Abstract
BackgroundPatients with ulcerative colitis (UC) are treated with prednisolone (PSL), which causes adverse side effects. Extracorporeal granulocyte/monocyte adsorption (GMA) with an Adacolumn depletes elevated/activated myeloid lineage leucocytes as sources of inflammatory cytokines. We were interested to evaluate the efficacy, safety and the treatment cost for PSL and GMA.MethodsForty-one patients with active UC had achieved remission with GMA, at 1 or 2 sessions/week, up to 10 sessions (n=24) or with orally administered PSL (1mg/kg bodyweight, n=17). Clinical activity index (CAI) ≤4 was considered clinical remission. Following remission, patients received 5-aminosalicylic acid (2250-3000mg/day) or sulphasalazine (4000-6000mg/day) as maintenance therapy and were followed for 600 days. The total treatment cost was assessed based on 1€=150JPY.ResultsPSL was tapered after two weeks, and discontinued when a patient achieved remission. The average time to the disappearance of at least one major UC symptom (haematochezia, diarrhoea, or abdominal discomfort) was 15.3 days in the GMA group and 12.7 days in the PSL group, while time to remission was 27.9 days in the GMA group and 27.6 days in the PSL group, CAI 0.8 and 2.0, respectively. The Kaplan-Meier plots showed similar remission maintenance rates over the 600 days follow-up period. The average medical cost was 12739.4€/patient in the GMA group and 8751.3€ in the PSL group (P<0.05). In the GMA group, 5 transient adverse events were observed vs 10 steroid related adverse events in the PSL group (P<0.001).ConclusionsIn appropriately selected patients, GMA has significant efficacy with no safety concern. The higher cost of GMA vs PSL should be compromised by good safety profile of this non-pharmacological treatment intervention.
Highlights
Patients with ulcerative colitis (UC) are treated with prednisolone (PSL), which causes adverse side effects
Neutrophil activation and prolonged survival is a feature of persistent intestinal inflammation and histological examinations of the mucosal tissue in biopsy specimens from patients with active UC reveals a spectrum of pathologic manifestations among which presence of neutrophils accounts for the morphologic lesions of UC, and for the prevailing patterns of mucosal inflammation [1,14,15,18]
The average Clinical activity index (CAI) value when at least one of the major complications of UC disappeared was 4.3 ± 2.9 in the granulocyte/monocyte adsorption (GMA) group and 6.7 ± 3.4 in the PSL group indicating that at this time point, clinical remission was not achieved by all patients
Summary
Patients with ulcerative colitis (UC) are treated with prednisolone (PSL), which causes adverse side effects. Extracorporeal granulocyte/monocyte adsorption (GMA) with an Adacolumn depletes elevated/activated myeloid lineage leucocytes as sources of inflammatory cytokines. Granulocytes together with monocytes/macrophages produce an array of pleiotropic cytokines like tumour necrosis factor (TNF)-α, interleukin (IL)-1β, IL6, IL-12, IL-23 which are strongly inflammatory [19,20,21,22,23]. These have given rise to the inference that elevated and activated granulocytes and monocytes should be targets of therapy in UC. The Adacolumn has been developed for selective depletion of granulocytes and monocytes by adsorption (GMA)
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