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  • Effect of certolizumab pegol over 96 weeks of treatment on inflammation of the spine and sacroiliac joints, as measured by MRI, and the association between clinical and MRI outcomes in patients with axial spondyloarthritis

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Imaging
Original article
Effect of certolizumab pegol over 96 weeks of treatment on inflammation of the spine and sacroiliac joints, as measured by MRI, and the association between clinical and MRI outcomes in patients with axial spondyloarthritis
  1. Jürgen Braun1,
  2. Xenofon Baraliakos1,
  3. Kay-Geert Hermann2,
  4. Robert Landewé3,
  5. Pedro M Machado4,
  6. Walter P Maksymowych5,
  7. Owen Davies6,
  8. Bengt Hoepken7,
  9. Tommi Nurminen7,
  10. Christian Stach7 and
  11. Désirée van der Heijde8
  1. 1Rheumazentrum Ruhrgebiet, Herne, Germany
  2. 2Charité Medical School, Berlin, Germany
  3. 3Academic Medical Center Amsterdam & Atrium Medical Center Heerlen, Amsterdam, The Netherlands
  4. 4Centre for Rheumatology Research & MRC Centre for Neuromuscular Diseases, University College London, London, UK
  5. 5Department of Medicine, University of Alberta, Alberta, Alberta, Canada
  6. 6UCB Pharma, Slough, UK
  7. 7UCB Pharma, Monheim, Germany
  8. 8Désirée van der Heijde: Leiden University Medical Centre, Leiden, The Netherlands
  1. Correspondence to Professor Jürgen Braun; juebraun{at}gmx.de

Abstract

Objective To report MRI outcomes and explore the relationship between clinical remission and MRI inflammation in patients with axial spondyloarthritis (axSpA) from the RAPID-axSpA trial, including radiographic (r-)axSpA and non-radiographic (nr-)axSpA.

Methods RAPID-axSpA (NCT01087762) was double-blind and placebo-controlled to week 24, dose-blind to week 48 and open-label to week 204. Patients were randomised to certolizumab pegol (CZP) or placebo. Placebo patients entering dose-blind were rerandomised to CZP. MRIs performed at baseline, weeks 12, 48 and 96 were scored by 2 reviewers independently: Spondyloarthritis Research Consortium of Canada (SPARCC) for sacroiliac (SI) joints; Berlin modification of the Ankylosing Spondylitis spine MRI scoring system for disease activity (Berlin) for spine. Inflammation thresholds: SPARCC≥2; Berlin>2. Remission thresholds: SPARCC<2 (SI joints); Berlin≤2 (spine); Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease (<1.3, clinical).

Results Across 163 patients in the MRI set (109 CZP; 54 placebo), week 12 mean changes from baseline in MRI scores were greater for CZP versus placebo: SPARCC: −4.8 (SD 8.6) vs −1.6 (7.8; p<0.001); Berlin: −2.9 (4.2) vs 0.2 (4.8; p<0.001). Improvements were maintained to week 96. Week 12 MRI remission was achieved by 52.6% of patients with baseline MRI inflammation in SI joints, 62.0% in the spine and 37.9% of patients with both. MRI remission rates were sustained to week 96, with similar trends in r-axSpA and nr-axSpA. At week 96, 57.5% vs 65.9% of patients achieving versus not achieving clinical remission had MRI remission.

Conclusions CZP reduced inflammation in the spine and SI joints in patients with r-axSpA and nr-axSpA, with improvements maintained over 96 weeks. Substantial proportions of patients achieved MRI remission. Concordance between clinical remission and current definitions of absence of MRI inflammation was limited.

Trial registration number NCT01087762; Post-results.

  • Ankylosing Spondylitis
  • Magnetic Resonance Imaging
  • Anti-TNF
  • Treatment

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/rmdopen-2017-000430

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    Footnotes

    • Funding UCB Pharma funded this study and manuscript. It reviewed only for scientific and legal accuracy.

    • Competing interests JB received consultant fees/research support from Abbott, Bristol Myers Squibb, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche and UCB Pharma. XB received consultancy/speaker fees/research grants from AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Chugai, Janssen, MSD, Novartis, Pfizer and UCB Pharma. K-GH received lecture fees from AbbVie, MSD, Pfizer and UCB Pharma. RL received consultancy fees from Abbott, Ablynx, Amgen, Astra-Zeneca, Bristol Myers Squibb, Centocor, Glaxo-Smith-Kline, Novartis, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth, research grants from Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth, and speaker's bureau from Abbott, Amgen, Bristol Myers Squibb, Centocor, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth. PMM received consultancy/speaker's fees/research grants from AbbVie, Centocor, Janssen, Merck, Novartis, Pfizer and UCB Pharma. WPM received consultant and/or speaker fees and/or grants from AbbVie, Amgen, Eli-Lilly, Janssen, Merck, Pfizer, Synarc, Sanofi and UCB Pharma. OD is the employee and stockholder of UCB Pharma. BH is the employee of UCB Pharma. TN is the consultant for UCB Pharma. CS is the employee of UCB Pharma. DvdH received consulting fees from AbbVie, Amgen, Astellas, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Daiichi, Eli-Lilly, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi and UCB Pharma, and is the Director of Imaging Rheumatology BV.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement No additional data are available.