Table 1

Baseline patient demographics and disease characteristics in pooled TULIP dataset

Pooled TULIP dataset
Anifrolumab 300 mg
(n=360)
Placebo
(n=366)
Age, mean (SD), years42.6 (12.0)41.0 (11.9)
Female, n (%)333 (92.5)341 (93.2)
Race,* n (%)
 White235 (65.3)244 (66.7)
 Asian41 (11.4)35 (9.6)
 Black/African American46 (12.8)48 (13.1)
 Other26 (7.2)29 (7.9)
Time from SLE diagnosis to randomisation, median (range), months91.0 (0–555)78.5 (4–503)
IFNGS status at screening, n (%)
  High298 (82.8)302 (82.5)
  Low62 (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/day190 (52.8)185 (50.5)
  Antimalarials243 (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.