Pooled TULIP dataset | ||
Anifrolumab 300 mg (n=360) | Placebo (n=366) | |
Age, mean (SD), years | 42.6 (12.0) | 41.0 (11.9) |
Female, n (%) | 333 (92.5) | 341 (93.2) |
Race,* n (%) | ||
White | 235 (65.3) | 244 (66.7) |
Asian | 41 (11.4) | 35 (9.6) |
Black/African American | 46 (12.8) | 48 (13.1) |
Other | 26 (7.2) | 29 (7.9) |
Time from SLE diagnosis to randomisation, median (range), months | 91.0 (0–555) | 78.5 (4–503) |
IFNGS status at screening, n (%) | ||
High | 298 (82.8) | 302 (82.5) |
Low | 62 (17.2) | 64 (17.5) |
≥1 BILAG-2004 A, n (%) | 174 (48.3) | 179 (48.9) |
No BILAG-2004 A and ≥2 BILAG-2004 B, n (%) | 170 (47.2) | 162 (44.3) |
SLEDAI-2K global score, mean (SD) | 11.4 (3.8) | 11.5 (3.7) |
SLEDAI-2K ≥10, n (%) | 254 (70.6) | 266 (72.7) |
PGA score, mean (SD) | 1.8 (0.4) | 1.8 (0.4) |
CLASI activity score, mean (SD) | 8.4 (7.6) | 7.8 (7.2) |
Swollen joint count,† mean (SD) | 6.8 (5.8) | 7.2 (5.7) |
Tender joint count,† mean (SD) | 10.3 (7.4) | 10.8 (7.5) |
SDI score, mean (SD) | 0.6 (1.0) | 0.6 (0.9) |
SLE treatments at baseline, n (%) | ||
Glucocorticoid‡ | 291 (80.8) | 304 (83.1) |
Glucocorticoid ≥10 mg/day | 190 (52.8) | 185 (50.5) |
Antimalarials | 243 (67.5) | 267 (73.0) |
Immunosuppressants§ | 173 (48.1) | 177 (48.4) |
*Race data were missing for 16 patients in TULIP-2 (8 each in the anifrolumab and placebo groups).
†Joint counts are based on 28 joints.
‡Glucocorticoid includes prednisone or equivalent.
§Azathioprine, methotrexate, mycophenolate mofetil, mycophenolic acid, and mizoribine.
BILAG-2004, British Isles Lupus Assessment Group-2004; CLASI, Cutaneous Lupus Erythematosus Disease Area and Severity Index; IFNGS, type I interferon gene signature; PGA, Physician’s Global Assessment; SDI, Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index; SLEDAI-2K, SLE Disease Activity Index 2000.