Table 1

Baseline demographics and disease characteristics

IVSCPooled IV+SC
Placebo (n=41)Rontalizumab
(n=81)
Placebo
(n=38)
Rontalizumab
(n=78)
Placebo
(N=79)
Rontalizumab
(N=159)
Age (years)38.4 (11.6)37.3 (11.4)43.7 (9.0)38.2 (11.5)40.9 (10.7)37.8 (11.4)
Female39 (95.1%)75 (92.6%)35 (92.1%)75 (96.2%)74 (93.7%)150 (94.3%)
Race
 White18 (43.9%)43 (53.1%)17 (44.7%)32 (41.0%)35 (44.3%)75 (47.2%)
 American Indian or Alaska native12 (29.3%)27 (33.3%)11 (28.9%)37 (47.4%)23 (29.1%)64 (40.3%)
 Black or African American7 (17.1%)9 (11.1%)9 (23.7%)9 (11.5%)16 (20.3%)18 (11.3%)
 Other*4 (9.8%)2 (2.5%)1 (2.6%)05 (6.3%)2 (1.3%)
Ethnicity, Hispanic or Latino (%) (vs other)13 (31.7%)34 (42.0%)20 (52.6%)50 (64.1%)33 (41.8%)84 (52.8%)
SLE duration (yr)6.2 (6.2)6.3 (6.4)6.9 (6.0)6.6 (6.5)6.6 (6.1)6.4 (6.4)
Prior use of an immunosuppressant*26 (63.4%)53 (65.4%)25 (65.8%)51 (65.4%)51 (64.6%)104 (65.4%)
Immunosuppressant use during screening12 (29.3%)20 (24.7%)14 (36.8%)19 (24.4%)26 (32.9%)39 (24.5%)
 AZA5 (12.2%)10 (12.4%)6 (15.8%)8 (10.3%)11 (13.9%)18 (11.3%)
 MMF02 (2.5%)2 (5.3%)7 (9.0%)2 (2.5%)9 (5.7%)
 MTX7 (17.1%)8 (9.9%)7 (18.4%)5 (6.4%)14 (17.7%)13 (8.2%)
Antimalarial use28 (68.3%)53 (65.4%)30 (79.0%)43 (55.1%)58 (73.4%)96 (60.4%)
Average prednisone dose during screening (mg/day)9.0 (7.0)10.8 (8.5)11.3 (8.6)12.7 (7.8)10.1 (7.8)11.7 (8.2)
 Dose >033 (80.5%)71 (87.7%)33 (86.8%)69 (88.5%)66 (83.5%)140 (88.1%)
 Dose >1013 (31.7%)29 (35.8%)13 (34.2%)38 (48.7%)26 (32.9%)67 (42.1%)
ISM-High30 (73.2%)63 (77.8%)25 (65.8%)62 (79.5%)55 (69.6%)125 (78.6%)
BILAG index (screening)
 ≥2A2 (4.9%)8 (9.9%)4 (10.5%)11 (14.1%)6 (7.6%)19 (11.9%)
 ≥1A28 (68.3%)54 (66.7%)30 (78.9%)60 (76.9%)58 (73.4%)114 (71.7%)
BILAG index global score20.3 (5.3)20.8 (6.1)19.8 (9.8)19.0 (7.0)20.1 (7.7)19.9 (6.6)
SELENA-SLEDAI score9.7 (2.4)10.1 (3.1)9.3 (4.5)9.8 (3.1)9.5 (3.6)10.0 (3.1)
PGA score59.2 (15.1)59.6 (14.6)51.9 (17.3)53.0 (17.5)55.7 (16.5)56.4 (16.4)
Immunoserology
 ANA positive (≥1:80)37 (90.2%)78 (96.3%)34 (89.5%)69 (88.5%)71 (89.9%)147 (92.5%)
 Complement C3
  Low (<90 mg/dL)15 (36.6%)23 (28.4%)13 (34.2%)35 (44.9%)28 (35.4%)58 (36.5%)
 Complement C4
  Low (<10 mg/dL)13 (31.7%)17 (21.0%)11 (28.9%)34 (43.6%)24 (30.4%)51 (32.1%)
 Anti-dsDNA+ (≥ 30 IU/mL)27 (65.9%)49 (60.5%)16 (42.1%)55 (71.4%)43 (54.4%)104 (65.8%)
 Anti-Sm (≥120 IU/mL)6 (14.6%)18 (22.2%)11 (29.0%)16 (20.5%)17 (21.5%)34 (21.4%)
 Anti-RNP (≥120 IU/mL)11 (26.8%)27 (33.3%)14 (36.8%)21 (26.9%)25 (31.7%)48 (30.2%)
 Anti-Ro (≥120 IU/mL)16 (39.0%)40 (49.4%)15 (39.5%)26 (33.3%)31 (39.2%)66 (41.5%)
 Anti-La (≥120 IU/mL)4 (9.8%)12 (14.8%)5 (13.2%)11 (14.1%)9 (11.4%)23 (14.5%)
 Anti-ENA+† (Sm+/RNP+/Ro+/La+)18 (43.9%) 55 (67.9%)24 (63.2%)46 (59.0%)42 (53.2%)101 (63.5%)
  • BILAG-2004 index global score calculated using the following scheme: A=12, B=8, C=1, D and E=0.39

  • *Asian, Native Hawaiian/Pacific Islander, not available.

  • ANA, antinuclear antibody; AZA, azathioprine; BILAG, British Isles Lupus Assessment Group; ENA, extractable nuclear antigens; IV, intravenous; ISM, interferon signature metric; La, anti-La/SS-B; MMF, mycophenolate mofetil; MTX, methotrexate; PGA, physician's global assessment of disease activity; RNP, ribonucleoprotein; Ro, anti-Ro/SS-A; SC, subcutaneous; SELENA–SLEDAI, Safety of Estrogens in Lupus Erythematosus National Assessment version of the SLE Disease Activity Index; SLE, systemic lupus erythematosus; Sm, anti-Smith.