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Rheumatology Advance Access originally published online on April 24, 2009
Rheumatology 2009 48(6):691-695; doi:10.1093/rheumatology/kep064
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© 2009 The Author(s)
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/2.0/uk/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

The BILAG-2004 index is sensitive to change for assessment of SLE disease activity

Chee-Seng Yee1, Vernon Farewell2, David A. Isenberg3, Bridget Griffiths4, Lee-Suan Teh5, Ian N. Bruce6, Yasmeen Ahmad7, Anisur Rahman3, Athiveeraramapandian Prabu1, Mohammed Akil8, Neil McHugh9, Christopher Edwards10, David D’Cruz11, Munther A. Khamashta11, Peter Maddison12 and Caroline Gordon1

1Rheumatology Research Group, University of Birmingham, Birmingham, 2MRC Biostatistics Unit, University of Cambridge, Cambridge, 3Centre for Rheumatology, University College London, London, 4Department of Rheumatology, Freeman Hospital, Newcastle-upon-Tyne, 5Department of Rheumatology, Royal Blackburn Hospital, Blackburn, 6ARC Epidemiology Unit, University of Manchester, Manchester, 7Department of Rheumatology, North West Wales NHS Trust, Wales, 8Department of Rheumatology, Sheffield Teaching Hospitals NHS Trust, Sheffield, 9Department of Rheumatology, Royal National Hospital for Rheumatic Diseases NHS Trust, Bath, 10Department of Rheumatology, University of Southampton, Southampton, 11Lupus Research Unit, St Thomas Hospital, London and 12Department of Rheumatology, University of Wales, Bangor, UK.

Correspondence to: Chee-Seng Yee, Rheumatology Research Group, Division of Infection and Immunity, The Medical School (East Wing), University of Birmingham, Birmingham, B15 2TT, UK. E-mail: csyee{at}ymail.com


  Abstract

Objective. To determine if the BILAG-2004 index is sensitive to change for assessment of SLE disease activity.

Methods. This was a prospective multi-centre longitudinal study of SLE patients. At every assessment, data were collected on disease activity (BILAG-2004 index) and treatment. Analyses were performed using overall BILAG-2004 index score (as determined by the highest score achieved by any of the individual systems) and all the systems scores. Sensitivity to change was assessed by determining the relationship between change in disease activity and change in therapy between two consecutive visits. Statistical analyses were performed using multinomial logistic regression.

Results. There were 1761 assessments from 347 SLE patients that contributed 1414 observations for analysis. An increase in therapy between visits occurred in 22.7% observations, while 37.3% had a decrease in therapy and in 40.0% therapy was unchanged. Increase in overall BILAG-2004 index score was associated with increase in therapy and inversely associated with decrease in therapy. Decrease in overall BILAG-2004 index score was associated with decrease in therapy and was inversely associated with increase in therapy. Changes in overall BILAG-2004 index score were differentially related to change in therapy, with greater change in score having greater predictive power. Increase in the scores of most systems was independently associated with an increase in treatment and there was no significant association between decreases in the score of any system with an increase in therapy.

Conclusions. The BILAG-2004 index is sensitive to change and is suitable for use in longitudinal studies of SLE.

KEY WORDS: BILAG-2004, SLE, Outcome measures, Epidemiology, Statistics, Sensitivity to change, Responsiveness, Disease activity

Submitted 19 September 2008; revised version accepted 26 February 2009.
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