A | LFA-REAL ClinRO: arthralgia/arthritis | LFA-REAL PRO symptoms of arthritis: overall arthritis | |||||
Baseline | Week 24 | Week 52 | Baseline | Week 24 | Week 52 | ||
SLEDAI arthritis | 0.54 | 0.66 | 0.65 | 0.27 | 0.44 | 0.33 | |
Subset: subjects with ≥8 active counts at baseline | 0.30 | 0.72 | 0.79 | 0.29 | 0.59 | 0.51 | |
Subset: subjects with ≥4 active counts at baseline | 0.38 | 0.73 | 0.69 | 0.19 | 0.48 | 0.42 | |
All subjects active joint count | 0.54 | 0.73 | 0.68 | 0.22 | 0.51 | 0.42 | |
B | LFA-REAL ClinRO | LFA-REAL PRO | |||||
Baseline | Week 24 | Week 52 | Baseline | Week 24 | Week 52 | ||
ClinRO mucosal ulcers/SLEDAI mucosal ulcers | 0.82 | 0.82 | 0.85 | NA | NA | NA | |
ClinRO alopecia/SLEDAI alopecia | 0.79 | 0.73 | 0.74 | PRO hair loss/SLEDAI alopecia | 0.36 | 0.35 | 0.48 |
ClinRO rash/SLEDAI rash | 0.58 | 0.65 | 0.73 | PRO rash/ SLEDAI rash | 0.25 | 0.31 | 0.60 |
ClinRO mucocutaneous global/BILAG mucocutaneous | 0.48 | 0.66 | 0.76 | PRO rash/BILAG mucocutaneous | 0.22 | 0.30 | 0.53 |
ClinRO mucocutaneous global/CLASI total activity | 0.57 | 0.77 | 0.81 | PRO rash/CLASI erythema | 0.42 | 0.42 | 0.61 |
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.