Table 1

Baseline demographics and patient characteristics

BLISS-52 (N=865)BLISS-76 (N=819)
Region/country, %
 Western Europe/Israel24.7
 Americas excluding US/Canada49.510.7
 Eastern Europe11.311.4
Mean age±SD, years35.540.2
Sex, %
Race, %
 Indigenous American*32.312.6
SLE characteristics
 Mean SLE duration±SD, years5.3±5.37.5±7.1
 Mean SELENA-SLEDAI±SD9.8±3.89.7±3.8
 BILAG 1 A or 2 B, %58.363.5
 BILAG 1 A, %19.012.1
 Mean SLICC damage index score0.571.00
 ANA ≥1 : 80, %93.992.1
 Anti-dsDNA ≥30 IU/ml, %74.564.0
 Low C3 (<90 mg/dl), %49.440.4
 Low C4 (<16 mg/dl), %59.352.6
 Anti-dsDNA and low C3/C4, %55.544.5
Prednisone use, %96.076.1
 Mean prednisone±SD, mg/d†12.7±8.48.8±8.2
 Dose >7.5 mg/d, %69.445.9
Immunosuppressive use, %‡42.255.6
Antimalarial use, %67.263.4
HRQOL scores
 SF-36 PCS, n853813
 Mean score±SD41.5±9.036.5±9.7
 SF-36 MCS, n853813
 Mean score±SD40.7±10.541.0±12.0
 SF-36 vitality, n863816
 Mean score±SD48.9±20.337.2±21.8
 FACIT-Fatigue, n842812
 Mean score±SD33.5±10.226.6±12.4
  • *Alaska native or American Indian from North/South/Central America.

  • †Prednisone or prednisone equivalent.

  • ‡Includes azathioprine, azathioprine sodium, ciclosporin, cyclophosphamide, leflunomide, methotrexate, methotrexate sodium, mizoribine, mycophenolate mofetil, mycophenolate sodium, mycophenolic acid and thalidomide.

  • ANA, antinuclear antibody; anti-dsDNA, antidouble-stranded DNA; BILAG, British Isles Lupus Assessment Group; C, complement; FACIT, Functional Assessment of Chronic Illness Therapy; HRQOL, health-related quality of life; MCS, Mental Component Summary; PCS, Physical Component Summary; SELENA-SLEDAI, Safety of Estrogens in Lupus Erythematosus National Assessment−Systemic Lupus Erythematosus (SLE) Disease Activity Index; SF-36, Short Form-36; SLE, systemic lupus erythematosus; SLICC, Systemic Lupus International Collaborating Clinics.