DISEASE ACTIVITY INDICES (DAIS) IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
Author(s)
Wyrwich K1, Winnette R2, Oglesby A3, Narayanan S41United BioSource Corporation, Bethesda, MD, USA, 2United BioSource Corporation, London, United Kingdom, 3GlaxoSmithKline, Research Triangle Park, NC, USA, 4Human Genome Sciences, Inc., Rockville, MD, USA
OBJECTIVES: Review the development and properties of systemic lupus erythematosus (SLE) disease activity indices (DAIs) used in clinical trials, observational studies, and case studies. METHODS: A structured search was conducted to identify published articles in 2005-2011 through key literature databases (EMBASE and MEDLINE/PUBMED). Conference abstracts from targeted rheumatology, outcomes research and quality-of-life scientific meetings in 2009-2011 were included. SLE therapy clinical trials within the past five years were identified through the ClinicalTrials.gov database. RESULTS: The search resulted in more than 15 different DAIs, with the most frequently used being the British Isles Lupus Assessment Group Scale (BILAG), European Consensus Lupus Activity Measure (ECLAM), Systemic Lupus Activity Measure (SLAM), SLAM-revised (SLAM-R), Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), SLEDAI-2K, Safety of Estrogen in Lupus Erythematosus National-SLEDAI (SELENA-SLEDAI), and SLEDAI-2K-50 (SRI-50). The number of items (24-97), time to complete (5-20 mins; >20 mins for some tools in case of less physician training/familiarity), scoring (no global score or 0-105), organ/systems assessed (8-24), and subscales observed in these measures varied widely. These eight DAIs all demonstrated substantial inter-rater reliability (ICC=.61-1.0) and had moderate to strong correlations with each other (r=0.43-0.97). Measures in all but BILAG were weighted. All of these tools require periodic laboratory assessments such as hemoglobin, white cell count, complement levels, or increased DNA binding. Ability to discriminate between-patient and between-visit differences varied across the tools. CONCLUSIONS: BILAG and SELENA-SLEDAI or instruments derived from these tools are used widely in SLE clinical research. However, given the complexity, clinician time required for accurate completion, and need for lab assessments to complete these tools, further investigation is needed to assess their feasibility for use outside of the research arena in routine clinical practice for optimal SLE management.
Conference/Value in Health Info
2012-11, ISPOR Europe 2012, Berlin, Germany
Value in Health, Vol. 15, No. 7 (November 2012)
Code
PSY3
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Systemic Disorders/Conditions