title: Major reduction in spinal inflammation in patients with ankylosing spondylitis after treatment with infliximab: results of a multicenter, randomized, double-blind, placebo-controlled magnetic resonance imaging study.
abstract: OBJECTIVE
  To determine whether the effects of anti-tumor necrosis factor alpha (TNFalpha) in reducing the signs and symptoms of ankylosing spondylitis (AS) coincide with a reduction in spinal inflammation as detected by magnetic resonance imaging (MRI).
  
  
  METHODS
  Pre- and postgadolinium T1 and STIR MR images of the spine were acquired at baseline and at week 24 in patients with AS who participated in a multicenter, randomized, double-blind, placebo-controlled study. Patients were randomly assigned at an 8:3 ratio to receive infusions of infliximab (5 mg/kg) or placebo at weeks 0, 2, and 6 and then every 6 weeks thereafter. MR images were obtained and evaluated independently by 2 readers who were blinded to the treatment allocation and time sequence of the images.
  
  
  RESULTS
  A total of 194 patients in the infliximab group and 72 patients in the placebo group had evaluable images at baseline and week 24. About 80% of the patients had at least 1 active spinal lesion at baseline, as assessed by MRI. The improvement in the MRI Activity Score after 6 months was significantly greater in the patients who received infliximab (mean 5.02, median 2.72) than in those who received placebo (mean 0.60, median 0.0) (P < 0.001). Almost complete resolution of spinal inflammation was seen in most patients who received infliximab, irrespective of baseline activity.
  
  
  CONCLUSIONS
  Patients with AS who received infliximab therapy showed a decrease in spinal inflammation as detected by MRI, whereas those who received placebo showed persistent inflammatory spondylitis.
authors.affiliation: Rheumazentrum Ruhrgebiet, Herne, Germany. j.braun@rheumazentrum-ruhrgebiet.de
authors.forename: Jürgen
authors.initials: J
authors.lastname: Braun
authors.forename: Robert
authors.initials: R
authors.lastname: Landewé
authors.forename: Kay-Geert A
authors.initials: KG
authors.lastname: Hermann
authors.forename: John
authors.initials: J
authors.lastname: Han
authors.forename: Songkai
authors.initials: S
authors.lastname: Yan
authors.forename: Paul
authors.initials: P
authors.lastname: Williamson
authors.forename: Désirée
authors.initials: D
authors.lastname: van der Heijde
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000069285:Infliximab; D008279:Magnetic Resonance Imaging; D008297:Male; D009187:Myelitis / Q000175:diagnosis* / Q000188:drug therapy*; D013167:Spondylitis, Ankylosing / Q000175:diagnosis* / Q000188:drug therapy*
chemical_list: D000911:Antibodies, Monoclonal; D000069285:Infliximab