BLISS-52 (N=865) | BLISS-76 (N=819) | |
---|---|---|
Region/country, % | ||
US/Canada | – | 53.2 |
Western Europe/Israel | – | 24.7 |
Americas excluding US/Canada | 49.5 | 10.7 |
Asia–Pacific | 39.2 | – |
Eastern Europe | 11.3 | 11.4 |
Mean age±SD, years | 35.5 | 40.2 |
Sex, % | ||
Women | 94.9 | 93.3 |
Race, % | ||
Asian | 37.8 | 3.4 |
Indigenous American* | 32.3 | 12.6 |
White/Caucasian | 26.5 | 69.5 |
Black/African–American | 3.5 | 14.4 |
Multiracial/other | 0.6 | 1.0 |
SLE characteristics | ||
Mean SLE duration±SD, years | 5.3±5.3 | 7.5±7.1 |
Mean SELENA-SLEDAI±SD | 9.8±3.8 | 9.7±3.8 |
BILAG 1 A or 2 B, % | 58.3 | 63.5 |
BILAG 1 A, % | 19.0 | 12.1 |
Mean SLICC damage index score | 0.57 | 1.00 |
ANA ≥1 : 80, % | 93.9 | 92.1 |
Anti-dsDNA ≥30 IU/ml, % | 74.5 | 64.0 |
Low C3 (<90 mg/dl), % | 49.4 | 40.4 |
Low C4 (<16 mg/dl), % | 59.3 | 52.6 |
Anti-dsDNA and low C3/C4, % | 55.5 | 44.5 |
Prednisone use, % | 96.0 | 76.1 |
Mean prednisone±SD, mg/d† | 12.7±8.4 | 8.8±8.2 |
Dose >7.5 mg/d, % | 69.4 | 45.9 |
Immunosuppressive use, %‡ | 42.2 | 55.6 |
Antimalarial use, % | 67.2 | 63.4 |
HRQOL scores | ||
SF-36 PCS, n | 853 | 813 |
Mean score±SD | 41.5±9.0 | 36.5±9.7 |
SF-36 MCS, n | 853 | 813 |
Mean score±SD | 40.7±10.5 | 41.0±12.0 |
SF-36 vitality, n | 863 | 816 |
Mean score±SD | 48.9±20.3 | 37.2±21.8 |
FACIT-Fatigue, n | 842 | 812 |
Mean score±SD | 33.5±10.2 | 26.6±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.