title: Granulocytapheresis in steroid-dependent and steroid-resistant patients with inflammatory bowel disease: a prospective observational study.
abstract: BACKGROUND
  Despite the mounting importance of granulocytapheresis (GCAP) for inflammatory bowel disease (IBD) treatment, its effectiveness in steroid-dependent (SD) and steroid-resistant (SR) patients has not been clearly evaluated. This prospective observational study describes the use of GCAP in SD and SR patients with either Ulcerative Colitis (UC) or Crohn's Disease (CD).
  
  
  METHODS
  118 patients, 83 affected by UC (55 SD and 28 SR) and 35 by CD (22 SD and 13 SR), were treated with GCAP, using Adacolumn™, for 5 consecutive weeks, 1 session/week. All patients were followed for 12 months after the end of GCAP. Clinical remission was defined as Clinical Activity Index (CAI) ≤6 for UC patients and Crohn's Disease Activity Index (CDAI) <150 for CD patients.
  
  
  RESULTS
  All patients completed the study; no major complications were reported. At the end of GCAP 71% of UC and 63% of CD patients showed clinical remission. At 6 months the remission was maintained by 66% and 54% of UC and CD patients respectively, while at 12 months the percentages were 48% and 43%, respectively. No differences between SD and SR subgroups were reported at any timepoint. CAI and CDAI values significantly dropped after GCAP treatment and at 6 and 12 months' follow-up (p<0.05 vs baseline for both timepoints). No differences were measured in CAI and CDAI between SD and SR patients.
  
  
  CONCLUSIONS
  GCAP therapy is safe and effective in inducing and maintaining clinical remission both in SD and in SR patients affected by either UC or CD.
authors.affiliation: Department of Gastroenterology, Pisa University Hospital, Pisa, Italy. Electronic address: r.sacco@ao-pisa.toscana.it.
authors.forename: Rodolfo
authors.initials: R
authors.lastname: Sacco
authors.forename: Antonio
authors.initials: A
authors.lastname: Romano
authors.forename: Alessandro
authors.initials: A
authors.lastname: Mazzoni
authors.forename: Marco
authors.initials: M
authors.lastname: Bertini
authors.forename: Graziana
authors.initials: G
authors.lastname: Federici
authors.forename: Salvatore
authors.initials: S
authors.lastname: Metrangolo
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Parisi
authors.forename: Cecilia
authors.initials: C
authors.lastname: Nencini
authors.forename: Celeste
authors.initials: C
authors.lastname: Giampietro
authors.forename: Michele
authors.initials: M
authors.lastname: Bertoni
authors.forename: Emanuele
authors.initials: E
authors.lastname: Tumino
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Scatena
authors.forename: Giampaolo
authors.initials: G
authors.lastname: Bresci
mesh_terms: D000328:Adult; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D001799:Blood Sedimentation; D002097:C-Reactive Protein / Q000378:metabolism; D003093:Colitis, Ulcerative / Q000097:blood / Q000188:drug therapy / Q000628:therapy*; D003424:Crohn Disease / Q000097:blood / Q000188:drug therapy / Q000628:therapy*; D004351:Drug Resistance; D005243:Feces / Q000737:chemistry; D005260:Female; D005500:Follow-Up Studies; D006098:Granulocytes; D006801:Humans; D007937:Leukapheresis; D039841:Leukocyte L1 Antigen Complex / Q000032:analysis; D008297:Male; D008775:Methylprednisolone / Q000627:therapeutic use; D008875:Middle Aged; D011446:Prospective Studies; D012008:Recurrence; D012074:Remission Induction; D012720:Severity of Illness Index
chemical_list: D000893:Anti-Inflammatory Agents; D039841:Leukocyte L1 Antigen Complex; D002097:C-Reactive Protein; D008775:Methylprednisolone
keywords: Crohn's Disease; Granulocytapheresis; Steroid-dependence; Steroid-resistance; Ulcerative Colitis