title: Safety and Efficacy of Granulocyte/Monocyte Apheresis in Steroid-Dependent Active Ulcerative Colitis with Insufficient Response or Intolerance to Immunosuppressants and/or Biologics [the ART Trial]: 12-week Interim Results.
abstract: OBJECTIVE
  Patients with active, steroid-dependent ulcerative colitis with insufficient response or intolerance to immunosuppressants and/or biologic therapies have limited treatment options. Adacolumn, a granulocyte/monocyte adsorptive apheresis device, has shown clinical benefit in these patients. This study aimed to provide additional clinical data regarding the safety and efficacy of Adacolumn in this patient subgroup.
  
  
  METHODS
  This single-arm, open-label, multicentre trial [ART] was conducted at 18 centres across the UK, France, and Germany. Eligible patients were 18-75 years old with moderate-to-severe, steroid-dependent active ulcerative colitis with insufficient response or intolerance to immunosuppressants and/or biologics. Patients received ≥ 5 weekly apheresis sessions with Adacolumn. The primary endpoint was clinical remission rate [clinical activity index ≤ 4] at Week 12.
  
  
  RESULTS
  In all, 86 patients were enrolled. At Week 12, 33/84 [39.3%] of patients in the intention-to-treat population achieved clinical remission, with 47/84 [56.0%] achieving a clinical response [clinical activity index reduction of ≥ 3]. Clinical remission was achieved in 30.0% of patients with previous immunosuppressant and biologic failure; steroid-free clinical remission and response were observed in 22.6% and 35.7% of these patients, respectively. Quality of life [Short Health Scale] significantly improved at Week 12 [p < 0.0001]. The majority of adverse events were of mild/moderate intensity.
  
  
  CONCLUSIONS
  At Week 12, Adacolumn provided significant clinical benefit in a large cohort of steroid-dependent ulcerative colitis patients with previous failure to immunosuppressant and/or biologic treatment, with a favourable safety profile. These results are consistent with previous studies and support Adacolumn use in this difficult-to-treat patient subgroup.
authors.affiliation: Department of Gastroenterology, Hepatology, Oncology and Metabolic Diseases, Markus-Krankenhaus, Frankfurt/Main, Germany axel.dignass@fdk.info.
authors.forename: Axel
authors.initials: A
authors.lastname: Dignass
authors.affiliation: IBD Unit, St Mark's Hospital and Academic Institute, London, UK.
authors.forename: Ayesha
authors.initials: A
authors.lastname: Akbar
authors.affiliation: IBD Unit, St Mark's Hospital and Academic Institute, London, UK.
authors.forename: Ailsa
authors.initials: A
authors.lastname: Hart
authors.affiliation: Department of Gastroenterology, Royal Liverpool University Hospital, Liverpool, UK.
authors.forename: Sreedhar
authors.initials: S
authors.lastname: Subramanian
authors.affiliation: Service Hépatologie-Gastroentérologie, CHU Clermont-Ferrand, Clermont-Ferrand, France.
authors.forename: Gilles
authors.initials: G
authors.lastname: Bommelaer
authors.affiliation: Department of Medicine, Division of Gastroenterology and Hepatology, Charité Medical Center - Virchow Hospital, Humboldt-University of Berlin, Germany.
authors.forename: Daniel C
authors.initials: DC
authors.lastname: Baumgart
authors.affiliation: Assistance PubliqueHôpitaux de Marseille, Marseille, France.
authors.forename: Jean-Charles
authors.initials: JC
authors.lastname: Grimaud
authors.affiliation: Service d'Hépato-gastro-entérologie, CHU du Reims, Hôpital Robert Debré, Reims, France.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Cadiot
authors.affiliation: Cheltenham General Hospital, Cheltenham, UK.
authors.forename: Richard
authors.initials: R
authors.lastname: Makins
authors.affiliation: Barts Health NHS Trust, Whipps Cross University Hospital, London, UK.
authors.forename: Syed
authors.initials: S
authors.lastname: Hoque
authors.affiliation: Service des Maladies de l'Appareil Digestif et CIC1414, University Hospital of Rennes, Pontchaillou, France.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Bouguen
authors.affiliation: Clinique Universitaire d'Hépato-Gastroentérologie, CHU Grenoble, Grenoble, France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Bonaz
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003093:Colitis, Ulcerative / Q000188:drug therapy / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006098:Granulocytes; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007937:Leukapheresis / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009000:Monocytes; D011358:Product Surveillance, Postmarketing; D012074:Remission Induction; D013256:Steroids / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D013256:Steroids
keywords: Ulcerative colitis; adacolumn; apheresis
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