Extracorporeal photopheresis for the treatment of refractory Crohn's disease: Results of an open-label pilot study

✍ Scribed by Maria T. Abreu; Christian von Tirpitz; Robert Hardi; Martin Kaatz; Gert Van Assche; Paul Rutgeerts; Emil Bisaccia; Sergi Goerdt; Stephen Hanauer; Robert Knobler; Peter Mannon; Lloyd Mayer; Thomas Ochsenkuhn; William J. Sandborn; Dennis Parenti; Kevin Lee; Walter Reinisch

• Publisher: John Wiley and Sons
• Year: 2009
• Tongue: English
• Weight: 250 KB
• Volume: 15
• Category: Article
• ISSN: 1078-0998
• DOI: 10.1002/ibd.20833

✦ Synopsis

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.