title: Long-term effects of secukinumab on MRI findings in relation to clinical efficacy in subjects with active ankylosing spondylitis: an observational study.
abstract: BACKGROUND
  A 28-week study suggested efficacy of the anti-interleukin-17A monoclonal antibody secukinumab in active ankylosing spondylitis (AS). MRI-assessed inflammation was reduced at weeks 6, 28.
  
  
  OBJECTIVE
  To analyse the longer-term effects of secukinumab on MRI inflammatory and non-inflammatory spinal lesions in relation to its clinical efficacy in subjects with active AS.
  
  
  METHODS
  Spinal MRI results (baseline, week 94) for 13 subjects with AS initially treated with secukinumab 2×10 mg/kg intravenously (n=10) or placebo (n=3) and receiving a secukinumab maintenance dose of 3 mg/kg IV every 4 weeks up to week 94 were evaluated by the Berlin score; inflammatory/non-inflammatory (fatty) changes were assessed at vertebral edges (VEs). Results were compared with clinical outcomes.
  
  
  RESULTS
  Most of the 13 subjects assessed at week 94 had sustained clinical responses: 8 (62%) achieved Assessment of SpondyloArthritis international Society 20% (ASAS20), including 6 (46%) achieving ASAS40 responses, corresponding to 75% and 83% reductions in the Berlin score, respectively. In the 10 subjects treated with secukinumab throughout the study period, 79/91 (87%) inflammatory VEs at baseline resolved by week 94; new fatty lesions occurred in 39/796 (4.9%) of VEs; 87/124 (70%) VEs with fatty lesions at baseline remained unchanged; 30% were no longer visible.
  
  
  CONCLUSIONS
  In this pilot study, secukinumab treatment up to 2 years yielded sustained clinical improvement accompanied by regression of spinal inflammation. The impact of secukinumab on the development of fatty changes and bone formation in AS will be assessed in larger trials.
  
  
  BACKGROUND
  This study is registered with ClinicalTrials.gov, number NCT00809159.
authors.affiliation: Rheumazentrum Ruhrgebiet, Herne, Germany.
authors.forename: Xenofon
authors.initials: X
authors.lastname: Baraliakos
authors.affiliation: Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.
authors.forename: Babul
authors.initials: B
authors.lastname: Borah
authors.affiliation: Rheumazentrum Ruhrgebiet, Herne, Germany.
authors.forename: Juergen
authors.initials: J
authors.lastname: Braun
authors.affiliation: University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: Dominique
authors.initials: D
authors.lastname: Baeten
authors.affiliation: Novartis Institutes for BioMedical Research, Basel, Switzerland.
authors.forename: Didier
authors.initials: D
authors.lastname: Laurent
authors.affiliation: Charite Campus Benjamin Franklin, Berlin, Germany.
authors.forename: Joachim
authors.initials: J
authors.lastname: Sieper
authors.affiliation: Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Emery
authors.affiliation: University of Glasgow, Glasgow, UK.
authors.forename: Iain B
authors.initials: IB
authors.lastname: McInnes
authors.affiliation: Newcastle University, Newcastle, UK.
authors.forename: Jacob M
authors.initials: JM
authors.lastname: van Laar
authors.affiliation: NIHR Oxford Comprehensive Biomedical Research Centre, Nuffield Orthopaedic Centre, Oxford, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Wordsworth
authors.affiliation: Schoen Klinik Hamburg, Eilbeck, Hamburg, Germany.
authors.forename: Juergen
authors.initials: J
authors.lastname: Wollenhaupt
authors.affiliation: Centre for Inflammatory Joint Diseases, Munich, Germany.
authors.forename: Herbert
authors.initials: H
authors.lastname: Kellner
authors.affiliation: Novartis Institutes for BioMedical Research, Basel, Switzerland.
authors.forename: Laurence
authors.initials: L
authors.lastname: Colin
authors.affiliation: ClinBAY, Genappe, Belgium.
authors.forename: Francois
authors.initials: F
authors.lastname: Vandenhende
authors.affiliation: Novartis Institutes for BioMedical Research, Basel, Switzerland.
authors.forename: Kath
authors.initials: K
authors.lastname: Radford
authors.affiliation: Novartis Institutes for BioMedical Research, Basel, Switzerland.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Hueber
mesh_terms: D061605:Administration, Intravenous; D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized; D001604:Berlin; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012720:Severity of Illness Index; D013167:Spondylitis, Ankylosing / Q000188:drug therapy* / Q000473:pathology; D013995:Time; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C555450:secukinumab
keywords: Ankylosing Spondylitis; Inflammation; Magnetic Resonance Imaging