title: Extracorporeal photopheresis (ECP) in patients with steroid-dependent Crohn's disease: an open-label, multicenter, prospective trial.
abstract: BACKGROUND
  Extracorporeal photopheresis (ECP) involves ex vivo leukocyte treatment with methoxsalen and UVA light to generate a tolerogenic response. A previous trial demonstrated that ECP permits corticosteroid withdrawal in steroid-dependent Crohn's disease (CD) patients who were in clinical remission. We studied the effect of ECP on steroid withdrawal in steroid-dependent CD.
  
  
  METHODS
  Patients with CD for ≥ 6 months, in remission at baseline while on steroids, but who had failed at ≥ 1 steroid withdrawal were included. Patients received two ECP treatments every 2 weeks for the 24-week steroid tapering period and underwent steroid-tapering. Patients completing steroid tapering could receive maintenance ECP (two treatments/week) every month for 24 weeks.
  
  
  RESULTS
  Thirty-one patients (Crohn's Disease Activity Index [CDAI] score 91; Inflammatory Bowel Disease Questionnaire [IBDQ] 172.5) were enrolled (baseline corticosteroid dose, 20 mg/day); 65% were refractory to/intolerant of anti-tumor necrosis factor (TNF) agents or immunosuppressants. After 24 weeks of ECP, 7 of 31 (22.6%) patients discontinued steroids while maintaining a CDAI of <150. At week 24, the steroid dose for the remaining patients on corticosteroids was 10 mg (P < 0.003 vs. baseline) with a CDAI of 110 and an IBDQ of 179. Following maintenance treatment, three patients remained in steroid-free remission. The 10 patients in the study and receiving ECP at week 48 had a steroid dose of 3.5 mg with a CDAI of 40 and an IBDQ of 188.
  
  
  CONCLUSIONS
  ECP permitted discontinuation or reduction of steroids in a population of refractory steroid-dependent CD patients. ECP may be useful in permitting steroid withdrawal in selected steroid-dependent CD patients. Ideally, these results need to be confirmed in a "sham-controlled clinical trial.
authors.affiliation: Medical University of Vienna, Vienna, Austria. walter.reinisch@meduniwien.ac.at
authors.forename: Walter
authors.initials: W
authors.lastname: Reinisch
authors.forename: Robert
authors.initials: R
authors.lastname: Knobler
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Rutgeerts
authors.forename: Thomas
authors.initials: T
authors.lastname: Ochsenkühn
authors.forename: Frank
authors.initials: F
authors.lastname: Anderson
authors.forename: Christian
authors.initials: C
authors.lastname: von Tirpitz
authors.forename: Martin
authors.initials: M
authors.lastname: Kaatz
authors.forename: C
authors.initials: C
authors.lastname: Janneke van der Woude
authors.forename: Dennis
authors.initials: D
authors.lastname: Parenti
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Mannon
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003424:Crohn Disease / Q000188:drug therapy*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use*; D006801:Humans; D060828:Induction Chemotherapy; D057194:Intention to Treat Analysis; D060046:Maintenance Chemotherapy; D008297:Male; D008875:Middle Aged; D017893:Photopheresis; D011241:Prednisone / Q000627:therapeutic use*; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D005938:Glucocorticoids; D011241:Prednisone