title: Intensive granulocyte and monocyte adsorption versus intravenous prednisolone in patients with severe ulcerative colitis: an unblinded randomised multi-centre controlled study.
abstract: OBJECTIVE
  Several uncontrolled studies have reported on the efficacy of adsorptive depletion of peripheral blood granulocytes and monocytes/macrophages (GM) in patients with moderate or severe ulcerative colitis. This study was to compare the efficacy and safety of intensive GMA with intensive intravenous prednisolone in patients with severe ulcerative colitis.
  
  
  METHODS
  Seventy patients with clinical activity index 10-23 were randomly assigned to intensive GMA with the Adacolumn, at 2 sessions/week in the first 3 weeks and then 1 session/week for up to 11 sessions (n = 35) or intravenous prednisolone, 40-60 mg/day for 5-10 days (n = 35). No patient received immunomodulators within 8 weeks prior to entry. Clinical response based on intention to treat was assessed at weeks 2, 6 and 12.
  
  
  RESULTS
  Four patients in the prednisolone group and two patients in the GMA group discontinued in week 1. At weeks 2, 6 and 12, the remission (clinical activity index < or = 4) rates (%) in the GMA group were 17.1, 54.4, 74.3, respectively. The corresponding values in the prednisolone group were 25.7, 51.4 and 48.6. Further, at week 12, 27 patients (77%) in the GMA group and 5 patients (14%) in the prednisolone group were steroid free (P = 0.0076). In the GMA group, flushing and light-headedness were observed in 5 patients versus typical steroid side effects in 29 patients of the prednisolone group.
  
  
  CONCLUSIONS
  In this clinical response to GMA was comparable or better than prednisolone. Further, the response to GMA was slower than to intravenous prednisolone, but was more sustainable than the latter.
authors.affiliation: Centre for Gastroenterology and Inflammatory Bowel Disease Research, Hamamatsu South Hospital, 26 Shirowacho, Hamamatsu 430-0846, Japan. flw-1013@topaz.plala.or.jp
authors.forename: H
authors.initials: H
authors.lastname: Hanai
authors.forename: T
authors.initials: T
authors.lastname: Iida
authors.forename: K
authors.initials: K
authors.lastname: Takeuchi
authors.forename: F
authors.initials: F
authors.lastname: Watanabe
authors.forename: Y
authors.initials: Y
authors.lastname: Maruyama
authors.forename: M
authors.initials: M
authors.lastname: Kageoka
authors.forename: K
authors.initials: K
authors.lastname: Ikeya
authors.forename: M
authors.initials: M
authors.lastname: Yamada
authors.forename: M
authors.initials: M
authors.lastname: Kikuyama
authors.forename: Y
authors.initials: Y
authors.lastname: Iwaoka
authors.forename: K
authors.initials: K
authors.lastname: Hirayama
authors.forename: S
authors.initials: S
authors.lastname: Nagata
authors.forename: Y
authors.initials: Y
authors.lastname: Sato
authors.forename: Y
authors.initials: Y
authors.lastname: Hosoda
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D005260:Female; D006098:Granulocytes; D006801:Humans; D007262:Infusions, Intravenous; D047589:Leukocyte Reduction Procedures; D008297:Male; D008875:Middle Aged; D009000:Monocytes; D011239:Prednisolone / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D011239:Prednisolone