Radiographic findings following two years of infliximab therapy in patients with ankylosing spondylitis

Authors

  • Désirée van der Heijde,

    Corresponding author
    1. Leiden University Medical Center, Leiden, The Netherlands
    • Department of Rheumatology, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands
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    • Dr. van der Heijde has received consulting fees, speaking fees, and/or honoraria from Abbott Laboratories, Amgen, Aventis, Bristol-Myers Squibb, Centocor, Pfizer, Roche, Schering-Plough, UCB, Wyeth, and Chugai (less than $10,000 each), and research grants from Centocor and Wyeth.

  • Robert Landewé,

    1. University Hospital Maastricht, Maastricht, The Netherlands
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    • Dr. Landewé has received consulting fees, speaking fees, and/or honoraria from Abbott, Amgen, Bristol-Myers Squibb, Centocor, Schering-Plough, UCB, and Wyeth (less than $10,000 each), and research grants from Abbott, Centocor, Schering-Plough, and Wyeth.

  • Xenofon Baraliakos,

    1. Rheumazentrum Ruhrgebiet, and Ruhr University, Herne, Germany
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  • Harry Houben,

    1. Atrium Medical Center, Herleen, The Netherlands
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    • Dr. Houben has received consulting fees from Centocor (less than $10,000).

  • Astrid van Tubergen,

    1. University Hospital Maastricht, Maastricht, The Netherlands
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  • Paul Williamson,

    1. Centocor Research and Development, Inc., Malvern, Pennsylvania
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    • Drs. Williamson, Xu, and Baker own stock in Johnson and Johnson, of which Centocor is a subsidiary.

  • Weichun Xu,

    1. Centocor Research and Development, Inc., Malvern, Pennsylvania
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    • Drs. Williamson, Xu, and Baker own stock in Johnson and Johnson, of which Centocor is a subsidiary.

  • Daniel Baker,

    1. Centocor Research and Development, Inc., Malvern, Pennsylvania
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    • Drs. Williamson, Xu, and Baker own stock in Johnson and Johnson, of which Centocor is a subsidiary.

  • Neil Goldstein,

    1. Centocor Research and Development, Inc., Malvern, Pennsylvania
    2. Precision Research, Malvern, Pennsylvania
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    • Dr. Goldstein has received consulting fees from Centocor (more than $10,000).

  • Jürgen Braun

    1. Rheumazentrum Ruhrgebiet, and Ruhr University, Herne, Germany
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    • Dr. Braun has received consulting fees, speaking fees, and/or honoraria from Abbott, Centocor, Schering-Plough, and Wyeth (less than $10,000 each), and research grants from Centocor, Schering-Plough, and Abbott.


Abstract

Objective

To evaluate the effect of infliximab on progression of structural damage over 2 years in patients with ankylosing spondylitis (AS).

Methods

In the Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy (ASSERT), a randomized, double-blind, placebo-controlled trial of the efficacy of infliximab compared with placebo, 279 patients with active AS received either placebo through week 24 and then infliximab 5 mg/kg from week 24 through week 96 (n = 78) or infliximab 5 mg/kg from baseline through week 96, administered every 6 weeks after a loading dose (n = 201; these patients were the focus of the radiographic analyses). Radiographic findings in patients from the ASSERT trial were indistinguishable from those in a historical control cohort of patients who had no prior use of anti–tumor necrosis factor agents (from the Outcome in Ankylosing Spondylitis International Study [OASIS] database; n = 192). Radiographic progression of structural damage from baseline to the 2-year followup was scored using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). All images were scored in one batch.

Results

Median changes in the mSASSS from baseline to year 2 were 0.0 for both the OASIS and the ASSERT cohorts (P = 0.541). Mean changes in the mSASSS were also similar between the OASIS and ASSERT cohorts (mean ± SD change over 2 years 1.0 ± 3.2 and 0.9 ± 2.6, respectively). In addition, results from sensitivity analyses did not show a statistically significant difference in the mSASSS between the OASIS and ASSERT cohorts.

Conclusion

AS patients who received infliximab from baseline through week 96 did not show a statistically significant difference in inhibition of structural damage progression at year 2, as assessed using the mSASSS scoring system, when compared with radiographic data from the historical control OASIS cohort. Improvements in clinical outcomes and spinal inflammation have been previously demonstrated with the use of infliximab therapy.

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