BACKGROUND: We assessed whether selective granulocyte and monocyte/macrophage adsorption apheresis maintained clinical remission in asymptomatic inflammatory bowel disease (IBD) patients at significant risk of clinical relapse. METHODS:Sixty asymptomatic patients (age 18-70 years) with IBD (in clinical remission) with fecal calprotectin over 250 microg/g (which defines those at risk of clinical relapse with >80% specificity and sensitivity) were recruited for this open-label, prospective, randomized, controlled study. Twenty-nine underwent selective leukocytapheresis, undergoing 5, once weekly, out-patient sessions. Thirty-one had unchanged maintenance treatment and acted as controls. Follow-up for a clinical relapse was 6 months. The secondary outcome variable was the time to relapse. RESULTS: The number of patients who remained in clinical remission at 6 months was significantly lower in controls (32.3%) than in the apheresis (72.4%) group (P = 0.0023, Fisher's exact test). The time to first relapse was significantly earlier in the control group (99 +/- 73 days) as compared with the apheresis group (161 +/- 44 days) (log-rank test; P = 0.0004). Mild and transient headache was reported by 16 of the 29 (55%) for up to 3 hours, but no serious side effects were observed. CONCLUSIONS: This study represents a new approach to the treatment of IBD by targeting a group of asymptomatic patients for treatment who are at significant risk of relapse based on high fecal calprotectin concentrations. Selective leukocytapheresis significantly reduced the number of, and increased the time to, clinical relapse in these patients without serious side effects.
RCT Entities:
BACKGROUND: We assessed whether selective granulocyte and monocyte/macrophage adsorption apheresis maintained clinical remission in asymptomatic inflammatory bowel disease (IBD) patients at significant risk of clinical relapse. METHODS: Sixty asymptomatic patients (age 18-70 years) with IBD (in clinical remission) with fecal calprotectin over 250 microg/g (which defines those at risk of clinical relapse with >80% specificity and sensitivity) were recruited for this open-label, prospective, randomized, controlled study. Twenty-nine underwent selective leukocytapheresis, undergoing 5, once weekly, out-patient sessions. Thirty-one had unchanged maintenance treatment and acted as controls. Follow-up for a clinical relapse was 6 months. The secondary outcome variable was the time to relapse. RESULTS: The number of patients who remained in clinical remission at 6 months was significantly lower in controls (32.3%) than in the apheresis (72.4%) group (P = 0.0023, Fisher's exact test). The time to first relapse was significantly earlier in the control group (99 +/- 73 days) as compared with the apheresis group (161 +/- 44 days) (log-rank test; P = 0.0004). Mild and transient headache was reported by 16 of the 29 (55%) for up to 3 hours, but no serious side effects were observed. CONCLUSIONS: This study represents a new approach to the treatment of IBD by targeting a group of asymptomatic patients for treatment who are at significant risk of relapse based on high fecal calprotectin concentrations. Selective leukocytapheresis significantly reduced the number of, and increased the time to, clinical relapse in these patients without serious side effects.
Authors: H Hanai; Y Takeda; M Eberhardson; R Gruber; A R Saniabadi; O Winqvist; R Lofberg Journal: Clin Exp Immunol Date: 2010-11-16 Impact factor: 4.330
Authors: Anders Lasson; Lena Öhman; Per-Ove Stotzer; Stefan Isaksson; Otto Überbacher; Kjell-Arne Ung; Hans Strid Journal: United European Gastroenterol J Date: 2015-02 Impact factor: 4.623