Improvement in BILAG (A or B) and SELENA-SLEDAI by organ domain/system
| SRI non-responders (n=358) | SRI responders (n=475) | Treatment difference, SRI responders vs non-responders (95% CI) | P values* | |
| BILAG organ domain | ||||
| General | ||||
| A or B score at baseline†, n | 28 | 40 | ||
| Improvement at week 52‡, n (%) | 15 (53.6) | 39 (97.5) | 43.9 (24.83 to 63.02) | <0.0001 |
| Cardiovascular and respiratory | ||||
| A or B score at baseline†, n | 12 | 8 | ||
| Improvement at week 52‡, n (%) | 3 (25.0) | 8 (100.0) | 75.0 (50.50 to 99.50) | 0.0014 |
| Haematology | ||||
| A or B score at baseline†, n | 67 | 70 | ||
| Improvement at week 52‡, n (%) | 12 (17.9) | 32 (45.7) | 27.8 (12.95 to 42.65) | 0.0005 |
| Mucocutaneous | ||||
| A or B score at baseline†, n | 235 | 329 | ||
| Improvement at week 52‡, n (%) | 54 (23.0) | 235 (71.4) | 48.5 (41.19 to 55.71) | <0.0001 |
| Musculoskeletal | ||||
| A or B score at baseline†, n | 251 | 369 | ||
| Improvement at week 52‡, n (%) | 50 (19.9) | 338 (91.6) | 71.7 (65.98 to 77.37) | <0.0001 |
| Neurological | ||||
| A or B score at baseline†, n | 1 | 3 | ||
| Improvement at week 52‡, n % | 1 (100.0) | 3 (100.0) | 0.0 (0.00 to 0.00) | |
| Renal | ||||
| A or B score at baseline†, n | 39 | 44 | ||
| Improvement at week 52‡, n (%) | 12 (30.8) | 37 (84.1) | 53.3 (35.25 to 71.39) | <0.0001 |
| Vasculitis | ||||
| A or B score at baseline†, n | 29 | 42 | ||
| Improvement at week 52‡, n (%) | 7 (24.1) | 37 (88.1) | 63.9 (45.56 to 82.36) | <0.0001 |
| SELENA-SLEDAI organ system improvement, by category, n (%) | ||||
| CNS total | ||||
| Baseline involvement†, n | 4 | 5 | ||
| Improvement at week 52§, n %) | 0 (0.0) | 5 (100.0) | 100.0 (100.00 to 100.00) | 0.0079 |
| Cardiovascular and respiratory total | ||||
| Baseline involvement†, n | 19 | 28 | ||
| Improvement at week 52§, n %) | 5 (26.3) | 25 (89.3) | 63.0 (40.09 to 85.85) | <0.0001 |
| Haematological total | ||||
| Baseline involvement†, n | 27 | 46 | ||
| Improvement at week 52§, n (%) | 6 (22.2) | 24 (52.2) | 30.0 (8.64 to 51.27) | 0.0146 |
| Immunological total | ||||
| Baseline involvement†, n | 267 | 369 | ||
| Improvement at week 52§, n (%) | 18 (6.7) | 143 (38.8) | 32.0 (26.20 to 37.82) | <0.0001 |
| Mucocutaneous total | ||||
| Baseline involvement†, n | 303 | 431 | ||
| Week 52§, n (%) | 92 (30.4) | 355 (82.4) | 52.0 (45.70 to 58.31) | <0.0001 |
| Musculoskeletal total | ||||
| Baseline involvement†, n | 256 | 398 | ||
| Improvement at week 52§, n (%) | 28 (10.9) | 363 (91.2) | 80.3 (75.54 to 85.00) | <0.0001 |
*Fisher’s exact test.
†Number used as denominator for percentages.
‡Patients who have an A at baseline and change to a B, C or D, or patients with a B at baseline who change to a C or D, are considered to have improvement.
§An improvement is defined as a decrease (compared with baseline) in SELENA-SLEDAI score within the same organ system.
BILAG, British Isles Lupus Assessment Group;CNS, central nervous system; SELENA-SLEDAI, Safety of Estrogens in Lupus Erythematosus National Assessment- Systemic Lupus Erythematosus Disease Activity Index; SRI, Systemic Lupus Erythematosus Responder Index.