title: Extracorporeal photopheresis for the treatment of refractory Crohn's disease: results of an open-label pilot study.
abstract: BACKGROUND
  Extracorporeal photopheresis (ECP) is effective in immune-mediated disorders. A prospective, uncontrolled pilot study was conducted to evaluate the safety and efficacy of ECP in patients with active Crohn's disease (CD) who were refractory to or intolerant of immunosuppressants and/or anti-TNF therapies.
  
  
  METHODS
  Patients with moderate-to-severely active CD (Crohn's Disease Activity Index [CDAI] 220-450 points) underwent 12 weeks of ECP treatment (Weeks 1-4: twice weekly, every week; Weeks 5-12: twice weekly, every other week). Clinical response was defined as a decrease in the CDAI of >or=100 points or remission (CDAI <150 points) at Week 12. Patients who responded at Week 12 could receive an additional 12 weeks of ECP treatment (twice weekly, every other week) in an extension study.
  
  
  RESULTS
  Twenty-eight patients were enrolled with a mean baseline CDAI score of 314 (range 207-457). At Week 12, 14 patients (50%) responded; 13 patients responded within 6 weeks. Seven patients (25%) attained remission by Week 12. Three of 5 patients with open fistulae at baseline had fistula closure. Response was similar among patients naïve to anti-TNF agents and patients who had previously been refractory or intolerant to anti-TNF agents. Of the 12 patients who entered the extension study, 9 (75%) maintained their response at Week 24.
  
  
  CONCLUSIONS
  In patients with moderate-to-severely active CD who were refractory to or intolerant of immunosuppressants and/or anti-TNF agents, ECP was well tolerated and induced clinical response (50%) and remission (25%) in patients. Most patients were able to maintain a response with continued treatments.
authors.affiliation: University of Miami Miller School of Medicine, Miami, FL 33101-6960, USA. MAbreu1@med.miami.edu
authors.forename: Maria T
authors.initials: MT
authors.lastname: Abreu
authors.forename: Christian
authors.initials: C
authors.lastname: von Tirpitz
authors.forename: Robert
authors.initials: R
authors.lastname: Hardi
authors.forename: Martin
authors.initials: M
authors.lastname: Kaatz
authors.forename: Gert
authors.initials: G
authors.lastname: Van Assche
authors.forename: Paul
authors.initials: P
authors.lastname: Rutgeerts
authors.forename: Emil
authors.initials: E
authors.lastname: Bisaccia
authors.forename: Sergi
authors.initials: S
authors.lastname: Goerdt
authors.forename: Stephen
authors.initials: S
authors.lastname: Hanauer
authors.forename: Robert
authors.initials: R
authors.lastname: Knobler
authors.forename: Peter
authors.initials: P
authors.lastname: Mannon
authors.forename: Lloyd
authors.initials: L
authors.lastname: Mayer
authors.forename: Thomas
authors.initials: T
authors.lastname: Ochsenkuhn
authors.forename: William J
authors.initials: WJ
authors.lastname: Sandborn
authors.forename: Dennis
authors.initials: D
authors.lastname: Parenti
authors.forename: Kevin
authors.initials: K
authors.lastname: Lee
authors.forename: Walter
authors.initials: W
authors.lastname: Reinisch
mesh_terms: D000328:Adult; D002097:C-Reactive Protein / Q000378:metabolism; D003424:Crohn Disease / Q000188:drug therapy* / Q000276:immunology; D016154:Digestive System Fistula / Q000188:drug therapy; D004351:Drug Resistance; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects*; D008297:Male; D008730:Methoxsalen / Q000627:therapeutic use; D008875:Middle Aged; D017893:Photopheresis / Q000009:adverse effects / Q000379:methods*; D017319:Photosensitizing Agents / Q000627:therapeutic use; D010865:Pilot Projects; D011446:Prospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D017319:Photosensitizing Agents; D014409:Tumor Necrosis Factor-alpha; D002097:C-Reactive Protein; D008730:Methoxsalen