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  • Modification of structural lesions on MRI of the sacroiliac joints by etanercept in the EMBARK trial: a 12-week randomised placebo-controlled trial in patients with non-radiographic axial spondyloarthritis

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Clinical and epidemiological research
Extended report
Modification of structural lesions on MRI of the sacroiliac joints by etanercept in the EMBARK trial: a 12-week randomised placebo-controlled trial in patients with non-radiographic axial spondyloarthritis
  1. Walter P Maksymowych1,
  2. Stephanie Wichuk1,
  3. Maxime Dougados2,
  4. Heather E Jones3,
  5. Ron Pedersen4,
  6. Annette Szumski5,
  7. Lisa Marshall3,
  8. Jack F Bukowski6,
  9. Robert G Lambert7
  1. 1 Department of Medicine, University of Alberta, Edmonton, Alberta, Canada
  2. 2 Paris Descartes University, Rheumatology Department, Cochin Hospital, Assistance Publique-Hôpitaux de Paris, INSERM (U1153): Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité, France
  3. 3 Medical Affairs, Pfizer, Collegeville, Pennsylvania, USA
  4. 4 Department of Biostatistics, Pfizer, Collegeville, Pennsylvania, USA
  5. 5 Biostatistics, inVentiv Health, Princeton, New Jersey, USA
  6. 6 Clinical Affairs, Pfizer, Collegeville, Pennsylvania, USA
  7. 7 Department of Radiology and Diagnostic Imaging, University of Alberta, Edmonton, Alberta, Canada
  1. Correspondence to Dr Walter P Maksymowych, Department of Medicine University of Alberta, Edmonton, Alberta T6G 2S2, Canada; walter.maksymowych{at}ualberta.ca

Abstract

Objective To evaluate the impact on structural lesions observed on MRI in the sacroiliac joints (SIJ) at 12 weeks in patients with non-radiographic axial spondyloarthritis (nr-axSpA) receiving etanercept or placebo in EMBARK (Effect of Etanercept on Symptoms and Objective Inflammation in nr-axSpA, a 104 week study).

Methods Patients were randomised to double-blind etanercept 50 mg/week or placebo for 12 weeks. Structural lesions at baseline and 12 weeks were scored by two independent readers using the Spondyloarthritis Research Consortium of Canada (SPARCC) SIJ structural score (SSS) on T1-weighted MRI. Change in SPARCC SSS and correlation with improvement in clinical outcomes was evaluated.

Results MRI scans from 185 patients (etanercept, n=88; placebo, n=97) were reviewed. At baseline, there were no significant differences in mean SPARCC SSS between etanercept and placebo. From baseline to 12 weeks, change in mean SPARCC SSS was significantly greater for etanercept than placebo for erosion (–0.57 vs –0.08, respectively, adjusted p value=0.017) and backfill (0.36 vs 0.06, adjusted p value=0.022). A treatment difference was also present for the subgroup of patients with SIJ inflammation on MRI (SPARCC bone marrow oedema ≥2): erosion: –0.81 versus –0.13 for etanercept versus placebo, respectively, p=0.007; backfill: 0.48 versus 0.08, respectively, p=0.032. Decrease in erosion and increase in backfill correlated with improvement in more clinical outcomes for etanercept than placebo.

Conclusion Treatment with etanercept was associated with significantly greater reduction in erosions and increase in backfill at 12 weeks compared with placebo, consistent with a very early reparative response to antitumour necrosis factor therapy. The impact on disease progression in spondyloarthritis should be studied further.

Trial registration number NCT01258738; Post-results.

  • spondyloarthritis
  • anti-TNF
  • magnetic resonance imaging

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/annrheumdis-2017-211605

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    Footnotes

    • Handling editor Tore K Kvien

    • Contributors Study conception or design: WPM, MD, HJ, RP, AS, JFB, RGL. Acquisition of data: WPM, MD, SW, JFB and RGL. All authors were involved in the drafting of the article, analysis or interpretation of data or revising it critically for important intellectual content. All authors approved the final version to be published. All authors agreed to be accountable for all aspects of the work.

    • Funding This study was funded by Pfizer. Medical writing support was provided by Jennica Lewis, PharmD, CMPP of Engage Scientific Solutions and was funded by Pfizer.

    • Competing interests WPM has received consulting fees from AbbVie, Amgen, Lilly, Janssen, Pfizer, Sanofi and UCB and is the chief medical officer of CaRE Arthritis Ltd. MD is a consultant for and has received research funding/grants from AbbVie, Lilly, Merck, Pfizer, Sanofi and UCB. HJ, RP, LM and JFB are employees of and own stock in Pfizer. AS is an employee of inVentiv Health and was contracted by Pfizer to provide statistical support for the development of this paper. SW and RGL have no competing interests to declare.

    • Ethics approval Each study center obtained approval by a duly constituted Institutional Review Board or Independent Ethics Committee.

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