title: Efficacy, safety and cost analyses in ulcerative colitis patients undergoing granulocyte and monocyte adsorption or receiving prednisolone.
abstract: BACKGROUND
  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. We were interested to evaluate the efficacy, safety and the treatment cost for PSL and GMA.
  
  
  METHODS
  Forty-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.
  
  
  RESULTS
  PSL 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).
  
  
  CONCLUSIONS
  In 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.
authors: Department of Gastroenterology, Dokkyo Medical University, 880, Kitakobayashi, Mibu, Shimotsuga, Tochigi, 321-0293, Japan. tominaga@dokkyomed.ac.jp
authors: Keiichi
authors: K
authors: Tominaga
authors: Masakazu
authors: M
authors: Nakano
authors: Mina
authors: M
authors: Hoshino
authors: Kazunari
authors: K
authors: Kanke
authors: Hideyuki
authors: H
authors: Hiraishi
mesh_terms: D000293:Adolescent; D000327:Adsorption; D000328:Adult; D000368:Aged; D015331:Cohort Studies; D003093:Colitis, Ulcerative / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D003362:Cost-Benefit Analysis; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D006098:Granulocytes / Q000473:pathology*; D006801:Humans; D053208:Kaplan-Meier Estimate; D007937:Leukapheresis / Q000191:economics* / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009000:Monocytes / Q000473:pathology*; D061214:Patient Safety; D011239:Prednisolone / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D012189:Retrospective Studies; D015996:Survival Rate; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D005938:Glucocorticoids; D011239:Prednisolone