SLEDAI-2K is a Global Disease Index used to assess disease activity in patients with SLE.¹
There is an extensive range of disease activity indices of systemic lupus erythematosus (SLE) based on clinical studies and trials. However, many are complex given the intent for which they were created. The SLEDAI-2K tool is often used in clinical trials to measure SLE disease activity. Other indices used in SLE clinical trials include British Isles Lupus Assessment Group-2004 (BILAG-2004) and Physician Global Assessment (PGA). These indices are components of composite endpoints, such as SLE Responder Index 4 (SRI-4) and British Isles Lupus Assessment Group–based Composite Lupus Assessment (BICLA).²
For a complete assessment using SLEDAI-2K, the following are required³:
- Urine specimens to include proteinuria, hematuria, pyuria, and urinary casts
- Blood specimens for anti–double-stranded DNA (anti-dsDNA), complement, white blood cells, and platelets
- Physical examination, including assessment for visual disturbances
Implementation of SLEDAI-2K
SLEDAI-2K is an index that¹ ⁴ ⁵:
- Tracks 24 manifestations across 9 organ systems
- Captures only complete improvement of an item in a one-month span
- Weighs certain manifestations more heavily than others on a spectrum from 1 to 8 points
The overall SLEDAI-2K score ranges from 0 to 105, with a score of 6 being deemed clinically important. A decrease of 4 in SLEDAI-2K is regarded as a meaningful improvement.¹
To download the SLEDAI-2K data collection sheet, please click here.
Data collection sheet provided with permission from The Journal of Rheumatology, Gladman DD, et al. SLEDAI 2K Systemic Lupus Erythematosus Disease Activity Index 2000. J Rheumatol. 2002;29(2):288-291. All rights reserved.
References: 1. Mikdashi J, Nived O. Measuring disease activity in adults with systemic lupus erythematosus: the challenges of administrative burden and responsiveness to patient concerns in clinical research. Arthritis Res Ther. 2015;17(1):183. doi:10.1186/s13075-015-0702-6 2. Ohmura K. Which is the best SLE activity index for clinical trials? Mod Rheumatol. 2021;31(1):20-28. 3. Gladman DD, Ibañez D, Urowitz MB. SLEDAI 2K Systemic Lupus Erythematosus Disease Activity Index 2000. J Rheumatol. 2002;29(2):288-291. 4. Arora S, Isenberg DA, Castrejon I. Measures of adult systemic lupus erythematosus: disease activity and damage. Arthritis Care Res (Hoboken). 2020;72 Suppl 10:27-46. doi:10.1002/acr.24221 5. Ramsey-Goldman R, Isenberg DA. Systemic Lupus Erythematosus Measures: British Isles Lupus Assessment Group (BILAG), European Consensus Lupus Activity Measurement (ECLAM), Systemic Lupus Activity Measure (SLAM), Systemic Lupus Erythematosus Disease Activity Measure (SLEDAI), and Systemic Lupus International Collaborating Clinics/American College of Rheumatology-Damage Index (SLICC/ACR-DI; SDI). Arthritis Care Res. 2003;49(S5):S225-S233.
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