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OP0171 Achievement of Remission of Inflammation in the Spine and Sacroiliac Joints Measured by Magnetic Resonance Imaging (MRI) in Patients with Axial Spondyloarthritis, and Associations Between MRI and Clinical Remission, Over 96 Weeks of Treatment with Certolizumab Pegol
  1. J. Braun1,
  2. W.P. Maksymowych2,
  3. R. Landewé3,
  4. X. Baraliakos4,
  5. K.-G. Hermann5,
  6. P. Machado6,7,
  7. B. Hoepken8,
  8. C. Stach8,
  9. O. Davies9,
  10. T. Nurminen8,
  11. D. van der Heijde10
  1. 1Rheumazentrum Ruhrgebiet, Herne, Germany
  2. 2Department of Medicine, University of Alberta, Alberta, Canada
  3. 3Academic Medical Center Amsterdam & Atrium Medical Center, Heerlen, Netherlands
  4. 4Ruhr-University Bochum, Herne
  5. 5Charité Medical School, Berlin, Germany
  6. 6Clínica Universitária de Reumatologia, Faculty of Medicine, University of Coimbra, Coimbra, Portugal
  7. 7MRC Centre for Neuromuscular Diseases, University College London, London, United Kingdom
  8. 8UCB Pharma, Monheim, Germany
  9. 9UCB Pharma, Slough, United Kingdom
  10. 10Leiden University Medical Center, Leiden, Netherlands

Abstract

Background Activity of axial spondyloarthritis (axSpA) can be assessed by clinical and laboratory assessments, as well as by inflammation on MRI of sacroiliac joints (MRI-SIJ) and spine (MRI-spine). Information on concordance of remission by both types of assessment is scarce.

Objectives To report the achievement of MRI remission in axSpA patients (pts), including both ankylosing spondylitis (AS) and non-radiographic (nr-)axSpA pts, treated with certolizumab pegol (CZP), and to investigate associations between MRI and clinical remission at 96 weeks (wks).

Methods RAPID-axSpA (NCT01087762),1 a phase 3 study, is double-blind and placebo (PBO)-controlled to Wk24, dose-blind to Wk48 and open-label to Wk204. Pts were randomized to CZP or PBO. PBO pts entering dose-blind phase were re-randomized to CZP. MRIs were recorded in a subset of pts using short-tau-inversion recovery sequences at baseline (BL) (±3 days), Wk12, Wk48 and Wk96, and assessed using SPARCC score for SIJ and Berlin method for spine (modification of ASspiMRI-a). Inflammation thresholds were SPARCC ≥2 and Berlin >2. Remission thresholds were SPARCC <2 (SIJ), Berlin ≤2 (spine) and ASDAS ID (<1.3, clinical). Data are reported as observed values for pts randomized to CZP at BL (Wk12 data) or for all pts regardless of randomization (Wk48 and Wk96 data).

Results 325 pts were randomized, of whom 163 were in the imaging set (109 CZP; 54 PBO). At BL, 90 (58.8%) had MRI-SIJ, 73 (47.7%) had MRI-spine, 43 (28.5%) had both MRI-SIJ and MRI-spine inflammation, and 34 (22.5%) had neither. At Wk12, at least half of pts with MRI-SIJ or MRI-spine inflammation at BL achieved MRI-SIJ or MRI-spine remission, respectively, and more than a third of pts with both MRI-SIJ and MRI-spine inflammation at BL achieved MRI remission of both SIJ and spine (Table A). MRI remission rates were sustained to Wk96, with similar trends observed for AS and nr-axSpA pts (Table A). Mean change from BL (SD) at Wk96 in SPARCC and Berlin was -7.2 (12.6) [BL: 9.2 (13.1)] and -3.3 (5.1) [BL: 4.7 (6.3)], respectively. At Wk96, nearly all pts in clinical remission had MRI-spine remission and a large proportion also achieved MRI-SIJ remission (Table B). While MRI remission in the spine was more frequent in pts with clinical remission, MRI remission in the SIJ, and MRI remission in both the SIJ and spine, occurred with similar frequency regardless of whether or not clinical remission was achieved (Table B).

Conclusions Over half of pts with BL MRI inflammation in SIJ or spine, and at least a third of pts with both, achieved MRI remission at Wk12, which was sustained to Wk96 with CZP treatment. At Wk96, concordance between clinical and MRI remission was limited, however concordance was better for spinal rather than SIJ MRI remission.

References

  1. Landewé R. Ann Rheum Dis 2014;73:39–47

Acknowledgements The authors acknowledge Costello Medical Consulting for writing and editorial assistance which was funded by UCB Pharma.

Disclosure of Interest J. Braun Grant/research support from: Abbott, Bristol Myers Squibb, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche, UCB Pharma, Consultant for: Abbott, Bristol Myers Squibb, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche, UCB Pharma, W. Maksymowych Grant/research support from: Abbott, Amgen, Bristol Myers Squibb, Eli-Lilly, Janssen, Merck, Pfizer, Synarc and UCB Pharma, Consultant for: Abbott, Amgen, Bristol Myers Squibb, Eli-Lilly, Janssen, Merck, Pfizer, Synarc and UCB Pharma, Speakers bureau: Abbott, Amgen, Bristol Myers Squibb, Eli-Lilly, Janssen, Merck, Pfizer, Synarc and UCB Pharma, R. Landewé Grant/research support from: Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth, Consultant for: Abbott, Ablynx, Amgen, Astra-Zeneca, Bristol Myers Squibb, Centocor, Glaxo-Smith-Kline, Novartis, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth, Speakers bureau: Abbott, Amgen, Bristol Myers Squibb, Centocor, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth, X. Baraliakos: None declared, K.-G. Hermann: None declared, P. Machado: None declared, B. Hoepken Employee of: UCB Pharma, C. Stach Shareholder of: UCB Pharma, Employee of: UCB Pharma, O. Davies Shareholder of: UCB Pharma, Employee of: UCB Pharma, T. Nurminen Employee of: UCB Pharma, D. van der Heijde Grant/research support from: AbbVie, Amgen, AstraZeneca, Augurex, BMS, Boehringer Ingelheim, Celgene, Centocor, Chugai, Covagen, Daiichi, Eli-Lilly, Galapagos, GSK, Janssen Biologics, Merck, Novartis, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, UCB Pharma, Consultant for: AbbVie, Amgen, AstraZeneca, Augurex, BMS, Boehringer Ingelheim, Celgene, Centocor, Chugai, Covagen, Daiichi, Eli-Lilly, Galapagos, GSK, Janssen Biologics, Merck, Novartis, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, UCB Pharma, Employee of: Vertex Director of Imaging Rheumatology bv.

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