title: The European ankylosing spondylitis infliximab cohort (EASIC): a European multicentre study of long term outcomes in patients with ankylosing spondylitis treated with infliximab.
abstract: OBJECTIVE
  To study the long-term efficacy and safety of treatment with infliximab in patients with ankylosing spondylitis (AS) in a real life setting.
  
  
  METHODS
  AS patients from 6 European countries who had finished the 2-year trial ASSERT were invited to participate in the open- label investigator-driven study EASIC. At baseline, 2 groups were formed: patients of group 1 had not been treated with infliximab after ASSERT, while those of group 2 had continuously received it. Patients of group 1 were further subdivided in group 1a: patients with a relapse and 1b: in remission. All patients of group 1a and 2 continuously received infliximab for 96 weeks, mean dose 5 mg/kg, intervals 6-8 weeks. Patients of group 1b were also treated in case of relapse.
  
  
  RESULTS
  A total of 103/149 patients (69%) were included in EASIC, 1.3 ± 0.9 years after the end of ASSERT: 9 in group 1a, 5 in group 1b and 89 in group 2. Most patients were male (83%), mean age 44 years. Most patients of group 2 completed the trial (86%) vs. only 5 of group 1 (33%) - mostly due to allergic reactions after readministration of infliximab. In total, there were 22 drop-outs due to 6 adverse events, 4 lack of efficacy, 3 planned pregnancy. All standard assessments indicated beneficial values over time, at week 96 significantly better than at baseline of ASSERT.
  
  
  CONCLUSIONS
  The majority of patients were continuously and successfully treated with infliximab for 5 years, whereas discontinuation and reintroduction of therapy was less satisfactory due to the frequent occurrence of hypersensitivity reactions. Anti-TNF therapy with infliximab proved to be effective and safe on a long-term basis.
authors: Rheumazentrum Ruhrgebiet, Herne, Germany. heldmann@rheumazentrum-ruhrgebiet.de
authors: F
authors: F
authors: Heldmann
authors: J
authors: J
authors: Brandt
authors: I E
authors: IE
authors: van der Horst-Bruinsma
authors: R
authors: R
authors: Landewe
authors: J
authors: J
authors: Sieper
authors: G R
authors: GR
authors: Burmester
authors: F
authors: F
authors: van den Bosch
authors: K
authors: K
authors: de Vlam
authors: P
authors: P
authors: Geusens
authors: H
authors: H
authors: Gaston
authors: S
authors: S
authors: Schewe
authors: T
authors: T
authors: Appelboom
authors: P
authors: P
authors: Emery
authors: M
authors: M
authors: Dougados
authors: M
authors: M
authors: Leirisalo-Repo
authors: M
authors: M
authors: Breban
authors: J
authors: J
authors: Listing
authors: J
authors: J
authors: Braun
mesh_terms: D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D004342:Drug Hypersensitivity / Q000209:etiology; D005060:Europe; D005260:Female; D006801:Humans; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D010352:Patient Dropouts; D011247:Pregnancy; D012008:Recurrence; D012074:Remission Induction; D013167:Spondylitis, Ankylosing / Q000175:diagnosis / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D000069285:Infliximab