Pilot feasibility studies of leukocytapheresis with the adacolumn apheresis system in patients with active ulcerative colitis or Crohn disease

Goals: Two uncontrolled, multicenter feasibility studies evaluated safety and pilot efficacy of selective granulocyte and monocyte adsorption apheresis (GMA) with the Adacolumn Apheresis System for treatment of moderate-to-severe ulcerative colitis (UC) and Crohn disease (CD) patients refractory/intolerant to conventional pharmacologic therapy. Background: Patients with UC and CD, characterized by elevations in peripheral blood granulocytes, monocytes/macrophages, and proinflammatory mediators, may benefit from reductions in activated granulocytes and monocytes by selective apheresis. Methods: Patients underwent weekly Adacolumn sessions for 5 weeks. Pilot efficacy assessments used disease activity index (DAI) for UC (0-12) or CD activity index (CDAI; 0-600) for CD. Results: Eleven of 15 UC patients completed all 5 treatments. Mean DAI scores fell from 8.4 +/- 1.3 (baseline) to 5.2 +/- 2.9 (week 7). Five patients had DAI reductions of >= 3 points at week 7. Fourteen of 15 CD patients completed all 5 treatments. Mean CDAI scores fell from 308.0 +/- 76.5 (baseline) to 200.6 +/- 117.4 (week 7). Nine CD patients responded (CDAI reductions >= 70 points) at week 7. Remission (CDAI score <= 150 at week 7) was observed in 6 patients. There were no device-related serious adverse effects. Conclusions: Treatment with Adacolumn may be feasible and effective in patients with moderate-to-severe refractory inflammatory bowel disease. Larger sham-controlled studies are ongoing.