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P319. Effectiveness of leukocyte adsorber LA25 in the treatment of inflammatory bowel disease (IBD) patients non-responder to conventional therapy: pilot study LEUKOSMART

M. Di Girolamo1, A. Scarcelli1, A. Bertani1, A. Sartini1, A. Merighi1, E. Villa1, 1Policlinico Modena, Italy

Background

Granulocyte/monocyte apheresis (GMA) is an extracorporeal procedure that selectively removes leucocytes (WBC) from peripheral blood with reduction of inflammatory process. Some GMA devices have been demonstrated safety and effectiveness in refractory or intolerant to conventional therapy IBD patients (pts). This open-label and prospective study assesses the performance, clinical efficacy and safety of GMA with leukocyte adsorber LA25 (Medica Spa., Medolla, Italy) in Crohn's disease (CD) or Ulcerative colitis (UC) non-responder to conventional therapy (steroids, thiopurine and anti-TNFa) pts. Primary outcome are the performance (reduction of WBC, neutrophils and monocytes in peripheral blood) and clinical efficacy (decrease more of 30% of diseases activity indexes: CDAI – Crohn's Disease Activity Index and MAYO) evaluation of LA25 respect to baseline.

Methods

Pts with a diagnosis of active moderate-severe IBD, according to MAYO (for UC pts) and to CDAI (for CD pts) scores were evaluated. The protocol required 5 weekly GMAs for each pt. LA25 was constituted by Medisulfone® (hydrophilic polysulfone) fibers. Blood samples were collected at the baseline, before, during and after completion of each GMA. The analysis of LA25 performance was corrected for the dilution factor. Study was approved by local IEC.

Results

From September 2011 to September 2012, 17 pts (10 UC, 7 CD) were enrolled. Two pts were withdrawn (one reactivation of autoimmune chronic hepatitis and one HZV exacerbation). Mean MAYO score at baseline was 9.40±1.40 (6 pts with MAYO more than 10 and 4 pts 6 < MAYO < 9). Mean CDAI was 213.14±31.99 (5 pts 150 < CDAI < 219 and 2 pts 220 < CDAI < 450). Red blood cells, haemoglobin, haematocrit and lymphocytes were not significantly influenced by LA25 during GMA (10–20%). WBC, neutrophils, monocytes and platelets (PLTs) were selectively removed (45–55%, 50–65%, 75–80% and 40–50%). All pts achieved clinical remission with a significant (p < 0.005) decrease in MAYO and CDAI score at 10 and 18 weeks of follow up (MAYO score: 5.63±2.56 and 4.75±1.16; CDAI score: 63.50±22.67 and 78.00±31.66). Treatment period is completed. Follow up phase still on going.

Conclusion

LA25 demonstrated a selective and significant reduction of WBC during GMA. Preliminary data show that pts who completed the study achieved clinical remission with significant reduction in MAYO and CDAI scores (more than 30%). No one developed side effects.