title: Course of Magnetic Resonance Imaging-Detected Inflammation and Structural Lesions in the Sacroiliac Joints of Patients in the Randomized, Double-Blind, Placebo-Controlled Danish Multicenter Study of Adalimumab in Spondyloarthritis, as Assessed by the Berlin and Spondyloarthritis Research Consortium of Canada Methods.
abstract: OBJECTIVE
  To investigate changes in magnetic resonance imaging (MRI)-assessed inflammation and structural lesions in the sacroiliac (SI) joints during treatment with adalimumab versus placebo.
  
  
  METHODS
  In a 48-week double-blind, placebo-controlled trial, 52 patients with spondyloarthritis were randomized to receive subcutaneous injections of either adalimumab 40 mg (n = 25) or placebo (n = 27) every other week for 12 weeks. Patients in the adalimumab group continued to receive and patients in the placebo group were switched to adalimumab 40 mg every other week for an additional 12 weeks. MRI of the SI joints was performed at weeks 0, 12, 24, and 48, and the images were assessed independently in a blinded manner using the modified Berlin and the Spondyloarthritis Research Consortium of Canada (SPARCC) MRI scores for inflammation and structural lesions of the SI joints.
  
  
  RESULTS
  At baseline, 56% of the adalimumab group and ∼72% of the placebo group had an MRI-assessed inflammation score of ≥1. Among the patients with inflammation at baseline, the mean percent reductions in MRI scores for inflammation from week 0 to 12 were greater in the adalimumab group compared with the placebo group (Berlin method, -62% versus -5%; SPARCC method, -58% versus -12% [both P < 0.04]). Furthermore, the mean SPARCC erosion score decreased (-0.6) and the SPARCC backfill score increased (+0.8) in the adalimumab group from week 0 to week 12. From week 12 to week 24, larger absolute reductions in the Berlin/SPARCC inflammation scores and the SPARCC erosion score and larger increases in the Berlin/SPARCC fatty lesion scores were seen in the placebo group compared with the adalimumab group. In univariate regression analyses (analysis of covariance) and multivariate stepwise regression analyses, treatment with adalimumab was independently associated with regression of the SPARCC erosion score from week 0 to 12 but not with changes in the other types of MRI lesions.
  
  
  CONCLUSIONS
  Significant changes in the Berlin and SPARCC MRI-assessed inflammation scores and in the SPARCC MRI-assessed erosion scores occurred within 12 weeks after initiation of adalimumab. Tumor necrosis factor inhibitor treatment was associated with resolution of erosions and the development of backfill.
authors.affiliation: Rigshospitalet, University of Copenhagen Glostrup Hospital, University of Copenhagen Gentofte Hospital, and University of Copenhagen, Copenhagen, Denmark.
authors.forename: Susanne J
authors.initials: SJ
authors.lastname: Pedersen
authors.affiliation: Charité Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany.
authors.forename: Denis
authors.initials: D
authors.lastname: Poddubnyy
authors.affiliation: Rigshospitalet, University of Copenhagen Glostrup Hospital and University of Copenhagen, Copenhagen, Denmark.
authors.forename: Inge J
authors.initials: IJ
authors.lastname: Sørensen
authors.affiliation: Sygehus Lillebaelt, Vejle, and Aarhus University Hospital, Noerrebrogade, Aarhus, Denmark.
authors.forename: Anne-Gitte
authors.initials: AG
authors.lastname: Loft
authors.affiliation: University of Copenhagen Gentofte Hospital and University of Copenhagen, Copenhagen, Denmark.
authors.forename: Jens S
authors.initials: JS
authors.lastname: Hindrup
authors.affiliation: Rigshospitalet, University of Copenhagen Glostrup Hospital and University of Copenhagen, Copenhagen, Denmark.
authors.forename: Gorm
authors.initials: G
authors.lastname: Thamsborg
authors.affiliation: Bispebjerg and Frederiksberg Hospital and University of Copenhagen, Copenhagen, Denmark.
authors.forename: Karsten
authors.initials: K
authors.lastname: Asmussen
authors.affiliation: King Christian 10th Hospital for Rheumatic Diseases, Graasten, Denmark.
authors.forename: Oliver
authors.initials: O
authors.lastname: Hendricks
authors.affiliation: Nordsjaellands Hospital, Hillerød, and University of Copenhagen, Copenhagen, Denmark.
authors.forename: Jesper
authors.initials: J
authors.lastname: Nørregaard
authors.affiliation: Slagelse Hospital, Slagelse, Denmark.
authors.forename: Anne-Dorthe
authors.initials: AD
authors.lastname: Piil
authors.affiliation: University of Copenhagen Herlev Hospital, Herlev, Denmark.
authors.forename: Jakob M
authors.initials: JM
authors.lastname: Møller
authors.affiliation: Aarhus University Hospital, Noerrebrogade, Aarhus, Denmark.
authors.forename: Anne-Grethe
authors.initials: AG
authors.lastname: Jurik
authors.affiliation: University of Copenhagen Herlev Hospital, Herlev, Denmark.
authors.forename: Lone
authors.initials: L
authors.lastname: Balding
authors.affiliation: University of Alberta, Edmonton, Alberta, Canada.
authors.forename: Robert G
authors.initials: RG
authors.lastname: Lambert
authors.affiliation: Charité Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany.
authors.forename: Joachim
authors.initials: J
authors.lastname: Sieper
authors.affiliation: Rigshospitalet, University of Copenhagen Glostrup Hospital and University of Copenhagen, Copenhagen, Denmark.
authors.forename: Mikkel
authors.initials: M
authors.lastname: Østergaard
mesh_terms: D000068879:Adalimumab / Q000627:therapeutic use*; D000328:Adult; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D003718:Denmark; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007249:Inflammation / Q000473:pathology*; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D012446:Sacroiliac Joint / Q000473:pathology*; D025242:Spondylarthropathies / Q000188:drug therapy / Q000473:pathology; D013167:Spondylitis, Ankylosing / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D000068879:Adalimumab