You are here

  • Home
  • Archive
  • Volume 77, Issue 2
  • Evaluation of the change in structural radiographic sacroiliac joint damage after 2 years of etanercept therapy (EMBARK trial) in comparison to a contemporary control cohort (DESIR cohort) in recent onset axial spondyloarthritis

Article Text

Article menu

Download PDFPDF

XML
Clinical and epidemiological research
Extended report
Evaluation of the change in structural radiographic sacroiliac joint damage after 2 years of etanercept therapy (EMBARK trial) in comparison to a contemporary control cohort (DESIR cohort) in recent onset axial spondyloarthritis
  1. Maxime Dougados1,
  2. Walter P Maksymowych2,
  3. Robert B M Landewé3,
  4. Anna Moltó1,
  5. Pascal Claudepierre4,
  6. Manouk de Hooge5,
  7. Robert G Lambert6,
  8. Randi Bonin7,
  9. Jack F Bukowski7,
  10. Heather E Jones8,
  11. Isabelle Logeart9,
  12. Ron Pedersen10,
  13. Annette Szumski11,
  14. Bonnie Vlahos7,
  15. Désirée van der Heijde5
  1. 1 Paris Descartes University, Rheumatology Department, Cochin Hospital, Assistance Publique-Hôpitaux de Paris, INSERM (U1153): Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité, France
  2. 2 Department of Medicine, University of Alberta, Edmonton, Alberta, Canada
  3. 3 Amsterdam Rheumatology and Immunology Center, Amsterdam, Netherlands
  4. 4 Universite Paris Est Creteil, EA 7379 – EpidermE, AP-HP, Service de Rhumatologie, Hopital Henri Mondor, Creteil, France
  5. 5 Leiden University Medical Center, Leiden, Netherlands
  6. 6 Department of Radiology and Diagnostic Imaging, University of Alberta, Edmonton, Alberta, Canada
  7. 7 Clinical Affairs, Pfizer, Collegeville, Pennsylvania, USA
  8. 8 Medical Affairs, Pfizer, Collegeville, Pennsylvania, USA
  9. 9 Pfizer France, Paris, France
  10. 10 Department of Biostatistics, Pfizer, Collegeville, USA
  11. 11 Biostatistics, inVentiv Health, Princeton, New Jersey, USA
  1. Correspondence to Professor Maxime Dougados, Paris Descartes University, Rheumatology Department, Cochin Hospital, Assistance Publique - Hôpitaux de Paris, INSERM (U1153): Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité, France; maxime.dougados{at}aphp.fr

Abstract

Objective To compare 2 years of radiographic sacroiliac joint (SIJ) changes in patients with recent onset axial spondyloarthritis (axSpA) receiving etanercept in a clinical trial (EMBARK) to similar patients not receiving biologics in a cohort study (DESIR).

Methods Endpoints were changes at week 104 per the modified New York (mNY) grading system in total SIJ score (primary endpoint) and net percentage of patients with progression defined three ways. Treatment effect was analysed with and without adjustment for baseline covariates.

Results At 104 weeks, total SIJ score improved in the etanercept group (n=154, adjusted least-squares mean change: –0.14) and worsened in the control group (n=182, change: 0.08). The adjusted difference between groups (etanercept minus control) was –0.22 (95% CI –0.38 to –0.06), p=0.008. The net percentage of patients with progression was significantly lower in the etanercept versus the control group for two of three binary endpoints: –1.9% versus 1.6% (adjusted difference for etanercept minus control: –4.7%,95% CI –9.9 to 0.5, p=0.07) for change in mNY criteria; –1.9% versus 7.8% (adjusted difference: –18.2%,95% CI –30.9 to –5.6, p=0.005) for change ≥1 grade in ≥1 SIJ; and –0.6% versus 6.7% (adjusted difference: –16.4%,95% CI –27.9 to –5.0, p=0.005) for change ≥1 grade in ≥1 SIJ, with shift from 0 to 1 or 1 to 0 considered no change.

Conclusion Despite the slow radiographic SIJ progression rate over 2 years in axSpA, this study suggests a lower rate of progression in the SIJ with etanercept than without anti-tumour necrosis factor therapy.

Trial registration numbers NCT01258738, NCT01648907; Post-results.

  • spondyloarthritis
  • 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/annrheumdis-2017-212008

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Footnotes

    • Handling editor Tore K Kvien

    • Contributors Study conception or design: MD, WPM, RL, DvdH, JFB, HJ, IL, RP, AS. Acquisition of data: MD, WPM, RL, DvdH, AM, PC, MdH, RGL, RB. Analysis or interpretation of data: MD, WPM, RL, DvdH, AM, PC, MdH, RGL, RB, JFB, HJ, IL, RP, AS, BV. All authors were involved in drafting the article or revising it critically for important intellectual content, and all authors approved the final version to be published. All authors agree to be accountable for all aspects of the work.

    • Funding The EMBARK trial was funded by Pfizer. The DESIR cohort is supported by unrestricted grants from the French Society of Rheumatology and Pfizer. Medical writing support was provided by Jennica Lewis, PharmD, CMPP, of Engage Scientific Solutions and was funded by Pfizer.

    • Competing interests MD reports grants and personal fees from Pfizer, AbbVie, UCB, Merck, Lilly, Janssen and Novartis during the conduct of the study. WPM reports grants and personal fees from AbbVie and Pfizer, personal fees from Janssen, Lilly, Novartis, Merck and UCB outside the submitted work. RGL reports personal fees from AbbVie and BioClinica outside the submitted work. JFB, HJ, IL, RP and BV are employees of, and own stock in Pfizer. RB was an employee of Pfizer at the time the article was written. AS is an employee of inVentiv Health and was contracted by Pfizer to provide statistical support for the development of this paper. DvdH reports personal fees from AbbVie, Amgen, Astellas, AstraZeneca, Bristol Meyers Squibb, Boehringer Ingelheim, Celgene, Daiichi, Galapagos,Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda and UCB outside the submitted work; and is director of Imaging Rheumatology BV. RL, AM, PC and MdH have no competing interests to declare.

    • Ethics approval EMBARK: The institutional review board or independent ethics committee at each participating centre reviewed and approved all consent forms and the study protocol; DESIR: Ile de France III Ethics Committee.

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