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Clinical Trial
. 2013 Feb;19(2):293-300.
doi: 10.1002/ibd.23012.

Extracorporeal photopheresis (ECP) in patients with steroid-dependent Crohn's disease: an open-label, multicenter, prospective trial

Walter Reinisch  1 , Robert Knobler, Paul J Rutgeerts, Thomas Ochsenkühn, Frank Anderson, Christian von Tirpitz, Martin Kaatz, C Janneke van der Woude, Dennis Parenti, Peter J Mannon
Affiliations
Clinical Trial

Extracorporeal photopheresis (ECP) in patients with steroid-dependent Crohn's disease: an open-label, multicenter, prospective trial

Walter Reinisch et al. Inflamm Bowel Dis. 2013 Feb.

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.

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Conflict of interest statement

Conflict-of-Interest Disclosure:

This work was supported by a grant from Therakos, Inc., Raritan, NJ

Figures

Figure 1
Figure 1
Subjects could enter study on any corticosteroid dose ≥10 to ≤40 mg/day.
Figure 2
Figure 2
132 subjects were enrolled. However, one subject never received any ECP treatments.
Figure 3
Figure 3
CAPTION: Number and percent of study subjects who achieved completed steroid Tapering without flare at the end of the Corticosteroid-Treatment Period (CS = Corticosteroid; IS = immunosupressant; TNF = tumor necrosis factor)
Figure 4
Figure 4
CAPTION: Number and percent of study subjects who achieved completed steroid tapering without flare at the end of the maintenance Period (CS = corticosteroid; IS = immunosupressant; TNF = tumor necrosis factor)
See this image and copyright information in PMC

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