Comparison of three methods for calculating the Bath Ankylosing Spondylitis Metrology Index in a randomized placebo-controlled study

Authors

  • Désirée van der Heijde,

    Corresponding author
    1. Leiden University Medical Center, Leiden, The Netherlands
    • Leiden University Medical Center, Department of Rheumatology, PO Box 9600, 2300 RC Leiden, The Netherlands
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    • Dr. van der Heijde has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Abbott, Amgen, AstraZeneca, BMS, Janssen (Centocor), Chugai, Eli-Lilly, GSK, Merck, Novartis, Otsuka, Pfizer, Roche, Sanofi- Aventis, Schering-Plough, UCB, and Wyeth.

  • Atul Deodhar,

    1. Oregon Health and Science University, Portland
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    • Dr. Deodhar has received consulting and speaking fees (less than $10,000 each) from Janssen (Centocor) and Genentech, as well as payments for educational lectures, teleconferences, and serving on advisory boards for Janssen, a company that may have a commercial interest in the results of this research. This potential conflict of interest has been reviewed and managed by Oregon Health & Science University.

  • Robert D. Inman,

    1. University of Toronto, Toronto, Ontario, Canada
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    • Dr. Inman has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Merck, Sanofi-Aventis, Abbott, Pfizer, Amgen, Janssen, and Wyeth.

  • Jürgen Braun,

    1. Rheumazentrum Ruhrgebiet, Herne, Germany
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    • Dr. Braun has received honoraria for talks, serving on advisory boards, and study grants (less than $10,000 each) from Janssen Research & Development, Celltrion, Amgen, Abbott, Roche, BMS, Novartis, Pfizer (Wyeth), MSD (Schering-Plough), Sanofi-Aventis, and UCB.

  • Ben Hsu,

    1. Janssen Research & Development, LLC, Spring House, Pennsylvania
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    • Drs. Hsu and Mack were employees of Janssen Research & Development and owned stock or stock options in Johnson & Johnson at the time of this study.

  • Michael Mack

    1. Janssen Research & Development, LLC, Spring House, Pennsylvania
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    • Drs. Hsu and Mack were employees of Janssen Research & Development and owned stock or stock options in Johnson & Johnson at the time of this study.


  • ClinicalTrials.gov identifier: NCT00265083.

Abstract

Objective

To compare 3 methods for calculating the Bath Ankylosing Spondylitis Metrology Index (BASMI) score using patients who participated in the GO-RAISE study.

Methods

Patients with active ankylosing spondylitis (AS) were randomly assigned in a 1:1.8:1.8 ratio to receive subcutaneous injections of placebo, golimumab 50 mg, or golimumab 100 mg every 4 weeks. Lumbar flexion, tragus-to-wall distance, lumbar side flexion, intermalleolar distance, and cervical rotation angle measurements at baseline, week 14, and week 24 were used to calculate the BASMI 2-step (BASMI2), 10-step (BASMI10), and linear (BASMIlin) scores.

Results

BASMI2 scores were generally lower than BASMI10 and BASMIlin scores, which were nearly identical. Median changes from baseline to week 14 in the combined golimumab group were similar to those in the placebo group when using the BASMI2 calculation method (0.00 versus 0.00; P = 0.288). The combined golimumab group showed significantly greater improvement from baseline to week 14 than the placebo group when using the BASMI10 (−0.20 versus 0.00; P = 0.018) and BASMIlin (−0.31 versus −0.07; P = 0.015) calculation methods, with the latter showing the greatest difference between golimumab and placebo. Guyatt's effect size was better for the BASMIlin and the BASMI10 versus the BASMI2 in the combined golimumab group at week 14 (0.58 and 0.53 versus 0.42, respectively) and week 24 (0.76 and 0.69 versus 0.61, respectively), despite the relatively short period to assess changes in spinal mobility.

Conclusion

The BASMIlin method was the most sensitive to changes in range of motion exhibited by patients with AS who received golimumab.

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