Preliminary test of the LFA rapid evaluation of activity in lupus (LFA-REAL): an efficient outcome measure correlates with validated instruments

Abstract

ObjectiveCurrent disease activity measures for systemic lupus erythematosus (SLE) are difficult to score or interpret and problematic for use in clinical practice. Lupus Foundation of America (LFA)-Rapid Evaluation of Activity in Lupus (REAL) is a pilot application composed of anchored visual analogue scores (0–100 mm each) for each organ affected by lupus. This study evaluated the use of LFA-REAL in capturing SLE disease activity.MethodsIn a preliminary test of LFA-REAL, this simplified, organ-based system was compared with the most widely used outcome measures in clinical trials, the British Isles Lupus Assessment Group 2004 Index (BILAG), the SLE Disease Activity Index (SLEDAI) and the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLEDAI Physician's Global Assessment (SS-PGA). The level of agreement was analysed using Spearman rank correlations.Results91 patients with SLE with mild to severe disease activity were evaluated, their median SLEDAI score was 4.0 (range 0–28) and BILAG score 8.0 (0–32). The median SS-PGA was 38 mm (4–92) versus the total REAL 50 mm (0–268), which expands in range by additive organ scores. Thirty-three patients had moderate to severe disease activity (≥1.5 on SS-PGA landmarks). The median SS-PGA score of this group was 66 mm (50–92) versus median REAL score of 100 mm (59–268), confirming ability to detect a wider distribution of scores at higher disease activity. Total REAL correlated with SLEDAI, BILAG and SS-PGA (correlation coefficient=0.816, 0.933 and 0.903, respectively; p<0.001 for all). Individual LFA-REAL organ scores for musculoskeletal and mucocutaneous also correlated with corresponding BILAG domain scores (correlation coefficient=0.925 and 0.934, p<0.001).ConclusionsIn this preliminary exercise, there were strong correlations between LFA-REAL and validated lupus disease activity indices. Further development may be valuable for consistent scoring in clinical trials, grading optimal assessment of change in disease activity and reliable monitoring of patients in practice.

Comparison of the Lupus Foundation of America–Rapid Evaluation of Activity in Lupus to More Complex Disease Activity Instruments As Evaluated by Clinical Investigators or Real‐World Clinicians

“…Only active disease requires scoring. The landmarks are identical to those found in the SELENA SLEDAI flare index PGA (where 0 = none, 1 = mild, 2 = moderate, and 3 = severe) . However, instructions, albeit brief, are more specific than the flare index PGA, to encourage uniformity in interpretation (0 = full remission and 3 = the worst lupus manifestation possible).…”

“…The LFA‐REAL clinician‐reported outcome, as previously described , uses multiple anchored visual analog scales (range 0–100 mm) (see , available on the Arthritis Care & Research web site at http://onlinelibrary.wiley.com/doi/10.1002/acr.23445/abstract). Each symptom is rated on its own individual scale and assigned to 1 of 6 commonly affected organs (mucocutaneous, musculoskeletal, cardiorespiratory, neuropsychiatric, renal, and hematologic) or other.…”

“…This instrument was designed to eliminate the esoteric glossaries and scoring rules of SLEDAI and BILAG, while expanding the information obtainable (and scoring versatility) using the PGA. It provides a series of anchored visual analog scores, each constructed in a manner similar to the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) version of the SLEDAI PGA but each only representing the individual severity of 1 currently active symptom, with the sum of individually weighted scores deriving an overall disease activity assessment. The data can be evaluated on the basis of individual features, organ‐based scoring, or overall disease activity, and it is easy to distinguish between different combinations of mild, moderate, or severe manifestations, allowing each to contribute appropriately to an overall score without confusing the rater.…”

Scoring systemic lupus erythematosus (SLE) disease activity with simple, rapid outcome measures

“…The most widely used disease activity measures in international, multicentre trials are the SLE Disease Activity Index (SLEDAI)4 5 and the British Isles Lupus Assessment Group Index (BILAG 2004) 6. Beyond their individual strengths and weaknesses (reviewed elsewhere3), both instruments were developed through a consensus approach to derive thresholds for changes in disease activity 7. The SLEDAI is less sensitive to change, sets a high bar for improvement, is scored based on the ‘typical’ severity of a symptom, regardless of current severity in an individual patient and cannot record worsening or partial improvement.…”

Dialogue: Cutaneous lupus erythematosus: a lone Wolf?

“…In addition, the very recent Lupus Foundation of America-Rapid Evaluation of Activity in Lupus is a pilot application with simplified SLE outcome measures and is also being developed for use in both clinical trials and clinical care. 9 Improvement in clinical outcomes by integrating all this new knowledge while extremely challenging is also exhilarating and relies on the continued dedication, passion and perseverance of all those who do research and/or care for people with this disease.…”