Table 1

Key outcome measures and instruments in SLE and LN for consideration in the definition of disease modification in SLE

Type of outcome measureSpecific instrument
Disease activity indices/measuresSLEDAI, BILAG, SFI, CLASI*, uPCR†, kidney histological findings†
HRQoL measures and PROsSF-36, FACIT-Fatigue scale, FSMC, EQ-5D, LIT, LupusQoL, LupusPRO
Global assessmentsPGA, PtGA
Damage measuresSDI, eGFR decline >30%–40% and average eGFR slope reduction (>0.5–1.0 mL/min/1.73 m2 per year over a 2-year to 3-year follow-up period in RCTs)†, chronicity index progression on kidney biopsy/histology†
Responder indicesSLEDAI-based and BILAG-based responder indices (SRI-4 and BICLA), different composite indices based on uPCR, eGFR and rescue medications†
  • *For mucocutaneous involvement.

  • †For LN.

  • BICLA, BILAG-based Combined Lupus Assessment; BILAG, British Isles Lupus Assessment Group; CLASI, Cutaneous Lupus Erythematosus Disease Area and Severity Index; eGFR, estimated glomerular filtration rate; EQ-5D, European Quality of Life Five Dimension; FACIT, Functional Assessment of Chronic Illness Therapy; FSMC, Fatigue Scale for Motor and Cognitive Functions; HRQoL, health-related quality of life; LIT, Lupus Impact Tracker; LN, lupus nephritis; LupusPRO, Lupus Patient-Reported Outcome; LupusQoL, Lupus Quality of Life; PGA, Physician Global Assessment; PRO, patient-reported outcome; PtGA, Patient/Parent Global Assessment; RCTs, randomised controlled trials; SDI, Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index; SELENA, Safety of Estrogens in Lupus Erythematosus National Assessment; SF-36, Medical Outcomes Survey Short Form-36; SFI, SELENA-SLEDAI Flare Index; SLEDAI, SLE Disease Activity Index; SRI-4, SLE Responder Index-4; uPCR, urinary protein-creatinine ratio.