Table 4

Correlation between LFA REAL ClinRO PRO musculoskeletal and mucocutaneous components and individual components of disease activity measures

ALFA-REAL ClinRO: arthralgia/arthritisLFA-REAL PRO symptoms of arthritis: overall arthritis
BaselineWeek 24Week 52BaselineWeek 24Week 52
SLEDAI arthritis0.540.660.650.270.440.33
Subset: subjects with ≥8 active counts at baseline0.300.720.790.290.590.51
Subset: subjects with ≥4 active counts at baseline0.380.730.690.190.480.42
All subjects active joint count0.540.730.680.220.510.42
BaselineWeek 24Week 52BaselineWeek 24Week 52
ClinRO mucosal ulcers/SLEDAI mucosal ulcers0.820.820.85NANANA
ClinRO alopecia/SLEDAI alopecia0.790.730.74PRO hair loss/SLEDAI alopecia0.360.350.48
ClinRO rash/SLEDAI rash0.580.650.73PRO rash/ SLEDAI rash0.250.310.60
ClinRO mucocutaneous global/BILAG mucocutaneous0.480.660.76PRO rash/BILAG mucocutaneous0.220.300.53
ClinRO mucocutaneous global/CLASI total activity0.570.770.81PRO rash/CLASI erythema0.420.420.61
  • Correlation scale very weak: 0–0.2; weak: 0.2–0.4; moderate: 0.4–0.6; strong: 0.6–0.8; very strong: 0.8–1.0. P≤0.05 across all correlation analyses.

  • (A) Correlations between LFA-REAL ClinRO arthralgia/arthritis and LFA-REAL PRO symptoms of arthritis, and their correlations with active joint counts, and SLEDAI arthritis. Active joint counts (62 joints) are defined as joints with pain and signs of inflammation. Tender (pain) joint count (64 joints) are defined as joints with pain on examination; LFA-REAL PRO symptoms of arthritis consist of three individual symptom domains each scored on 0–100 mm VAS. Overall arthritis is a 0–100 mm VAS indicating patient’s global consideration of joint pain, swelling and stiffness.

  • (B) Correlations between LFA-REAL ClinRO mucocutaneous global and components with CLASI, BILAG and SLEDAI, LFA-REAL PRO rash and LFA-REAL PRO hair loss, with CLASI, BILAG and SLEDAI. CLASI is a measure of skin disease severity, with scores ranging from 0 (least severe) to 70 (most severe). LFA-REAL ClinRO mucocutaneous global is a 0–100 mm VAS as an overall consideration of three mucocutaneous domains: rash, alopecia, mucosal.

  • BILAG, British Isles Lupus Assessment Group Index; CLASI, Cutaneous Lupus Erythematosus Disease Area and Severity Index; ClinRO, clinician-reported outcomes; LFA-REAL, Lupus Foundation of America Rapid Evaluation of Activity in Lupus; PRO, patient-reported outcomes; SLEDAI, SLE Disease Activity Index; VAS, Visual Analogue Scale.