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Long-term effects of secukinumab on MRI findings in relation to clinical efficacy in subjects with active ankylosing spondylitis: an observational study
  1. Xenofon Baraliakos1,
  2. Babul Borah2,
  3. Juergen Braun1,
  4. Dominique Baeten3,
  5. Didier Laurent4,
  6. Joachim Sieper5,
  7. Paul Emery6,
  8. Iain B McInnes7,
  9. Jacob M van Laar8,
  10. Paul Wordsworth9,
  11. Juergen Wollenhaupt10,
  12. Herbert Kellner11,
  13. Laurence Colin4,
  14. Francois Vandenhende12,
  15. Kath Radford4,
  16. Wolfgang Hueber4
  1. 1Rheumazentrum Ruhrgebiet, Herne, Germany
  2. 2Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA
  3. 3University of Amsterdam, Amsterdam, The Netherlands
  4. 4Novartis Institutes for BioMedical Research, Basel, Switzerland
  5. 5Charite Campus Benjamin Franklin, Berlin, Germany
  6. 6Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK
  7. 7University of Glasgow, Glasgow, UK
  8. 8Newcastle University, Newcastle, UK
  9. 9NIHR Oxford Comprehensive Biomedical Research Centre, Nuffield Orthopaedic Centre, Oxford, UK
  10. 10Schoen Klinik Hamburg, Eilbeck, Hamburg, Germany
  11. 11Centre for Inflammatory Joint Diseases, Munich, Germany
  12. 12ClinBAY, Genappe, Belgium
  1. Correspondence to Professor Juergen Braun, Rheumazentrum Ruhrgebiet, Claudiusstr 45, Herne 44649, Germany; juergen.braun{at}elisabethgruppe.de

Abstract

Introduction 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.

Trial registration number This study is registered with ClinicalTrials.gov, number NCT00809159.

  • Ankylosing Spondylitis
  • Magnetic Resonance Imaging
  • Inflammation

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