Selective white cell apheresis reduces relapse rates in patients with IBD at significant risk of clinical relapse.
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.
Maiden
Laurence
L
Guy's, King's and St Thomas' Medical School, London, UK.
Takeuchi
Ken
K
Baur
Rosie
R
Bjarnason
Ingi
I
O'Donohue
John
J
Forgacs
Ian
I
Chung-Faye
Guy
G
Sanderson
Jeremy
J
Bjarnason
Ingvar
I
D000293:Adolescent; D000327:Adsorption; D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000032:analysis; D018450:Disease Progression; D005243:Feces / Q000737:chemistry*; D005260:Female; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000453:epidemiology* / Q000378:metabolism / Q000473:pathology / Q000628:therapy*; D007937:Leukapheresis / Q000379:methods*; D039841:Leukocyte L1 Antigen Complex / Q000032:analysis*; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D012307:Risk Factors; D055502:Secondary Prevention; D012720:Severity of Illness Index; D055815:Young Adult
D015415:Biomarkers; D039841:Leukocyte L1 Antigen Complex