Extracorporeal Photopheresis to Maintain Symptoms Remission During Steroid Withdrawal in Patients With Steroid-Dependent Crohn's Disease

This protocol aims to measure the safety and effectiveness of extracorporeal photopheresis (ECP) therapy for maintaining remission of symptoms during withdrawal of corticosteroids from patients with steroid-dependent Crohn's disease. Potential subjects will be asymptomatic or have a low level of symptoms that respond to an increase in their steroid dose; furthermore potential subjects will be dependent on steroids to control their symptoms and have a history of failing other immunosuppressive drugs to control their symptoms. This is an unblinded, single-arm study of ECP in Crohn's disease. This trial will use ECP twice a week every two weeks over 24 weeks during which time the dose of corticosteroids will be tapered. If the corticosteroids are able to be withdrawn without an increase in symptoms, then subjects may be eligible for further ECP (twice a week every four weeks over 24 weeks) as a maintenance regimen. Outcome parameters include the rates of complete and partial steroid tapering while maintaining remission, the rates of adverse events, and secondary clinical outcomes such as duration of response, rate of and time to relapse, and changes in symptom index scores. In addition, the NIH will perform a substudy that includes serial colonoscopy to measure cytokine and cell population changes in mononuclear cells extracted from biopsies. The long-term goals of this study are to test the safety and efficacy of ECP as a steroid-sparing and remittive therapy in Crohn's disease, to determine the immune response it effects in the gut mucosa, and identify factors associated with responders versus non-responders to ECP.