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Extracorporeal Photopheresis (ECP) in Patients with Steroid-dependent Crohn's Disease: An Open-label, Multicenter, Prospective Trial

Reinisch, Walter MD*; Knobler, Robert MD*; Rutgeerts, Paul J. MD; Ochsenkühn, Thomas MD; Anderson, Frank MD§; von Tirpitz, Christian MD; Kaatz, Martin MD; van der Woude, C. Janneke MD**; Parenti, Dennis MD††; Mannon, Peter J. MD, MPH‡‡

doi: 10.1002/ibd.23012
Original Clinical Articles

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 immunosup-pressants. 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.

Article first published online 9 May 2012

*Medical University of Vienna, Vienna, Austria

University of Leuven, Leuven, Belgium

University of Munich, Munich, Germany

§LAIR Centre, Vancouver, BC, Canada

University of Ulm, Ulm, Germany

University of Jena, Jena, Germany

**Erasmus University, Rotterdam, Netherlands

††Therakos, Johnson & Johnson, Raritan, New Jersey

‡‡Mucosal Immunity Section, National Institute of Allergy and Infectious Disease, NIH, Bethesda, Maryland.

Reprints: Walter Reinisch, Medical University of Vienna, Waehringer Guertel 18-20, Vienna, A-1090, Austria (e-mail: walter.reinisch@meduniwien.ac.at).

Current address for P.J. Mannon: Division of Gastroenterology and Hepatology, University of Alabama at Birmingham, Birmingham, AL.

Supported by a grant from Therakos, Inc., Raritan, NJ.

Received April 17, 2012

Accepted April 18, 2012

© Crohn's & Colitis Foundation of America, Inc.
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