Multicenter Randomized Controlled Trial for the Treatment of Ulcerative Colitis with a Leukocytapheresis Column

Abstract

The administration of steroids is not always effective for the treatment of ulcerative colitis (UC). Their long-term use often causes adverse effects which sometimes result in their stoppage and acute exacerbation. Therefore, an alternative treatment is necessary in order to decrease steroid dosage and avoid the clinical problems associated with steroids. Methods The effectiveness and adverse effects of a leukocytapheresis (LCAP) were investigated in a controlled multicenter trial with randomized assignment of 76 active-stage UC patients in two groups. In the LCAP group (39 patients), LCAP weekly for 5 weeks as an intensive therapy was added to the on-going drug therapy, while steroids were maintained but not increased, and then LCAP was gradually reduced to once every 4 weeks as a maintenance therapy. In the high dose prednisolone (h-PSL) group (37 patients), PSL was added or increased 30 approximately 40 mg/day for moderately severe and 60 approximately 80 mg/day for severe patients and then gradually tapered. Findings The LCAP group showed a significantly higher effectiveness (74% vs. 38%; p=0.005) and lower incidence of adverse effects (24% vs. 68%; p<0.001). The patients were able to continue the trial for a longer period in the LCAP group than the h-PSL group (p=0.012). Clinical activity and endoscopic indexes showed the LCAP group had better improvements than the h-PSL group. Interpretation The results of the trial show that LCAP permits a reduction in total PSL dosage and is more effective and safer than high-dose PSL administration for intensive therapy, and LCAP may maintain remission longer than PSL.

Cytapheresis as a Nonpharmacological Therapy for Inflammatory Bowel Disease

“…This polyester unwoven leukocyte removal filter installed in polycarbonate outer shell is designed to remove almost 100% of granulocytes and monocytes and 64% of lymphocytes [3]. Furthermore, approximately 35% of platelets can be trapped to the filter from processed peripheral blood [3]. LCA is usually performed weekly using a Cellsorba EX set in a simple one-way hemofiltration circuit [2][3][4].…”

“…Furthermore, approximately 35% of platelets can be trapped to the filter from processed peripheral blood [3]. LCA is usually performed weekly using a Cellsorba EX set in a simple one-way hemofiltration circuit [2][3][4]. A roller pump drained peripheral blood of the patient from an antecubital vein under constant flow rate of 30-50 ml/min.…”

“…We have proven that the clinical efficacy of LCA in severe UC patients can be predicted by the reduction of activated platelets achieved during the first LCA session [17]. Sawada et al [3] conducted a randomized multicenter trial on the effects of LCA in patients with active UC. UC patients who were resistant to conventional steroid therapy with at least 30 mg/day were randomized to either receive LCA (adding LCA without increasing the corticosteroid dose) or high-dose steroid therapy (h-PSL; increasing the corticosteroid dose to 60 mg/day).…”

“…Although, for steroid-resistant severe UC, intravenous infusion therapy of cyclosporine has been widely accepted as an adjunct therapy [42], a large proportion of patients may have surgery in future years. Clinical experience so far suggests that cytapheresis has superior efficiency as a non-pharmacological immunomodulative therapy for steroid-resistant UC patients before colectomy [1][2][3][4].…”

Cytapheresis in Patients with Severe Ulcerative Colitis after Failure of Intravenous Corticosteroid: A Long-Term Retrospective Cohort Study

“…4,5 A new non-drug strategy introduced in recent years is cytapheresis (CAP) for the treatment of patients with active UC, including patients with severe refractory UC. [6][7][8][9][10][11][12] The primary action of CAP is to regulate the dysregulated immune response by removing inflammatory cytokine producing circulating leukocytes, especially granulocytes, which are destined for infiltration into the mucosa. 12 Currently, filtration leukocytapheresis (LCA), 7 and adsorptive granulocyte/monocyte apheresis (GMA) [8][9][10][11][12] are the two major CAP therapies for patients with an acute UC flare.…”