title: Administration of adalimumab in the treatment of Crohn's disease of the ileal pouch.
abstract: BACKGROUND
  Crohn's disease (CD) of the pouch can develop in patients with ileal pouch-anal anastomosis (IPAA). Scant data are available on the treatment of this disease entity.
  
  
  OBJECTIVE
  To evaluate efficacy and safety of adalimumab in treating CD of the ileal pouch.
  
  
  METHODS
  From June 2007 to June 2008, 17 IPAA patients with inflammatory (n = 10), fibrostenotic (n = 2) or fistulizing (n = 5) CD of the pouch treated with adalimumab were evaluated. Inclusion criteria were CD of the pouch who failed medical therapy and were otherwise qualified for permanent pouch diversion or excision. All qualified patients received the standard dosing regimen of subcutaneous injection adalimumab (160 mg at week 0, 80 mg at week 1, and 40 mg every other week thereafter). Complete clinical response was defined as resolution of symptoms. Partial clinical response was defined as improvement in symptoms. Endoscopic inflammation before and after therapy was recorded, using the Pouchitis Disease Activity Index (PDAI) endoscopy subscores.
  
  
  RESULTS
  The median age was 36 years with 12 patients (70.6%) being male. At 4 weeks, seven patients (41.2%) had a complete symptom response and 6 (35.3%) had a partial response. There was also a significant improvement in the PDAI endoscopy subscores at week 4 (P < 0.05). At the last follow-up (median of 8 weeks), eight patients (47.1%) had a complete symptom response and 4 (23.5%) had a partial response. Four patients (23.6%) developed adverse effects. Three patients (17.7%) eventually had pouch failure after failing to respond to adalimumab therapy.
  
  
  CONCLUSIONS
  Adalimumab appeared to be well-tolerated and efficacious in treating CD of the pouch in this open-labelled induction study.
authors.affiliation: The Pouchitis Clinic, Digestive Disease Institute, Cleveland Clinic Foundation, Cleveland, OH 44195, USA. shenb@ccf.org
authors.forename: B
authors.initials: B
authors.lastname: Shen
authors.forename: F H
authors.initials: FH
authors.lastname: Remzi
authors.forename: I C
authors.initials: IC
authors.lastname: Lavery
authors.forename: R
authors.initials: R
authors.lastname: Lopez
authors.forename: E
authors.initials: E
authors.lastname: Queener
authors.forename: L
authors.initials: L
authors.lastname: Shen
authors.forename: J
authors.initials: J
authors.lastname: Goldblum
authors.forename: V W
authors.initials: VW
authors.lastname: Fazio
mesh_terms: D000068879:Adalimumab; D000328:Adult; D001003:Anal Canal / Q000601:surgery*; D000714:Anastomosis, Surgical / Q000009:adverse effects; D000893:Anti-Inflammatory Agents / Q000009:adverse effects*; D000911:Antibodies, Monoclonal / Q000009:adverse effects*; D061067:Antibodies, Monoclonal, Humanized; D039021:Colonic Pouches / Q000009:adverse effects*; D003424:Crohn Disease / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D013223:Statistics as Topic
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000068879:Adalimumab