Treatment of Crohn's disease by lymphocyte apheresis: a randomized controlled trial. Groupe d'Etudes Thérapeutiques des Affections Inflammatoires Digestives.

BACKGROUND/AIMS: Several uncontrolled trials suggest that lymphapheresis improves the clinical course of patients with Crohn's disease; this study was designed to assess the efficacy of lymphapheresis in preventing early relapses of Crohn's disease in patients in clinical remission after steroid treatment for an acute attack.

METHODS

Twenty-eight patients in clinical remission at the end of 3-7 weeks of steroid therapy were included in this randomized multicenter prospective trial. Before starting steroid tapering, patients were randomly assigned either to the lymphapheresis group (9 procedures within 4-5 weeks) or to the control group. The primary judgement criterion was the cumulated recurrence rate after steroid discontinuation.

RESULTS

All the patients treated by lymphapheresis (12 of 12) were successfully withdrawn from prednisolone and only 10 of 15 in the control group (NS). At the end of the 18-month follow-up period, the cumulated relapse rate was 83% in the lymphapheresis group and 62% in the control group.

CONCLUSIONS

Although there was a trend towards a diminished incidence of corticosteroid dependence, lymphapheresis did not prevent the occurrence of early relapses.