastroenterology, Toyohashi Municipal Hospital, Toyohashi, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Yamada
authors.affiliation: Japan Operation Division, Blood Purification Business Unit, Scientific and Technical Affairs Department, Asahi Kasei Medical Co. Ltd., Tokyo, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Nakamura
authors.affiliation: Japan Operation Division, Blood Purification Business Unit, Scientific and Technical Affairs Department, Asahi Kasei Medical Co. Ltd., Tokyo, Japan.
authors.forename: Tomoko
authors.initials: T
authors.lastname: Ino
authors.affiliation: Japan Operation Division, Blood Purification Business Unit, Scientific and Technical Affairs Department, Asahi Kasei Medical Co. Ltd., Tokyo, Japan.
authors.forename: Toyoko
authors.initials: T
authors.lastname: Numata
authors.affiliation: Japan Operation Division, Blood Purification Business Unit, Scientific and Technical Affairs Department, Asahi Kasei Medical Co. Ltd., Tokyo, Japan.
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Aoki
authors.affiliation: Japan Operation Division, Blood Purification Business Unit, Scientific and Technical Affairs Department, Asahi Kasei Medical Co. Ltd., Tokyo, Japan.
authors.forename: Jun-Ichi
authors.initials: J
authors.lastname: Sakou
authors.affiliation: Japan Operation Division, Blood Purification Business Unit, Scientific and Technical Affairs Department, Asahi Kasei Medical Co. Ltd., Tokyo, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Kusada
authors.affiliation: Product Vigilance and Quality Assurance Department, Regulatory Affairs, Product Vigilance and QA Division, Asahi Kasei Medical Co. Ltd., Tokyo, Japan.
authors.forename: Tomoki
authors.initials: T
authors.lastname: Maekawa
authors.affiliation: Center for Advanced IBD Research and Treatment, Kitasato University, Kitasato Institute Hospital, Tokyo, Japan. Electronic address: thibi@insti.kitasato-u.ac.jp.
authors.forename: Toshifumi
authors.initials: T
authors.lastname: Hibi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D055815:Young Adult; D003093:Colitis, Ulcerative / Q000453:epidemiology / Q000628:therapy; D005500:Follow-Up Studies; D007564:Japan / Q000453:epidemiology; D007937:Leukapheresis / Q000379:methods; D009017:Morbidity / Q000639:trends; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome
keywords: Large-scale observational study; Leukocytapheresis; Safety; Treatment outcomes; Ulcerative colitis