title: Clinical experience with the European Ankylosing Spondylitis Infliximab Cohort (EASIC): long-term extension over 7 years with focus on clinical efficacy and safety.
abstract: OBJECTIVE
  Knowledge on the long-term effects of anti-TNF therapy in patients with ankylosing spondylitis (AS) is still limited. Our objective was to study the long-term efficacy and safety of anti-TNF therapy in AS.
  
  
  METHODS
  After having completed the first part of the EASIC trial a total of 71 patients were enrolled into this 96-week extension study. Patients were treated with the same dosages and dosing intervals of infliximab as in the EASIC core study. Efficacy was assessed by using standardised assessment tools such as BASDAI, BASFI, BASMI, patient global assessment, CRP levels and the proportion of patients without any sign of enthesitis or arthritis. Long-term safety was assessed by documenting adverse events (AE), serious adverse events (SAE) and reasons for dropping out.
  
  
  RESULTS
  Of the 71 patients included, 64 (90.1%) completed the trial , and 7 discontinued: one was lost to follow-up, 3 withdrew informed consent and in 3 patients therapy was stopped for different reasons: secondary loss of response, recurrent infections and basal cell carcinoma of the skin. The completers showed rather stable low scores of BASDAI (mean 2.4, median 2.52), BASFI (mean 3.1, median 2.76) and BASMI (mean 3.2, median 3) as well as patients global assessment and CRP. The vast majority of patients did not have enthesitis or arthritis. A total of 476 AE were observed, 13 of which were SAE. The majority of these were infections and most of them affected the respiratory tract. Two malignancies occurred: one basal cell carcinoma and one malignant melanoma. These were the only SAE judged to be possibly related to the study drug.
  
  
  CONCLUSIONS
  Anti-TNF treatment with infliximab is efficacious over long periods of time in patients with AS. The observation of two skin related malignancies, including one melanoma, during the whole study period of 7 years is in line with reports from previous large AS data sets.
authors.affiliation: Rheumazentrum Ruhrgebiet, Herne, Germany. frank.heldmann@ediacon.de.
authors.forename: Frank
authors.initials: F
authors.lastname: Heldmann
authors.affiliation: Rheumazentrum Ruhrgebiet, Herne, Germany.
authors.forename: Xenofon
authors.initials: X
authors.lastname: Baraliakos
authors.affiliation: Rheumazentrum Ruhrgebiet, Herne, Germany.
authors.forename: Uta
authors.initials: U
authors.lastname: Kiltz
authors.affiliation: Rheumapraxis-Steglitz/Charité, Berlin, Germany.
authors.forename: Jan
authors.initials: J
authors.lastname: Brandt
authors.affiliation: VU Medical Center, Amsterdam, the Netherlands.
authors.forename: Irene E
authors.initials: IE
authors.lastname: van der Horst-Bruinsma
authors.affiliation: Department of Clinical Immunology and Rheumatology, Academic Medical Center/University of Amsterdam, the Netherlands.
authors.forename: Robert
authors.initials: R
authors.lastname: Landewé
authors.affiliation: Charité Campus Benjamin Franklin, Berlin, Germany.
authors.forename: Joachim
authors.initials: J
authors.lastname: Sieper
authors.affiliation: Charité University Medicine Berlin, Germany.
authors.forename: Gerd Rüdiger
authors.initials: GR
authors.lastname: Burmester
authors.affiliation: Universitair Ziekenhuis Ghent, Belgium.
authors.forename: Filip
authors.initials: F
authors.lastname: van den Bosch
authors.affiliation: University Hospital Leuven, Belgium.
authors.forename: Kurt
authors.initials: K
authors.lastname: de Vlam
authors.affiliation: Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Chapel Allerton Hospital, Leeds, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
authors.forename: Hill
authors.initials: H
authors.lastname: Gaston
authors.affiliation: Klinikum der Universität München, Germany.
authors.forename: Mathias
authors.initials: M
authors.lastname: Gruenke
authors.affiliation: Klinikum der Universität München, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Witt
authors.affiliation: Hopital Erasme Brussels, Belgium.
authors.forename: Thierry
authors.initials: T
authors.lastname: Appelboom
authors.affiliation: University of Leeds, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Emery
authors.affiliation: Hopital Cochin Paris, France.
authors.forename: Maxime
authors.initials: M
authors.lastname: Dougados
authors.affiliation: Helsinki University Central Hospital, Helsinki, Finland.
authors.forename: Marjatta
authors.initials: M
authors.lastname: Leirisalo-Repo
authors.affiliation: Hopital Ambroise Paré, Boulogne, France.
authors.forename: Maxime
authors.initials: M
authors.lastname: Breban
authors.affiliation: Rheumazentrum Ruhrgebiet, Herne, Germany.
authors.forename: Juergen
authors.initials: J
authors.lastname: Braun
mesh_terms: D000328:Adult; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002097:C-Reactive Protein / Q000032:analysis; D015331:Cohort Studies; D005260:Female; D006801:Humans; D000069285:Infliximab / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D013167:Spondylitis, Ankylosing / Q000097:blood / Q000188:drug therapy*; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D018501:Antirheumatic Agents; D014409:Tumor Necrosis Factor-alpha; D002097:C-Reactive Protein; D000069285:Infliximab