Document Detail


Extracorporeal photopheresis (ECP) in patients with steroid-dependent Crohn's disease: an open-label, multicenter, prospective trial.
MedLine Citation:
PMID:  22573600     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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:
Walter Reinisch; Robert Knobler; Paul J Rutgeerts; Thomas Ochsenkühn; Frank Anderson; Christian von Tirpitz; Martin Kaatz; C Janneke van der Woude; Dennis Parenti; Peter J Mannon
Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Inflammatory bowel diseases     Volume:  19     ISSN:  1536-4844     ISO Abbreviation:  Inflamm. Bowel Dis.     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2013-02-04     Completed Date:  2013-08-20     Revised Date:  2014-02-04    
Medline Journal Info:
Nlm Unique ID:  9508162     Medline TA:  Inflamm Bowel Dis     Country:  United States    
Other Details:
Languages:  eng     Pagination:  293-300     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Aged
Aged, 80 and over
Crohn Disease / drug therapy*
Drug Administration Schedule
Drug Therapy, Combination
Female
Glucocorticoids / therapeutic use*
Humans
Induction Chemotherapy
Intention to Treat Analysis
Maintenance Chemotherapy
Male
Middle Aged
Photopheresis*
Prednisone / therapeutic use*
Prospective Studies
Treatment Outcome
Young Adult
Grant Support
ID/Acronym/Agency:
Z01 AI000903-06/AI/NIAID NIH HHS
Chemical
Reg. No./Substance:
0/Glucocorticoids; VB0R961HZT/Prednisone
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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