Table 2

Correlation between LFA REAL ClinRO Total Score from baseline and composite response measures/disease activity measures, and LFA-REAL PRO change form baseline with other PROs at 24 and 52 weeks

ALFA-REAL ClinRO change from baselineBLFA-REAL PRO change from baseline
Week 24Week 52Week 24Week 52
DORIS remission−0.09−0.20FACIT-F−0.32−0.44
LLDAS−0.11−0.27Lupus QoL−0.22−0.44
BICLA response−0.31−0.33SF-36v2 vitality−0.21−0.49
SRI-4 response−0.38−0.40SF-36 PCS−0.32−0.42
  • 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.

  • (A) Correlations between the change in LFA-REAL ClinRO Total Score from baseline and composite response measures and change from baseline in other disease measures. P<0.001 across all correlation analyses except with DORIS remission at week 24 (p=0.064) and week 52 (p=0.002), and LLDAS at week 24 (p=0.029).

  • (B) Correlations between change in LFA-REAL PRO score from baseline with change in other PRO measures from baseline to weeks 24 and 52. P<0.001 across all correlation analyses except Lupus QoL at week 24 (p=0.024), and SF-36v2 vitality at week 24 (p=0.033). The LFA-REAL PRO increases with disease severity while the other PROs increase with improvement, accounting for the inverse correlations observed.

  • BICLA, BILAG-based Composite Lupus Assessment; BILAG, British Isles Lupus Assessment Group 2004 Index Total Score; ClinRO, clinician-reported outcomes; DORIS remission, clinical temission on treatment; FACIT-F, Functional Assessment of Chronic Illness Therapy Fatigue Scale; LFA-REAL, Lupus Foundation of America Rapid Evaluation of Activity in Lupus; LLDAS, Lupus Low Disease Activity State; Lupus QoL, Lupus Quality of Life questionnaire; PGA, Physician Global Assessment; PRO, patient-reported outcomes; SF-36, 36-item Short-Form Health Survey; SF-36 PCS, 36-item SF-36 Physical Component Summary; SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index 2000; SRI-4, SLEDAI-2K SLE Responder Index.