Clinical and Ultrasound-Based Composite Disease Activity Indices in Rheumatoid Arthritis: Results From a Multicenter, Randomized Study

Authors

  • P. Mandl,

    Corresponding author
    • Medical University of Vienna, Vienna, Austria, and National Institute of Rheumatology and Physiotherapy, Budapest, Hungary
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    • Drs. Mandl and Balint contributed equally to this work.

    • Dr. Mandl has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Pfizer, Wyeth, and Abbott.

  • P. V. Balint,

    1. National Institute of Rheumatology and Physiotherapy, Budapest, Hungary
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    • Drs. Mandl and Balint contributed equally to this work.

    • Dr. Balint has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Pfizer, Abbott, MSD, Roche, UCB, Esaote, GE, Philips, Sonosite, the European League Against Rheumatism, and the American College of Rheumatology.

  • Y. Brault,

    1. Pfizer, Paris, France
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  • M. Backhaus,

    1. University Hospital Charité, Berlin, Germany
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    • Dr. Backhaus has received a scientific grant from Pfizer.

  • M. A. D'Agostino,

    1. Versailles-Saint Quentin en Yvelines University, AP-HP, Ambroise-Paré Hospital, Boulogne-Billancourt, France
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  • W. Grassi,

    1. Università Politecnica delle Marche, Jesi, Ancona, Italy
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    • Dr. Grassi has received consultant fees and/or speaking fees (less than $10,000 each) from Abbott, Amgen, BMS, Esaote, GE, Menarini, MSD, Pfizer, Savient, Schering-Plough, Roche, UCB, and Wyeth.

  • D. van der Heijde,

    1. Leiden University Medical Center, 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, Centocor, Chugai, Eli Lilly, GSK, Merck, Novartis, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB, and Wyeth.

  • E. de Miguel,

    1. La Paz University Hospital, Madrid, Spain
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    • Dr. de Miguel has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from AbbVie, Pfizer, Menarini, BMS, MSD, Schering-Plough, Roche, UCB, Wyeth, and Abbott.

  • R. J. Wakefield,

    1. University of Leeds and Chapel Allerton Hospital, Leeds, UK
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  • I. Logeart,

    1. Pfizer, Paris, France
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    • Dr. Logeart owns stock and/or stock options in Pfizer.

  • M. Dougados

    1. Paris-Descartes University, UPRES-EA 4058, AP-HP, Cochin Hospital, Paris, France
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    • Dr. Dougados has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Pfizer and Abbott.


Address correspondence to P. Mandl, MD, PhD, 20-21 Währinger Gürtel, 1080 Vienna, Austria. E-mail: mandlpeter@yahoo.com.

Abstract

Objective

To evaluate the metrologic properties of composite disease activity indices in rheumatoid arthritis (RA), utilizing information derived from clinical, gray-scale (GS), and power Doppler (PD) ultrasound examinations, and to assess the classification of patients according to disease activity using such indices.

Methods

This ancillary study utilized data from a multicenter, prospective, randomized, parallel-group study conducted in subjects with moderate RA randomized to receive etanercept and methotrexate (ETN + MTX) or usual care (various disease-modifying antirheumatic drugs [DMARDs]). In multimodal indices, the 28 swollen joint count was either supplemented or replaced by clinically nonswollen joints in which the presence of synovitis was detected either by GS and/or PD and was calculated according to the Disease Activity Score in 28 joints (DAS28) or the Simplified Disease Activity Index (SDAI). Reliability, external validity, and discriminative capacity were calculated at baseline/screening by intraclass correlation coefficient, Pearson's correlation, and standardized response mean, respectively.

Results

Data from 62 patients (mean ± SD age 53.8 ± 13.2 years, mean ± SD disease duration 8.8 ± 7.7 years, mean ± SD disease activity 4.6 ± 0.5 [DAS28] and 20.9 ± 5.9 [SDAI]) were analyzed, with 32 receiving ETN + MTX and 30 receiving DMARDs. The metrologic properties were at least as good for GS- and/or PD-based indices as for their clinical counterparts. Using GS- and PD-supplemented indices, an additional 67.8% and 32.3% of patients (DAS28-derived and SDAI-derived indices, respectively) could be classified as having high disease activity at the screening visit.

Conclusion

Multimodal indices incorporating ultrasound and clinical data had similar metrologic properties to their clinical counterparts; certain indices allowed for a significantly larger number of patients to be classified to either high or moderate disease activity at the screening visit.

Ancillary